DETAILED ACTION
This Office Action is responsive to application number 18/699,539 - SYSTEMS AND METHODS FOR TREATING FLUID OVERLOAD, filed on 9/28/2009. Claims 1, 3, 5, 9-12, 14-15, 17-22, 24-25, 30, 32-33, 35-40 are pending. Claims 2, 4, 6-8, 13, 16, 23, 26-29, 31 , 34 and 41-44 have been canceled.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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, 9, 17-18, 30 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feldman et al. (DE 10 2011 107 813 A1).
Regarding Claim 1 Feldman shows a fluid stimulation system comprising: a wearable treatment device (1; Fig. 1) to provide a warm air environment (13; provides a second fluid aka warm air; for example, using continuously exchanged tempered air or tempered liquid as the pressure medium) at a controlled air volume flow rate (the temperature or the flow rate of a fluid can be set) around a body part (body garment 1) of a patient to shift fluids directly and non-invasively from an interstitial compartment of the patient to skin of the patient resulting in controlled fluid loss in the form of sweating ( the multi-functional system in a - spacesuit or pressure suit, preferably for astronauts or pilots, - massage or fitness suit, - sweat suit or - Therapeutic suit, trousers, jacket, arm or leg cuff, preferably for the treatment of skin injuries, edema, cellulitis, joint injuries and the like be used); a console unit (13-16) operably coupled to the treatment device and configured to provide at least air to the treatment device; and a computing device (17) configured to communicate with the console unit and control operation thereof.
Regarding Claim 3 Feldman shows the system of claim 1, wherein the console unit comprises a controller (included in 17) communicatively coupled with a plurality of sensors (11) that provide feedback data to the controller (note, abstract), the controller comprising a processor coupled to memory containing instructions executable by the processor to cause the controller to monitor and control conditions of the treatment device based, at least in part, on the feedback data provided from the plurality of sensors (inherent in detecting and monitoring ; In addition, there are connections 12a the sensor units provided via connecting lines 12b in conjunction with the computerized system 17 to monitor the individual or the organism. About a program for the multi-functional system may be due to the information about the state of the individual or the organism or of components of the organism, the sensor unit 11 are recorded as parameters, promptly the operation and intensity of the pumps 13 . 14 and 15 as well as the regeneration plant 16 to be controlled).
Regarding Claim 9 Feldman shows the system of claim 3, wherein the console unit comprises at least one of an air fan (pump 13) and a heat source for providing air or heated air to the treatment device (tempered air; the temperature or the flow rate of a fluid can be set), the console unit further comprising a flow meter associated with the air fan (implicit if flow can be set).
Regarding Claim 17 Feldman shows the system of claim 3, wherein sweating is stimulated by controlling at least one of relative humidity, airflow, pressure, and temperature within the treatment device (the temperature or the flow rate of a fluid can be set).
Regarding Claim 18 Feldman shows the system of claim 17, wherein the controller is configured to adjust output of at least one of air and heated air from the console unit to thereby control at least one of relative humidity, airflow, pressure, and temperature within the treatment device based on feedback data received from the plurality of sensors (pumps 13 controls air flow; the sensor unit 11 are recorded as parameters, promptly the operation and intensity of the pumps 13 14 and 15 as well as the regeneration plant 16 to be controlled).
Regarding Claim 30 Feldman shows the system of claim 1, wherein the treatment device comprises a wearable device configured to cover one or more body parts (Fig. 1) of the patient to undergo treatment wherein the wearable device comprises an outer layer (2a) of material and an inner layer of material (3a) cooperatively forming a chamber therebetween configured to receive air from the console unit (the garment comprises an outer cover 2a and an inner shell 3a which is a chamber 2 B form. In this chamber 2 B can via flexible hoses 6b a second fluid, preferably air are introduced. Also, the interior of the flexible suit in the area between the shell 3a and the surface of the organism with the second fluid via flexible tubes 6a be charged).
Regarding Claim 32 Feldman shows the system of claim 30, wherein the outer and inner layers are joined to another via a plurality of separate fixation points (at least separate fixation points around arm holes, collar and front (8)).
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(s) 5, 10-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Nitzan (WO 2021/014207).
Regarding Claim 5 Feldman shows the system of claim 3, wherein the computing device The chamber can generate results of the fluid removal, including sweat content status and heat generation, for display on a user interface or for transmitting to network for monitoring by a physician that is remote. The patient can apply the treatment for duration throughout the day, at home, and use the treatment to balance fluid status). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include a convention portion of a computerized system by including a user interface for the purpose of interaction and programming the computerized system as shown by Nitzan.
Regarding Claim 10 Feldman shows the system of claim 9, but fails to show wherein the flow meter is communicatively coupled with the controller. However, Nitzan shows wherein a flow meter is communicatively coupled with the controller. (The system further comprises an air fan and heat source coupled to the chamber. The system further comprises an inflow flow meter associated with the air fan. The flow meter is communicatively coupled with the controller and data from the flow meters is used for calculation of the sweat rate within the chamber.). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include the flow meters communicating with the controller for calculation of the sweat rate in the device for the purpose of preventing too much fluid loss as shown by Nitzan.
Regarding Claim 11 Feldman shows the system of claim 3, further comprising a skin temperature sensor positioned within a portion of the treatment device and configured to collect skin temperature data of the patient, the skin temperature sensor being communicatively coupled with the controller (wherein a constant control of all parameters of the body state of the organism by means of known devices and sensors done This can be done by recording these parameters in real-time and using these data for computer-controlled alteration or adjustment of exercise conditions for lavage, cleansing, exercise or massage.)
While skin temperature would be an necessary parameter of the body state that included inducing sweating, Feldman fails to specifically disclose a skin temperature sensor positioned within a portion of the treatment device and configured to collect skin temperature data of the patient, the skin temperature sensor being communicatively coupled with the controller. However, Nitzan shows a skin temperature sensor positioned within a portion of the treatment device and configured to collect skin temperature data of the patient, the skin temperature sensor being communicatively coupled with the controller (In some embodiments, the system further comprises a skin temperature sensor. The skin temperature sensor is placed on the skin of the patient and monitors the skin temperature and verifies that the skin temperature does not, in any circumstance, elevate above 38°C. If the skin temperature elevates above 38°C, the system stops operation of the device). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include a skin temperature sensor at part of the measurement of all of the parameters of the body state while inducing sweating for the purpose of keeping the user for over sweating and becoming dehydrated.
Regarding Claim 12 Feldman as combined shows the system of claim 11, wherein the controller is configured to stop operation of the system if the skin temperature exceeds a threshold value, wherein the threshold value is less than 40°C (In some embodiments, the system further comprises a skin temperature sensor. The skin temperature sensor is placed on the skin of the patient and monitors the skin temperature and verifies that the skin temperature does not, in any circumstance, elevate above 38°C. If the skin temperature elevates above 38°C, the system stops operation of the device).
Regarding Claim 19 Feldman shows the system of claim 18, but fails to show wherein skin temperature and sweat rate of the patient is controlled by the controller closing a control loop inputting relative humidity at an inflow and an outflow associated with the treatment device, an air flow rate, and skin temperature, and changing the flow rate and inflow air temperature until a sufficient sweat rate is achieved. However, Nitzan shows wherein skin temperature and sweat rate of the patient is controlled by the controller closing a control loop inputting relative humidity at an inflow and an outflow associated with the treatment device, an air flow rate, and skin temperature, and changing the flow rate and inflow air temperature until a sufficient sweat rate is achieved (wherein skin temperature and sweat rate of the patient is controlled by the controller closing a control loop inputting relative humidity at an inflow and an outflow associated with the treatment device, an air flow rate, and skin temperature, and changing the flow rate and inflow air temperature until a sufficient sweat rate is achieved). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include wherein skin temperature and sweat rate of the patient is controlled by the controller closing a control loop inputting relative humidity at an inflow and an outflow associated with the treatment device, an air flow rate, and skin temperature, and changing the flow rate and inflow air temperature until a sufficient sweat rate is achieved as shown by Nitzan for the purpose of not dehydrating the user.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Devanaboyina (US Pub. 2016/0008206).
Regarding Claim 14 Feldman shows the system of claim 3, but fails to show further comprising at least one accelerometer sensor positioned within a portion of the treatment device and configured to collect acceleration data of the patient, the accelerometer sensor being communicatively coupled with the controller. However, Devanaboyina shows a wearable body device with includes accelerometers (¶ [0537]) coupled to a controller to monitor and collect movement data (¶ [0537]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include at least one accelerometer sensor positioned within a portion of the treatment device and configured to collect acceleration data of the patient, the accelerometer sensor being communicatively coupled with the controller for the purpose of monitoring the users movement in any direction as suggested by Devanaboyina.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Devanaboyina (US Pub. 2016/0008206) on further view of Tai et al. (US Pub. 2020/0082926).
Regarding Claim 15 Feldman shows the system of claim 14, but fails to show wherein the controller is configured to determine a patient's pose based, at least in part, on data received from the at least one accelerometer, wherein the patient's pose is selected from the group consisting of a supine or prone position, a sitting position, and a standing position. However, Tai teaches using an accelerometer sensor for collecting data on a user’s position and generating a 3D model of an organ with a user’s pose being selected from a group of a supine (Fig. 3) or prone position, a sitting position, and a standing position. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include an accelerometer to determine a user’s pose as shown by Tai for the purpose of further determining all the necessary parameters of the body state.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Xing et al. (US Pub. 2019/0206538).
Regarding Claim 20 Feldman shows the system of claim 18, wherein the console unit is configured to adjust output of at least one of air and heated air therefrom based, at least in part, .
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Xing et al. (US Pub. 2019/0206538) in view of Nitzan (WO 2021/014207).
Regarding Claim 21 Feldman shows the system of claim 20, wherein the console unit is configured to obtain and process feedback data received from the plurality of sensors, but fails to show wherein the feedback data comprises at least one of skin temperature, ambient temperature, core patient temperature, blood pressure, heart rate, patient acceleration, sweat rate at the ambient temperature, and sweat rate at the skin temperature. However, Nitzan shows a skin temperature sensor positioned within a portion of the treatment device and configured to collect skin temperature data of the patient, the skin temperature sensor being communicatively coupled with the controller (In some embodiments, the system further comprises a skin temperature sensor. The skin temperature sensor is placed on the skin of the patient and monitors the skin temperature and verifies that the skin temperature does not, in any circumstance, elevate above 38°C. If the skin temperature elevates above 38°C, the system stops operation of the device). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include a skin temperature sensor at part of the measurement of all of the parameters of the body state while inducing sweating for the purpose of keeping the user for over sweating and becoming dehydrated.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (DE 10 2011 107 813 A1) in view of Cooper et al. (US Pub. 2022/0110822).
Regarding Claim 33 Feldman shows the system of claim 32, wherein the outer and inner layers are joined to another via fabric welding. This claim is considered a product by process claim. “Even though product by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product by process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP § 2113). Turning attention to Cooper. Cooper shows a wearable garment that is has fabric welded into an airtight garment (¶ [0097[). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feldman to include fabric welding for creating the device for the purpose of maintaining and air tight garment as shown by Cooper.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 9-12, 17-19, 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,883,353. Although the claims at issue are not identical, they are not patentably distinct from each other because have similar limitations and are similar in scope.
Claims 1, 3, 5, 9-12, 17-19, 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,938,085. Although the claims at issue are not identical, they are not patentably distinct from each other because have similar limitations and are similar in scope.
Claims 1, 3, 5, 9-12, 17-19, 24-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,121,495. Although the claims at issue are not identical, they are not patentably distinct from each other because have similar limitations and are similar in scope.
Allowable Subject Matter
Claims 22, 24-25 and 35-40 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nitzan (US 11,883,353), (US 11,938,085) and (US 12, 121,495) shows a similar device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE J SKUBINNA whose telephone number is (571)270-5163. The examiner can normally be reached Monday thru Thursday, 9:30 AM to 6PM EST.
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, DAVID ANGWIN can be reached at 571-270-3735. 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.
/CHRISTINE J SKUBINNA/Primary Examiner, Art Unit 3754 6/3/2026
Prosecution Insights