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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 1, 2026 has been entered.
As directed by the amendment: Claims 1 and 11 were amended. Claims 4-8, 12-13, and 17-19 were cancelled. Claims 1-3, 9-11, 14-16, and 20-26 are pending and currently under consideration for patentability under 37 CFR 1.104.
Claim Interpretation
3. 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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
4. This application includes 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 limitations use 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 limitations are:
“a stimulation unit, configured to generate a stimulation action and apply a stimulation action” (claim 1, ln. 6, with the term “stimulation unit” additionally recited in claim 1, ln. 9; claim 5, ln. 1; claim 7, ln. 1; claim 8, ln. 1; claim 9, ln. 1; claim 11 (twice), ln. 2 and 5; claim 14, ln. 1; claim 16, ln. 7);
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the limitation “stimulation unit” appears to be a “stimulation unit 210 capable of inducing a mechanical stimulation” (Page 28, ln. 31-32). While “stimulation unit 210” does not disclose much structure, the “actuator (electric motor)” (Page 31, ln. 12-13) is interpreted as providing an example of structural support for the “stimulation unit” of the wearable device.
If applicant does not intend to have these limitations)interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 11, 16, and 22 are objected to because of the following informalities:
Claim 11, line 12 recites “obtain from” and the Examiner suggests –obtained from--.
Claim 16, line 9 recites “obtain” and the Examiner suggests –obtaining—to match the verbiage of the remainder of the claim.
Claim 16, line 9 recites “device” and the Examiner suggests –the stimulation device—to clarify the antecedent basis.
Claim 22, line 1 recites “wherein is the” which appears to be an error. The Examiner suggests deleting “is.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1-3, 9-11, 14-16, and 20-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, lines 10-11 recite “applying a pressure excluding vibrations” which appears to be new matter. “Any negative limitation or exclusionary proviso must have basis in the original disclosure” see MPEP 2173.05(i).
Claim 11, lines 5-6 recite “applying a pressure excluding vibrations” which appears to be new matter. “Any negative limitation or exclusionary proviso must have basis in the original disclosure” see MPEP 2173.05(i).
Claim 14, the limitation “said stimulation inducer is configured to affect a stimulation “by providing a magnetic signal to a target body part, by physical movement, by electromagnetic signal emission, by temperature alteration, and/or by including pressure, or by any combination thereof” (ln. 1-4) is new matter without support in the original disclosure. The disclosure does not provide support for having a “wearable device” that provides both pressure stimulation and a magnetic signal, electromagnetic signal, and/or temperature alteration or by any combination thereof.
The remaining claims are rejected based on their dependence on a rejected base claim.
Claim Rejections - 35 USC § 112(b)
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claims 1-3, 9-11, 14-16, and 20-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it recites each of the following: “stimulation parameters” (line 8), “one or more parameters of the pressure” (line 11), “one or more stimulation parameters” (line 14), “at least one parameter of the stimulation” (lines 15-16), and “stimulation parameters” (line 19). It is unclear whether some or all of these “parameters” are referring to the same parameters, or different parameters. The Examiner suggests using the same terminology, and “the” or “said” to clarify whether these are the same parameters or intended to be different sets of parameters.
Claim 1, line 7 recites “one or more target organs and/or regions” which is confusing because it is unclear if this is intended to be different from the previously recited “a target body region” (line 5).
Claim 1, line 10 recites “a stimulation” and it is unclear what the distinction is between “a stimulation action” and the previously recited “a stimulation action” (line 6).
Claim 1, line 18 recites “a signal from said sensor” and it is unclear if this is intended to be different from the previously recited “a signal” (line 2).
Claim 9, line 2 recites “a stimulation” which is confusing because claim 1 already recites “stimulation action” (claim 1, line 6) and “a stimulation” (claim 1, line 10).
Claim 11, line 5 recites “a stimulation” and it is unclear what the distinction is between “a stimulation” and the previously recited “a stimulation action” (line 2).
Claim 11, the last line recites “a target body region” and it is unclear if this is intended to be distinct from the previously recited “a target organ and/or region” (line 3).
Claim 14, line 2 recites “a stimulation” which is confusing because claim 11 already recites “stimulation action” (claim 11, line 2) and “a stimulation” (claim 11, line 5).
Claim 16, line 3 recites “a target body part” which is confusing because it is unclear if this is intended to be distinct from the “target organ and/or region” recited in claim 11 (line 3).
Claim 21, line 1 recites “the control circuitry” which lacks antecedent basis.
Claim 21, line 2 recites “a sensor” which is confusing because a sensor has already been recited in claim 1. It is unclear if this is intended to be a different sensor.
Claim 22, lines 1-3 recite “the stimulation device is configured to induce a random combination of stimuli, each being delivered in a random-chaotic way” and it is unclear how this “random combination of stimuli” relates to the previously recited “configured to randomly alter at least one parameter of the stimulation.” Is this referring to an additional randomization?
Claim 24, line 1 recites “the control circuitry” which lacks antecedent basis.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 10-11, 14-15, 21-22, and 25-26, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rembrand (2016/0001034).
Regarding claim 1, Rembrand discloses a system (Fig. 2) for closed loop abdominal stimulation (It is noted that this is a recitation of an intended use occurring in the preamble. When reading the preamble in the context of the entire claim, the recitation “for closed loop abdominal stimulation” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02), comprising:
a sensor (one or more sensors 38, Fig. 2; see para. [0071]), configured to measure a physiological property (“including a heart rate sensor, a body temperature sensor, a skin moisture sensor (e.g. GSR sensor), a muscle activity sensor, a blood pressure sensor, a respiratory sensor, a brain activity sensor, respiratory depth sensor, eye movement sensor” para. [0071]), and provide a signal indicative thereof:
a stimulation device having a form of a wearable device (wearable device 12, Fig. 2, which includes actuatable units 14-24), configured to be placed and/or held on and/or near a target body region (it is a wearable vest) comprising:
a stimulation unit (individually inflatable unit(s) 14, Fig. 2) configured to generate a stimulation action (“preferably actuated (inflated/deflated) via a fluid such as air” see the first sentence of [0052]) and apply said stimulation action to one or more target organs and/or regions (units 14 are “arranged such that they contact the lower back (unit 16), the sides of the back (units 18 and 20) and shoulders/chest (units 22 and 24) of the individual when device 12 is worn thereby” see para. [0053] and Figs. 1-2) based on stimulation parameters (the timing instruction(s) of the valves controlling the inflation/deflation of each expandable unit 14-26, see para. [0059], para. [0061]-[0062]) to affect a physiological change in the one or more target organs and/or regions (reducing anxiety, by applying deep pressure to activate a vegetative skin reflex, see the first two sentences of the Abstract); wherein the stimulation unit (14) is configured to affect a stimulation, by applying a pressure excluding vibrations (“individually expandable units for applying pressure to a specific body region of the individual when expanded” see the Abstract. There is no mention of any vibration), and altering one or more parameters of the pressure according to an irregular pattern (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0077]-[0079] and the Example 2 actuation script in para. [0099]-[0131]. This includes at least one irregular pattern); and
communication links (wired or wireless communication is provided between control unit 36 and pump 34, see para. [0060]-[0061], and sensor(s) may transmit data wirelessly to the control unit via Bluetooth, see para. [0073]-[0074]. These read on “communication links”), configured to allow transfer of data (i.e., control signals from control unit 36) to the stimulation device (14, via signals to pump 34) for modifying one or more stimulation parameters (the control unit 36 controls the operation of the valves and pump associated with the stimulation device(s) 14, see para. [0060]-[0061]), and
a controller (control unit 36, Fig. 2; para. [0060]-[0061]) configured to randomly alter at least one parameter of the stimulation action during operation of the device (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0078]. See also para. [0062]); wherein the controller (36) comprises; a processing circuitry (“Control unit 36 includes a processing unit for processing information from sensors … and for providing commands to pump 34 and valves, thereby controlling actuation (inflation/deflation) of units 16-24 and support unit 26” see para. [0061]), configured to:
obtain a signal from said sensor (“processing unit for processing information from sensors” see the first sentence of [0061]):
determine stimulation parameters based on the signal obtained from said sensor (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0078]. See also para. [0020], [0044], the sensor data is used as input for the controlled application of pressure); and
provide said stimulation device with the determined stimulation parameters via said communication links (controller 36 utilizes the communication links to send control signal(s) to the valves and pump to carry out the determined stimulation parameters).
Regarding claim 2, Rembrand discloses wherein the stimulation is provided for achieving a desired physiological change (reducing anxiety, activating vegetative skin reflex, see the first two sentences of the Abstract).
Regarding claim 10, Rembrand discloses wherein the sensor (38) is configured to measure temperature, oxygen levels, blood pressure, and/or blood tests (“including a heart rate sensor, a body temperature sensor, a skin moisture sensor (e.g. GSR sensor), a muscle activity sensor, a blood pressure sensor, a respiratory sensor, a brain activity sensor, respiratory depth sensor, eye movement sensor” para. [0071]).
Regarding claim 11, Rembrand discloses a stimulation device (Fig. 2) for abdominal stimulation (It is noted that this is a recitation of an intended use occurring in the preamble. When reading the preamble in the context of the entire claim, the recitation “for abdominal stimulation” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02), comprising:
a stimulation unit (individually inflatable unit(s) 14, Fig. 2), configured to generate a stimulation action (“preferably actuated (inflated/deflated) via a fluid such as air” see the first sentence of [0052]) and apply said stimulation action to a target organ and/or region (units 14 are “arranged such that they contact the lower back (unit 16), the sides of the back (units 18 and 20) and shoulders/chest (units 22 and 24) of the individual when device 12 is worn thereby” see para. [0053] and Figs. 1-2) based on stimulation parameters (the timing instruction(s) of the valves controlling the inflation/deflation of each expandable unit 14-26, see para. [0059], para. [0061]-[0062]) to affect a physiological change in the target organ and/or region (reducing anxiety, by applying deep pressure to activate a vegetative skin reflex, see the first two sentences of the Abstract); wherein the stimulation unit (14) is configured to affect a stimulation, by applying a pressure excluding vibrations (“individually expandable units for applying pressure to a specific body region of the individual when expanded” see the Abstract. There is no mention of any vibration), and altering one or more parameters of the pressure according to an irregular pattern (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0077]-[0079] and the Example 2 actuation script in para. [0099]-[0131]. This includes at least one irregular pattern); and
communication links (wired or wireless communication is provided between control unit 36 and pump 34, see para. [0060]-[0061], and sensor(s) may transmit data wirelessly to the control unit via Bluetooth, see para. [0073]-[0074]. These read on “communication links”), configured to allow transfer of data (i.e., control signals from control unit 36) between the stimulation unit (14) and a controller (the control unit 36 controls the operation of the valves and pump associated with the stimulation device(s) 14, see para. [0060]-[0061]);
wherein the controller (control unit 36, Fig. 2; para. [0060]-[0061]) comprises a processing circuitry (“Control unit 36 includes a processing unit for processing information from sensors … and for providing commands to pump 34 and valves, thereby controlling actuation (inflation/deflation) of units 16-24 and support unit 26” see para. [0061]), configured to
obtain a signal from a sensor (“processing unit for processing information from sensors” see the first sentence of [0061]) indicative of a physiological property (“including a heart rate sensor, a body temperature sensor, a skin moisture sensor (e.g. GSR sensor), a muscle activity sensor, a blood pressure sensor, a respiratory sensor, a brain activity sensor, respiratory depth sensor, eye movement sensor” para. [0071]);
determine stimulation parameters based on the signal obtain from said sensor (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0078]. See also para. [0020], [0044], the sensor data is used as input for the controlled application of pressure); and
provide said stimulation device with the determined stimulation parameters via said communication links (controller 36 utilizes the communication links to send control signal(s) to the valves and pump to carry out the determined stimulation parameters); and
wherein the controller (36) is configured to randomly alter at least one parameter of the stimulation action during operation of the device (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0078]. See also para. [0062]); and wherein the stimulation device having a form of a wearable device (Fig. 2 includes a wearable device 12), configured to be placed and/or held on and/or near a target body region (it is a wearable vest).
Regarding claim 14, Rembrand discloses wherein said stimulation unit (14) is configured to affect a stimulation by … physical movement (inflation/deflation of 14). It is noted that these limitations of claim 14 are recited as a list of alternatives.
Regarding claim 15, Rembrand discloses wherein the sensor (38) is configured to measure temperature, oxygen levels, blood pressure, and/or blood tests (“including a heart rate sensor, a body temperature sensor, a skin moisture sensor (e.g. GSR sensor), a muscle activity sensor, a blood pressure sensor, a respiratory sensor, a brain activity sensor, respiratory depth sensor, eye movement sensor” para. [0071]).
Regarding claim 21, Rembrand discloses wherein the control circuitry (circuitry associated with controller 36) is further configured to obtain a signal indicative of a state or operation of the target organ (i.e., skin moisture sensor or heart rate) from a sensor (sensor 38; see para. [0071]), and generate stimuli based on the obtained signal (see para. [0044]; “Control unit 36 preferably actuates units 16-24 and support unit 26 (i.e., triggers a script) in response to physiological parameter(s) sensed from the individual…” see para. [0071]; “Physiological data monitored by sensors 38 is transmitted to control unit 36 and processed to yield a therapeutic script which activates pump 34 and valves” see para. [0074]).
Regarding claim 22, Rembrand discloses wherein the stimulation device (14) is configured to include a random combination of stimuli, each being delivered in a random-chaotic way (“individually expandable units for applying pressure to a specific body region of the individual when expanded” see the Abstract. There is no mention of any vibration), and altering one or more parameters of the pressure according to an irregular pattern (“when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above” see para. [0077]-[0079] and the Example 2 actuation script in para. [0099]-[0131]).
Regarding claim 25, Rembrand discloses wherein the parameters of the pressure comprise one of more of: amplitudes, intermittencies and intervals (the control of the timing of the valves to inflate/deflate the units 14 will involve changes in amplitude, intermittencies, and intervals).
Regarding claim 26, Rembrand discloses wherein the parameters of the pressure comprise one of more of: amplitudes, intermittencies and intervals (the control of the timing of the valves to inflate/deflate the units 14 will involve changes in amplitude, intermittencies, and intervals).
Claim Rejections - 35 USC § 103
12. 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 of this title, 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.
13. 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.
14. Claims 1-3, 9-11, 14-16, 20-23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Elkah (2012/0310311) in view of Zheng (CN 2489764 Y) and Rembrand (2016/0001034).
Regarding claim 1, Elkah discloses system for closed loop abdominal stimulation (Fig. 1B depicts a waist cuff 120, a controller 112, and a power source 106 that form a “system for closed loop abdominal stimulation.” See annotated Fig. 1B below for convenience), comprising:
a sensor (Fig. 3B, sensor(s) 110 are part of the energy delivery modular components 104 found within the waist cuff 120), configured to measure a physiological property, and provide a signal indicative thereof (Para. [0035] discloses one or more sensors 110 as temperature sensors, pressure sensors, and/or impedance sensors. [0036] discloses that these sensors 110 provide controller 112 with feedback signals regarding temperature, pressure, and tissue impedance);
a stimulation device having a form of a wearable device (Fig. 1B, waist cuff 120 is a “wearable device”), configured to be placed and/or held on and/or near a target body region (Fig. 2A depicts the waist cuff 120 being placed and held on a stomach or abdominal region of a user), comprising:
a stimulation unit (energy delivery modular components 104 are “stimulation inducers” see Fig. 1B), configured to generate a stimulation action and apply said stimulation action to one or more target organs and/or regions based on stimulation parameters to affect a physiological change in the one or more target organs and/or regions (Para. [0031] discloses energy delivery modular components 104 providing RF energy, light energy, and mechanical energy. [0032] discloses the stimulation as increasing muscle tone, blood circulation, and fat tissue metabolism in the area treated); wherein the stimulation unit is configured to affect a stimulation by applying a pressure, and altering one or more parameters of the pressure (Fig. 3B, mechanical energy delivery elements 108 would deliver “a pressure” to the body of the user. [0032] discloses that mechanical energy elements 108 may include vibrating balls),
and a communication links, configured to allow transfer of data to the stimulation device for modifying one or more stimulation parameters (Fig. 1B, the wiring between the controller 112 and the plurality of energy delivery components 104 creates “communication links” between the structures and provides control over one or more stimulation parameters), and
a controller (Fig. 1B, controller 112); wherein the controller comprises a processing circuitry ([0034] discloses the controller including a timer, a time control unit, and a counter unit, which would require “processing circuitry”), configured to:
obtain a signal from said sensor ([0036] discloses sensors 110 providing the controller 112 with feedback);
determine stimulation parameters based on the signal obtained from said sensor ([0049] discloses adjusting cosmetic treatment parameters in accordance with the input from sensor(s) 110. In order to adjust the parameters, the controller must first “determine” the stimulation parameters); and
provide said stimulation device with the determined stimulation parameters via said communication unit ([0049] discloses adjusting cosmetic treatment parameters in accordance with the input from sensor(s) 110. The communication links between the control unit 112 and stimulation unit(s) 108 would provide the stimulation parameters).
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Elkah is silent regarding the stimulation unit applying a pressure excluding vibrations, altering the pressure according to an irregular pattern; and the controller configured to randomly alter at least one parameter of the stimulation action during operation of the device. With respect to the pressure “excluding vibrations” it is noted that Elkah merely states that the “mechanical energy elements 108 may include, for example, vibrating balls that temporarily increase muscle tone, blood circulation and fat tissue metabolism in the local area to be treated” (see the last sentence of [0032]) which suggests that other forms of mechanical energy are contemplated to increase muscle tone, blood circulation and/or fat tissue metabolism.
Zheng teaches a related abdominal massage garment (covering 30, Fig. 1, Fig. 6) comprising a stimulation unit (air bags 41, 42, 43, 44, 45, Fig. 1, Fig. 6) applying pressure excluding vibrations (the air bags are inflated under the direction of controller 10, control circuit 12, air pump 13, distribution valve 20, see Figs. 1-2, Fig. 6. Inflating an air bag applies pressure: “pressing the abdomen of the human body in a cyclical charging mode generating motion effect. The circulation of the abdomen pressing action, which can increase intestine peristalsis of intestine, good absorbing effect of the small intestine is also favorable for a defecation function” see the third to last paragraph of page 2 of the English translation; “the pressing operation, increasing movement of the hip muscle, the blood of the smooth [muscle], with strengthening muscle, with function of reducing fat” see the fourth paragraph of page 3 of the English translation). The stimulation pressure is also altered according to an irregular pattern (see Fig. 4, the sequencing of the activation among the air bags 41, 42, 43, includes irregular pauses). Thus, the pressure stimulation provided by Zheng performs functions of increasing muscle tone, blood circulation, and/or fat metabolism, while also providing the advantage of augmenting peristalsis of the intestine.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical energy elements of Elkah to be substituted with the inflatable pressure applying stimulation elements taught by Zheng because these elements would be expected to still be suitable for performing the functions of increasing muscle tone, blood circulation, and/or fat metabolism, while also providing the advantage of augmenting peristalsis of the intestine.
The modified Elkah/Zheng device is still silent regarding the controller configured to randomly alter at least one parameter of the stimulation action during operation of the device. However, randomly adjusting stimulation parameters to avoid sensory adaptation or habituation is well known.
For example, Rembrand teaches a wearable device (wearable device 12, Fig. 2) with a controller (control unit 36, Fig. 2) with a sensor (sensor(s) 38, Fig. 2) and a stimulus unit comprising inflatable pressure applicators (individually inflatable units 14, part of stimulation regions 16-24, see Fig. 2; see para. [0052]). Rembrand states “Habituation is the sensory system’s mechanism of filtering out constant stimuli to assist in detecting the varying ones … [an] example could be constant deep pressure that does not affect the parasympathetic nervous system after a short time thus rendering an instrument that does not vary the pressure, useless” (para. [0076]), and the controller is configured to randomly alter at least one parameter of the stimulation action during operation of the device to prevent habituation (See para. [0077]-[0078], “when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Elkah/Zeng to be configured to trigger the pump and valves to apply a sequence of seemingly random inflation-deflations as taught by Rembrand because this will reduce habituation response to the treatment, over time.
Regarding claim 2, the modified system of Elkah has the stimulation provided for achieving a desire physiological change (Elkah, [0043], discloses the treatment as contributing to fat reduction).
Regarding claim 3, the modified system of Elkah has the desired physiological change as a lowering of bodyweight (Elkah, [0043], discloses the treatment as contributing to fat reduction).
Regarding claim 9, the modified system of Elkah discloses said stimulation unit (as modified by Zheng and Rembrand) is configured to affect a stimulation by using various types of rate and rhythms of stimuli with various frequencies, amplitudes, durations, and interval, in structured or random manner (see for example Fig. 4 of Zheng and the random control manner taught by Rembrand. Inflating and deflating actuators will necessarily have different amplitudes i.e., inflated vs deflated, and the modified device discloses different frequencies, durations, interval(s)).
Regarding claim 10, the modified system of Elkah discloses the sensor is configured to measure temperature (Elkah, [0035], discloses the sensor(s) 110 as temperature sensors).
Regarding claim 11, Elkah discloses a stimulation device for abdominal stimulation (Fig. 1B depicts a waist cuff 120 is a “stimulation device.” See annotated Fig. 1B above for convenience), comprising:
a stimulation unit (Fig. 1B, energy delivery modular components 104 are “stimulation unit(s)”), configured to generate a stimulation action and apply said stimulation action a target organ and/or region based on stimulation parameters to affect a physiological change in the target organ and/or region (Para. [0031] discloses energy delivery modular components 104 providing RF energy, light energy, and mechanical energy. [0032] discloses the stimulation as increasing muscle tone, blood circulation, and fat tissue metabolism in the area treated); wherein the stimulation unit is configured to affect a stimulation by applying a pressure, and altering one or more parameters of the pressure (Fig. 3B, mechanical energy delivery elements 108 would deliver “a pressure” to the body of the user. [0032] discloses that mechanical energy elements 108 may include vibrating balls); and a communication links, configured to allow transfer of data between the stimulation device and a controller (Fig. 1B, the wiring between the controller 112 and the energy delivery components 104 creates “communication links” between the structures and provides control over one or more stimulation parameters);
wherein the controller (112, Fig. 1B) comprises, a processing circuitry ([0034] discloses the controller including a timer, a time control unit, and a counter unit, which would require “processing circuitry”), configured to:
obtain a signal from said sensor indicative of a physiological property ([0036] discloses sensors 110 providing controller 112 with feedback);
determine stimulation parameters based on the signal obtained from said sensor ([0049] discloses adjusting cosmetic treatment parameters in accordance with the input from sensor(s) 110. In order to adjust the parameters, the controller must first “determine” the stimulation parameters); and
provide said stimulation device with the determined stimulation parameters via said communication unit ([0049] discloses adjusting cosmetic treatment parameters in accordance with the input from sensor(s) 110. The communication links between the control unit 112 and stimulation unit(s) 108 would provide the stimulation parameters);
wherein the stimulation device having a form of a wearable device (Fig. 1B, waist cuff 120 is a “wearable device”), configured to be placed and/or held on and/or near a target body region (Fig. 2A depicts the waist cuff 120 being placed and held on a stomach of a user).
Elkah is silent regarding the stimulation unit applying a pressure excluding vibrations, altering the pressure according to an irregular pattern; and the controller configured to randomly alter at least one parameter of the stimulation action during operation of the device. With respect to the pressure “excluding vibrations” it is noted that Elkah merely states that the “mechanical energy elements 108 may include, for example, vibrating balls that temporarily increase muscle tone, blood circulation and fat tissue metabolism in the local area to be treated” (see the last sentence of [0032]) which suggests that other forms of mechanical energy are contemplated to increase muscle tone, blood circulation and/or fat tissue metabolism.
Zheng teaches a related abdominal massage garment (covering 30, Fig. 1, Fig. 6) comprising a stimulation unit (air bags 41, 42, 43, 44, 45, Fig. 1, Fig. 6) applying pressure excluding vibrations (the air bags are inflated under the direction of controller 10, control circuit 12, air pump 13, distribution valve 20, see Figs. 1-2, Fig. 6. Inflating an air bag applies pressure: “pressing the abdomen of the human body in a cyclical charging mode generating motion effect. The circulation of the abdomen pressing action, which can increase intestine peristalsis of intestine, good absorbing effect of the small intestine is also favorable for a defecation function” see the third to last paragraph of page 2 of the English translation; “the pressing operation, increasing movement of the hip muscle, the blood of the smooth [muscle], with strengthening muscle, with function of reducing fat” see the fourth paragraph of page 3 of the English translation). The stimulation pressure is also altered according to an irregular pattern (see Fig. 4, the sequencing of the activation among the air bags 41, 42, 43, includes irregular pauses). Thus, the pressure stimulation provided by Zheng performs functions of increasing muscle tone, blood circulation, and/or fat metabolism, while also providing the advantage of augmenting peristalsis of the intestine.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical energy elements of Elkah to be substituted with the inflatable pressure applying stimulation elements taught by Zheng because these elements would be expected to still be suitable for performing the functions of increasing muscle tone, blood circulation, and/or fat metabolism, while also providing the advantage of augmenting peristalsis of the intestine.
The modified Elkah/Zheng device is still silent regarding the controller configured to randomly alter at least one parameter of the stimulation action during operation of the device. However, randomly adjusting stimulation parameters to avoid sensory adaptation or habituation is well known.
For example, Rembrand teaches a wearable device (wearable device 12, Fig. 2) with a controller (control unit 36, Fig. 2) with a sensor (sensor(s) 38, Fig. 2) and a stimulus unit comprising inflatable pressure applicators (individually inflatable units 14, part of stimulation regions 16-24, see Fig. 2; see para. [0052]). Rembrand states “Habituation is the sensory system’s mechanism of filtering out constant stimuli to assist in detecting the varying ones … [an] example could be constant deep pressure that does not affect the parasympathetic nervous system after a short time thus rendering an instrument that does not vary the pressure, useless” (para. [0076]), and the controller is configured to randomly alter at least one parameter of the stimulation action during operation of the device to prevent habituation (See para. [0077]-[0078], “when a physiological parameter remains unchanged for several seconds to several minutes, control unit 36, which is programmed to recognize as such situations as potential habituation, triggers pump 34 and valves to apply a sequence of inflation-deflations which are seemingly random but are designed to reduce habituation as described above”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Elkah/Zeng to be configured to trigger the pump and valves to apply a sequence of seemingly random inflation-deflations as taught by Rembrand because this will reduce habituation response to the treatment, over time.
Regarding claim 14, the modified device of Elkah discloses said stimulation unit is configured to affect a stimulation by providing a magnetic signal to a target body part, by physical movement, by electromagnetic signal emission, by temperature alteration, and/or by including pressure, or by any combination thereof (Elkah as modified by Zheng and Rembrand has at least physical movement as taught by Zheng’s inflatable actuators). It is noted that these limitations of claim 14 are recited as a list of alternatives.
Regarding claim 15, the modified device of Elkah discloses the sensor is configured to measure temperature (Elkah, [0035], discloses the sensor(s) 110 as temperature sensors).
Regarding claim 16, the modified device of Elkah is also a method for a continuous, semi-continuous, conditional, or non-continuous closed loop abdominal stimulation, comprising: providing and/or placing in a proximity of a target body part the stimulation device of claim 11 (Elkah, Fig. 2A, depicts the device placed on the stomach area of the user. See rejection of claim 11 above); providing initial stimulation parameters to the stimulation device based on initial acquired information and a desired physiological change (Elkah, [0039], discloses controller 112 receiving treatment parameter settings from a remote source. This would be the “initial stimulation parameters based on initial acquired information.” [0012] discloses end goals of the treatment as increase in muscle tone, blood-circulation, and fat cell metabolism); applying stimulation via the stimulation inducer based on the initial stimulation parameters (Elkah, [0049], discloses adjusting cosmetic treatment parameter, indicating the application of initial stimulation parameters); and obtaining information from the user and/or device ([0049] discloses adjusting cosmetic treatment parameters in accordance with the input from sensor(s) 110 that obtain information from the user) and randomly altering characteristics of the stimulation, thereby mitigating the habituation effect to the stimulation (as taught by Rembrand, see para. [0077]-[0079] and the Example 2 actuation script in para. [0099]-[0131]).
Regarding claim 20, the modified method of Elkah discloses the physiological change as a treatment of any metabolic, inflammatory, infectious malignant condition (Elkah, [0008], discloses fat reduction (i.e. a metabolic condition/obesity)).
Regarding claim 21, the modified system of Elkah discloses the control circuitry further configured to obtain a signal indicative of a state or operation of the target organ from a sensor, and generate stimuli based on the obtained signal (Elkah, [0046], discloses a temperature sensor 110 for detecting the temperature of the target tissue. The controller 112 would then alter stimulation parameters based on the data from the sensor).
Regarding claim 22, the modified system of Elkah discloses the stimulation device configured to induce a random combination of stimuli, each being delivered in a random-chaotic way (as taught by Rembrand, see para. [0077]-[0079] and the Example 2 actuation script in para. [0099]-[0131]).
Regarding claim 23, the modified system of Elkah discloses the stimulation device is further configured to induce a stimulation which is based on pre-programmed patient-tailored algorithm, according to physiologic parameters of a user comprising body weight, BMI, metabolic and endocrine (Elkah, [0039], discloses controller 112 receiving treatment parameter settings from a remote source. This would be a “preprogramed patient-tailored algorithm” based on physiologic parameters of the user).
Regarding claim 25, the modified system of Elkah has the parameters of the pressure comprising one or more of amplitudes, durations, and interval (see for example Fig. 4 of Zheng and the random control manner taught by Rembrand. Inflating and deflating actuators will necessarily have different amplitudes i.e., inflated vs deflated, and the modified device discloses different durations, interval(s)).
Regarding claim 26, the modified device of Elkah discloses the parameters of the pressure comprising one or more of amplitudes, durations, and interval (see for example Fig. 4 of Zheng and the random control manner taught by Rembrand. Inflating and deflating actuators will necessarily have different amplitudes i.e., inflated vs deflated, and the modified device discloses different durations, interval(s)).
15. Claim 24 is rejected under 35 U.S.C. 103 as being obvious over Elkah in view of Zheng and Rembrand, as applied to claim 1 above, and further in view of Moffitt et al (2016/0096025).
Regarding claim 24, the modified system of Elkah does not have the control circuitry further configured to apply machine learning capability for adapting to the reaction of a user to the stimulation, and alter the generated stimuli accordingly.
However, Moffit teaches methods for delivering electrical stimulation using feedback to adjust stimulation parameters (Abstract), wherein the adjustment of the parameters takes place using machine learning ([0066]). The use of machine learning helps to improve or optimize stimulation to produce a desired sensed clinical effect ([0066]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the controller of the modified system of Elkah to use machine learning to determine its stimulation parameters as taught by Moffit. The use of machine learning would help to improve or optimize stimulation to produce a desired sensed clinical effect.
Claim 24 is rejected under 35 U.S.C. 103 as being obvious over Rembrand, as applied to claim 1 above, and further in view of Moffitt et al (2016/0096025).
Regarding claim 24, Rembrand is silent regarding the control circuitry further configured to apply machine learning capability for adapting to the reaction of a user to the stimulation, and alter the generated stimuli accordingly.
However, Moffit teaches methods for delivering electrical stimulation using feedback to adjust stimulation parameters (Abstract), wherein the adjustment of the parameters takes place using machine learning ([0066]). The use of machine learning helps to improve or optimize stimulation to produce a desired sensed clinical effect ([0066]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the controller of the modified system of Elkah to use machine learning to determine its stimulation parameters as taught by Moffit. The use of machine learning would help to improve or optimize stimulation to produce a desired sensed clinical effect.
Response to Arguments
Applicant's arguments filed January 7, 2026, have been fully considered but they are not persuasive.
Regarding the argument that the claims have been amended to exclude vibrations as stimulation action, and thus overcome the prior art cited in the 103 rejection (see the 35 USC 103 section of page 7 of the Remarks), this argument is not persuasive.
It is noted that Elkah merely states that the “mechanical energy elements 108 may include, for example, vibrating balls that temporarily increase muscle tone, blood circulation and fat tissue metabolism in the local area to be treated” (see the last sentence of [0032]). This suggests that other forms of mechanical energy are contemplated to increase muscle tone, blood circulation and/or fat tissue metabolism. In the current 103 rejection(s), Zheng has been relied upon to teach such a mechanical energy actuator. Furthermore, the newly cited Rembrand reference anticipates claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Frenkel (DE 3622987 A1) discloses a related inflatable pressure belt to enhance bowel peristalsis. Frenkel (DE 3238425 A1) discloses a related inflatable pressure belt to enhance bowel peristalsis. Heller et al. (2015/0112380) discloses a related wearable device with pressure application for treating GERD. O’Brien (2010/0318007) discloses a related wearable device with stimulators that provide tactiles stimulation and use randomized stimulation patterns “to prevent the person’s brain from becoming accustomed to, and ignoring, the therapeutic stimulation from the tactile stimulation device.” Amalaha (2012/0010049) discloses a related wearable belt with stimulation that applies pressure without vibration, for reducing fat. Sekula et al. (2016/0008205) discloses a related wearable belt with stimulation that applies pressure without vibration, for reducing fat. Sabri (2007/0078296) discloses a related wearable belt with stimulation that applies pressure without vibration, for reducing fat. Fielding et al. (6,168,573) discloses a related wearable device that applies pressure to the body, and includes a timing circuit with a provision to randomly program the pressures over time. KR 20110047794 A discloses a related pressure application device to the abdomen to treat obesity, without vibration. Yang et al. (CN 204446549 U) discloses a related wearable device with inflatable pressure applicators, without vibration, to treat obesity. Gan (CN 201410093 Y) discloses a related wearable apparatus with pressure application without vibration, to treat constipation. Brinston (WO 2006/014341 A2) discloses a related wearable apparatus with pressure application without vibration, to treat obesity.
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/CHRISTOPHER E MILLER/Examiner, Art Unit 3785
