DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 February 2026 has been entered. Claims 37-49 and 51-57 are now pending. The Examiner acknowledges the amendments to claims 37, 44 and 56.
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 .
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.
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.
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: “controller” in claim 37; and “attachment device” in claim 51.
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 § 112
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.
Claims 44 and 48 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 44 at line 2 recites the limitation "each applied rhythmic tactile stimulus". There is insufficient antecedent basis for this limitation in the claim as claim 37 recites that the device is “configured to provide a rhythmic tactile stimulus”. (The same rejection was set forth in the Office action mailed 21 February 2025.)
Claim 48 is indefinite as the bio-monitor recited in claim 37 is different than the recited heart rate monitor of claim 37.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 47 and 48 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 47 does not appear to further define claim 37, as claim 37 appears to have been amended to incorporate the subject matter of claim 47. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 37-49 and 51-57 are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (U.S. Pub. No. 2013/0123570) as evidenced by Zaimi (U.S. Pub. No. 2011/0190570). Regarding claim 37, Ly et al. (hereinafter Ly) discloses an apparatus configured to provide a relaxing or stimulating effect on a user ([0004], [0030] and [0041]), the apparatus comprising:
a wearable device configured to engage the user's skin (backpack – [0009]-[0012], [0029] and [0036]) and also configured to provide a rhythmic tactile stimulus to the user via the integrated vibrating, hugging or breathing apparatus ([0041], [0029] and [0027]) as a “heart beat-like pulse” in an individual ([0025] and 0029]);
a heart rate monitor configured to monitor a heart rate of the user (heart rate sensor integrated into backpack - [0041], [0009] and [0036]);
a bio-monitor configured to receive bio-monitoring input, the bio-monitoring input comprising one or more of skin conductance, breathing rate, pupil dilation, brain activity and temperature [0036]; and
a controller, wherein the controller is configured to instigate application of the rhythmic tactile stimulus in response to the received bio-monitoring input ([0036]: “computing device 50010 may then use any received or recorded information to modify the breathing-like motion of the apparatus, communicate that information to another computing device, store the information, or use it for other purposes as described herein. The computing device 50010 may be programmed to control the motors or actuators in such a way as to respond to any information received, recorded, or sensed”);
wherein the controller is configured to adjust a frequency, tempo, duration and/or intensity of the stimulus to apply the rhythmic tactile stimulus at a rate that is different to that of the monitored heart rate ([0030] and Fig. 2), wherein the rhythmic tactile stimulus changes over time (the controller is configured to change the rhythmic tactile stimulus over time – [0030]), wherein the controller is configured to introduce variability into the “heart beat-like pulse” to simulate a heart beat ([0030], wherein Ly discloses the controller controls the heartbeat to slow down/speed up, increase/decrease intensity via a pre-programmed routine or in response to user input or configuration). Of note, “variability” is simply construed as the ability of the controller to control the heartbeat to slow down/speed up or increase/decrease intensity as previously mentioned.
While Ly does not disclose explicitly that the “heart beat-like pulse” is a “double-peaked beat pattern” (as claimed), Ly does make such obvious as the claimed “double-peaked beat pattern” is “akin to a user’s heartbeat” and pulses “are akin to a user’s heartbeat” (as disclosed by Applicant) and Ly teaches that the feedback mechanisms may simulate “heart beat-like pulses” and “[p]ulses can be effectuated by any structure that allows for a beat and/or sound, including a vibrating device…an air bladder…and/or a speaker…” ([0025] of Ly). Of note, with respect to the word “pattern” after “double-peaked beat,” Ly discloses heart beat-like pulses and a heart rate (as indicated above), and a heart beat/heart rate is a cyclical process, which is repeated, and therefore would constitute a pattern, by definition.
While Ly does not disclose explicitly that the “slow down/speed up” of the heartbeat by the controller is with respect to time of the double-peaked beat pattern, slowing down or speeding up the heart rate is construed as slowing down or speeding up the time between the beats, which is evidenced by Zaimi as heart rate variability, where the time interval between heart beats varies [0036]. Of note, the recitation “variability into the…time of the double-peaked beat pattern” is interpreted as time between beats in the pattern; not as time between peaks.
While Ly does not disclose explicitly that the controller instigates application when the bio-monitoring input reaches a threshold level, Ly makes such obvious as Ly teaches that the various one or more disclosed sensors/bio-monitors may comprise pressure sensors, skin conductivity sensors, temperature sensors, blood oxygen level sensors, blood sugar level sensors, alcohol sensors, or any other type of biometric sensor [0036], and one of ordinary skill in the art would recognize each of the disclosed sensors/bio-monitors monitor/sense a quantity of the physiological parameter and thus, reaching a particular “level” or threshold is what is sought in order to determine when the controller should act to start or instigate the stimulus.
Regarding claim 38, the controller of Ly is configured to apply the rhythmic tactile stimulus at a rate that matches that of the monitored heart rate for a predetermined period of time (“Maintain Mode” [0030]), and the controller is further configured to adjust the rhythmic tactile stimulus to a rate that is different to that of the monitored heart rate after the predetermined period of time ([0030] – “…computing device 20010 may be programmed to respond to the individual's breathing rate or any other factors by controlling the heartbeat and/or breathing apparatus to slow down, speed up, increase or decrease intensity, or any other command; in response to a pre-programmed routine or in response to user input or configuration”; “After a configurable period of time the computing device 20010 will gradually start to slow the breathing rate of the breathing apparatus…”).
Regarding claim 39, the heart rate monitor of Ly is configured to monitor the user's heart rate in real-time or offline to record a user's resting or previous heart rate for later use ([0030], [0034], [0036] and [0041]).
Regarding claim 40, the controller of Ly is configured to adjust the rhythmic tactile stimulus in response to the monitored heart rate [0030].
Regarding claim 41, the controller of Ly is configured to adjust the rhythmic tactile stimulus after the predetermined period of time to a rate that represents a desired heart rate of the user, or to a rate that is slightly less than or greater than a current or resting heart rate of the user [0030].
Regarding claim 42, the controller of Ly is configured to iteratively increase or decrease the rhythmic tactile stimulus until a user's desired heart rate is reached [0030].
Regarding claim 43, the controller of Ly is configured such that changes in value of frequency and/or intensity between iterations may be equal or unequal to slow the user’s breathing or achieve a pre-set breathing level [0030].
Regarding claim 44, the controller is configured to introduce variability to a delay between each applied rhythmic tactile stimulus ([0030] – slowing of the breathing apparatus would impart greater delay between the applied stimuli).
Regarding claim 45, the heart rate monitor of Ly is configured to monitor the user's heart rate in real-time ([0030], [0034] and [0041]), and the controller is configured to apply reactive adjustments to the rhythmic tactile stimulus based on the monitored heart rate, with the device being configured to create a feedback loop to change the heart rate of the user in a gradual manner [0030].
Regarding claim 46, the feedback loop is configured to change the heart rate of the user by moving the heart rate one beat at a time (interpreted as the feedback loop gradually starting to slow the rate of the breathing apparatus – [0030] of Ly).
Regarding claim 47, the apparatus of Ly further includes a bio-monitor configured to monitor and receive bio-monitoring inputs, the apparatus being configured to instigate the rhythmic tactile stimulus in response to the received bio-monitoring inputs [0036].
Regarding claim 48 and in view of its indefinite nature, the bio-monitor of Ly is a heart rate monitor [0036].
Regarding claim 49, the apparatus of Ly is further configured to playback the monitored heart beat via tactile, visual or audio means ([0029], [0030] and [0034]).
Regarding claim 51, the apparatus of Ly further includes an attachment device (“chest strap”) configured to secure the wearable device to the user's wrist such that the device can apply the stimulus to an inner wrist of the user (although not ideal, the chest strap meets the limitations of claim interpretation invoked by 112(f) as indicated above) and would be “configured to secure” the back pack to a user’s wrist (see Fig. 10 and [0030] and [0035]).
Regarding claim 52, Ly discloses a system comprising: the apparatus of claim 37; and an external controller or monitor (Fig. 4, [0032] and [0034]).
Regarding claim 53, the system of Ly further comprises a means for recording a user's desired heart rate preferences as one or more profiles, the system being configured such that a user can access the one or more profiles via the apparatus and/or the external controller or monitor to set a desired tactile stimulus ([0032], [0036] and Fig. 4).
Regarding claim 54, the system of Ly is further configured to learn a user's preferences based on one or more of the user's preferences and/or profiles, data on a current location of the user, and data on a current activity of the user [0034].
Regarding claim 55, the external controller or monitor of Ly further comprises a clock to activate to provide the rhythmic tactile stimulus and/or deactivate the apparatus and stop the apparatus from applying the rhythmic tactile stimulus at a pre-set time ([0032]-[0034] and [0045]).
Regarding claim 56, Ly discloses a method for providing a relaxing or stimulating effect on a user ([0004], [0030] and [0041]), the method comprising:
physically engaging a device to the user's skin where a rhythmic tactile stimulus is to be applied to the user (Fig. 2, [0030] and [0036]);
monitoring a heart rate of the user ([0029], [0030] and [0041]);
receiving bio-monitoring input comprising one or more of skin conductance, breathing rate, pupil dilation, brain activity and temperature [0036];
instigating the application of the rhythmic tactile stimulus in response to the received bio-monitoring input ([0036]: “computing device 50010 may then use any received or recorded information to modify the breathing-like motion of the apparatus, communicate that information to another computing device, store the information, or use it for other purposes as described herein. The computing device 50010 may be programmed to control the motors or actuators in such a way as to respond to any information received, recorded, or sensed”);
applying the rhythmic tactile stimulus to the user via the device at a rate that is different to that of the monitored heart rate ([0029], [0030], [0027] and [0041]), the rhythmic tactile stimulus being applied as a “heart beat-like pulse” in an individual ([0025] and 0029]);
changing the rhythmic tactile stimulus over time via a controller [0030], and
introducing variability into the “heart beat-like pulse” to simulate a heart beat ([0030], wherein Ly discloses the controller controls the heartbeat to slow down/speed up, increase/decrease intensity via a pre-programmed routine or in response to user input or configuration). Of note, “variability” is simply construed as the controller controlling the heartbeat to slow down/speed up or increase/decrease intensity as previously mentioned.
While Ly does not disclose explicitly that the “heart beat-like pulse” is a “double-peaked beat pattern” (as claimed), Ly does make such obvious as the claimed “double-peaked beat pattern” is “akin to a user’s heartbeat” and pulses “are akin to a user’s heartbeat” (as disclosed by Applicant) and Ly teaches that the feedback mechanisms may simulate “heart beat-like pulses” and “[p]ulses can be effectuated by any structure that allows for a beat and/or sound, including a vibrating device…an air bladder…and/or a speaker…” ([0025] of Ly). Of note, with respect to the word “pattern” after “double-peaked beat,” Ly discloses heart beat-like pulses and a heart rate (as indicated above), and a heart beat/heart rate is a cyclical process, which is repeated, and therefore would constitute a pattern, by definition.
While Ly does not disclose explicitly that the “slow down/speed up” of the heartbeat by the controller is with respect to time of the double-peaked beat pattern, slowing down or speeding up the heart rate is construed as slowing down or speeding up the time between the beats, which is evidenced by Zaimi as heart rate variability, where the time interval between heart beats varies [0036]. Of note, the recitation “variability into the…time of the double-peaked beat pattern” is interpreted as time between beats in the pattern; not as time between peaks.
While Ly does not disclose explicitly that the application is instigated when the bio-monitoring input reaches a threshold level, Ly makes such obvious as Ly teaches that the various one or more disclosed sensors/bio-monitors may comprise pressure sensors, skin conductivity sensors, temperature sensors, blood oxygen level sensors, blood sugar level sensors, alcohol sensors, or any other type of biometric sensor [0036], and one of ordinary skill in the art would recognize each of the disclosed sensors/bio-monitors monitor/sense a quantity of the physiological parameter and thus, reaching a particular “level” or threshold is what is sought in order to determine when the controller should act to start or instigate the stimulus.
Regarding claim 57, the apparatus and/or system of Ly is operable as an alarm as the apparatus further includes a cell phone, for instance [0010] which is operable as an alarm.
Response to Arguments
12. Applicant’s arguments filed 2 February 2026 with respect to the interpretation of “controller” and “attachment device” under 35 U.S.C. 112(f) have been fully considered and are not persuasive. Applicant references the arguments set forth in the amendment of 21 May 2025, which were addressed in the previous Office action dated 11 June 2025.
13. Applicant’s arguments filed 2 February 2026 with respect to the rejection of claim 44 under 35 U.S.C. 112(a) have been fully considered and are persuasive in light of the amendments.
14. Applicant’s arguments filed 2 February 2026 with respect to the rejection of claims 37-43, 45-49 and 51-57 under 35 U.S.C. 103 citing Ly (’570) in view of Zaimi have been fully considered and are not persuasive. Regarding claims 37 and 56, Applicant contends that Ly fails to disclose or teach measuring both heart rate and a second bio-monitoring input, as required by claim 37, as the only teaching in Ly is to measure a single parameter (which may be one of a number of options). However, this argument is not persuasive. Ly teches that the computing device “may be connected to one or more sensors” and further that the computing device may use any received information to modify the breathing-like motion of the apparatus, and further be programmed to control the motors in such a way to respond to any information received, recorded or sensed, and therefore Ly is not limited to measuring a single parameter. Applicant further notes that Ly does not teach adjusting the stimulus based on reaching a threshold, which is now addressed above in the preceding rejection to Ly. While Ly does not explicitly teach a threshold, Ly obviates such as indicated above. With respect to Zaimi, Zaimi is included as an evidentiary reference, to show that Ly’s teaching of a “slow down/speed up” of the heartbeat by the controller is evidence of the introduction of heart rate variability in Ly. Of note, to make this rejection, the recitation “variability into the…time of the double-peaked beat pattern” is interpreted as time between beats in the pattern; not as time between peaks. If the latter is the case, an appropriate amendment could be made to potentially obviate the rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached on (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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