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 .
Status of Claims
The present Office action is responsive to the Remarks and Amendments filed on 07-28-2025. As directed, claims 1, 10-11, 13, 27, 36-37, 40, 42-43, and 45-50 have been amended, claims 8-9 and 34-35 have been canceled, and no new claims have been added. Thus, claims 1-7, 10-33, and 36-51 are currently pending examination.
Response to Amendment
Applicant has amended claims 1, 10-11, 13, 36-37, and 49-50 to address minor informalities within these claims, the previously held claim objections are hereby withdrawn except where indicated below.
Response to Arguments
Applicant argues, see Remarks as filed pages 10-11, that “securing mechanism” as recited throughout the claims does not invoke 35 USC 112(f) because the structure intended is clearly delineated in the specification and drawings.
Examiner reminds Applicant that the criteria for 112(f) invocation, which was set forth in the previous Office action. The term “securing mechanism” describes a function, “securing”, of a structure, material, or act, and uses a non-structural term, or nonce term, mechanism, as a generic placeholder for the structure that achieves the given function. Thys, the term “securing mechanism” very clearly invokes 35 USC 112(f), and is covered by the structures outlined in the specification as pointed out in the current and previous Office action, and echoed by Applicant in their arguments. The interpretation of the claim term under 35 USC 112(f) will be maintained below.
Applicant argues, see Remarks as filed pages 11-12, that each of independent claims 1, 13, 27, and 40 are patentable over Burnett, owing to amendment of each of these claims to further distinguish over Burnett.
Each grounds of rejection for these independent claims have been updated with additional teaching references (claim 1, with further reliance on Marciniak, claim 13 with further reliance on Vergara, and claim 27 with further reliance on Naumann, claim 40 with further reliance on Vergara), and the statutory class of each rejection has been changed from 35 USC 102 to 35 USC 103 to address the newly amended limitations.
Applicant argues, see Remarks as filed at page 12, that the rejections of claims 3-6, and 29-32 with additional reliance on Naumann and Simonson respectively, fail to cure the deficiencies of the independent claims, and therefore are patentable over each of Burnett and Naumann and Burnett and Simonson.
With respect to claims 3-6 and 29-32, additional teachings from Marciniak and Naumann are relied on to teach the amended limitations of claims 1 and 27. Naumann and Simonson will be relied on in the manner of the previous Office action for their previously relied on teachings for each of claims 3-6 and 29-32.
Applicant’s arguments, see Remarks, filed 07-28-2020, with respect to claims 7, 9, 11, 33, 35, and 37 have been fully considered and are persuasive. The rejections of these claims employing Johnson’s teachings have been withdrawn. Johnson does not simultaneously teach use of an accelerometer, frequency, or pressure in determining a treatment time. Rather, Johnson relies on these metrics as well as treatment time (duration) in modulating its device parameters.
Applicant argues, see Remarks as filed at page 14, that the rejections of claims 17, 20-25, 43, and 46-49 with additional reliance on Burnett, Zgoda, and Petrofsky respectively, fail to cure the deficiencies of the independent claims, and therefore are patentable over each of Burnett, Zgoda, and Petrofsky.
With respect to claims 17, 20-25, 43, and 46-49, additional teachings from Vergara are relied on to teach the amended limitations of claims 13 and 40. Burnett, Zgoda, and Petrofsky will be relied on in the manner of the previous Office action for their previously relied on teachings for each of claims 17, 20-25, 43, and 46-49.
Claim Objections
Claims 2-7, 10-26, 28-33, 36-39, and 41-51 are objected to because of the following informalities:
At line 1 of each of claims 2-7, 10-12, 14-26, 28-39, and 41-51, it is suggested that a comma be added following the recitation of the claim that each individual claim depends from (e.g. for claim 2, line 1 would recite “claim 1,”) for clarity.
At lines 1-2 of each of claims 3-6, “wherein the maximum exposure comprises a treatment time of” should be replaced with “wherein the maximum exposure comprises the treatment time, and the treatment time is” as the limitation has now been recited in amended claim 1, and for clarity.
At line 6 of claim 13, it is suggested that “configured to be” be added before “positioned in proximity” to more clearly avoid claiming the human organism.
At line 2 of claim 7, “a treatment time” should be replaced with “the treatment time” as the limitation is already introduced in claim 1.
At lines 2-3 of claim 11, “a treatment time” should be replaced with “the treatment time” as the limitation is already introduced in claim 1.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The “securing mechanism” in claims 1, 12-14, and 26 which is interpreted relative to the instant specification at paragraphs 33, 38, and 40 to be straps and functional equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 non-obviousness.
Claims 1-2, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2015/0272805) in view of Marciniak (DE 20-2005-002086-U1).
Examiner notes that the citations with respect to Marciniak are derived from the provided translation.
Regarding claim 1, Burnett discloses a vibration apparatus (10) for treating a subject (paragraph 41, lines 1-9; paragraph 50, lines 1-4; Fig. 3), comprising:
an actuator (12) configured to generate vibrational energy (paragraph 50, lines 3-4; Fig. 3);
a securing mechanism (14) for positioning the actuator (12) upon a body of the subject while maintaining portability such that the vibrational energy generated by the actuator (12) is configured to be directed into an area of the body of the subject to be treated (paragraph 41, lines 9-14; paragraph 42, lines 1-16; paragraph 50, lines 1-3; Fig. 3; see also paragraph 63, lines 1-2);
a controller (see paragraph 59: “computer chip with control software H”) in communication with the actuator (12) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”), wherein the controller (see paragraph 59: “computer chip with control software H”) is programmed to determine an exposure level of the vibrational energy to the area of the body for comparison against a maximum exposure level such that the exposure level is limited by the maximum exposure level within a predetermined period of time (paragraph 25, lines 1-5, where the exposure level is the instantaneous length that vibrational treatment has been delivered, maximum exposure is regarded as the acceptable length of time that the vibrational treatment is delivered at its frequency/amplitude etc., the predetermined period of time is regarded as the time at which the device is automatically turned off, and the device is “automatically” turned off when a time of treatment completion is reached, such a function understood to require the control software and computer chip); and
an accelerometer (either of 17’ placed within pockets 17 in Fig. 3) in communication with the controller (see paragraph 59: “computer chip with control software H”) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”).
While Burnett discloses a controller (see paragraph 59: “computer chip with control software H”) in communication with the actuator (12) and the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”), Burnett fails to disclose that the controller is configured to receive a signal via the accelerometer in determining a treatment time.
However, Marciniak teaches a device including a vibration platform (4) (abstract, lines 1-2) wherein a control unit (15) is configured to receive a signal from an accelerometer (13) in determining a treatment time, such that a limit load of the delivered vibration is not exceeded, and the user’s safety is maintained (page 4: “During exercise, vibrations are transmitted through the vibration platform 4 introduced into the body of the user. A vibration sensor unit 12 at the same time takes over an acceleration sensor 13 on the body of the user B vibrations and sends them in the form of signals by radio to a receiver 14 , From there, the signals are sent to a control unit 15 forwarded via a wire connection. The control unit 15 regulates the vibration generator 3 based on the recorded vibrations. When a limit load is exceeded, the control unit regulates 15 by means of an automatic shutdown the vibration generator 3” and page 3: “In Advantageous development is according to claim 8 an automatic shutdown provided, which the vibration generator when exceeding a threshold load down regulates and / or shut down. This solution ensures that the Users cannot get into a situation in which he himself endangered”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capabilities of the Burnett accelerometer and controller such that the controller is configured to receive a signal via the accelerometer in determining a treatment time, as taught by Marciniak, in order to ensure that a limit load of the delivered vibration is not exceeded, and the user’s safety is maintained during use of the device by measuring the applied vibration over time.
Regarding claim 2, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
Burnett further discloses wherein the actuator (12) comprises a motor configured to generate mechanical vibrational energy (paragraph 44, lines 1-5 and 16-18).
Regarding claim 10, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
Burnett further discloses the apparatus (10) comprising a pressure sensor (see “force or tension sensor” in paragraph 58) in communication with the controller (see paragraph 59: “computer chip with control software H”) and configured to be in contact with the area of the body of the subject to be treated (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 58, lines 1-7, where securing mechanism contain the sensors and contacts the patient, and outlines use of the sensor in a feedback loop).
Regarding claim 12, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
Burnett further discloses wherein the securing mechanism (14) is configured to position the actuator (12) upon the body such that the vibrational energy is directed into at least one bone of the subject to be treated (paragraph 41, lines 9-14; paragraph 50, lines 1-3, see “hips”; Fig. 3; abstract, lines 1-3).
Claims 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2015/0272805) in view of Marciniak (DE 20-2005-002086-U1), as applied to claim 1 above, in further view of Naumann (US 2014/0316311).
Regarding claim 3, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
While Burnett indicates that the actuator (12) is comfortable enough for use of 10 minutes or longer (paragraph 47, lines 10-13), Burnett does not explicitly disclose wherein the maximum exposure level comprises a treatment time of 30 minutes within a 24-hour predetermined period of time.
However, Nauman teaches a device (10) employing vibration to treat osteoporosis (paragraph 55, lines 1-12 and Fig. 1; paragraph 97, lines 1-5; paragraph 98, lines 1-5), wherein an identified beneficial treatment time is 30 minutes per day for preservation of bone density (paragraph 30, lines 1-7 and 18-20).
Given that both Burnett and Nauman are directed towards vibrational devices which treat osteoporosis (Burnett: abstract, lines 1-5, Nauman: abstract, lines 1-5), and that Burnett discusses the use of an exposure level and its comparison to a maximum exposure level in order to automatically turn the device off when maximum exposure is reached (paragraph 25, lines 1-5, where the exposure level is the instantaneous length that vibrational treatment has been delivered, maximum exposure is regarded as the acceptable length of time that the vibrational treatment is delivered at its frequency/amplitude etc., the predetermined period of time is regarded as the time at which the device is automatically turned off, and the device is “automatically” turned off when a time of treatment completion is reached, such a function understood to require the control software and computer chip), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maximum exposure level of Burnett to be a treatment time of 30 minutes within a 24-hour predetermined period of time, as taught by Nauman, given that Nauman indicates that the prescribed range of time is beneficial in preserving a patient’s bone density.
Regarding claim 5, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
While Burnett indicates that the actuator (12) is comfortable enough for use of 10 minutes or longer (paragraph 47, lines 10-13), Burnett does not explicitly disclose wherein the maximum exposure level comprises a treatment time of between 20 and 30 minutes within a 24-hour predetermined period of time.
However, Nauman teaches a device (10) employing vibration to treat osteoporosis (paragraph 55, lines 1-12 and Fig. 1; paragraph 97, lines 1-5; paragraph 98, lines 1-5), wherein an identified beneficial treatment time is 30 minutes per day for preservation of bone density (paragraph 30, lines 1-7 and 18-20).
In the case where a specific example in the prior art is within a claimed range, the exemplary value anticipates the range (MPEP 2131.03 I). Given that Nauman teaches a treatment time of 30 minutes within a 24-hour period, that the range claimed is 20-30 minutes, and that the value 30 minutes taught by Nauman is within the claimed range, Nauman’s example anticipates the claimed range.
Further, given that both Burnett and Nauman are directed towards vibrational devices which treat osteoporosis (Burnett: abstract, lines 1-5, Nauman: abstract, lines 1-5), and that Burnett discusses the use of an exposure level and its comparison to a maximum exposure level in order to automatically turn the device off when maximum exposure is reached (paragraph 25, lines 1-5, where the exposure level is the instantaneous length that vibrational treatment has been delivered, maximum exposure is regarded as the acceptable length of time that the vibrational treatment is delivered at its frequency/amplitude etc., the predetermined period of time is regarded as the time at which the device is automatically turned off, and the device is “automatically” turned off when a time of treatment completion is reached, such a function understood to require the control software and computer chip), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maximum exposure level of Burnett to be a treatment time of 30 minutes within a 24-hour predetermined period of time, as taught by Nauman, given that Nauman indicates that the prescribed range of time is beneficial in preserving a patient’s bone density.
Regarding claim 6, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
While Burnett indicates that the actuator (12) is comfortable enough for use of 10 minutes or longer (paragraph 47, lines 10-13), Burnett does not explicitly disclose wherein the maximum exposure level comprises a treatment time of between 30 and 40 minutes within a 24-hour predetermined period of time.
However, Nauman teaches a device (10) employing vibration to treat osteoporosis (paragraph 55, lines 1-12 and Fig. 1; paragraph 97, lines 1-5; paragraph 98, lines 1-5), wherein an identified beneficial treatment time is 30 minutes per day for preservation of bone density (paragraph 30, lines 1-7 and 18-20).
In the case where a specific example in the prior art is within a claimed range, the exemplary value anticipates the range (MPEP 2131.03 I). Given that Nauman teaches a treatment time of 30 minutes within a 24-hour period, that the range claimed is 30-40 minutes, and that the value 30 minutes taught by Nauman is within the claimed range, Nauman’s example anticipates the claimed range.
Further, given that both Burnett and Nauman are directed towards vibrational devices which treat osteoporosis (Burnett: abstract, lines 1-5, Nauman: abstract, lines 1-5), and that Burnett discusses the use of an exposure level and its comparison to a maximum exposure level in order to automatically turn the device off when maximum exposure is reached (paragraph 25, lines 1-5, where the exposure level is the instantaneous length that vibrational treatment has been delivered, maximum exposure is regarded as the acceptable length of time that the vibrational treatment is delivered at its frequency/amplitude etc., the predetermined period of time is regarded as the time at which the device is automatically turned off, and the device is “automatically” turned off when a time of treatment completion is reached, such a function understood to require the control software and computer chip), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maximum exposure level of Burnett to be a treatment time of 30 minutes within a 24-hour predetermined period of time, as taught by Nauman, given that Nauman indicates that the prescribed range of time is beneficial in preserving a patient’s bone density.
Regarding claim 7, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
Burnett further discloses wherein the controller (see paragraph 59: “computer chip with control software H”) is configured to obtain a frequency of the actuator (12) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”; claim 17, lines 1-8 and claim 18, lines 1-3, where element 12 is described as a vibrating element in the specification).
Burnett fails to disclose wherein the controller specifically obtains a frequency of the actuator in determining a treatment time.
However, Naumann further teaches that in delivering vibratory treatment to the body, specific frequencies should be targeted in order to eliminate the risk of encountering natural body frequencies (paragraph 47, lines 1-5), and further indicates that the particularly delivered vibratory frequency is safe over a particular treatment time such that loss of bone density is prevented (paragraph 30, lines 1-7).
Therefore, given that Burnett’s controller is capable of receiving signals from the accelerometer (see at least claim 18, lines 1-2), that the accelerometer is configured to measure a frequency of the actuator as modified (see at least claim 18, lines 1-2), and that the sensor data can be utilized in a control/feedback loop (paragraph 55, lines 1-8), and further since Naumann teaches the skilled artisan that vibrational treatment is safely delivered over a treatment time at particular frequencies, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burnett to utilize the accelerometer data in determining a treatment time for the delivered vibration, as taught by Naumann, given that Naumann indicates that vibration therapy is safely delivered at particular doses that account for both frequency and length (time).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2015/0272805) in view of Marciniak (DE 20-2005-002086-U1), as applied to claim 1 above, in further view of Simonson (US 2015/0342824).
Regarding claim 4, Burnett in view of Marciniak disclose the apparatus of claim 1, as discussed above.
While Burnett indicates that the actuator (12) is comfortable enough for use of 10 minutes or longer (paragraph 47, lines 10-13), Burnett does not explicitly disclose wherein the maximum exposure level comprises a treatment time of between 20 minutes within a 24-hour predetermined period of time.
However, Simonson teaches that it is known to employ vibration to treat osteoporosis (paragraph 7, lines 1-15), and further wherein an identified beneficial treatment time is between 10 and 20 minutes per day for promotion of bone growth (paragraph 7, lines 11-15, where the range of 10-20 minutes encapsulates the claimed value of 20 minutes).
Further, given that both Burnett and Simonson are directed towards vibrational devices which treat osteoporosis (Burnett: abstract, lines 1-5, Simonson: abstract, lines 1-5), and that Burnett discusses the use of an exposure level and its comparison to a maximum exposure level in order to automatically turn the device off when maximum exposure is reached (paragraph 25, lines 1-5, where the exposure level is the instantaneous length that vibrational treatment has been delivered, maximum exposure is regarded as the acceptable length of time that the vibrational treatment is delivered at its frequency/amplitude etc., the predetermined period of time is regarded as the time at which the device is automatically turned off, and the device is “automatically” turned off when a time of treatment completion is reached, such a function understood to require the control software and computer chip), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maximum exposure level of Burnett to be a treatment time of 10-20 minutes within a 24-hour predetermined period of time, as taught by Simonson, given that Simonson indicates that the prescribed range of time is beneficial in promoting bone growth.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2015/0272805) in view of Marciniak (DE 20-2005-002086-U1), as applied to claim 10 above, in further view of Turo (US 2011/0239370).
Regarding claim 11, Burnett in view of Marciniak disclose the apparatus of claim 10, as discussed above.
While Burnett discloses the apparatus (10) comprising a pressure sensor (see “force or tension sensor” in paragraph 58) in communication with the controller (see paragraph 59: “computer chip with control software H”) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 58, lines 1-7, where securing mechanism contain the sensors and contact the patient), Burnett fails to disclose wherein the controller is configured to determine a treatment time based on a pressure signal.
However, Turo teaches vibrational actuators and sensors capable of determining pressure, wherein the treatment time (“duration of the vibrating forces”) is based on a pressure signal (“pressure levels detected”) from the sensors (paragraph 14, lines 1-12, see in particular “the duration of the vibrating forces generated by the actuators is responsive to the pressure levels detected by the sensors”; paragraph 16, lines 7-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burnett to include the capability of basing the treatment time on the pressure signal derived from the Burnett pressure sensor, as taught by Turo, as a known control feedback loop capable of being used in vibrational therapy delivery.
Claims 13-19, 21, 26, 40-45, 47, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (US 2015/0272805) in view of Vergara (WO 2017/176271).
Regarding claim 13, Burnett discloses a vibration apparatus (10) for treating a subject (paragraph 41, lines 1-9; paragraph 50, lines 1-4; Fig. 3), comprising:
an actuator (12) configured to generate vibrational energy (paragraph 50, lines 3-4; Fig. 3);
a securing mechanism (14) for positioning the actuator (12) upon a body of the subject while maintaining portability such that the vibrational energy generated by the actuator (12) is configured to be directed into an area of the body of the subject to be treated (paragraph 41, lines 9-14; paragraph 42, lines 1-16; paragraph 50, lines 1-3; Fig. 3; see also paragraph 63, lines 1-2);
a first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) positioned in proximity to the area of the body of the subject and configured to detect a resultant vibrational energy transmitted into the area of the body of the subject (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor” and outline the capturing of information relative to the subject’s spine and hip; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”; Fig. 3);
a controller (see paragraph 59: “computer chip with control software H”) in communication with the actuator (12) and the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”), wherein the controller (see paragraph 59: “computer chip with control software H”) is programmed to receive a signal indicative of the resultant vibrational energy from the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) and automatically calibrate the actuator (12) to adjust the generated vibrational energy until the resultant vibrational energy is within a predetermined range (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”; finally, see paragraph 57, lines 1-8 “returned to pre-loosening level”).
Burnett fails to disclose wherein the automatic calibration occurs to adjust a frequency of the actuator.
However, Vergara teaches an apparatus for vibrational treatment of osteopenia and osteoporosis (abstract, lines 1-10), wherein the device is configured to automatically calibrate an actuator to adjust a frequency of the actuator in order to ensure that treatment and fit are optimized during use of the device (paragraph 15, lines 1-7, where the motor is the actuator; paragraph 34, lines 1-9 mentions both the actuator (motor) and the use of an accelerometer/other sensors for monitoring fit of the device and/or efficacy of vibrational transfer; and paragraph 45, lines 2-9, a processor is configured to adjust frequency, amplitude, and other motor parameters in response to a fit alarm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burnett to include the capability of adjusting the frequency of the actuator during an automatic calibration, as taught by Vergara, in order to ensure that treatment and fit are optimized during use of the device.
Regarding claim 14, Burnett in view of Vergara disclose the apparatus of claim 13, as discussed above.
Burnett further discloses wherein the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) is positioned upon the securing mechanism (14) (paragraph 42, lines 1-7 and 13-20, and paragraph 55, lines 5-8 and 13-18, here the actuators 12 are described as being placed on the securing mechanism, and the accelerometers are described as being placed between the actuators 12 and the subject; see Fig. 3 for placement of pockets 17 on securing mechanism 14).
Regarding claim 15, Burnett in view of Vergara disclose the apparatus of claim 13, as discussed above.
Burnett further discloses wherein the apparatus (10) is configured to position the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) at or in proximity to a hip of the subject when secured to the body of the subject (paragraph 50, lines 1-4).
Regarding claim 16, Burnett in view of Vergara disclose the apparatus of claim 13, as discussed above.
Burnett further discloses wherein the controller (see paragraph 59: “computer chip with control software H”) is further programmed to provide an alert for repositioning of the apparatus (10) relative to the body of the subject (see paragraph 50, lines 1-3 which outlines the use of the Fig. 3 embodiment on the waist, and note that the preferred embodiment shown in Fig. 7 and discussed at paragraph 59 outlines the attachment of the preferred embodiment to the waist; paragraph 58, lines 1-7, see “feedback”, “too loose”, and “alert”), or increase the vibrational energy when the resultant vibrational energy is below a first lower threshold level (paragraph 56, lines 1-10, see “Adjust the acceleration to the desired level and maintain it”, “”any other event that may impact the acceleration felt by the user”, and “feedback control”; paragraph 57, lines 1-8 and see also Fig. 6 where the acceleration in g is increased at 60 seconds resulting from a loosening of the device, and the value of around 0.4 g that the acceleration drops to before increasing is the threshold).
Regarding claim 17, Burnett in view of Vergara disclose the apparatus of claim 16, as discussed above.
Burnett further discloses wherein the range of desired values for the acceleration delivered to the subject’s body by the actuator (12) is within the range of 0.1-1.5 g (see paragraph 24 which gives the ranges of 0.1-1.5 g for desired peak to peak accelerations delivered by the actuator, where the claimed value of 0.1 g is contained within the ranges).
Given that Burnett discloses increasing the vibrational energy when the resultant vibrational energy is below a first lower threshold level (paragraph 56, lines 1-10, see “Adjust the acceleration to the desired level and maintain it”, “”any other event that may impact the acceleration felt by the user”, and “feedback control”; paragraph 57, lines 1-8 and see also Fig. 6 where the acceleration in g is increased at 60 seconds resulting from a loosening of the device, and the value of around 0.4 g that the acceleration drops to before increasing is the threshold), and indicates that the range of desired values for the acceleration delivered to the subject’s body by the actuator (12) may be within the range of 0.1-1.5 g, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the value of 0.1 g as the first lower threshold value from the range disclosed by Burnett in order to ensure that the actuator of the device reliably induces an appropriate mechanical load to the bone tissue of the subject for treatment of osteoporosis (paragraph 27, lines 1-7; paragraph 46, lines 9-11 which outlines the relationship between mechanical load and acceleration).
Regarding claim 18, Burnett in view of Vergara disclose the apparatus of claim 16, as discussed above.
Burnett discloses the apparatus (10) further comprising a second accelerometer (second of 17’ placed within pockets 17 in Fig. 3) in communication with the actuator (12) and configured to detect vibrational energy from the actuator (12) (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”).
Regarding claim 19, Burnett in view of Vergara disclose the apparatus of claim 18, as discussed above.
Burnett further discloses wherein the controller (see paragraph 59: “computer chip with control software H”) is further programmed to increase the vibrational energy from the actuator (12) when the resultant vibrational energy detected by the second accelerometer (second of 17’ placed within pockets 17 in Fig. 3) is below a second upper threshold level (paragraph 57, lines 1-8, see and see Fig. 6, where the second threshold value occurs just before 200 seconds at a value between 0.8 and 1 g, and when this value is reached, the acceleration begins increasing again).
Regarding claim 21, Burnett in view of Vergara disclose the apparatus of claim 13, as discussed above.
Burnett further discloses wherein the controller (see paragraph 59: “computer chip with control software H”) is further programmed to provide an alert for repositioning of the apparatus (10) relative to the body of the subject (paragraph 58, lines 1-7, see “feedback”, “too loose”, and “alert”).
Regarding claim 26, Burnett in view of Vergara disclose the apparatus of claim 13, as discussed above.
Burnett further discloses wherein the securing mechanism (14) is configured to position the actuator (12) upon the body such that the vibrational energy is directed into at least one bone of the subject to be treated (paragraph 41, lines 9-14; paragraph 50, lines 1-3, see “hips”; Fig. 3; abstract, lines 1-3).
Regarding claim 40, Burnett discloses a method for treating a subject (paragraph 41, lines 1-9; paragraph 50, lines 1-4; Fig. 3), comprising:
generating vibrational energy from an actuator (12) such that the vibrational energy is directed into an area of the body of the subject while maintaining portability of the actuator (12) (paragraph 41, lines 9-14; paragraph 42, lines 1-16; paragraph 50, lines 1-4; Fig. 3; see also paragraph 63, lines 1-2);
monitoring a resultant vibrational energy transmitted into the area of the body of the subject via a first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) positioned in proximity to the area of the body of the subject and configured to detect a resultant vibrational energy transmitted into the area of the body of the subject, wherein the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) and the actuator (12) are in communication with a controller (see paragraph 59: “computer chip with control software H”) (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor” and outline the capturing of information relative to the subject’s spine and hip; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction” , such a “control” function is understood to require the control software and computer chip; Fig. 3);
automatically calibrating the actuator (12) via the controller (see paragraph 59: “computer chip with control software H”) by adjusting the vibrational energy until the resultant vibrational energy is within a predetermined range (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”; finally, see paragraph 57, lines 1-8 “returned to pre-loosening level”).
Burnett fails to disclose wherein the automatic calibration occurs to adjust a frequency of the actuator.
However, Vergara teaches an apparatus and method for vibrational treatment of osteopenia and osteoporosis (abstract, lines 1-10), wherein the device is configured to automatically calibrate an actuator to adjust a frequency of the actuator in order to ensure that treatment and fit are optimized during use of the device (paragraph 15, lines 1-7, where the motor is the actuator; paragraph 34, lines 1-9 mentions both the actuator (motor) and the use of an accelerometer/other sensors for monitoring fit of the device and/or efficacy of vibrational transfer; and paragraph 45, lines 2-9, a processor is configured to adjust frequency, amplitude, and other motor parameters in response to a fit alarm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller and method of Burnett to include the capability of adjusting the frequency of the actuator during an automatic calibration, as taught by Vergara, in order to ensure that treatment and fit are optimized during use of the device.
Regarding claim 41, Burnett in view of Vergara disclose the method of claim 40, as discussed above.
Burnett further discloses wherein monitoring the resultant vibrational energy comprises monitoring via the first accelerometer (one of 17’ placed within pockets 17 in Fig. 3) positioned at or in proximity to a hip of the subject when secured to the body of the subject (paragraph 50, lines 1-4).
Regarding claim 42, Burnett in view of Vergara disclose the method of claim 40, as discussed above.
Burnett further discloses providing an alert for repositioning of the apparatus (10) relative to the body of the subject (paragraph 58, lines 1-7, see “feedback”, “too loose”, and “alert”), or increase the vibrational energy when the resultant vibrational energy is below a first lower threshold level (paragraph 56, lines 1-10, see “Adjust the acceleration to the desired level and maintain it”, “”any other event that may impact the acceleration felt by the user”, and “feedback control”; see also Fig. 6 where the acceleration in g both increases and decreases over the graph).
Regarding claim 43, Burnett in view of Vergara disclose the method of claim 42, as discussed above.
Burnett further discloses wherein the range of desired values for the acceleration delivered to the subject’s body by the actuator (12) is within the range of 0.1-1.5 g (see paragraph 24 which gives the ranges of 0.1-1.5 g for desired peak to peak accelerations delivered by the actuator, where the claimed value of 0.1 g is contained within the ranges).
Given that Burnett discloses increasing the vibrational energy when the resultant vibrational energy is below a first lower threshold level (paragraph 56, lines 1-10, see “Adjust the acceleration to the desired level and maintain it”, “”any other event that may impact the acceleration felt by the user”, and “feedback control”; paragraph 57, lines 1-8 and see also Fig. 6 where the acceleration in g is increased at 60 seconds resulting from a loosening of the device, and the value of around 0.4 g that the acceleration drops to before increasing is the threshold), and indicates that the range of desired values for the acceleration delivered to the subject’s body by the actuator (12) may be within the range of 0.1-1.5 g, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the value of 0.1 g as the first lower threshold value from the range disclosed by Burnett in order to ensure that the actuator of the device reliably induces an appropriate mechanical load to the bone tissue of the subject for treatment of osteoporosis (paragraph 27, lines 1-7; paragraph 46, lines 9-11 which outlines the relationship between mechanical load and acceleration).
Regarding claim 44, Burnett in view of Vergara disclose the method of claim 40, as discussed above.
Burnett discloses monitoring the vibrational energy via a second accelerometer (second of 17’ placed within pockets 17 in Fig. 3) in communication with the actuator (12) (paragraph 55, lines 1-20 describe the use of accelerometers to determine the acceleration delivered by actuators 12, and note that the accelerometers are in communication with a “processor”; see also paragraph 46, lines 1-11 which outline that actuators output vibration with an acceleration; see paragraph 21, lines 1-3 which outline closed-loop feedback control of the actuators based on feedback from the accelerometers, and paragraph 56, lines 1-9 which echoes the notion of feedback control as well as “self-correction”).
Regarding claim 45, Burnett in view of Vergara disclose the method of claim 44, as discussed above.
Burnett further discloses wherein automatically calibrating the actuator (12) comprises increasing the vibrational energy from the actuator (12) when the vibrational energy detected by the second accelerometer (second of 17’ placed within pockets 17 in Fig. 3) is below a second upper threshold (paragraph 57, lines 1-8, see “increasing the magnitude” until “it has returned to the pre-loosening level”, where the pre-loosening level is the threshold; see also Fig. 6).
Regarding claim 47, Burnett in view of Vergara disclose the method of claim 40, as discussed above.
Burnett further discloses providing an alert for repositioning of the apparatus (10) relative to the body of the subject (paragraph 58, lines 1-7, see “feedback”, “too loose”, and “alert”).
Regarding claim 50, Burnett in view of Vergara disclose the method of claim 40, as discussed above.
Burnett furt