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 Objections
Claim 29 is objected to because of the following informalities:
“1 megahertz determining an output” should read instead as “1 megahertz; determining an output” or the like.
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.
Claims 18, 22-24, 29, 31-34, 37, and 40 are 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.
Re. Claims 18, 22-24, 29, 31-34, 37, and 40: Each of these claims listed above recite the term “about,” which is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Re. Claim 31: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation “wherein the input signal has a frequency ranging from about 0 hertz to about 1 gigahertz,” and the claim, by dependency to claim 29, also recites a range of 400 kHz to 1 MHz, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 18-20, 26-31, 37, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over:
Jersey-Willuhn et al. (US 20030216663 A1) (hereinafter – JW) in view of
Farringdon et al. (US 20050113703 A1) (hereinafter – Farringdon).
Re. Claim 18: JW teaches a system for detecting extravasation into a tissue (Abstract),
the system comprising:
an article (Fig. 1: sensor dressing 118)
comprising:
a body comprising a first major surface (Paragraph 0089: any surface defined by electrode contact with skin, as described in “A plurality of electrodes 330 are patterned in the conductive ink and also in conductive portions of the adhesive and integrated hydrogel to make contact with the patient's skin”),
an opposing second major surface (Fig. 3: any surface opposing the previously defined surface),
a first side, and an opposing second side (Fig. 1: any opposing sides; Examiner notes that “side” is not used later in the claims);
wherein the first electrode is electrically connected to the second electrode
(Paragraph 0092: “The electrodes 330 are typically configured as two or more electrode pairs. For example, so that alternating electrical energy may be applied to a first pair of electrodes to generate an electric field to induce a signal in a second electrode pair. The generated field is a function of the impedance of the tissue”); and
a controller electrically connected to the first electrode and the second electrode (Fig. 1: control unit connected to electrodes 120 via sensor signal pathway 126; Fig. 2: physiological monitoring system 200 communicating with sensor pathway 126 via fiber optic line 128; Figs. 5, 6a, 6b: combination of any processing components aside from electrodes),
wherein the controller is configured to:
provide an input signal across the first electrode and the second electrode (Paragraph 0095: “The control unit applies a voltage across a first pair of electrodes to induce a signal in a second pair of electrodes and measures impedance at the second pair of electrodes. The control unit stores the impedance measurements over time and determines changes in the impedance from a baseline measurement taken prior to commencing the injection procedure”);
determine an output signal across the first electrode and the second electrode in response to the input signal (see previous citations of Paragraphs 0092, 0095; similarly recited in Paragraphs 0174, 0191),
wherein the input signal ranges from about 400 kilohertz to about 1 megahertz (Paragraph 0103: “The current source 412 typically injects radio frequency (RF) energy in a suitable range of frequencies, for example from one kilohertz to about one megahertz;” Paragraph 0174: “Other suitable currents and frequencies may be used. For example, Electrical Impedance Tomography imaging typically uses frequencies above 1 kHz and less than 100 kHz, although some applications may utilize frequencies up to 10 mHz and above. A system with capability to operate in a frequency range between 10 kHz and 10 MHz is highly flexible”);
determine at least one electrical parameter based on the output signal and the input signal (Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182: impedance sensing from injected signals);
and detect extravasation of a fluid into the tissue based on a change in the at least one electrical parameter (see citations of Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182).
JW describes first and second electrodes disposed on the first major surface of the body (Fig. 3: electrodes 330; Fig. 4: electrodes 410, 416; Fig. 5: electrodes 510; Fig. 6: electrode array 616). JW does not describe such electrodes as having at least one skin-penetrating microfeature.
Farringdon teaches analogous art in the technology of electrode-based sensors (Abstract). Farringdon further teaches that electrodes may comprise microneedles to penetrate the skin (Paragraph 0075).
It would have been obvious to one having skill in the art before the effective filing date to have modified JW to include a skin-penetrating microfeature on each of the electrodes as taught by Farringdon, the motivation being that doing so enhances the electrodes’ ability to remain properly positioned at a measurement location (Paragraph 0075).
Re. Claim 19: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention wherein the controller is further configured to determine at least one of
an extravasated volume of the fluid (Paragraph 0104: “Extravasation causes a volume change due to tissue swelling and a conductivity change which, in combination, change the electrical impedance sensed by the receiving electrodes 416;” Paragraph 0168: “One or more of various types of data can be stored, compared, and analyzed, for example including current data, reference data, baseline data, information trends, preset parameters, automatic comparison results, patient condition information for disease condition adjustments, environment information, cannula position and motion information, and infusion flow information;” Paragraph 0178: infusion rate is known; Examiner notes that since the device of JW knows an infusion rate, identifies an occurrence of extravasation within a window of infusion, and further discloses that various types of data may be compared to baseline, then the combination of identifying each of these features indicates that the controller of JW is configured to determine an extravasated volume of fluid)
and a time period of extravasation (since this is an alternative clause, see rejection of Williams Jr. in the rejection of claim 25 – this portion of the claim would be rejected in light of JW as modified by Farringdon and Williams Jr.)
based on the change in the at least one electrical parameter.
Re. Claim 20: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention wherein the at least one electrical parameter comprises one or more of
an impedance magnitude (Paragraph 0178: “In one example, extravasation is indicated if the impedance changes with a substantially consistent slope of .+-.0.5 .OMEGA./s or more during infusion at a rate of at least 1000 cc over 24 hours or an intermittent infusion of over 100 cc in one hour;” Paragraph 0179: “In an example, tissue impedance is considered to be affected by extravasation because ionic contrast media has lower impedance than tissue. For ionic contrast media extravasation, measured impedance is less than the measured tissue impedance prior to extravasation. A non-ionic contrast media has higher impedance than tissue and causes increased impedance during an extravasation”),
an impedance phase angle,
a capacitance,
a resistance, and
a reactance.
Re. Claim 26: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention wherein the controller is coupled to the article (Fig. 1: control unit 124 coupled to sensor dressing 118 via sensor pathway 126, described as “any suitable technology including conductive wires, fiberoptic channels, wireless channels, and others” in Paragraph 0057).
Re. Claim 27: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention wherein the controller is spaced apart from the article (Fig. 1: control unit 124 is spaced from sensor dressing 118).
Re. Claim 28: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention wherein, upon detecting extravasation of the fluid, the controller is further configured to perform at least one of:
generating an alert (Paragraph 0070: “The control unit 124 may have an alarm…”); and
providing a stop signal to an infusion system to automatically stop infusion of the fluid (Paragraph 0071: “… the control unit 124, can detect harmful tissue conditions and reduce complications by adjusting infusion flow or terminate infusion in response to the alarm condition”).
Re. Claim 29: Claim 29 recites, mutatis mutandis, limitations of claims 18 and 20 in combination. Thus, the citations of the rejection of claim 20 teaches each requirement of claim 29.
Re. Claim 30: JW as modified by Farringdon teaches the invention according to claim 29. Claim 30 recites, mutatis mutandis, limitations of claim 19. Thus, the citations of the rejection of claim 19 teaches each requirement of claim 30.
Re. Claim 31: JW as modified by Farringdon teaches the invention according to claim 29. JW further teaches the invention wherein the input signal has a frequency ranging from about 0 hertz to about 1 gigahertz (Paragraph 0103: “The current source 412 typically injects radio frequency (RF) energy in a suitable range of frequencies, for example from one kilohertz to about one megahertz;” Paragraph 0174: “Other suitable currents and frequencies may be used. For example, Electrical Impedance Tomography imaging typically uses frequencies above 1 kHz and less than 100 kHz, although some applications may utilize frequencies up to 10 mHz and above. A system with capability to operate in a frequency range between 10 kHz and 10 MHz is highly flexible”).
Re. Claim 37: JW as modified by Farringdon teaches the invention according to claim 29. JW further teaches the invention further comprising determining the impedance magnitude for a frequency of the input signal ranging from about 400 kilohertz to about 1 megahertz (JW teaches the requisite frequency ranges as well as identifying impedance, i.e., a magnitude thereof).
Re. Claim 41: JW as modified by Farringdon teaches the invention according to claim 18. JW further teaches the invention further comprising generating an alert upon detecting extravasation (Paragraph 0070: “The control unit 124 may have an alarm…”).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over:
Jersey-Willuhn et al. (US 20030216663 A1) (hereinafter – JW) in view of
Farringdon et al. (US 20050113703 A1) (hereinafter – Farringdon) in further view of
Williams Jr. et al. (US 20060089544 A1) (hereinafter – Williams Jr.).
Re. Claim 25: JW as modified by Farringdon teaches the invention according to claim 18, but does not teach the wherein the controller is further configured to store a timestamp indicative of extravasation of the fluid in a memory.
Williams Jr. teaches analogous art in the technology of monitoring extravasation (Paragraph 0005). Williams Jr. further teaches the invention wherein the controller is further configured to store a timestamp indicative of extravasation of the fluid in a memory (Paragraph 0005: “Such EDA data may include but is not limited to, time and date stamps, an indication as to whether or not the EDA was enabled, and indication of whether or not an extravasation event was detected during a given dispensing operation, and an impedance profile (over time) generated by the EDA as it is adhered to an injection site;” similarly recited in Paragraphs 0040, 0045, 0049, 0056, 0057; Figs. 6, 7).
It would have been obvious to one having skill in the art before the effective filing date to have modified JW as modified by Farringdon to include logging a time/date stamp of when extravasation occurred as taught by Williams Jr., the motivation being that doing so allows a third party (e.g., medical professional) to assess the status of an infusion or injection relative to how long ago possible extravasation occurred (Figs. 6, 7) and how such presence of extravasation may impact an assessed patient.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over:
Jersey-Willuhn et al. (US 20030216663 A1) (hereinafter – JW) in view of
Farringdon et al. (US 20050113703 A1) (hereinafter – Farringdon) in further view of
Rubinsky et al. (US 20080224688 A1) (hereinafter – Rubinsky).
Re. Claim 40: JW as modified by Farringdon teaches the invention according to claim 29, but does not teach the invention further comprising determining the reactance for a frequency of the input signal of about 1 megahertz.
Rubinsky teaches analogous art in the technology of analyzing tissue water content (Abstract), including detection of extravasation (Paragraph 0049). Rubinsky further teaches the invention further comprising determining the reactance for a frequency of the input signal of about 1 megahertz (Paragraph 0037: use of 1MHz signals; Paragraph 0048: “Briefly, body tissues contain intra and extracellular fluids that behave as electrical conductors and cell membranes that act as electrical capacitors. At DC and low frequencies electrical current passes mainly through the extracellular fluid; at higher frequencies, however, current penetrates both intra and extracellular fluids. Therefore, body fluids and electrolytes are responsible for electrical resistance and cell membranes for reactance. At MHz frequencies the impedance of proteins becomes important…”).
It would have been obvious to one having skill in the art before the effective filing date to have modified JW as modified by Farringdon to include identifying reactance of an input signal for signals of about 1 MHz, the motivation being that Rubinsky teaches that the impedance of proteins in intra- and extracellular fluids become an important consideration for assessing net water content in a volume (Paragraph 0037).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over:
Jersey-Willuhn et al. (US 20030216663 A1) (hereinafter – JW) in view of
Farringdon et al. (US 20050113703 A1) (hereinafter – Farringdon) in further view of
Montalvo et al. (US 20150105724 A1) (hereinafter – Montalvo).
Re. Claim 42: JW as modified by Farringdon teaches the invention according to claim 29, but does not teach the invention further comprising:
providing a securement device on a second major surface of the body; and
detachably coupling an intravenous catheter with the securement device.
Montalvo teaches analogous art in the technology of therapeutic injection devices (Abstract). Montalvo further teaches the invention further comprising:
providing a securement device on a second major surface of the body (Fig. 1: body 110 on patch 120); and
detachably coupling an intravenous catheter with the securement device (Fig. 1: body 110 having parts as described in Paragraph 0023: “The introducer port 130 is used to place a delivery tube subcutaneously in the patient. The injection port 140 is used by the patient to inject a therapeutic agent, which as defined herein can be any liquid such as a liquid including a therapeutic agent, drug, diagnostic agent, or the like”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the device of JW as modified by Farringdon to include the body 110 of Montalvo, the motivation being that doing so provides a variety of ports to detachably couple requisite medical devices, depending on the medication or fluid required by the patient (Paragraph 0023).
Examiner’s Note
Claims 21-24 and, similarly, claims 32-34 are dependent claims which do not possess prior art rejections. None of the current prior art of record teach or suggest:
“for the input signal having a frequency of about 1 megahertz,
the first electrode and the second electrode provide a data set correlating a percentage change of the at least one electrical parameter to the extravasated volume of the fluid, and
wherein a best linear fit to the data set has a slope of at least about 5% per milliliter of the fluid.”
Claims 21-24 and 32-34 are presently rejected under 35 U.S.C. 112(b) and possess prior rejections due to the dependency on claims 18 and 29.
Conclusion
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/JUSTIN XU/Primary 3Examiner, Art Unit 3791