Ex Parte Langley et alDownload PDFPatent Trial and Appeal BoardNov 8, 201310433642 (P.T.A.B. Nov. 8, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte CHRISTOPHER NIGEL LANGLEY, SHANE ALISTAIR DAY, ROBERT FREDERICK VEASEY, and ROBERT WOOLSTON ____________________ Appeal 2010-009672 Application 10/433,642 Technology Center 3700 ____________________ Before: PHILLIP J. KAUFFMAN, LYNNE H. BROWNE, and BART A. GERSTENBLITH, Administrative Patent Judges. KAUFFMAN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-009672 Application 10/433,642 2 STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from the Examiner’s decision to reject claims 1-3, 5-7, 10, 11, 13, 14, and 16. Appellants’ representative presented oral argument on October 17, 2013. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. The Invention Appellants’ claimed invention relates to “improvements in a portable injection device for dispensing controlled quantities of a medicament.” Spec. 1:3-5. Independent claim 1, reproduced below, is the sole independent claim on appeal: 1. An injection device, comprising: a drive mechanism to expel selectively a dose of medicament from a medicament cartridge through a needle unit; an electronic control unit to control the drive mechanism, and a dispense button to generate a dispense button signal to the electronic control unit indicative of the dose to be expelled in which an arm button causes a first arm button signal to be sent to the electronic control unit to permit the dose to be expelled, wherein the arm button must generate the first arm button signal for a predetermined period of time greater than the transmission time of the first arm button signal to the electronic control unit before the electronic control unit will respond to the dispense button signal. Evidence Relied Upon Niehoff Jensen Klitmose US 5,681,286 US 6,248,090 B1 US 6,277,098 B1 Oct. 28, 1997 Jun. 19, 2001 Aug. 21, 2001 Appeal 2010-009672 Application 10/433,642 3 The Rejections The following rejections are before us on appeal: I. Claim 1 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. II. Claims 1, 3, 6, and 14 under 35 U.S.C. § 102(b) as anticipated by Niehoff. III. Claims 2, 5, 7, 10, 11, 13, and 16 under 35 U.S.C. § 103(a) as unpatentable over Niehoff and either Klitmose or Jensen. OPINION I. Written description requirement Appellants amended claim 1 so that the last clause recites “wherein the arm button must generate the first arm button signal for a predetermined period of time greater than the transmission time of the first arm button signal to the electronic control unit before the electronic control unit will respond to the dispense button signal.” App. Br. 32, Claims App’x, Claim 1 (added language underlined); see also Ans. 3. The Examiner determined that Appellants’ original disclosure does not contain an adequate written description of the added language. Ans. 3. Appellants concede that the added language does not have verbatim support in the original disclosure, but assert that the disclosure reasonably conveys Appellants possessed the claimed subject matter for two reasons. App. Br. 15-16; see also Reply Br. 2. These reasons relate to a timing sequence and a display panel. Timing Sequence According to Appellants, a person of ordinary skill in the art Appeal 2010-009672 Application 10/433,642 4 would understand that, based on the application's objective of avoiding inadvertent pressing of the arm button based on timing, rather than for example, physical placement of actuating buttons, the recited predetermined period of time would necessarily be greater than the recited transmission time. App. Br. 16. Appellants elaborate that the Specification describes that the device is configured so that it is not possible to inadvertently depress the primer button and “describes a timing sequence to address a concern the inventors had over inadvertent button pressing.” App. Br. 16-17 (citing Fact 4, at App. Br. 10). For the reasons that follow, this contention is unpersuasive. Appellants’ disclosure states that when end cap 6 is in place over the second end of main housing 4 it is not possible to inadvertently depress primer button 26. Spec. 2:25; 3:5-8; figs. 1, 2. In light of this, Appellants’ characterization that the device is configured to prevent inadvertent pressing of the arm button through a timing sequence is a mischaracterization in that inadvertent button pressing is prevented by end cap 6, not a timing sequence. Further, the Specification’s disclosure that end cap 6 protects the primer button from being inadvertently depressed, may fairly imply that Appellants sought to prevent inadvertently priming the device. However, such disclosure falls short of demonstrating that Appellants possessed an injection device wherein the first arm button signal is generated for a predetermined period of time greater than the transmission time of that signal to the electronic control unit. Display Panel Appellants assert that “one skilled in the art would understand that, based on the application's disclosure of the display panel displaying the Appeal 2010-009672 Application 10/433,642 5 armed status, the recited predetermined period of time would necessarily be greater than the recited transmission time.” App. Br. 16. Appellants’ argument that the first arm button signal must necessarily be generated for a predetermined period of time greater than the transmission time of that signal to the receiving device so that the signal may be displayed is premised on the interpretation that claim 1 calls for the signal to be displayed. However, claim 1 does not recite a display panel, and does not otherwise call for the signal to be displayed.1 Therefore, Appellants’ contention is unpersuasive. Further, to the extent that Appellants’ argument suggests that a signal necessarily must be generated for a period of time greater than the transmission time of that signal to the receiving device (i.e., the electronic control unit), we cannot agree. First, the Specification describes that the “arm button is preferably held down for a predetermined period of time before injector 2 becomes armed” (Spec. 5:23-25), but does not state that the predetermined period of time must exceed the transmission time of the signal to the receiving device. Second, once generated, a signal may be successfully transmitted to another device, such as an electronic control unit, even if the transmission time exceeds the period of time the signal was generated. The “hallmark of written description is disclosure.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Here 1 Dependent claims 5, 10, and 11 add a display panel, further supporting the interpretation that claim 1 does not call for a display panel. See Liebel- Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004) (the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim). Appeal 2010-009672 Application 10/433,642 6 Appellants’ Specification broadly discloses an injection device having an arm button that is held for a predetermined period of time before the electronic control unit will respond to the dispense button signal. We fail to see and Appellants fail to cogently articulate how such disclosure demonstrates Appellants possessed an injection device having an arm button that is held for a predetermined period of time great than the transmission time of the first arm button signal to the electronic control unit before the electronic control unit will respond to the dispense button. Appellants’ arguments do not apprise us of error in the rejection of claim 1. Accordingly, we sustain the rejection of claim 1. II. & III. Anticipation by Niehoff & Obviousness over Niehoff and either Klitmose or Jensen Given that we sustained the written description rejection of claim 1, we consider the amended language that lacks an adequate written description not to be part of the subject matter of claim 1. Therefore, for purposes of these prior art rejections, we consider the last clause of claim 1 to read as follows: wherein the arm button must generate the first arm button signal for a predetermined period of time greater than the transmission time of the first arm button signal to the electronic control unit before the electronic control unit will respond to the dispense button signal. Rejections II and III each rely upon the Examiner’s findings that Niehoff’s dispense button (forward manual motion button 46 or reverse manual motion button 47) generates a signal, and Niehoff’s arm button (enable/accelerate button 48) inherently generates a signal for a Appeal 2010-009672 Application 10/433,642 7 predetermined period of time. Ans. 4 (Rejection II), 4-5 (relying upon Rejection II findings for Rejection III). The Examiner’s inherency finding with regard to the arm button signal is based upon the Examiner’s interpretation that any signal exists for some timeframe, and because Appellants have not defined “a predetermined amount of time” as recited in claim 1, existence of a signal for some timeframe is a predetermined period of time as claimed.2 Ans. 4. To the extent that the Examiner reasons that if a signal exists, it exists for some period of time, we agree. However, that reasoning is not commensurate in scope with claim 1 because claim 1 does not simply call for a signal to exist for some period of time. Claim 1 calls the first arm button signal to be generated for a predetermined period of time before the electronic control unit will respond to the dispense button signal. App. Br. 32, Claims App’x, Claim 1. Consistent with this claim language, the Specification states that the function of the arm button 16 is to make the dispense button 18 active. Spec. 5:23. Therefore, if the first arm button signal is generated for a period of time less than or equal to the predetermined period of time, the electronic control unit will not respond to the dispense button signal (the dispense button will not be active), and if the first arm button signal is generated for a period of time greater than the predetermined period of time, the electronic control unit will respond to the dispense button signal (the dispense button is active). As the Examiner acknowledges, Niehoff’s dispense button (forward manual motion button 46 or reverse manual motion button 47) and arm 2 The Examiner misquotes claim 1 which recites “a predetermined period of time” rather than “a predetermined amount of time.” See Ans. 4 (emphasis added); App. Br. 32, Claims App’x, Claim 1. Appeal 2010-009672 Application 10/433,642 8 button (enable/accelerate button 48) are depressed simultaneously to move the plunger drive (permitting a dose to be expelled). See Niehoff, col. 4, l. 65 - col. 5, l. 5. Because Niehoff’s first arm button signal (produced by enable/accelerate button 48) and dispense button signal (produced by forward manual motion button 46 or reverse manual motion button 47) are generated simultaneously, Niehoff’s dispense button (forward manual motion button 46 or reverse manual motion button 47) is active at the time the arm button signal (from enable/accelerate button 48) is generated without a delay of a predetermined period of time with respect to the first arm button signal. Therefore, a preponderance of the evidence does not support a finding that Niehoff’s arm button necessarily generates a signal for a predetermined period of time before the electronic control unit will respond to the dispense button signal as called for in independent claim 1. See App. Br. 20; Reply Br. 4. Consequently, we do not sustain Rejections II and III. DECISION We affirm the Examiner’s decision to reject claim 1 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. We reverse the Examiner’s decision to reject claims 1, 3, 6, and 14 under 35 U.S.C. § 102(b) as anticipated by Niehoff, and we reverse the Examiner’s decision to reject claims 2, 5, 7, 10, 11, 13, and 16 under 35 U.S.C. § 103(a) as unpatentable over Niehoff and either Klitmose or Jensen. Appeal 2010-009672 Application 10/433,642 9 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-IN-PART mls Copy with citationCopy as parenthetical citation