Ex Parte Partanen et alDownload PDFPatent Trial and Appeal BoardOct 16, 201713879412 (P.T.A.B. Oct. 16, 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. 13/879,412 04/15/2013 Ari Ilkka Mikael Partanen PMIP.USPAT.1000 9086 93255 7590 10/16/2017 Intrinsic Law Corp. 760 Main Street Third Floor Waltham, MA 02451 EXAMINER SMITH, RUTH S ART UNIT PAPER NUMBER 3737 MAIL DATE DELIVERY MODE 10/16/2017 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 ARI IIKKA MIKAEL PARTANEN, MATTHEW ROBERT DREHER, PAVEL SERGEYEVICH YARMOLENKO, ANTTI JOHANNES VIITALA, JULIA KRISTINA ENHOLM, and MAX OSKAR KOHLER ____________ Appeal 2016-006030 Application 13/879,4121 Technology Center 3700 ____________ Before DONALD E. ADAMS, TIMOTHY G. MAJORS, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims 1–3, 5–13, and 15 (Final Act.2 1). Examiner entered rejections under 35 U.S.C. § 112, second paragraph, 35 U.S.C. § 112 fourth paragraph, and the written description and enablement provisions of 35 U.S.C. § 112. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the real party in interest as “Koninklijke Philips, N.V.” (App. Br. 4.) 2 Examiner’s August 19, 2015 Final Office Action. Appeal 2016-006030 Application 13/879,412 2 STATEMENT OF THE CASE Appellants’ disclosure “relates to magnetic resonance guided high intensity focused ultrasound therapy, in particular to the controlled heating of a target zone in a subject” (Spec. 1). Claims 1, 5, 12, and 13 are representative and reproduced below: 1. A therapeutic apparatus comprising: a high intensity focused ultrasound system for heating a target zone of a subject; a magnetic resonance imaging system for acquiring magnetic resonance data; a processor for controlling the therapeutic apparatus; a memory containing machine executable instructions for execution by the processor, wherein execution of the instructions cause the processor to generate heating commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with heating trajectories; wherein execution of the instructions further cause the processor to repeatedly: acquire the magnetic resonance data during execution of the heating commands; calculate a spatially dependent parameter from the magnetic resonance data; and modify the heating commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold; and wherein execution of the instructions further cause the processor to generate waiting commands which cause the high intensity focused ultrasound system to halt sonication for a predetermined period of time after executing the heating commands; wherein execution of the instructions further cause the processor to generate maintaining commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with maintaining trajectories, wherein Appeal 2016-006030 Application 13/879,412 3 execution of the instructions further cause the processor to repeatedly: acquire the magnetic resonance data during execution of the maintaining commands; calculate the spatially dependent parameter from the magnetic resonance data acquired during execution of the maintaining commands; and modify the maintaining commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below the first predetermined threshold and above the second predetermined threshold; wherein execution of the instructions cause the processor to allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration. (App. Br. 26–27 (emphasis added).) 5. The therapeutic apparatus of claim 1, wherein the spatially dependent parameter is any one of the following: proton signal intensity, maximum proton signal intensity, minimum proton signal intensity, mean proton signal intensity, median proton signal intensity, Tl signal intensity, maximum Tl signal intensity, minimum Tl signal intensity, mean Tl signal intensity, median Tl signal intensity, T2 signal intensity, maximum T2 signal intensity, minimum T2 signal intensity, mean T2 signal intensity, median T2 signal intensity, T2* signal intensity, minimum T2* signal intensity, maximum T2* signal intensity, mean T2* signal intensity, mean T2* signal intensity, temperature, minimum temperature, mean temperature, median temperature, minimum ultrasonic dose, maximum ultrasonic dose, median ultrasonic dose, maximum temperature deviation, minimum signal intensity, maximum signal intensity, mean signal intensity, median signal intensity, minimum thermal dose, mean thermal dose, median thermal dose, and maximum thermal dose, and combinations thereof. (App. Br. 28 (emphasis added).) Appeal 2016-006030 Application 13/879,412 4 12. A non-transitory computer program product comprising machine executable instructions for execution by a processor controlling a therapeutic apparatus, wherein the therapeutic apparatus comprises a high intensity focused ultrasound system for heating a target zone of a subject, wherein the therapeutic apparatus further comprises a magnetic resonance imaging system for acquiring magnetic resonance data, wherein execution of the instructions causes the processor to generate heating commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with heating trajectories, wherein execution of the instructions further cause the processor to repeatedly: acquire the magnetic resonance data during execution of the heating commands; calculate a spatially dependent parameter from the magnetic resonance data; and modify the heating commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold, and allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration. (App. Br. 30–31.) 13. A method of operating a therapeutic apparatus, wherein the therapeutic apparatus comprises a high intensity focused ultrasound system for heating a target zone of a subject, wherein the therapeutic apparatus further comprises a magnetic resonance imaging system for acquiring magnetic resonance data, wherein the method comprises the steps of generating heating commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with heating trajectories, wherein the method comprises the steps of repeatedly: acquiring the magnetic resonance data during execution of the heating commands; Appeal 2016-006030 Application 13/879,412 5 calculating a spatially dependent parameter from the magnetic resonance data; and modifying the heating commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold and generating waiting commands which cause the high intensity focused ultrasound system to halt sonication for a predetermined period of time after executing the heating commands; further to generate maintaining commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with maintaining trajectories, and to repeatedly: acquiring the magnetic resonance data during execution of the maintaining commands; calculating the spatially dependent parameter from the magnetic resonance data acquired during execution of the maintaining commands; and modifying the maintaining commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below the first predetermined threshold and above the second predetermined threshold, allowing the spatially dependent parameter to exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration. (App. Br. 31–32.) The claims stand rejected as follows: Claims 1–3, 5–13, and 15 stand rejected under 35 U.S.C. § 112, second paragraph. Claim 6 stands rejected under 35 U.S.C. § 112, fourth paragraph. Claims 1–3, 5–13, and 15 stand rejected under the written description provision of 35 U.S.C. § 112, first paragraph. Appeal 2016-006030 Application 13/879,412 6 Claims 1–3, 5–13, and 15 stand rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. Definiteness: ISSUE Does the preponderance of evidence support Examiner’s conclusion that Appellants’ claims are indefinite? ANALYSIS Claim 1: Appellants’ claim 1 is reproduced above. I Appellants’ claim 1 requires, inter alia, the modification of “heating commands in accordance with [a] spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold . . .” (see App. Br. 26). Examiner finds that the foregoing limitation “appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of Appellants’] claim 1,” which requires the “execution of [machine executable] instructions cause the processor to allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration” (Ans. 3; see App. Br. 27 (emphasis added)). In this regard, Examiner finds that Appellants’ claim fails to require “that the heating commands are modified such that within the target area the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold except when a [sonication] duration Appeal 2016-006030 Application 13/879,412 7 is less than a predetermined minimum [sonication] duration as argued” by Appellants (Ans. 7; see App. Br. 18). We are not persuaded. Notwithstanding Examiner’s assertion to the contrary, Appellants’ claim 1 requires that the “execution of [machine executable] instructions cause the processor to allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone if [(i.e. except when)] the sonication duration is less than a predetermined minimum sonication duration” (see App. Br. 27 (emphasis added)). As Appellants explain, “[t]he conditional execution [required by Appellants’ claim] does not create an inconsistency” (App. Br. 18; Reply Br. 12). II Appellants’ claim 1 uses the term “spatially dependent parameter” (see App. Br. 26). Appellants’ claim 5 limits the scope of the genus defined by the term “spatially dependent parameter” to include, inter alia, “temperature” (see id. at 28). In addition, Appellants’ Specification defines the term “spatially dependent parameter” as “a physical property of the subject since it may be a local temperature or some other local parameter which is affected by the heating of the various sonication points within the target zone” and specifically identifies various spatially dependent parameters (Spec. 7:10–13; see also id. at 10:5–12:14). Appellants also disclose that “[t]he spatially dependent parameter may be a single numerical value or it may also be a mapping, . . . such as a temperature map” (Spec. 9:17–23). Examiner finds that “if the spatially dependent parameter[, set forth in Appellants’ claim 1,] is not temperature, it is unclear as to what would be Appeal 2016-006030 Application 13/879,412 8 defined as a first and second predetermined threshold” (Ans. 3). In this regard, Examiner finds that Appellants’ only disclosed examples for the first and second predetermined threshold are ones applicable for a spatially dependent parameter being temperature. Therefore, while the claims do not preclude the parameter being temperature, it is unclear as to what the limits would be for the predetermined threshold to be used if the parameter is other than temperature. [] Appellant[s] [] provided no guidance for determination of other thresholds that can be defined when different parameters are used. (Id. at 7.) We are not persuaded. Initially, we note that Appellants’ Specification is not limited to its exemplified embodiments, i.e. temperature (cf. Ans. 7). See generally In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982) (working examples are not required to satisfy section 112, first paragraph). Therefore, we are not persuaded by Examiner’s assertion that Appellants’ “only disclosed examples for the first and second predetermined threshold are ones applicable for a spatially dependent parameter being temperature” (Ans. 7). Further, as Appellants explain, the subject matter of claim 1 determines whether the value of a spatially dependent parameter is between the values of first and second thresholds. [Examiner] seemingly asserts that temperature is the only parameter whose value may be compared to two other values. [Examiner, however,] does not explain its basis for this assertion, and none would be discernible to a skilled artisan. (App. Br. 18–19; Reply Br. 14.) On this record, we agree with Appellants. Examiner failed to precisely explain why Appellants’ claim is indefinite (see e.g., App. Br. 19). More specifically, Examiner failed to explain why a person of ordinary skill in this art, reading Appellants’ claimed invention in light of Appellants’ Specification, would have difficulty determining first or Appeal 2016-006030 Application 13/879,412 9 second predetermined thresholds for any spatially dependent parameter within the scope of Appellants’ claimed invention or comparing a spatially dependent parameter to first or second predetermined thresholds (cf. Ans. 7). See, Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1217 (Fed. Cir. 1991) (The legal standard for indefiniteness under 35 U.S.C § 112, second paragraph, is whether a claim reasonable apprises those of skill in the art of its scope). See also In re Mattison, 509 F.2d 563, 565 (CCPA 1975) (Claims are not indefinite simply because they do not describe the invention using numerical values). Claim 7: Appellants’ claim 7 depends from and further limits “the instructions” of Appellants’ claim 1 to “further cause the processor to: receive medical image data; receive a treatment plan, wherein the treatment plan is descriptive of the location of the target zone; and generate the heating trajectories in accordance with the medical image data and the treatment plan” (App. Br. 29). Examiner finds that “one skilled in the art would recognize that the magnetic resonance data acquired by the magnetic resonance imaging system of claim 1 is imaging data” and that “the data acquired in claim 1 and received in claim 7 [is] the same data” (Ans. 7–8). Therefore, Examiner finds that “it is unclear as to how the medical image data differs from the magnetic resonance data set forth in claim 1” (Ans. 3). In this regard, Examiner finds that “[i]f the data is not the same, such a limitation appears to conflict with the disclosed invention” (id.; see id. at 8 (“If the data is not the same (meaning both are not magnetic resonance image data), it is unclear Appeal 2016-006030 Application 13/879,412 10 as to where the medical image data is received from and how it differs from the magnetic resonance data acquired by the imaging system”)). We are not persuaded. Instead, we agree with Appellants assertion that those of ordinary skill in th[is] art [would recognize that], magnetic resonance data is not data of an image; instead, it is data of magnetic resonance, as is implied by the nomenclature “magnetic resonance data.” Image data is data of an image, as is similarly implied by the nomenclature “image data.” (App. Br. 19; Reply Br. 15.) Claim 8: Appellants’ claim 8 depends from and further limits the phase “execution of the instructions,” as it appears in Appellants’ claim 7 to “further cause[] the processor to: receive magnetic resonance data from the magnetic resonance imaging system; and reconstruct the medical image data from the magnetic resonance data” (App. Br. 29). Examiner finds that “[i]n claim 8, it is unclear as to how one reconstructs medical image data from magnetic resonance data” (Ans. 3). In this regard, Examiner asserts that “one skilled in the art would recognize that the magnetic resonance data is used to reconstruct a medical image and not medical image data” (id. at 8). We are not persuaded. As Appellants explain, “those of ordinary skill in th[is] art, [would recognize that] magnetic resonance data is transformed into imagery data through a mathematical algorithm (App. Br. 20; see Reply Br. 16–17). Appeal 2016-006030 Application 13/879,412 11 Claim 10: Appellants’ claim 10 makes use of the acronym “LINAC” (App. Br. 30). Examiner finds that “the acronym ‘LINAC’ should be defined” in Appellants’ claim 10 (Ans. 3; see also id. at 8). We are not persuaded. Examiner recognizes that a person of ordinary skill in this art would recognize that, on this record, the term “LINAC” refers to a linear accelerator (Ans. 8; see also Spec. 14:14–15 (“the radiation therapy system is linac or a linear accelerator”)). See Standard Oil Co. v. Am. Cyanamid Co., 114 F.2d 448, 452 (Fed. Cir. 1985) (“[T]he specification aids in ascertaining the scope and meaning of the claims inasmuch as the words of the claims must be based upon the description. The specification is, thus, the primary basis for construing the claims”). On this record, Examiner failed to establish an evidentiary basis to support a finding that a person of ordinary skill in this art would not understand that the acronym LINAC refers to a linear accelerator. Claim 12: Appellants’ claim 12 is reproduced above. I Appellants’ claim 12 requires, inter alia, the modification of “heating commands in accordance with [a] spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold . . .” (see App. Br. 31). Examiner finds that the foregoing limitation “appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of Appellants’] claim 12,” which “allow[s] the spatially dependent parameter to Appeal 2016-006030 Application 13/879,412 12 exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration” (Ans. 3; see also id. at 7; see App. Br. 31). We are not persuaded for the reasons set forth above, with respect to rejection I of claim 1. II Examiner finds that Appellants’ “[c]laim 12 is incomplete for omitting essential steps, such omission amounting to a gap between the steps” (Ans. 3). In this regard, Examiner finds: The omitted steps are: causing the processor to generate waiting commands which cause the high intensity focused ultrasound system to halt sonication for a predetermined period of time after executing the heating commands; causing the processor to generate maintaining commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with maintaining trajectories, causing the processor to repeatedly acquire the magnetic resonance data during execution of the maintaining commands; calculating the spatially dependent parameter from the magnetic resonance data acquired during execution of the maintaining commands; and modifying the maintaining commands in accordance with the spatially dependent parameter such that within the target zone the spatially dependent parameter remains below the first predetermined threshold and above the second predetermined threshold. (Id. at 3–4; see id. at 8 (“such limitations are considered to be essential steps in the disclosed invention” and Appellants “failed to provide any evidence to the contrary”).) We are not persuaded. As Appellants explain, Examiner “provides no evidence to support [Examiner’s] assertion that [] claim 12 omits essential steps” (Reply Br. 18; see App. Br. 21). We agree. It is Examiner who “bears the initial burden, Appeal 2016-006030 Application 13/879,412 13 on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1442, 1445 (Fed. Cir. 1992). On this record, Examiner failed to carry the initial burden of presenting a prima facie case of unpatentability (see Reply Br. 18). III Examiner finds that “if the spatially dependent parameter[, set forth in Appellants’ claim 12,] is not temperature, it is unclear as to what would be defined as a first and second predetermined threshold” (Ans. 4; see id. at 7). We are not persuaded for the reasons set forth above, with respect to rejection II of claim 1. Claim 13: Appellants’ claim 13 is reproduced above. I Appellants claim 13 requires, inter alia, the modification of “heating commands in accordance with [a] spatially dependent parameter such that within the target zone the spatially dependent parameter remains below a first predetermined threshold and above a second predetermined threshold . . .” (see App. Br. 31). Examiner finds that the foregoing limitation “appear[s] to be inconsistent with,” the limitation in “[t]he last three lines [of Appellants’] claim 13,” which “allow[s] the spatially dependent parameter to exceed the first predetermined threshold in the target zone if the sonication duration is less than a predetermined minimum sonication duration” (Ans. 3; see also id. at 7; see App. Br. 31). We are not persuaded for the reasons set forth above, with respect to rejection I of claim 1. Appeal 2016-006030 Application 13/879,412 14 II Examiner finds that “if the spatially dependent parameter[, set forth in Appellants’ claim 13,] is not temperature, it is unclear as to what would be defined as a first and second predetermined threshold” (Ans. 4; see id. at 7). We are not persuaded for the reasons set forth above, with respect to rejection II of claim 1. Claim 15: Appellants’ claim 15 depends from and further limits the therapeutic apparatus of Appellants’ claim 1 to: Further compris[e] a thermometry module to measure temperature in a measurement field and in particular to compute a thermal dose, wherein execution of the instructions cause the processor to generate heating commands which cause the high intensity focused ultrasound system to sonicate the subject in accordance with heating trajectories on the basis of the measured temperature and/or thermal dose. (App. Br. 32.) According to Examiner, “the MRI system and the processor that calculates temperature from the magnetic resonance data provides means to measure temperature and compute thermal dose” (Ans. 8). Therefore, Examiner finds that “it is unclear as to how the thermometry module differs from the magnetic resonance imaging system” (Ans. 4). In this regard, Examiner finds that Appellants’ “claim appears to define means other than the MRI system and processor for providing such temperature measurements and thermal dose” (id. at 9). We are not persuaded. Appellants Specification discloses “a therapy system comprising: . . . a thermometry module to measure temperature [in] a Appeal 2016-006030 Application 13/879,412 15 measurement field and in particular to compute a thermal dose . . .” (Spec. 1: 6–10). Although, Appellants disclose that “[t]he thermometry module may be the magnetic resonance imaging system” (Spec. 15: 32–33 (emphasis added)), Examiner failed to establish that, as presented, the thermometry module of Appellants’ claim 15 is the magnetic resonance imaging system of Appellants’ claim 1. To the contrary Appellants’ claim 15 requires that the therapeutic apparatus of Appellants’ claim 1, which requires a magnetic resonance imaging system, further comprises a thermometry module (see App. Br. 32; cf. id. at 26). Therefore, we agree with Appellants’ assertion that “claim 15 unequivocally recites that a thermometry module measures the temperature and computes the thermal dose” and “a skilled artisan would recognize that the ‘thermometry module differs from the magnetic resonance imaging system’ in that the: (1) thermometry module measures temperature and computes a thermal dose and (2) the magnetic resonance imaging system acquires magnetic resonance data” (see Reply Br. 19; App. Br. 22, see also Reply Br. 19 (“Appellants’ respectfully submit that measuring temperature and calculating temperature are not identical things, as would be recognized by a skilled artisan in light of the definitions of calculating and measuring”). CONCLUSION OF LAW The preponderance of evidence fails to support Examiner’s conclusion that Appellants’ claims are indefinite. The rejection of claims 1–3, 5–13, and 15 under 35 U.S.C. § 112, second paragraph is reversed. Appeal 2016-006030 Application 13/879,412 16 Improper Dependency: ISSUE Does the preponderance of evidence support Examiner’s conclusion that Appellants’ claim 6 fails to further limit the subject matter of Appellants’ claim 1? ANALYSIS Appellants’ claim 6 depends from and limits the “trajectories” of Appellants’ claim 1 to “define any one of the following: concentric circles, concentric spheres, closed loops, closed surfaces, a single sonication location, and linear patterns” (App. Br. 28). Examiner finds that Appellants’ claim 6 “fails to set forth a further structural limitation of the apparatus” set forth in Appellants’ claim 1 (Ans. 5; see id. at 9 (“Examiner maintains that the claim fails to set forth a further structural limitation of the apparatus and merely define[s] an intended use/result of using the apparatus”)). We are not persuaded. As Appellants explain, their claim 6 uses functional language to define and further limit the scope of the term “trajectories,” as set forth in their claim 1 (App. Br. 23–25; see generally Reply Br. 20). See In re Swinehart, 439 F.2d 210, 213 (CCPA 1971) (“We are convinced that there is no support, either in the actual holdings of prior cases or in the statute, for the proposition, put forward here, that ‘functional’ language, in and of itself, renders a claim improper.”) CONCLUSION OF LAW The preponderance of evidence fails to support Examiner’s conclusion that Appellants’ claim 6 fails to further limit the subject matter of Appeal 2016-006030 Application 13/879,412 17 Appellants’ claim 1. The rejection of claim 6 under 35 U.S.C. § 112, fourth paragraph is reversed. Written Description: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Appellants’ Specification fails to provide written descriptive support for the claimed invention? ANALYSIS Examiner recognizes that Appellants’ “claims fail to specifically set forth a step of determining the minimum [sonication] duration or a maximum [sonication] duration” (Ans. 5). Examiner reasons, however, that “in order to program the processor to carry out functions as set forth in [Appellants’] claims . . ., one must determine or know [] the [values for the] predetermined minimum [sonication] duration and the predetermined maximum [sonication]” and “[n]owhere in [Appellants’] disclosure is such an example provided nor is there any explanation as to how one would know how to determine such a value” (id.). In this regard, Examiner reasons that “[w]ithout such information, one skilled in the art would not be able to carry out [Appellants’] claimed invention” (id.). Therefore, Examiner finds that “[i]t is unclear as to how one would determine the minimum [sonication] duration that would allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone” and “how a predetermined maximum [sonication] duration is determined” (id. at 2). In this regard, Examiner finds that Appellants fail “to provide any guidance used by one skilled in the art to make such determinations” (id.). Appeal 2016-006030 Application 13/879,412 18 It is Examiner who “bears the initial burden of presenting a prima facie case of unpatentability.” In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002). Examiner’s burden is discharged by “presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263 (CCPA 1976). On this record, Examiner found that: (1) a minimum and maximum sonication duration value must be determined or known in order to practice Appellants’ claimed invention and (2) Appellants’ Specification does not exemplify or describe known values or how such values are determined (Ans. 5). Examiner further makes clear that Appellants “failed to provide evidence” to support a finding that a person of ordinary skill in this art knew or would have been able to determine minimum and maximum sonication duration values (Ans. 5–6). Cf. Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998) (Because the sufficiency of the written description is evaluated by one of ordinary skill in the art, details that would be known by the skilled artisan need not be included in a patent specification). For the foregoing reasons, we find that Examiner established a prima facie case that Appellants’ Specification lacks written descriptive support for the claimed invention (see Reply Br. 7 (referencing Examiner’s “prima facie case of an insufficient written description set forth in the Final Rejection”)). Therefore, we are not persuaded by Appellants’ contention that Examiner failed to provide “‘evidence or reasoning’ to rebut the presumption that Appellants’ description, as filed, is adequate” (see App. Br. 12; see also id. at 12–13 (Examiner’s statements that “‘it is unclear . . . are conclusions, not Appeal 2016-006030 Application 13/879,412 19 findings of fact from which an inference may be drawn that the disclosure is inadequate”); Reply Br. 4 and 6). Because a minimum and maximum sonication duration value must be determined or known in order to practice Appellants’ claimed invention, we are not persuaded by Appellants’ contention that, “Appellants’ claims do not recite ‘determin[ing] the minimum sonification [sic] duration that would allow the spatially dependent parameter to exceed the first predetermined threshold in the target zone,’” and thus Examiner’s “basis for rejecting the claims is misdirected toward subject matter that is not claimed by Appellants” (App. Br. 9–10). We appreciate Appellants’ contention that, once a minimum or maximum sonication duration value is known or determined, “a person of ordinary skill in the art of computer programming would have no difficulty programming this subject matter into computer code” (App. Br. 11). Appellants’ contention, however, fails to establish that those of ordinary skill in this art would have, a priori, known such values or known how to determine such values. In addition, we are not persuaded by Appellants’ contention that: Appellants’ guidance is that a skilled artisan would use his/her ability to think and, by the act of thinking, select a maximum value of the duration that he/she deems appropriate. Appellants’ claims require nothing more, and a skilled artisan is capable of thinking and selecting a value that he/she deems appropriate (App. Br. 13; see also id. at 13–14 (“Appellants’ patent application ‘need not teach, and preferably omits,’ the guidance for a skilled artisan to think and, by the act of thinking, select minimum and maximum values of the duration that he/she deems appropriate”); see Reply Br. 8). Appellants’ contention, at Appeal 2016-006030 Application 13/879,412 20 best, supports a finding that a person of ordinary skill in this art would have found it obvious to determine appropriate minimum and maximum sonication duration values. Our reviewing court has, however, repeatedly stated that actual “possession” or reduction to practice outside of the specification is not enough. Rather, [] it is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, Carnegie Mellon Univ. v. Hoffmann–La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008), or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement, Lockwood v. Am. Airlines, 107 F.3d 1565, 1571–72 (Fed. Cir. 1997). Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010. For the foregoing reasons, we are not persuaded by Appellants’ contention that Examiner “does not identify any fact or reasoning to support an inference that Appellants’ evidence is insufficient to rebut the Office’s prima facie case of an insufficient written description set forth in the Final Rejection” (Reply Br. 7). CONCLUSION OF LAW The preponderance of evidence on this record supports Examiner’s finding that Appellants’ Specification fails to provide written descriptive support for the claimed invention. The rejection of claim 1 under the written description provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims 2, 3, 5–13, and 15 are not separately argued and fall with claim 1. Appeal 2016-006030 Application 13/879,412 21 Enablement: ISSUE Does the evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention? ANALYSIS Examiner finds that, although Appellants provide an enabling disclosure of a spatially dependent parameter that is temperature, “[i]t is unclear as to how a spatially dependent parameter other than temperature could be used to provide the procedure disclosed and claimed,” as encompassed by the full scope of Appellants’ claimed invention (Ans. 2; see id. at 6 (Appellants “failed to disclose other types of parameters and thresholds associated with such other parameters”)). In this regard, Examiner finds that Appellants fail to disclose a first and second predetermined threshold that is not a temperature threshold (id. at 2–3). Therefore, Examiner finds that Appellants’ “[S]pecification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with [Appellants’] claims” (id. at 6). The scope of Appellants’ claimed invention does not limit the spatially dependent parameter to temperature; therefore, we are not persuaded by Appellants’ contention their “claims 1–3, 6–13, and 15 do not require that the recited spatially dependent parameter be anything other than temperature. And the Final Rejection expressly acknowledges that Appellants’ specification is ‘enabling for the spatially dependent parameter being temperature’ (see Final Rejection page 3, lines 2 and 3 of last Appeal 2016-006030 Application 13/879,412 22 paragraph)” (App. Br. 14; see Reply Br. 9 (Examiner “tacitly acknowledges such (see Examiner’s Answer 6, last sentence)”)). Nevertheless, we are persuaded by Appellants’ contention that Examiner failed to “provide evidence that undue experimentation would be required to make or use the invention if a ‘spatially dependent parameter other than temperature [was] used to [practice] the procedure disclosed and claimed’” (App. Br. 15; see id. at 16–17; see also Reply Br. 10–11). Whether the disclosure is enabling, is a legal conclusion based on several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735– 737 (Fed. Cir. 1988). Factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims. Id. Rather than provide a fact-based reasoned analysis, Examiner provides only unsupported conclusions as to why Examiner believes Appellants’ Specification does not enable the claimed invention. Ans. 6. In the absence of a fact-based statement of a rejection based upon the relevant legal standards, Examiner failed to meet the initial burden of establishing a prima facie case of non-enablement. The burden of proof does not shift to Appellants until Examiner establishes a prima facie case of non-enablement. In re Marzocchi, 439 F.2d 220, 223–224 (CCPA 1971). Appeal 2016-006030 Application 13/879,412 23 CONCLUSION OF LAW The evidence of record fails to support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claims 1–3, 5–13, and 15 under the enablement provision of 35 U.S.C. § 112, first paragraph is reversed. 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 Copy with citationCopy as parenthetical citation