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
Applicant’s election without traverse of Fig. C (Fig. 4) in the reply filed on 6/2/2026 is acknowledged.
Drawings
The drawings are objected to because they are not in condition for reproduction and include hand drawn, indistinct lines that are not sufficiently sharp. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Antwerp et al. (US 2009/0062767; hereafter Van Antwerp).
In regard to claim 1, Van Antwerp discloses a system to monitor an analyte and dispense an infusate, comprising: an on-body assembly having a first piece (100) and a second piece (160 and associated pump; see par. [0010]-[0011], [0036], [0040], [0049], [0051], [0056], [0142], and [0145]), the first piece containing a sensor (120) and a cannula (130), the cannula being in fluid communication to a first piece fluid channel (the unnumbered connector shown in Fig. 4C; connects to 160), the second piece (160) containing a pump mechanism (see par. [0010]-[0011], [0036], [0040], [0049], [0051], [0056], [0142], and [0145]) having a second piece fluid channel (tubing of 160 at least partially defines second channel), wherein coupling the first piece to the second piece places the first piece fluid channel in fluid communication with the second piece fluid channel to establish fluid transport from the pump mechanism through the cannula (attaching 160 to housing 100 connects the tubing of 160 to the interior of the connector seen in 4C to deliver drugs through cannula 130).
In regard to claim 2, Van Antwerp discloses wherein the first piece fluid channel includes a first partial fluid channel (the interior of the connector can be considered first partial fluid channel as this limitation only denotes functional limitations).
In regard to claim 3, Van Antwerp discloses wherein the second piece fluid channel includes a second partial fluid channel (the interior of the tubing of 160 can be considered a second partial fluid channel as this limitation only denotes functional limitations).
In regard to claim 4, Van Antwerp discloses, wherein coupling the first piece to the second piece aligns the first partial fluid channel and the second partial fluid channel and forms a connector fluid channel between the first piece and the second piece (attaching 160 to housing 100 connects the tubing of 160 to the interior of the connector seen in 4C to deliver drugs through cannula 130).
In regard to claim 5, Van Antwerp discloses, further comprising a sharp (see dual lumen embodiments in Figs. 6a-6b) having an interior, the sharp being sized to accommodate at least a distal end of the sensor and a distal end of the cannula within the interior (sensor and cannula are positioned within the needle).
In regard to claim 6, Van Antwerp discloses, wherein the distal end of the cannula extends beyond the distal end of the sensor (see Fig. 6B).
In regard to claim 7, Van Antwerp discloses, wherein the sensor further includes a proximal end, the distal end of the sensor being offset from the proximal end by a sensor jog (see Figure 6a-6d- the jog can be considered the mid-portion of the sensor).
In regard to claim 8, Van Antwerp discloses wherein the sensor further includes a bend, the bend placing the distal end of the sensor substantially normal to the proximal end of the sensor (see bend in Fig. 6C).
In regard to claim 9, Van Antwerp discloses further comprising an extension located between the proximal end of the sensor and the bend (any portion between the proximal end and the bend can be considered the extension).
In regard to claim 10, Van Antwerp discloses, further comprising a seal (see “seals” in Fig. 6C) being positioned across the extension, the seal preventing fluid ingress toward the proximal end of the sensor.
In regard to claim 11, Van Antwerp discloses a system to monitor an analyte and dispense an infusate, comprising: an on-body assembly that includes a communication module, a processors, a memory and a power supply (see par. [0036]; the incorporated reference 6,554,798 for the pump includes the communication module, processors, memory and power supply), an on-body assembly having a first piece (100) and a second piece (160 and associated pump; see par. [0010]-[0011], [0036], [0040], [0049], [0051], [0056], [0142], and [0145]), the first piece containing a sensor (120) and a cannula (130), the cannula being in fluid communication to a first piece fluid channel (the unnumbered connector shown in Fig. 4C; connects to 160), the second piece (160) containing a pump mechanism (see par. [0010]-[0011], [0036], [0040], [0049], [0051], [0056], [0142], and [0145]) having a second piece fluid channel (tubing of 160 at least partially defines second channel), wherein coupling the first piece to the second piece places the first piece fluid channel in fluid communication with the second piece fluid channel to establish fluid transport from the pump mechanism through the cannula (attaching 160 to housing 100 connects the tubing of 160 to the interior of the connector seen in 4C to deliver drugs through cannula 130).
In regard to claim 12, Van Antwerp discloses, wherein the communication module, the processor, the memory and the power supply are distributed between the first piece and the second piece (the claim scope includes unequal distribution).
In regard to claim 13, Van Antwerp discloses wherein the first piece fluid channel includes a first partial fluid channel (the interior of the connector can be considered first partial fluid channel as this limitation only denotes functional limitations).
In regard to claim 14, Van Antwerp discloses wherein the second piece fluid channel includes a second partial fluid channel (the interior of the tubing of 160 can be considered a second partial fluid channel as this limitation only denotes functional limitations).
In regard to claim 15, Van Antwerp discloses, wherein coupling the first piece to the second piece aligns the first partial fluid channel and the second partial fluid channel and forms a connector fluid channel between the first piece and the second piece (attaching 160 to housing 100 connects the tubing of 160 to the interior of the connector seen in 4C to deliver drugs through cannula 130).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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