Ex Parte Hickle et alDownload PDFPatent Trial and Appeal BoardFeb 11, 201611716609 (P.T.A.B. Feb. 11, 2016) 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. 11/716,609 03/12/2007 Randall S. Hickle Case 0019 7207 7590 02/11/2016 Dorsey L. Baker Scott Labotatories, Inc. 4603 Eleventh Street Lubbock, TX 79416 EXAMINER CARPENTER, WILLIAM R ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 02/11/2016 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 RANDALL S. HICKLE and NICHOLAS EDWARD COBB ____________________ Appeal 2014-000204 Application 11/716,609 Technology Center 3700 ____________________ Before JENNIFER D. BAHR, JOHN C. KERINS, and MICHAEL L. WOODS, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Randall S. Hickle and Nicholas Edward Cobb (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1– 18. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing in accordance with 37 C.F.R. § 41.47 was held on January 28, 2016. We AFFIRM. Appeal 2014-000204 Application 11/716,609 2 THE CLAIMED SUBJECT MATTER Claims 1 and 10, reproduced below, are illustrative of the claimed subject matter. 1. An enhanced safety method of providing safe delivery of a sedative and/or analgesic drug by a nonanesthetist without general anesthesia to a non-intubated patient in need of sedation and/or pain relief during a medical and/or surgical procedure, said method comprising the steps of: coupling a drug delivery device to said patient for delivering a sedative and/or analgesic drug to said patient during said procedure; providing a quality assurance marker with one or more disposable components to be used by said drug delivery device during said procedure, said marker carrying information to confirm the quality, condition and/or identification of said components to said nonanesthetist; using a reader for reading the quality assurance marker carried by a disposable drug container and/or a disposable cassette to insure said nonanesthetist that said components conform to the requirements of quality, condition and/or identification of said disposable components prior to activation of said drug delivery device; infusing said drug to said patient to provide sedation and/or pain management without causing general anesthesia, said infusion rate to be initiated, at least in part, by a processor in accord with safe and effective practices. 10. An integrated drug delivery system for enabling safe delivery of a sedative and/or analgesic drugs by a nonanesthetist to a patient in need thereof during a medical and/or surgical procedure, said system comprising: a patient health monitor adapted so as to be coupled to a patient during said procedure, said monitor generating a signal reflecting measurements of at least one monitored physiological condition of the patient; a drug delivery mechanism for delivering a drug dosage rate of sedative to the patient during said procedure; Appeal 2014-000204 Application 11/716,609 3 at least one medical product removably coupled to the system, said product associated with a quality assurance module for storing information regarding the product and for assuring said nonanesthetist of the quality and condition of said product prior to delivery thereof to said patient; a reader device for reading information stored on the quality assurance module of said medical product and communicating said information to a processor; and said processor operably connected to the patient health monitor, the drug delivery controller, and the reader device, said processor having accessible parameters that indicate values for said measurements of said monitored physiological condition, said values correlating to a range of patient conditions associated with said procedure; wherein said processor operates according to software to receive said signals during said procedure, analyze said measurements reflected in said signal using said parameters to identify onset or possible onset of a patient condition outside of a normal range, and generate a signal indicating possible modifications of said drug dosage rate to remedy said onset or possible onset of said patient condition, wherein said processor signal indicates an action dependent upon an extent by which said current measurements are outside said normal range. REJECTIONS I. Claims 1–4 stand rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter. II. Claims 1–18 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. III. Claims 1–13 and 16–18 stand rejected under 35 U.S.C. § 102(e) as being anticipated by Flaherty (US 2002/0072733 A1, published June 13, 2002). IV. Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Flaherty. Appeal 2014-000204 Application 11/716,609 4 DISCUSSION Rejection under 35 U.S.C. § 101 The Examiner explains that claims 1–4 are directed to non-statutory subject matter because patentability of the claimed method or apparatus cannot be concerned with qualities of the practitioner/user, particularly the level of training/knowledge of the practitioner. Examiner submits that such qualities of the user/practitioner, i.e. the level of training/understanding required for them to be considered to comprise a “nonanesthetist” cannot constitute statutory subject matter as it amounts to intangible qualities of the user and reflects only their mental state/acuity. Namely, there is no patentable, fundamental difference between a “nonanesthetist” and an “anesthetist” and the claimed methods/apparatuses possess exactly the same fundamental qualities regardless of whether or not they possess the mental acumen required to be considered an anesthetist or a lay-person. Appellant cannot positively claim such mental knowledge or possibly restrict practice of the method/use of the device based on such accord and any attempts to limit the claimed invention in such manner constitutes an attempt by Appellant to capture non-statutory subject matter. Ans. 4–5. Appellants point out that “the Examiner cites not a single case or other authority for the above rejection,” and assert that the rejection under 35 U.S.C. § 101 “is not only unsupported by law, it is directly contrary to the law mandated by the Federal Circuit Court of Appeals and by the MPEP.” Appeal Br. 10. Appellants’ observation is correct; the Examiner has not cited a single case or other specific authority, aside from the statute itself, in support of the rejection. However, the basis of the Examiner’s rejection appears to be that the level of training or understanding required for a person to be considered to be a nonanesthetist amounts to intangible qualities of the user and reflects Appeal 2014-000204 Application 11/716,609 5 only on the user’s mental state or acuity, and, therefore, cannot constitute statutory subject matter. Thus, the Examiner considers the level of training for a person to be considered to be a nonanesthetist to be a patent-ineligible concept, but does not specify what type of patent-ineligible concept (i.e., law of nature, natural phenomena, or abstract idea) it is. Moreover, even assuming the Examiner is correct that the level of training or understanding required for a non-anesthetist is a patent-ineligible concept, the Examiner’s analysis is incomplete and inadequate to establish that claims 1–4 recite a patent-ineligible invention. Under 35 U.S.C. §101, an invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The Supreme Court, however, has long interpreted § 101 to include an implicit exception: “Laws of nature, natural phenomena, and abstract ideas” are not patentable. See, e.g., Alice Corp. Pty Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). In judging whether claims 1–4 fall within one of the excluded categories, we are guided in our analysis by the Supreme Court’s two-step framework, described in Mayo and Alice. Id. at 2355 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1296–97 (2012)). In accordance with that framework, we first determine whether the claim is “directed to” a patent-ineligible concept (i.e., law of nature, natural phenomena, or abstract idea). If so, we then consider the elements of the claim both individually and as “an ordered combination” to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application of the law of nature, natural phenomena, or abstract idea. Id. The Supreme Court characterizes the second step of the analysis as “a search for an ‘inventive concept,’—i.e., an Appeal 2014-000204 Application 11/716,609 6 element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’” Id. With respect to the first step of the Supreme Court’s two-step framework, as noted above, the Examiner does not specify under which excluded category claims 1–4 fall. However, even assuming that the level of training or understanding required for a nonanesthetist is a patent-ineligible concept, such as an abstract idea, for example, the Examiner fails to perform the second step of the two-step analysis. More specifically, the Examiner fails to consider all the elements of claims 1–4 both individually and as an ordered combination to determine whether the additional elements in the claim transform the nature of claims 1–4 into a patent-eligible application of the law of nature, natural phenomena, or abstract idea. For the reasons set forth above, we do not sustain the rejection of claims 1–4 under 35 U.S.C. § 101. Rejection under 35 U.S.C. § 112, second paragraph The Examiner considers claims 1, 5, and 10, as well as their dependent claims, to be indefinite because of the reference therein to a “nonanesthetist.” Ans. 5–6. The Examiner explains that Appellants argue that “the ‘nonanesthetist’ is a positive quality of the claimed method/apparatus,” but “this limitation renders the claims indefinite as it is not clear what qualities a ‘nonanesthetist’ possesses as compared to an anesthetist.” Id. at 5. Specifically, the Examiner queries whether a person must have specific training/education and accreditation to be an “anesthetist” or whether a user/practitioner who is not formally trained but performing the functions of an anesthetist (i.e., delivering an anesthetic/sedative) should be Appeal 2014-000204 Application 11/716,609 7 considered an anesthetist, and, thus, not a “nonanesthetist” as used in the claims. Id. Further, the Examiner finds it unclear how Appellants intend “to limit the use of the device to ‘nonanesthetists’ when such qualities are chiefly mental and reflect the intent/mental acumen of the user” and “how the practice of the method or the functioning of the device is fundamentally altered by the state or mind/level of knowledge or understanding of the user.” Id. at 5–6. In determining whether a claim is indefinite, the claim’s language must be analyzed, not in a vacuum, but in light of the content of the particular application disclosure, the teachings of prior art, and the claim interpretation that would be given by one possessing the ordinary level of skill in the pertinent art at the time the invention was made. In re Skvorecz, 580 F.3d 1262, 1268 (Fed. Cir. 2009) (citing MPEP § 2173.02). Moreover, “the context of the surrounding words of the claim also must be considered in determining the ordinary and customary meaning of those terms.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) (citing ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003). Each of Appellants’ independent claims 1, 5, and 18 refers to delivery of a sedative and/or analgesic drug by a “nonanesthetist.” Appeal Br. 20, 21, 22 (Claims App.). Thus, a person having ordinary skill in the art construing the term “nonanesthetist” within the context of the claims as a whole, considering the context of the surrounding words of these claims, could not reasonably understand this term as excluding all persons who perform the Appeal 2014-000204 Application 11/716,609 8 function of delivering an anesthetic/analgesic or sedative.1 A person having ordinary skill in the art would understand the term “anesthetist” to have a specialized meaning in the art. Further, the discussion of “nonanesthetists” and “nonanesthetist practitioner[s]” in columns 1 and 2 of the Hickle patent,2 whether properly incorporated by reference into the Specification of the present application or not, is instructive as to the meaning of the term “nonanesthetist” in the art and, more particularly, as to the manner in which it is used by Appellants. See, e.g., Hickle, col. 1, ll. 42–44 (defining a “nonanesthetist practitioner” as “a physician or other clinician who is not an anesthesiologist (M.D.A.) or certified nurse anesthetist (C.R.N.A.)”). With respect to the question of how the state of mind/level of knowledge or understanding of the user limits the claimed method or device, the “Examiner submits that the preamble makes clear that the goal of the method is to provide analgesia and/or pain relief without sedation of a non- intubated patient” and that this “goal is accomplished by performing the method steps as directed, these method steps being identical regardless of whether or not the practitioner happens to be a formally trained US board certified anesthesiologist or nurse anesthetist.” Ans. 11. Thus, the Examiner determines that the qualities of the practitioner do not alter the method. Id. 1 Indeed, the Examiner appears to recognize that an “ordinary English reading of “nonanesthetist” [] as ‘not an anesthetist[,’] with the ‘anesthetist’ being read as ‘a person delivering or providing anesthesia’” would not be a reasonable construction of “nonanesthetist” as used in Appellants’ claims. See Ans. 13 (noting that “[a]ny user who operates the system to deliver anesthesia to the patient would certainly be acting as an anesthetist and would not seem to qualify as a ‘nonanesthetist’ under an ordinary English understanding of the term”). 2 US 6,807,965 B1, issued Oct. 26, 2004 (hereinafter “Hickle”). Appeal 2014-000204 Application 11/716,609 9 In other words, we understand the Examiner’s position to be that the reference to a “nonanesthetist” in the preamble of claim 1 does not further limit claim 1, or its dependent claims, because this reference appears as part of a phrase setting forth a goal that is achieved by performance of the method steps, regardless of who performs the method steps. The Examiner’s concern appears to be that Appellants attempt to patentably distinguish their claims over the prior art by relying on language that “amounts solely towards the intended use,” and, thus, according to the Examiner, does not limit the structure of the device or the steps of the method. See Ans. 17. This concern is directed to issues of claim breadth, as well as novelty and nonobviouness, but not indefiniteness.3 The fact that Appellants and the Examiner may disagree on the proper degree of patentable weight to be accorded to particular language in the claims does not necessarily render the claims indefinite. For the foregoing reasons, the Examiner does not set forth a cogent explanation of why the reference to a “nonanesthetist” renders claims 1–18 indefinite. Accordingly, we do not sustain the rejection of claims 1–18 under 35 U.S.C. § 112, second paragraph. Rejection under 35 U.S.C. § 102(e) Appellants argue for patentability of claims 1–13 and 16–18 subject to this ground of rejection as a group. Appeal Br. 14–17. We select claim 10 3 Merely that a claim is broad does not mean that it is indefinite. See In re Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977); In re Miller, 441 F.2d 689, 693 (CCPA 1971); In re Gardner, 427 F.2d 786, 788 (CCPA 1970); see also Ultimax Cement Mfg. Corp. v. CTS Cement Mfg. Corp., 587 F.3d 1339, 1352 (Fed. Cir. 2010) (pointing out that merely claiming broadly does not prevent the public from understanding the scope of the claim). Appeal 2014-000204 Application 11/716,609 10 as representative of this group, and claims 1–9, 11–13, and 16–18 stand or fall with claim 10. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). The Examiner finds that Flaherty discloses all elements of the system recited in claim 10. See Ans. 6–8. Appellants argue that their claimed invention “is defined, in large part, by the preamble and such is directed, not to an ambulatory, light weight infusion device that a conscious patient may carry, but to a . . . device for infusing sedatives by a non-anesthetist during a medical or surgical procedure such as a pacemaker placement, colonoscopy, would [sic] dressings in burn units, etc.” Appeal Br. 14–15 (citing Hickle, col. 2, l. 5 et seq.). Appellants contend that Flaherty “is focused on an ambulatory device in which the patient is alert and awake” and “does not teach or suggest use of his device during a surgical and/or medical procedure such as a colonoscopy.” Id. at 15–16. Appellants add that “Flaherty even fails to recognize the problems of respiratory depression and airway obstruction that can result from the administration of sedatives during such medical and/or surgical procedures.” Id. at 16. Appellants’ argument is not commensurate with the scope of claim 10. In particular, even assuming that the preamble defines the claimed invention, as Appellants assert, the preamble of claim 10 does not limit the claimed system to a system for delivery of a sedative during a specified medical procedure such as a colonoscopy. Rather, the preamble of claim 10 recites a “drug delivery system for enabling safe delivery of a sedative and/or analgesic drugs by a nonanesthetist to a patient in need thereof during a medical and/or surgical procedure.” Appeal Br. 22 (Claims App.) (emphases added). Notably, Appellants’ Specification does not define Appeal 2014-000204 Application 11/716,609 11 “medical procedure” as being limited to procedures requiring sedation, and, as the Examiner points out, does not even mention the procedures (i.e., pacemaker placement, colonoscopy, or wound dressing in a burn unit) alluded to in Appellants’ argument. Ans. 19. In fact, “the administration of drugs (e.g., sedative and analgesic drugs)” is a “medical procedure” consistent with Appellants’ Specification. Spec. 1, ll. 14–15. Accordingly, the preamble of claim 10 is sufficiently broad to encompass an ambulatory, light weight drug infusion system, such as Flaherty’s drug delivery system, which can be used to deliver “analgesics” to a conscious patient. See Flaherty ¶ 48. We appreciate that claim 10 recites “a drug delivery mechanism for delivering a drug dosage rate of sedative to the patient during said procedure.” Appeal Br. 22 (Claims App.) (emphasis added). However, Appellants’ Specification does not disclose or imply any structural distinction between a drug delivery mechanism for delivering a drug dosage rate of sedative and one for delivering a drug dosage rate of analgesic. See, e.g., Spec. 5, ll. 28–30; Hickle, col. 10, ll. 19–26. Appellants submit that Flaherty has no concern with “reliev[ing] the clinician of the memory chore of identifying the proper disposables for use during the procedure and to enhance the safety of the sedation procedure claims.” Appeal Br. 16. This is not accurate. As the Examiner points out, Flaherty discloses providing an information bar code, which can include information about the device and/or the drug contained in reservoir 30 therein, both of which are disposable, and providing programming designed such that the bar code must be read prior to programming or otherwise using the fluid delivery device, thereby greatly reducing programming errors. Ans. 8; Flaherty ¶¶ 11, 82, 101, 104. Appeal 2014-000204 Application 11/716,609 12 Finally, Appellants argue that Flaherty “gives no hint [that] the system that [Appellants claim] is to be used for sedation by a nonanesthetist who is untrained in the field of anesthesiology, unacquainted with intubation, and/or the various levels of sedation.” Appeal Br. 16. This argument is not convincing. Flaherty expressly discloses that the remote controller of the patient infusion system “allows a user, such as a patient, nurse or doctor, to remotely program the fluid delivery device to provide a desired infusion of fluid into the patient.” Flaherty ¶ 17; see also id. ¶ 55 (disclosing use by a “user, such as a patient or a clinician”). Thus, Flaherty’s system is adapted for use by a nonanesthetist who is untrained in the field of anesthesiology, intubation, and sedation. For the above reasons, Appellants fail to apprise us of error in the rejection of claim 10 as anticipated by Flaherty. Accordingly, we sustain the rejection of claim 10, as well as claims 1–9, 11–13, and 16–18, which fall with claim 10, under 35 U.S.C. § 102(e) as anticipated by Flaherty. Rejection under 35 U.S.C. § 103(a) In contesting this rejection, Appellants argue only that “[t]his rejection is premised on the fallacious assumption that the prior rejection under 35 U.S.C. §102 is proper” and that “[l]ike the rejection under 35 U.S.C. § 102, there remains so many missing elements in the cited prior art, that the rejection is also unwarranted.” Appeal Br. 17. For the reasons set forth above in discussing the rejection under 35 U.S.C. § 102(e), Appellants fail to show any missing elements in Flaherty vis-à-vis claim 10. Thus, for the same reasons, Appellants’ arguments alleging missing elements fail to apprise us of error in the rejection of claims 14 and 15, which depend from Appeal 2014-000204 Application 11/716,609 13 claim 10. Accordingly, we sustain the rejection of claims 14 and 15 under 35 U.S.C. § 103(a) as unpatentable over Flaherty. DECISION The Examiner’s decision rejecting claims 1–4 under 35 U.S.C. § 101 is REVERSED. The Examiner’s decision rejecting claims 1–18 under 35 U.S.C. § 112, second paragraph, is REVERSED. The Examiner’s decision rejecting claims 1–13 and 16–18 under 35 U.S.C. § 102(e) as anticipated by Flaherty is AFFIRMED. The Examiner’s decision rejecting claims 14 and 15 under 35 U.S.C. § 103(a) as unpatentable over Flaherty 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation