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 Group I and Species B in the reply filed on 02/26/2025 is acknowledged.
Claims 6-9 and 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/26/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/08/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 3, and 5 are objected to because of the following informalities:
Regarding claim 1, in lines 8-9 the phrase “a irregularity threshold” should read “an irregularity threshold” in order to be grammatically correct.
Regarding claim 3, in line 4 the phrase “a surface of the skin” should read “a surface of skin” because this claim limitation has not been introduced previously.
Regarding claim 5:
In line 2 the phrase “an infusion set” should read “the infusion set” since this claim limitation was previously introduced in claim 1.
In line 3 the phrase “providing an infusion fluid from a fluid source” should read “providing the fluid from the fluid source” since these claim limitations were previously introduced in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4, in lines 2-3 the phrase “a baseline light intensity of the first venous rhythm” is recited. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not introduce a light source (whereas claim 2 does). For examination reasons, this claim will be interpreted as depending from claim 2 instead.
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.
Claims 1, 5, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hochman et al. (WO 2021216089 A1).
Regarding claim 1, Hochman et al. discloses a method for detecting an infusion site failure (para. 0011), comprising:
detecting a first venous rhythm (Fig. 1, para. 0025, measurement of the cardiac pulse via needle 302 or catheter 310) of a patient (Fig. 2, patient 20) above a venous insertion site of the patient (Fig. 2, para. 0025, para. 0070, selected treatment location may be a vein) when a venous catheter (Fig. 1, catheter 310) is inserted into the venous insertion site (para. 0025), the venous catheter being connected to an infusion set providing a fluid to the venous insertion site from a fluid source (Fig. 1, para. 0025, an in-line pressure sensor 300 may be provided in fluid communication with, and between, the needle 302 (or catheter 310) and a manual, handheld syringe 200);
detecting, concurrently with the first venous rhythm, a second venous rhythm at a location remote from the venous insertion site (see Fig 2, para. 0026, a cardiac pulse may be detected using a finger pulse oximeter);
identifying an irregularity between the first and second venous rhythms (para. 0068, no pulse wave correlation found between the signal from the in-line pressure sensor and the secondary input source); and
detecting a failure of the venous catheter based on the identified irregularity satisfying an irregularity threshold (para. 0055, para. 0068).
Regarding claim 5, Hochman et al. discloses the method of claim 1, further comprising:
providing an infusion set configured to connect the venous catheter to an infusion line providing an infusion fluid from a fluid source (see Figs. 1-2, para. 0025, handheld syringe 200 is coupled to catheter 310), the infusion set comprising a transducer configured to detect the first venous rhythm (Fig. 1, para. 0025, sensor 300).
Regarding claim 11, Hochman et al. discloses the method of claim 1, further comprising:
providing audio, visual, or haptic alarm responsive to detecting the failure of the venous catheter (para. 0055).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman et al. (WO 2021216089 A1) in view of Eagle et al. (U.S. Patent Application Publication No. 20210267468 A1).
Regarding claim 2, Hochman et al. discloses the method of claim 1. Hochman et al. fails to teach wherein identifying the irregularity comprises: detecting a leakage of a fluid infused into tissue proximate the venous insertion site based on a pulsatile amplitude of the first venous rhythm declining with respect to a baseline pulsatile amplitude.
However, Eagle et al. teaches a method for detecting an infusion site failure (para. 0132, IV infiltration) wherein identifying the irregularity comprises: detecting a leakage of a fluid infused into tissue proximate the venous insertion site (Fig. 2B, para. 0102, Fig. 2B shows a result of IV infiltration) based on a pulsatile amplitude of the first venous rhythm declining with respect to a baseline pulsatile amplitude (para. 0132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of identifying an irregularity of Hochman et al. to include detecting a leakage of a fluid infused into tissue proximate the venous insertion site based on a pulsatile amplitude of the first venous rhythm declining with respect to a baseline pulsatile amplitude, as taught by Eagle et al., in order to determine the functionality of an IV catheter (para. 0132).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman et al. (WO 2021216089 A1) in view of Eagle et al. (U.S. Patent Application Publication No. 20210267468 A1) and further in view of Hollis (U.S. Patent No. US 6081741 A).
Regarding claim 3, the modified method of Hochman et al. discloses the method of claim 2, further comprising:
wherein the first venous rhythm is detected based on detecting a time varying amplitude of a light source (Hochman et al., see para. 0030, para. 0070, sensor 300 may be an optical sensor).
Hochman et al. fails to teach determining that the venous catheter has moved closer to a surface of the skin based on an intensity of the light source increasing to satisfy a first threshold; and determining that the venous catheter has punctured deeper into the tissue based on the intensity of the light source decreasing to satisfy a second threshold.
However, Hollis teaches a method to locate a surgical site (col. 2 lines 29-31), comprising determining that the catheter (Fig. 1, emitter assembly 10) has moved closer to a surface of the skin based on an intensity of the light source increasing to satisfy a first threshold, and determining that the catheter has punctured deeper into the tissue based on the intensity of the light source decreasing to satisfy a second threshold (col. 5 lines 6-23, the intensity of the energy at any point is lessened as the distance from a point source is increased).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hochman et al. to include determining the catheter depth based on the intensity of a light source, as taught by Hollis, in order to easily locate the center of a field of light emanating from a point source (col. 5 lines 19-23).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman et al. (WO 2021216089 A1) in view of Eagle et al. (U.S. Patent Application Publication No. 20210267468 A1) and further in view of in view of Willard et al. (U.S. Patent Application Publication No. 20150174355 A1) (see 112(b) rejection above regarding claim interpretation).
Regarding claim 4, the modified method of Hochman et al. discloses the method of claim 1, further comprising: detecting an occlusion associated with the venous insertion site (Hochman et al., para. 0069, if the pressure does not dissipate over time, and no pulse wave correlation is found between the signal from the in-line pressure sensor and the secondary input source the clinician can conclude that the catheter is clogged). The modified method of Hochman et al. fails to teach detecting an occlusion associated with the venous insertion site based on a baseline light intensity of the first venous rhythm remaining unchanged while a pulsatile amplitude of the first venous rhythm is declining.
However, Willard et al. teaches a method for detecting an occlusion of a blood vessel (para. 0042) based on a baseline light intensity of the first venous rhythm remaining unchanged while a pulsatile amplitude of the first venous rhythm is declining (para. 0042, the degree of occlusion of the blood vessels can be assessed based on the (change in) detected oscillation, one of ordinary skill in the art can appreciate that an occlusion of a blood vessel can case a decrease of pulse amplitude).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hochman et al. to include detecting an occlusion associated with the venous insertion site based on a baseline light intensity of the first venous rhythm remaining unchanged while a pulsatile amplitude of the first venous rhythm is declining, as taught by Willard et al., in order to measure blood flow in the blood vessels (para. 0042).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman et al. (WO 2021216089 A1) in view of Atkins et al. (U.S. Patent No. 4877034 A).
Regarding claim 10, Hochman et al. discloses the method of claim 1, further comprising: determining that an extravasation has occurred (para. 0069). Hochman et al. fails to teach detecting, when the irregularity is identified, a change in topography or light absorption of a portion of epidermis adjacent the venous insertion site; determining that an extravasation has occurred based on the change in topography or light absorption satisfying an extravasation threshold.
However, Atkins et al. teaches a method of detecting infusion site failure (col. 2 lines 58-61) including detecting, when an irregularity is identified (col. 5 lines 5-10, when the difference or ratio of EM radiation wavelength readings deviate outside the normal range), a change in topography or light absorption of a portion of epidermis adjacent the venous insertion site (col. 3 lines 62-68); determining that an extravasation has occurred based on the change in topography or light absorption satisfying an extravasation threshold (col. 3 lines 62-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hochman et al, to include detecting an extravasation based on a change in light absorption adjacent to the venous insertion site, as taught by Atkins et al., in order to prevent edema or necrosis of the tissue (col. 2 lines 8-11).
Conclusion
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/AMBER R VENTURA/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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