DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 58-60, 62-63, and 68-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 15, 2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 71-76, 78, and 80-82 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Both et al. (US 8,303,535).
Regarding claim 71, Both et al. (henceforth Both) discloses a handheld auto-injector, comprising: a handheld housing (Figure 2; housing 12 is handheld for attaching to an injection site during a procedure; e.g., Col. 4, lines 37-44) having a longitudinal axis (oriented along the cartridge axis) and a transverse axis that is perpendicular to the longitudinal axis (through the top and bottom of the device), the handheld housing having a shorter dimension along the transverse axis (Figure 2) than along the longitudinal axis, wherein the handheld auto-injector is configured to complete an injection procedure in 30 seconds or less (this feature depends entirely upon the volume to be infused and the flow rate of the device, however, the device is considered fully capable of performing an injection of the claimed duration, and Col. 23, lines 13-15 disclose a run time of about 5 seconds); a flowpath (34, 36; Figures 5, and 12-13) having a first end (at cartridge needle 194; Col. 15, lines 34-39) and a second end (at hollow needle 38 for delivery); and a container (32) configured to enclose a first fluid (Col. 5, lines 17-26), the container extending from a first end toward a second end along or parallel to the longitudinal axis (Figures 2 and 5) and being movable from a first position to a second position along or parallel to the longitudinal axis (the cartridge is moved along the axis during insertion to engage with the cartridge holder 34 and to engage the flow path), the container being fluidly isolated from the flowpath in the first position (before being inserted it is not connected to the flow path; the claim does not require the device to move the cartridge into engagement with the first end of the flow path; see also Figure 18 which depicts the installed cartridge before needle 194 pierces 132 to provide fluid communication through the needle) and fluidly connected to the flowpath in the second position (e.g., Col. 16, lines 18-24); and the container further including a plunger (68; Figure 12, Col. 16, lines 30-34) configured to move from the first end toward the second end of the container to expel the first fluid from the container into the flowpath (Col. 16, lines 30-34); and wherein the first end of the flowpath is insertable into the container and the second end of the flowpath (through needle 38) is extendable from the handheld housing in a direction along or parallel to the transverse axis through an opening in the handheld housing (it comes out the bottom of the device after applying to the target site through sterile barrier 62; Col. 16, lines 24-30).
Regarding claim 72, Both further discloses wherein the handheld housing includes a platform (extension at circular end of housing comprising button 26 and marking 29) raised relative to a top surface of the handheld housing (it extends beyond the main body surface of the housing), the platform extending along the longitudinal axis of the handheld housing (see e.g., Figures 3 and 5).
Regarding claim 73, Both further discloses wherein the handheld housing includes a button (start button 26 and status indicator 28; Figures 5-6) positioned along a surface of the handheld housing, the button being flush, recessed, or raised relative to the surface, and the surface is selected from a group consisting of a top surface, a side surface, or a bottom surface (see Figures 2-3 which depict the button extending from the top surface).
Regarding claim 74, Both further discloses wherein at least a portion of the button (status indicator 26) includes a visual appearance or feature that is different from the handheld housing and is embodied as a color change (Col. 9, lines 46-56 disclose a green color, yellow color, or flashing to indicate a status of the device during use).
Regarding claim 75, Both further discloses a second button (e.g., sensor 24) on an opposing side of the housing from the first button (26; Figure 3; sensor 24 is depressed into the housing an in this manner it acts as a button as claimed).
Regarding claim 76, Both further discloses wherein the handheld housing includes a window (30) positioned along a wall of the handheld housing, the window extending along the longitudinal axis, and the wall is a side wall (Figure 2, it extends along a sidewall of the device).
Regarding claim 78, Both further discloses wherein the handheld device includes flat or rounded ends (Figure 2, the housing comprises rounded edge features on both ends).
Regarding claim 80, Both further discloses wherein the handheld housing has a lateral axis (across the body of the device from side to side) that is perpendicular to the longitudinal axis (Figure 2), the handheld housing having a shorter dimension along the lateral axis than along the transverse or longitudinal axis (for the purposes of claim 80, the lateral axis may be considered as the axis across the narrowed part of the housing extending adjacent reference numeral 22 in Figure 2; the claim does not require the axis to extend through any specific part of the housing assembly such as the center).
Regarding claim 81, Both further discloses wherein the handheld housing includes a feature positioned along a bottom surface of the handheld housing which is a removable seal (liner 56, Figure 4; also button 24, Figure 4 which is a depressible contact switch).
Regarding claim 82, Both further discloses wherein the handheld housing further includes a removable cap (e.g., power pack 18, Figure 5, is removable for replacing a battery for operating the device and in this manner it acts as a cap).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Both in view of Shang et al. (US 8,992,476).
Regarding claim 77, Both discloses the claimed invention substantially as set forth above for claim 76, but fails to explicitly disclose a second window positioned along a second wall of the housing.
Shang et al. (henceforth Shang) teaches (Figure 2) and injection device comprising a window (130) and further teaches that a second window may be provided opposite the first window on the housing.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the housing assembly of Both to comprise an additional window on a side opposite the first so as to allow viewing of the contents of the device, including the cartridge, from either side as taught by Shang (Col. 7, lines 30-42).
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Both in view of Flaherty et al. (US 2002/0123740).
Regarding claim 79, Both discloses the claimed invention substantially as set forth above for claim 71, but fails to explicitly disclose the claimed slider.
Flaherty et al. (henceforth Flaherty) teaches an injection device comprising a housing (10) and which comprises a slider (701K; Figures 11-12) configured to move along the longitudinal axis of the housing (Figure 11) and provide an indication of a corresponding position or state of the flowpath (it discloses the state of the needle position which is a corresponding position of the needle and which also might be considered a state of the flowpath; ¶ [0084]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the housing of Both to comprise the control knob of Flaherty to provide an additional means of displaying to a user the state of the needle during a procedure when the housing is applied to the injection site as taught by Flaherty. In such a combination, the button of Both could be modified to provide the actuation means to display the needle position on the housing or the button would be replaced by the sliding actuator to provide the insertion means along with the identification of needle position.
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Both in view of Stonecipher (US 2019/0192766).
Regarding claim 83, Both discloses the claimed invention substantially as set forth above for claim 71, but fails to explicitly disclose the shroud having a plurality of colors for identifying an approximate location of an opening along the shroud.
Stonecipher teaches (Figure 1) an injection device comprising a shroud (label 300) comprising a plurality of colors for identifying an approximate location of an opening along the shroud (the label is a shroud as it covers a portion of the device housing and the light sources 200a-d are disclosed in ¶ [0017] as being different colors and they are located in openings on the shroud as the label surrounds the lights; the claim does not require the shroud to cover the needle or to have any specific function at all).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the housing of Both to comprise the label of Stonecipher to provide an alternate means of displaying system readiness and delivery status during a procedure as taught by Stonecipher (¶¶ [0017] and [0019]). In such a combination, the status ring of Both could be left out and the label with LEDs attached to show the same information to a user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783