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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 20171259.3, filed on 04/30/2021.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-19, 23-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand (US 7837667) in view of Abdolahi (US 20180235539).
Regarding claim 15, Gelfand discloses a monitoring device for monitoring the fluid balance of an animal or human body (Fig. 1: system 10 monitors an maintains fluid balance of body P; col. 5, lines 47-55), the device comprising: a fluid delivery device (Fig. 1: infusion pump 22) for providing a controllable supply of fluid to the body (col. 8, lines 60-62, the supply of fluid from 22 is controlled), a urine output sensor for determining the urine output of the body (urine output sensor being meter 36 comprising scale 50; col. 8, lines 63 – col. 9, lines 4, 50 measures the urine output from P), and a processor (38 of controller 34’’), wherein said processor is adapted for: determining a fluid outtake (Fig. 4: fluid outtake measured by the urine weight, steps 110 and 112; col. 10, lines 38-48) due to a signal provided by the urine output sensor (col. 8, line 66 – col. 9, line 4) and a determined fluid intake into account (Fig. 4: at step 116 of adjusting the hydration pump setting, current pumping of fluid intake is taken into account for the desired adjustment; col. 11, lines 35-42, the intake of the hydration fluid taken into account); and providing a control signal to the fluid delivery device (col. 13, lines 14-17) to regulate a volume, flow velocity or flow rate of the fluid delivered to the body, so as to maintain a predetermined fluid balance in the body (Fig. 12: infusion flow is adjusted by the controller and pump to maintain the patient’s net hydration rate, being the predetermined fluid balance; col. 14, lines 22-24). Gelfand, however, fails to disclose the device including a body weight sensor for weighing the body continuously or periodically.
Abdolahi teaches an analogous device (Fig. 1: 10) for monitoring the fluid retention, and therefore fluid balance, of a patient, the device including a body weight sensor (Fig. 1: 20) for continuously or periodically weighing the body (para. [0031], sentences 2-3; para. [0023], sentence 3, the continuous monitoring of the weight for changes). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Gelfand device system by incorporating the weight sensor (20) in the sole of the sock device (12) taught by Abdolahi, in order to integrate continuous weight measurements into the fluid balance monitoring and analysis of Gelfand for a more complete and accurate assessment of the patient’s changes in body fluids. Additionally, this combination would help ensure a more accurate assessment of the patient’s changes in body fluids in the case of a leak or error with the fluid output collection (Gelfand: col. 31, lines 27-32). It directly follows that this combination would meet the limitation of determining a fluid outtake due to perspiration and respiration by taking a signal provided by the body weight sensor, since the weight measurements of Abdolahi take into consideration all fluid outtake of the body including respiration and perspiration, and this data would be integrated into the processor and edema detection performed by Gelfand.
Regarding claim 16, Gelfand in view of Abdolahi teaches the device of claim 15, as described above, further comprising a fluid retention detector for detecting edema in at least a part of the body (Abdolahi: Fig. 1: ankle edema sensors 16, 18; para. [0030], sentence 1), wherein the processor is adapted for detecting a condition of edema based on a signal from the fluid retention detector (Abdolahi: processor 28 uses signals form 16 and 18 to determine edema; para. [0035], last three sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also integrated the fluid retention detector of the sock device taught by Abdolahi into the Gelfand-Abdolahi combination, in order to provide an additional method of evaluating edema, and further improve the accuracy of the system’s edema detection, and specifically, early edema detection (Abdolahi: para. [0024], sentence 4).
Regarding claim 17, Gelfand in view of Abdolahi teaches the device according to claim 15, as described above, wherein the body weight sensor comprises at least one load cell (Abdolahi: Fig. 1: piezoresistive force sensor 20), integrated in or operably connected to a support structure for supporting the body in use of the device (Abdolahi: Fig. 1: sock 12 supporting 20 and the body; para. [0031], sentences 3-5).
Regarding claim 18, Gelfand in view of Abdolahi teaches the device according to claim 15, as described above, further comprising an alarm to alert an operator (Gelfand: Fig. 3: alarms 104 on the interface), wherein said processor is adapted to activate the alarm when the condition of edema is detected (Gelfand: col. 13, lines 45-48; Fig. 8C showing the body’s retention of fluid, just as in edema).
Regarding claim 19, Gelfand in view of Abdolahi teaches the device according to claim 15, as described above, wherein said processor is adapted to control the fluid delivery device so as to block the delivery of fluid to the body when the condition of edema is detected (Gelfand: col. 23, lines 59-63, net hydration limit relating to fluid retention, or edema, causing at least some blocking of fluid delivery by stopping net gain infusion).
Regarding claim 23, Gelfand in view of Abdolahi teaches the device according to claim 16, as described above, wherein the fluid retention detector comprises an element for enclosing a part of the body (Abdolahi: Fig. 1, band of sock 12 around the ankle) and a sensor module (Abdolahi: 16 and 18), which is integrated in or operably attached to the element (Abdolahi: Fig. 1: 16 and 18 integrated in ankle bank of sock; para. [0030], sentence 1) and adapted for generating a signal indicative of a circumference of the body part (Abdolahi: para. [0030], sentences 2-3).
Regarding claim 24, Gelfand in view of Abdolahi teaches the device according to claim 23, as described above, wherein said sensor module comprises a capacitive, inductive or resistive strain sensor, and/or a linear variable differential transformer (Abdolahi: para. [0030], sentence 1, inductive coil for strain).
Regarding claim 26, Gelfand in view of Abdolahi teaches the device according to claim 15, as described above, wherein the fluid delivery device comprises an intravenous pump (Gelfand: Fig. 1: pump 22 delivers fluids to patient via IV 30+32).
Regarding claim 27, Gelfand in view of Abdolahi teaches the device according to claim 15, as described above, wherein said urine output sensor comprises an optical sensing chamber, an ultrasonic transceiver, a measuring head, and/or a weighing system (Gelfand: weighing system 50 of urine output sensor 36).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand (US 7837667) in view of Abdolahi (US 20180235539) in further view of Sundaram (US 20190029566).
Regarding claim 25, Gelfand in view of Abdolahi teaches the device according to claim 16, as described above, but fails to teach the fluid retention detector having multiple parts positioned on various body parts, as the fluid retention detector taught by Abdolahi is taught as one detector placed around the ankle.
Sundaram teaches fluid retention detectors that detect the circumference and swelling of parts of the body (para. [0057]), analogous to the ankle fluid retention detector taught by Abdolahi. However, Sundaram teaches that the fluid retention detector comprises multiple parts for being positioned around different body parts (Figs. 4D-H: sensors 320 containing strain gauge 360 and circumference sensor 361, positioned at multiple, various parts of the body) and for generating separate signals indicative of swelling of each of the different body parts (Fig. 9: analysis of separate signals of swelling from the different body portions). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teaching of Sundaram to include multiple fluid retention detectors of the Gelfand-Abdolahi combination across different parts of the body in order to create a more accurate assessment of edema in the patient, regardless of where the fluid may collect first.
Claims 16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand (US 7837667) in view of Abdolahi (US 20180235539) in further view of Husheer (GB 2564243).
Regarding claim 16, Gelfand in view of Abdolahi teaches the device of claim 15, as described above, but does not teach a three-dimensional body scanning fluid retention detector.
Husheer teaches an analogous system for detecting swelling and edema in the body, further comprising a fluid retention detector (100) for detecting edema in at least a part of the body wherein the processor is adapted for detecting a condition of edema based on a signal from the fluid retention detector (pg. 12, lines 4-13, 100 detecting edema). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the type of fluid retention detector taught by Husheer into the Gelfand-Abdolahi combination in order to visually monitor the entire body for edema to get more accurate and early edema detection.
Regarding claim 20, Gelfand in view of Abdolahi in further view of Husheer teaches the device according to claim 16, as described above, wherein the fluid retention detector comprises a range detector for determining a distance from at least a point of reference to a plurality of points on the surface of the body (Husheer: pg. 9, lines 21-25, the software detecting the distance to the points on the patient), said range detector forming a three-dimensional imaging system (Husheer: Fig. 3; pg. 9, lines 21-25, 3D image generation), wherein said processor is adapted for determining a volume of the body based on data provided by the range detector (Husheer: pg. 12, lines 29-34).
Regarding claim 21, Gelfand in view of Abdolahi in further view of Husheer teaches the device according to claim 20, as described above, wherein said range detector comprises at least two cameras (Husheer: Fig. 1: 102 and 104), and wherein said processor is adapted for determining an image depth in images obtained by the cameras (Husheer: pg. 9, lines 11-18), for generating a three-dimensional contour model of the body based on the determined image depth (Husheer: pg. 9, lines 30-31) and for determining a volume of the body based on the three-dimensional contour model as indicative of edema (Husheer: Fig. 3; pg. 9, lines 21-25).
Regarding claim 22, Gelfand in view of Abdolahi in further view of Husheer teaches the device according to claim 20, as described above, wherein said range detector comprises at least one laser light source for illuminating the body (Husheer: pg. 6, lines 32-34 light projector), a sensor for measuring the reflected light (Husheer: pg. 6, lines 32-34, cameras 102 and 104 sense the reflected light), and a scanning system for scanning the laser light beam(s) emitted by the at least one laser light source over at least a part of the surface of the body (Husheer: pg. 13, lines 23-26) while measuring the reflected light for a plurality of scanned points (Husheer: Fig. 3; pg. 11, lines 19-27), wherein the processor is adapted for collecting point cloud data of the body based on measured reflected light for the plurality of scanned points (Husheer: pg. 11, lines 7-10 and 19-20), for generating a three-dimensional contour model of the body based on the point cloud data and for determining a volume of the body (Husheer: Fig. 3; pg. 11, lines 19-27) based on the three-dimensional contour model as indicative of edema (Husheer: pg. 16, lines 4-9).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand (US 7837667) in view of Abdolahi (US 20180235539) in further view of Roth (US 20180289890).
Regarding claim 28, Gelfand in view of Abdolahi teaches a monitoring device in accordance with claim 15, as described above, but fails to teach such a system for increasing the patient’s body temperature.
Roth teaches an analogous fluid balance monitoring device (para. [0010]) and infusion system adapted for bringing a body into a prolonged state of increased temperature (para. [0044], sentences 4-5). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have applied the Gelfand-Abdolahi system to be used for balancing a patient’s body temperature through the infusions, as taught by Roth, in order to concurrently treat patients with hypothermia using the same system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783