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 Arguments
Regarding independent claim 1, Applicant argues on pages 4-6 of the remarks filed 11/17/2025 that one of ordinary skill in the art would have not been led to combine the prior art references of Hansen and Bernhardt, noting that Hansen’s method is directed towards a device/method configured to apply vibrational forces to a user for the purposes of promoting blood circulation, mucus elimination, and relieving muscular tension; whereas Bernhardt’s device/method is directed towards applying vibrational forces to a user for the purpose of dislodging kidney/urinary stones. The Examiner respectfully disagrees, first noting that both Hansen and Bernhardt teach the same general underlying concept – administering circumferential mechanical vibrations to a user’s chest. Although the mechanism in which the mechanical vibrations are generated may be different (Hansen’s device utilizes inflatable air bladders, Bernhardt utilizes vibrational transducers), both devices impart adjustable, mechanical vibrational forces to a user’s chest, as the claim requires.
In regards to Applicant’s arguments that the intended purposes of Hansen’s device and Bernhardt’s device differ, the Examiner notes that Paragraph 0021 of Bernhardt specifically states that the method of dislodging kidney stones is achieved by relaxing the muscles of the uterus, via the mechanical vibrational forces imparted on the user’s chest. Therefore, Bernhardt’s method of dislodging kidney stones involves the process of relieving muscular tension, similar to Hansen’s device which similarly uses mechanical vibrations imparted on to the user for the purpose of muscular tension relief. Therefore, the Examiner maintains that one of ordinary skill in the art would have been led to combine the device/methods of Hansen with Bernhardt, as both references teach the same underlying concept of applying circumferential, mechanical vibrational forces onto the user’s chest for the purpose of relaxing muscles of the user.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 4, 11 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 5,569,170) in view of Bernhardt (US 2018/0303458 A1) and in further view of Rousso (WO 2020/0070748 A1).
Regarding claim 1, Hansen discloses a method comprising: circumferentially administering vibrations to a subject's torso or a portion thereof via a vest placed on the subject's torso (vest 24 circumferentially applies mechanical vibrations to a user’s torso via pressure pulses imparted by inflatable air bags 31 and 32, Col. 3 lines 55-60 and Col. 5 lines 20-35 and an Figure 1), wherein the vibrations are produced by inflation and deflation of air pockets (inflatable air bags 31, 32, Figure 1) through a first hose connection and a second hose connection (first and second hoses 37 and 38 carry pulses of air under pressure to the internal chambers of the air bags 31, 32, Figure 1 and Col. 4 lines 12-15), wherein the air pockets that are part of the vest (air bags 31 and 32 are incorporated within vest 24, Figure 1), wherein the vibrations cause a lower portion of the torso to experience a pressure ranging from 1 psi to 5 psi (air pump 42 is operated to inflate air bags 31, 32 to a selected pressure such as 1 psi, therefore within the claimed pressure range, Col. 5 lines 35-36).
However, although Hansen teaches a method of administering mechanical circumferential vibrations to a user’s torso via inflatable air pockets (Figure 1 and Abstract), Hansen doesn’t explicitly state the method being used for facilitating passage of a urinary stone and/or alleviating a pain caused by a urinary stone; and although Hansen further teaches the operating frequency being adjustable (Col. 1 lines 50-55), Hansen doesn’t explicitly state wherein the vibrations are administered with a frequency ranging from 5 Hz to 20 Hz; and Hansen is silent wherein the vibrations are administered to the subject for a plurality of periods each ranging from between 15 minutes and 40 minutes, and wherein each period of administration is followed by a lull period ranging from 1 minute to 30 minutes.
However, in regards to a method of administering vibrations to a user’s torso for facilitating passage of a urinary stone and/or alleviating a pain caused by a urinary stone, and wherein the vibrations have a frequency of between 5 Hz to 20 Hz, Bernhardt discloses a method for facilitating passage of a urinary stone and/or alleviating a pain caused by a urinary stone (method for creating mechanical waves that travel through an individual’s body to the kidneys and/or associated ureters to loosen/dislodge kidney stones, Abstract and Paragraph 0019), the method comprising circumferentially administering vibrations to a subject's torso or a portion thereof via a vest placed on the subject’s torso (a circumferential wearable belt/band apparatus 100 includes a waist band 105 comprising tactile transducers 110a,b that produce mechanical waves toward the kidney of the user, Paragraph 0025; mechanical waves produced by the transducers cause the kidneys to vibrate, Paragraph 0019; band 105 may be worn and arranged in a position in which the tactile transducers are in the vicinity of the individual’s kidneys, therefore administrating vibrations to a portion of the torso, Paragraph 0006; the Examiner notes the wearable belt/band 105 of Bernhardt’s device constitutes as a “vest” as it is a sleeveless, close-fitting waist-length garment, the same general configuration as shown in Applicant’s Figures 2 and 5); wherein the vibrations have a frequency of between 5 Hz to 20 Hz (the tactile transducers produce mechanical vibrations at a resonant frequency of a kidney tissue which may be in the range of 9-16 Hz, therefore falling in the range of between 5 to 20 Hz, Paragraph 0006).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to use Hansen’s method of administering vibrations to a user’s torso for the facilitating of passage of a urinary stone and/or alleviating pain from a urinary stone, at a frequency of between 5 Hz to 20 Hz, as taught by Bernhardt, as applying such mechanical vibrations to a user’s torso serves as a therapeutically effective means of treating kidney and/or urinary stones (Abstract of Bernhardt).
In regards to wherein the vibrations are administered to the subject for a plurality of periods each ranging from between 15 minutes and 40 minutes, and wherein each period of administration is followed by a lull period ranging from 1 minute to 30 minutes,
Rousso teaches a method of treating post-renal disorders such as formation of kidney stones (Abstract, Page 2 lines 1-2) wherein ultrasonic vibrations (Page 22 lines 9-10) are applied to user’s torso via a wearable vest (Figure 61) via ultrasonic transducers (transducers 6104, 6106, and 6108, Figure 61 and Page 22), wherein the vibrations are administered to the subject for a plurality of periods each ranging from between 15 to 40 minutes (therapy sessions are applied repeatedly for at least 30 minutes, therefore administered for a plurality of periods with each period falling within the claimed range of 15 to 40 minutes, Page 122 lines 10-13), wherein each therapy session is followed by a lull period ranging from 1 minute to 30 minutes (the therapeutic sessions has intermittent breaks of at least 1 minute, Page 122 lines 17-18).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hansen’s method of applying vibrations to a user’s chest to include administering the vibrations to the subject for a plurality of periods each ranging from between 15 to 40 minutes, as well as being followed by intermittent lull periods each ranging from 1 minute to 30 minutes, as taught by Rousso, as providing vibrations to the user’s torso for relatively long time intervals such as between 15 to 40 minutes may assist in the breaking up of kidney stones, and applying periods of no vibrational therapy for a period of at least 1 minute may allow the patient to rest and/or slowly adapt to the treatment process.
Regarding claim 2, Hansen further discloses wherein circumferentially administering vibrations to the subject's torso or a portion thereof comprises simultaneously administering vibrations at a plurality of locations (pulsator 36 causes air bags 28, 29 to transmit controller air pressure pulses simultaneously as indicated by arrows 33 and 34 to the thoracic wall 13 of the user, air bags 28 and 29 are disposed in different locations, Figures 1 and Col. 3 lines 60-65).
Regarding claim 4, Hansen further discloses wherein the portion of the subject's torso comprises a lower portion of the torso covering the kidneys, ureter, and/or urinary bladder (see vest 24 covering entire torso of user, therefore covering the kidneys, ureter, and/or bladder, Figure 1).
Regarding claim 11, Hansen further discloses wherein the subject is in an upright sitting position (see Figure 1 showing subject in an upright position).
Regarding claim 42, Hansen further discloses wherein the vest is also configured to provide high frequency chest wall compression (HFCWC) (wave generator 178 has a wave frequency adjusting control 194 to allow controlling the frequency of the pulses, to allow pulsator to delivery controlled pulsating air pressure forces to the vest, Col. 6 lines 1-5).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 5,569,170) in view of Bernhardt (US 2018/0303458 A1), Rousso (WO 2020/0070748 A1), and in further view of Rousso (WO 2018/185767 A1).
Regarding claim 3, Hansen in view of Bernhardt and Rousso (‘748) teach the method of claim 1, and although Hansen further teaches circumferentially administering vibrations to a subject’s torso or a portion thereof, Hansen doesn’t explicitly state wherein circumferentially administering vibrations to the subject's torso or a portion thereof comprises sequentially administering vibrations at a plurality of locations.
However, Rousso (‘767) teaches a method of circumferentially administrating vibrations to a subject’s torso for the purpose of treating the kidneys (a device is fully mobile and worn by the patient as a vest or a belt 400, with ultrasonic transducers that convert electrical energy into acoustic vibrations and pressure waves, inducing vibrations to the kidneys, Page 25 lines 25-29 and Figure 4) and further teaches the vibrations being sequentially administered at a plurality of locations (device may comprise multiple independently transmitting transducers, delivering sequential pressure waveforms to different regions of the target organ, Page 21 lines 12-15).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Hansen to include the option of administering the vibrations at a plurality of locations sequentially, as further taught by Rousso, as sequentially administering vibrations at a plurality of locations may allow the vibrations to reach a wider area of the kidney or target area (Page 21 lines 9-11 of Rousso).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 5,569,170) in view of Bernhardt (US 2018/0303458 A1), Rousso (WO 2020/0070748 A1) and in further view of Cao (DE 112013006858 T5).
Regarding claim 9, Hansen in view of Bernhardt and Rousso teach the method of claim 1, however are silent wherein the subject is in a supine position.
However, Cao teaches a method of and apparatus configured to assist in the removal or urinary stones comprising a vibrating bed and primary oscillator (Abstract, Figure 1) wherein the subject is in a supine position (if the kidney stone is located in the upper pole of the kidney, the patient should take a supine position, Page 7, paragraph 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Hansen to include the subject being placed in a supine position, as taught by Cao, as this position allows the urinary stone to enter the funnel and the ureter, aiding in the removal process of the stone (Page 7 of Cao).
Regarding claim 10, Cao further teaches wherein the subject is in a prone position (if the kidney stone is a right or left kidney stone, the patient should take a prone position, Page 7, paragraphs 4 and 5).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Hansen to include the subject being placed in a prone position, as taught by Cao, as this position allows the urinary stone to enter the funnel and the ureter, aiding in the removal process of the stone (Page 7 of Cao).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bernhardt (US 2018/0303458 A1) in view of Robinson et al. (US 2011/0054576 A1), Rousso (WO 2020/070748 A1), and in further view of Chen (CN 203852563 U).
Regarding claim 12, Hansen in view of Bernhardt and Rousso teach the method of claim 1, however is silent wherein the subject is in an upright standing position.
However, Chen teaches a urinary stone discharging device (Abstract) comprising a plurality of vibrating elements in a plurality of locations (vibrating devices 5, Figure 1 and Paragraph 0029) wherein the subject is in an upright standing position (the device allows a variety of body positioning, including a standing posture, Paragraph 0029).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Hansen to include administering vibrations to a subject in a standing position, as taught by Chen, as positioning the subject in an upright standing position aids in facilitating urinary stone removal as the body is positioned along a physiological drainage pipeline (Paragraph 0029 of Chen).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785