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 and 5-19 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). Furthermore, Neftel teaches a reservoir (103) which is flexible to at least a minimal extent, that the occlusion sensor includes a strain gauge (at least element 4, see paragraph 130), and 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). Furthermore, Neftel teaches a reservoir (103) which is flexible to at least a minimal extent, that the occlusion sensor includes a strain gauge (at least element 4, see paragraph 130), and that the sensor does not contact the medicament (see Fig. 1a, sensor shown on non-fluid contacting side of diaphragm at 13).
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).
Response to Arguments
Applicant's arguments filed 20 April 2026 have been fully considered but they are not persuasive.
With respect to the argument that Neftel does not teach an occlusion sensor connected to the reservoir, the examiner is not persuaded. Regarding claim 1, the claim requires only an occlusion sensor “connected to the reservoir” which does not require direct physical contact. Instead, a broadest reasonable interpretation includes at least operational connection and indirect physical connection. Since indirect physical connection is present in Neftel, this is sufficient to establish anticipation. Regarding claim 16, the claim requires securing the sensor to an outer surface of the reservoir. Again, all elements of the assembly are considered to be assembled and secured together. This is sufficient to anticipate the claim.
With respect to the argument that the strain gauge contacts the medicament in Neftel, the examiner notes that the lead lines from the processor as illustrated in Fig. 1a are drawn to the lower side, opposite the pumping chamber. The examiner concludes that Neftel teaches strain gauges which do not contact the medicament. The examiner is referring to the actual Wheatstone bridge elements as the recited sensor, and not the diaphragm to which they are attached.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,989,222 teaches another occlusion sensor for an infusion pump. US Pre-Grant Publication 2011/0208123 teaches a strain gauge (708) attached to the plunger of a reservoir (paragraph 197). US Pre-Grant Publication 2015/0088092 teaches occlusion and non-occlusion by measuring a property related to a deformable reservoir (paragraph 25).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 26 June 2026
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