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 .
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) 1-19 is/are rejected under 35 U.S.C. 102(b)(1) as being anticipated by US Pre-Grant Publication 2018/0214634 to Neftel et al. (Neftel hereinafter).
Regarding claim 1, Neftel teaches a medicament delivery system (1) comprising a reservoir (103) carrying a medicament (paragraph 3), a pump (100) to draw the fluid out of the reservoir for delivery, and an occlusion sensor (4, 13) connected (at least indirectly) to the reservoir that senses whether an occlusion is present (see e.g. paragraph 227).
Regarding claim 2, Neftel teaches a reservoir (103) which is flexible to at least a minimal extent.
Regarding claim 3, Neftel teaches that the occlusion sensor includes a strain gauge (at least element 4, see paragraph 130).
Regarding claim 4, Neftel teaches that the sensor does not contact the medicament (see Fig. 1a, sensor shown on non-fluid contacting side of diaphragm at 13).
Regarding claims 5-6, Neftel teaches a strain gauge (which detects strain, not pressure or current draw).
Regarding claim 7, Neftel teaches determination of resistance and output thereof to control electronics (see e.g. paragraphs 335-343). To the extent necessary, the electronics and programming accomplishing this determination are considered herein to be a part of the occlusion sensor.
Regarding claim 8, resistance decay is an inherent part of operating such an infusion device.
Regarding claim 9, Neftel teaches that the occlusion is detected when the resistance does not decay according to a designated pattern (paragraph 354, e.g. decreasing resistance).
Regarding claim 10, Neftel teaches a strain gauge which will detect changes in at least some forces across the reservoir, such as pressure forces therein.
Regarding claim 11, Neftel teaches that medicament exits the reservoir, upon which at least tension caused by the weight of the medicament will be reduced.
Regarding claim 12, Neftel teaches that the tension is measured along at least some axis.
Regarding claim 13, Neftel teaches that the occlusion sensor (4, 13) is insensitive to forces along at least some lateral axes across the reservoir.
Regarding claim 14, Neftel teaches that either as a result of the occlusion or the operation of the pump, the occlusion prevents the medicament from exiting the reservoir (see e.g. paragraph 248).
Regarding claim 15, Neftel teaches that the occlusion sensor (4, 13) is at least indirectly bonded to an outer surface of the reservoir (see Fig. 1a).
Regarding claim 16, Neftel teaches operation of a medicament delivery system (1) comprising a reservoir (103) carrying a medicament (paragraph 3), a pump (100) to draw the fluid out of the reservoir for delivery, and an occlusion sensor (4, 13) connected (at least indirectly) to the reservoir that senses whether an occlusion is present (see e.g. paragraph 227). Neftel teaches at least indirectly securing the occlusion sensor (4, 13) to an outer surface of the reservoir, operating the delivery system, measuring resistance (paragraphs 335-343) and providing such to control electronics, and determining the presence of occlusion (paragraph 248).
Regarding claim 17, Neftel teaches securing the occlusion sensor at least indirectly to all parts, including a mid-section, of the outer surface of the flexible reservoir.
Regarding claim 18, measurement of axial tension and compression along at least some axis is inherent in the operation of a strain gauge (paragraph 130).
Regarding claim 19, Neftel teaches that the occlusion is detected when the resistance does not decay according to a designated pattern (paragraph 354, e.g. decreasing resistance).
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 23 December 2025