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 .
Response to Amendment
Applicant’s amendment filed June 16, 2026 has been entered. Claims 18-20, 22-25, 28-34, 37, 40 and 43-46 are pending.
In light of continued examination, an objection to the Specification is presented.
Applicant’s amendments have obviated previous claim objections.
Applicant’s arguments regarding indefiniteness of the term “about” are persuasive, and have overcome each rejection to the claims under 35 U.S.C. 112(b).
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 103.
Response to Arguments
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 103 dated June 16, 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 28, and 45 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) in further view of
Hunt et al. (US 20210145354 A1) (hereinafter -- Hunt).
Re. Claim 18: JW teaches a system comprising:
an article (Fig. 1: system 100)
comprising:
a body (Figs. 1, 3: sensor dressing 300).
JW does not teach the invention comprising a first electrode disposed on the body, wherein the first electrode comprises at least one skin-penetrating microfeature; and a second electrode disposed on the body, wherein the second electrode comprises at least one skin-penetrating microfeature. 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.
The concept of electrodes having skin-penetrating microfeatures is well-known. 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).
JW as modified by Farringdon does not teach a controller mounted to the body of the article and electrically connected to the first electrode and the second electrode. JW as modified by Farringdon teaches a controller electrically connected to the first 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). Thus, JW as modified by Farringdon is solely deficient in teaching that the controller is mounted to the body of the sensor dressing 118, i.e., the article.
Hunt teaches analogous art in the technology of sensor-enabled wound dressings (Title; Abstract). Hunt further teaches the invention wherein a controller is mounted to the body of the wound dressing, i.e., an article, and also electrically connected to sensors thereon (Paragraph 0236: “In certain implementations, a controller (such as a microprocessor) can be mounted on the wound dressing and connected to the one or more sensors. Such a mounted controller can communicate with a control module over a connection, such as 3 or 4 wire connection (or less or more wires), to alleviate burdens associated with connecting to external component(s)”).
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 mount a controller on the wound dressing itself as taught by Hunt, the motivation being that doing so creates a more compact sensing apparatus.
JW as modified by Farringdon and Hunt further teaches the invention wherein the controller is configured to:
provide an input to the first 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”);
receive an output from the second electrode based on providing to the input signal to the first electrode (see previous citations of Paragraphs 0092, 0095; similarly recited in Paragraphs 0174, 0191);
determine at least one electrical parameter based on the output (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 a tissue based on the at least one electrical parameter (see citations of Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182).
Re. Claim 19: JW as modified by Farringdon and Hunt teaches the invention according to claim 18. JW further teaches the invention wherein the controller is further configured to determine
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)
or a time period of extravasation (since this is an alternative clause, see rejection of Williams Jr. in the rejection of claim 25),
or a combination thereof, based on the at least one electrical parameter.
Re. Claim 20: JW as modified by Farringdon and Hunt 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 28: JW as modified by Farringdon and Hunt teaches the invention according to claim 18. JW further teaches the invention wherein, based on detecting extravasation of the fluid, the controller is further configured to:
generate an alert (Paragraph 0070: “The control unit 124 may have an alarm…”); or
provide an input 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”);
or a combination thereof.
Re. Claim 45: JW as modified by Farringdon teaches the invention according to claim 44 (see rejection of claim 44), but does not teach the invention wherein the controller is mounted to the body of the article.
JW as modified by Farringdon teaches a controller electrically connected to the first 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). JW is solely deficient in teaching that the controller is mounted to the body of the sensor dressing 118, i.e., the article.
Hunt teaches analogous art in the technology of sensor-enabled wound dressings (Title; Abstract). Hunt further teaches the invention wherein a controller is mounted to the body of the wound dressing, i.e., an article, and also electrically connected to sensors thereon (Paragraph 0236: “In certain implementations, a controller (such as a microprocessor) can be mounted on the wound dressing and connected to the one or more sensors. Such a mounted controller can communicate with a control module over a connection, such as 3 or 4 wire connection (or less or more wires), to alleviate burdens associated with connecting to external component(s)”).
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 mount a controller on the wound dressing itself as taught by Hunt, the motivation being that doing so creates a more compact sensing apparatus.
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
Hunt et al. (US 20210145354 A1) (hereinafter -- Hunt) in further view of
Williams Jr. et al. (US 20060089544 A1) (hereinafter – Williams Jr.).
Re. Claim 25: JW as modified by Farringdon and Hunt 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 and Hunt 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.
Claims 29-31, 37, 43, 44, and 46 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) in further view of
Hunt et al. (US 20210145354 A1) (hereinafter -- Hunt).
Re. Claim 29: JW teaches a method of using an article that comprises a body (It is understood that the term “body” as claimed does not encompass a human body, but is directed to a body of a device as shown in Applicant’s Fig. 2: element 202 and in light of Applicant’s Specification; Paragraph 0006: “The invention relates generally to physiological monitoring devices and, more particularly, to tissue monitoring devices and methods for detecting harmful conditions including conditions that occur during intravascular infusion;” Fig. 1: system 100 comprising film barrier dressing 300),
a securement device mounted to the body (Paragraph 0088: “The film barrier dressing 300 has a laminar structure comprising, for example, a base film 312, an adhesive layer 314 coupled to an application side of the base film 312 and a foam layer 316 coupled to the base film surface opposite the adhesive”).
JW does not teach the invention further comprising a first electrode mounted to the body on a first lateral side of the securement device and comprising a first skin- penetrating microfeature, and a second electrode mounted to the body on a second lateral side of the securement device and comprising a second skin-penetrating microfeature. JW describes first and second electrodes disposed on lateral sides of the securement device (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.
The concept of electrodes having skin-penetrating microfeatures is well-known. 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).
JW as modified by Farringdon further teaches the invention wherein the method comprises:
supporting an intravenous catheter at an injection site with the securement device (Claim 3: film barrier dressing is capable of securing an intravenous catheter);
piercing skin with the first skin-penetrating microfeature on a first lateral side of the injection site (Examiner notes that such a step is implicit when applying the film dressing of JW modified by the skin-penetrating microfeatures of Farringdon);
providing an input to the first 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”);
receiving an output signal from the second electrode based on providing the input (Paragraphs 0092, 0095; similarly recited in Paragraphs 0174, 0191);
determining at least one electrical parameter based on the output (Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182: impedance sensing from injected signals); and
determining extravasation of a fluid into a tissue based on the at least one electrical parameter (Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182).
Re. Claim 30: JW as modified by Farringdon teaches the invention according to claim 29. JW further teaches the invention further comprising determining
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)
or a time period of extravasation (since this is an alternative clause, see rejection of Williams Jr. in the rejection of claim 25),
or a combination thereof, based on the at least one electrical parameter.
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 43: JW teaches a system (Fig. 1: system 100),
comprising:
an article (Fig. 1: system 100 comprising a film barrier dressing 300), comprising:
a body (Fig. 1: film barrier dressing 300);
a securement device mounted to the body (Paragraph 0088: “The film barrier dressing 300 has a laminar structure comprising, for example, a base film 312, an adhesive layer 314 coupled to an application side of the base film 312 and a foam layer 316 coupled to the base film surface opposite the adhesive”)
and operable to support an intravenous catheter at an injection site (Claim 3: film barrier dressing is capable of securing an intravenous catheter).
JW does not teach the invention comprising a first electrode mounted to the body on a first lateral side of the securement device and including a skin-penetrating microfeature; and a second electrode mounted to the body on a second lateral side of the securement device and including a second skin-penetrating microfeature. JW describes first and second electrodes disposed on lateral sides of the securement device (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.
The concept of electrodes having skin-penetrating microfeatures is well-known. 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 44: JW as modified by Farringdon teaches the invention according to claim 43. JW further teaches the invention further comprising a controller in electrical communication with the first and second electrodes and operable to:
provide an input to the first 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”);
receive an output from the second electrode (Paragraphs 0092, 0095; similarly recited in Paragraphs 0174, 0191);
determine a parameter based on the output (Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182: impedance sensing from injected signals); and
detect extravasation of fluid based on the parameter (see citations of Paragraphs 0062, 0080, 0094, 0100, 0104, 0107, 0109, 0173, 0177, 0178, 0179, 0181, 0182).
Re. Claim 46: JW as modified by Farringdon teaches the invention according to claim 43. JW further teaches the invention wherein the securement device includes a retention feature to secure to the intravenous catheter (Claim 3: the film barrier dressing is claimed as capable of securing an intravenous catheter; thus, it also comprises a retention feature which secures to the intravenous catheter).
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 a 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 a 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).
Allowable Subject Matter
Claims 21-24 and, similarly, claims 32-34 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
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.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN XU/Primary 3Examiner, Art Unit 3791
Prosecution Insights