DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I (claims 1-17) in the reply filed on 7/6/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The applicant only provided traversal argument for the species restriction.
Applicant's election with traverse of Species D (Fig. 5) in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that there is not a burdensome search. This is not found persuasive because the species would require at least divergent text searches.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 8-9, and 11-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/6/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-3, 10, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rensen et al. (US 9,915,523; hereafter Rensen).
In regard to claim 1, Rensen discloses a system for detecting fluid infiltration (see at least Figs. 3A-3B), the system comprising: a fluid delivery cannula (304; see col. 6, lines 62-63) comprising a distal end and a proximal end (see Figs. 3A-3B); a fluid source (“intravenous supply”; see col. 6, lines 62-63) fluidly coupled to the proximal end of the fluid delivery cannula; an optical sensor (320) optically coupled to an interior of the fluid delivery cannula (the sensor is optically coupled to the interior of 314 which in the embodiments of Figs. 3A-3B is an interior of the integrated single component; see at at least col. 7, lines 5-7), wherein the optical sensor is disposed between the distal end and the proximal end of the fluid delivery cannula (see Figs. 3A-3B) and configured to generate an electronic signal based on one or more characteristics of light sensed in the interior of the fluid delivery cannula when fluid from the fluid source is passed therethrough (see col. 7, lines 11-32; the characteristics of the light within 314 are measured); and a controller (324) configured to receive the electronic signal from the optical sensor and determine a fluid infiltration event based on the electronic signal (output 330 indicates to physician that the distal end of the system in not within a blood vessel; improper placement is an infiltration event).
In regard to claim 2, Rensen discloses further comprising: an outer cover (313) at least partially surrounding the fluid delivery cannula, the outer cover comprising an interior reflective surface (314) to internally reflect the light in the interior of the fluid delivery cannula (see col. 7, lines 1-32).
In regard to claim 3, Rensen discloses a light emitting device (310) optically coupled to the interior of the fluid delivery cannula and disposed between the distal end and the proximal end of the fluid delivery cannula (see Figs. 3A-3B), the light emitting device emitting light that is carried through the interior of the fluid delivery cannula (see col. 7, lines 1-32).
In regard to claim 10, Rensen discloses wherein the fluid delivery cannula (304) is a gravity fed fluid delivery cannula (functional limitation; “intravenous supply”; see col. 6, lines 62-63).
In regard to claim 15, Rensen discloses a fluid infiltration detection device (see Figs. 3A-3B), comprising: an optical sensor (320) optically coupled to a fluid delivery cannula (304) delivering fluid from a fluid source therethrough and positioned at a location remote from a distal end of the fluid delivery cannula (see Figs. 3A-3B), the optical sensor configured to generate an electronic signal based on one or more characteristics of light sensed in the interior of the fluid delivery cannula when the fluid from the fluid source passes therethrough (see col. 7, lines 11-32; the characteristics of the light within 314 are measured); and a controller (324) comprising a processor and a non-transitory, processor-readable storage medium, the non-transitory, processor-readable storage medium comprising programming instructions stored thereon that, when executed, cause the processor to: receive the electronic signal from the optical sensor, determine, based on the electronic signal, the one or more characteristics of the light, determine, based on the one or more characteristics of the light, a fluid infiltration event at the distal end of the fluid delivery cannula, and provide an alert indicating the fluid infiltration event (see col. 7, lines 11-32).
In regard to claim 16, Rensen discloses further comprising a light emitting device (310) that emits light that is carried through an interior of the fluid delivery cannula, reflected at a target site adjacent to the distal end of the fluid delivery cannula, and sensed by the optical sensor (see col. 6, line 60- col. 7, line 32).
In regard to claim 17, Rensen discloses wherein the programming instructions that cause the processor to determine the fluid infiltration event further cause the processor to measure a brightness and/or intensity of the light at the distal end of the fluid delivery cannula (see col. 6, lines 21-59).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Pesach et al. (US 8,622,991; hereafter Pesach).
In regard to claims 4-5, Rensen fails to disclose wherein the light emitting device is a laser diode and wherein the light emitting device is a plurality of light emitting devices.
In a similar art, Pesach discloses that optical irradiation elements can be made of known in the art light sources, such as LEDs, laser diodes, lamps, etc. The light source may emit pulsed light (see col. 32, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rensen with the art-recognized substitute of laser diodes as taught by Pesach because substituting equivalents to produce a predictable result is considered well within the skill of the ordinary artisan.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Moskal (US 2016/0209483).
In regard to claim 7, Rensen fails to disclose wherein the optical sensor is a silicon photomultiplier avalanche diode (SPAD).
In a similar art, Moskal teaches the use of a silicon photomultipliers or avalanche diode (see par. [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rensen with the art-recognized substitute as taught by Moskal because substituting equivalents to produce a predictable result is considered well within the skill of the ordinary artisan.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rensen in view of Warren et al. (US 2013/0317373; hereafter Warren).
In regard to claims 13-14, Rensen fails to disclose further comprising: a user interface communicatively coupled to the controller and wherein the user interface is configured to provide an alert to a user when the fluid infiltration event is determined by the controller.
In a similar art, Warren discloses a user interface (see Figs. 28A-28C) communicatively coupled to the controller and wherein the user interface is configured to provide an alert to a user when the fluid infiltration event is determined by the controller (see par. [0264]-[0265]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rensen with the graphical user interface in order to provide an art-recognized means for providing an input/output means for a medical device.
Conclusion
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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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