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 .
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
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 for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that 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. Such claim limitations is/are:
(Claim 7) “a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate the pressure sensed by the pressure sensor to an external device” / (Claim 15) “a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate pressure readings to an external device”
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
(Claim 7) “a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate the pressure sensed by the pressure sensor to an external device” / (Claim 15) “a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate pressure readings to an external device”: As identified by the Specification, the following is recognized as the corresponding structure to the communication module: “In still other embodiments, the vibration of the motor can be processed by software to generate a sonic waveform indicating or correlating with the pressure detected by the pressure sensor. This data is transmitted to a receiver, then to an audio interface where the amplitude and frequency of the force are recorded. In this manner the user can immediately track the pressure detected by the pressure sensor directly recorded alongside data from a task, such as playing music, to identify where pressures exceed an acceptable limit.” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-8, 10-11 and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uehara (US 10,765,908).
Regarding Claim 1, Uehara teaches a bracing system for indicating a potential strain to a muscle (Abstract, Figs. 1a-2b, Col. 10, L. 63 - Col. 12, L. 8, Fig. 19, Col. 29, L. 28 – Col. 30, L. 12), the bracing system comprising:
a strap having at least a first side and a second side, the first side configured to be positioned over and removably fastened to a body surface directly over a preselected body muscle (Figs. 1c-2b, Col. 11, L. 49 - Col. 12, L. 8, belt 12 / strap has a first side and a second side, the first side facing the body surface and the belt 12 / strap is removably fastened to a body surface with a hook and loop mechanism from outer side 18 and loops 19);
a pressure sensor coupled to the strap and configured to detect changes in pressure applied to the first side of the strap in response to a change in a status of the preselected body muscle from a relaxed state to a flexed state, and vice versa (Fig. 3a-3b, Col. 11, L. 50 - Col. 12, L. 8, extruding bumper 30 (mislabeled 42) contains a pressure sensor to detect changes in pressure applied to the first side of the strap / belt 12 in response to a change in a status of the preselected body muscle from a relaxed state to a flexed state, and vice versa. A body muscle for monitoring is preselected by practitioner when placing the system on the patient); and
an indicator circuit communicatively coupled to the pressure sensor and drawing power from a power source, the indicator circuit configured to provide one or more indications of the status of said preselected body muscle, including the relaxed state and the flexed state (Fig. 19, Col. 29, L. 28 – Col. 30, L. 12, indicator circuit / display 1914 communicatively coupled to the muscle contraction sensor 1907 / pressure sensor and drawing power from a power source / battery 1910, Col. 15, L. 55 – Col. 16, L. 19, displaying of system values includes the determined status of relaxed or engaged of preselected body muscles. Alternatively, the indicator circuit may be the communication device 1901 that enables the app functionality and enables the indication of results at an external device).
Regarding Claim 2, Uehara teaches the bracing system of claim 1, wherein the pressure sensor is integral to the strap (See Claim 1 Rejection, the pressure sensor is integral to the strap as it is a necessary component for muscle monitoring).
Regarding Claim 3, Uehara teaches the bracing system of claim 1, further comprising a motion sensor coupled to the strap and configured to detect a movement of the preselected body muscle (See Claim 1 Rejection, Col. 29, L. 28 – Col. 30, L. 12, movement sensor 1909 where all components of the diagram may reside in housing 1915 of the wearable device 10, Col. 17, L. 3, - Col. 18, 46, movement sensor is measuring body motion to detect if the muscle moves based on whole body movement).
Regarding Claim 4, Uehara teaches the bracing system of claim 3, wherein the motion sensor is an accelerometer (See Claim 3 Rejection, Col. 29, L. 28 – Col. 30, L. 12).
Regarding Claim 5, Uehara teaches the bracing system of claim 1, further comprising a display communicatively coupled to the pressure sensor, wherein the display is configured to display the pressure detected by the pressure sensor (See Claim 1 Rejection, Col. 29, L. 28 – Col. 30, L. 12, Col. 13, L. 60 – Col. 14, L. 5, Col. 15, L. 55 – Col. 16, L. 19, Col. 16, L. 41 – Col. 17, L. 3, Fig. 8c, “The myokinesiograph 860 is a graph for displaying muscle (myo) data, movement (kinesio) data, raw sensor data, thresholds, parameter status, and feedback over time 149. In an embodiment, other data, instruction, and information relevant to the application or useful to the user 100 may be displayed in the myokinesiograph 860.“ raw sensor data and data relevant to the invention may be displayed in the myokinesiograph 860, indicating the raw pressure data reflecting the muscle engagement can be included as relevant data and useful to the user by ensuring the relationship between input pressure and output muscle engagement is rationally based).
Regarding Claim 7, Uehara teaches the bracing system of claim 1, further comprising a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate the pressure sensed by the pressure sensor to an external device (See Claim 1 Rejection, Col. 29, L. 28 – Col. 30, L. 12, communication device 1901).
Regarding Claim 8, Uehara teaches the bracing system of claim 1, further comprising a memory configured to record at least one of instances when the preselected body muscle transitions from the relaxed state to the flexed state, or vice versa (See Claim 1 Rejection, Col. 29, L. 28 – Col. 30, L. 12, memory 1902 stores various system parameters, Abstract, which includes muscle engagement and relaxing transitions, Fig. 8c and 8d shows a myokinesiograph 860 which displays the muscle engaged value 80 which records the muscle transitions, to display the graph the data including the transitions would have to be stored in memory).
Regarding Claim 10, Uehara teaches the bracing system of claim 1, wherein the indicator circuit is further configured to transmit or communicate the pressure sensed by the pressure sensor to an external device (See Claim 1 Rejection).
Regarding Claim 11, Uehara teaches a pressure sensing brace for monitoring a preselected body muscle (Abstract, Figs. 1a-2b, Col. 10, L. 63 - Col. 12, L. 8, Fig. 19, Col. 29, L. 28 – Col. 30, L. 12), the pressure sensing brace comprising:
a strap having a sensing portion and a latching portion, the latching portion structured to removably fasten the strap about a circumference of the preselected body muscle and configured to position the sensing portion on or proximate to the preselected body muscle (Figs. 1c-2b, Col. 10, L. 64 - Col. 11, L. 49, belt 12 / strap has a sensing portion / wearable device 10 and a latching portion / hook and loop fasteners 18 and 19, the latching portion / hook and loop fasteners 18 and 19 structured to removably fasten the strap about a circumference of the preselected body muscle and configured to position the sensing portion on or proximate to the preselected body muscle based on placement of the belt);
a pressure sensor coupled to or integrated with the sensing portion of the strap, the pressure sensor configured to sense at least a first pressure corresponding to a first preselected body muscle state and a second pressure corresponding to a second preselected body muscle state (Fig. 3a-3b, Col. 11, L. 50 – Col. 12, L. 8, wearable device 10’s extruding bumper 30 contains a pressure sensor to detect changes in pressure in response to a change in a status of the preselected body muscle from a relaxed state to a flexed state, the preselected body muscle chosen by practitioner placement, Col. 13, L. 60 – Col. 14, L. 5, a first pressure of a body muscle relaxed state and a second pressure of a body muscle engaged state); and
a sensing circuit communicatively coupled to the pressure sensor, the sensing circuit configured to generate a first alert responsive to the pressure sensor sensing the first pressure and generate a second alert responsive to the pressure sensor sensing the second pressure (Fig. 19, Col. 29, L. 28 – Col. 30, L. 12, sensing circuit / processor 1900 coupled to the pressure sensor / muscle contraction sensor 1907, Figs. 8a-8b, Col. 15, L. 55 – Col. 16, L. 19, generates an alert of pressure state by displaying the muscle state).
Regarding Claim 13, Uehara teaches the pressure sensing brace of claim 11, wherein at least one of the first alert or the second alert is a visual alert (See Claim 11 Rejection).
Regarding Claim 14, Uehara teaches the pressure sensing brace of claim 11, wherein the second pressure is greater than the first pressure (Col. 13, L. 60 – Col. 14, L. 5).
Regarding Claim 15, Uehara teaches the pressure sensing brace of claim 11, further comprising a communication module communicatively coupled to the pressure sensor and is configured to transmit or communicate pressure readings to an external device (See Claim 11 Rejection, Col. 29, L. 28 – Col. 30, L. 12, communication device 1901).
Regarding Claim 16, Uehara teaches the pressure sensing brace of claim 15, wherein the external device includes a pressure gauge, a smart watch, or a smart phone (Col. 15, L. 55 – Col. 17, L. 3, smart devices may be the external devices, Col. 1, L. 66 – Col. 2, L. 14, where the application recognizes smart phones as example of a smart device).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uehara.
Regarding Claim 17, while Uehara teaches a method of using a pressure sensing brace (Abstract, Figs. 1a-2b, Col. 10, L. 64- Col. 12 L. 8, Figs. 18-19, Col. 28, L. 53 – Col. 30, L. 12), the method comprising:
selecting a body part having a muscle or a muscle group (Fig. 18, step 180, Col. 28, L. 53 – Col. 30, L. 12);
providing a brace having a strap with two sides and structured to be secured about a circumference of the body part (Fig. 18, step 180, Col. 28, L. 53 – Col. 30, L. 12, Figs. 1c-2b, Col. 10, L. 64- Col. 11 L. 49, belt 12 / strap has a first side and a second side, the first side facing the body surface and the belt 12 / strap is removably fastened to a body surface with a hook and loop mechanism from outer side 18 and loops 19), wherein the strap includes a pressure sensor configured to monitor a state of the muscle or the muscle group and provide a first indication when the muscle or the muscle group is in a relaxed state and provide a second indication when the muscle or the muscle group transitions from the relaxed state to a flexed state (Fig. 3a-3b, Col. 11, L. 50- Col. 12 L. 8, extruding bumper 30 contains a pressure to detect changes in pressure applied to the first side of the strap / belt 12 in response to a change in a status of the preselected body muscle from a relaxed state to a flexed state, and vice versa. A body muscle for monitoring is preselected by practitioner when placing the system on the patient);
positioning the strap about the circumference of the selected body part (Fig. 18, step 180, Col. 28, L. 53 – Col. 30, L. 12, Col. 11, L. 32-49);
positioning the pressure sensor over the muscle or the muscle group of the selected body part (Fig. 18, step 180, Col. 28, L. 53 – Col. 30, L. 12, Col. 11, L. 32-49); and
securing the strap about the circumference of the selected body part at the operating tension (Fig. 18, step 180, Col. 28, L. 53 – Col. 30, L. 12, Col. 11, L. 32-49).
And teaches characteristics of the system that enable an adjusting a tension of the strap from a positioning tension to an operating tension (Col. 13, L. 29-45, Col. 25, L. 65-Col. 26, L. 22), Uehara fails to explicitly teach a step of adjusting a tension of the strap from a positioning tension to an operating tension after positioning the pressure sensor over the muscle or the muscle group of the selected body part.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the tension adjusting teachings of Uehara prior to operation as these adjusting teachings are used to configure the system for proper monitoring.
Regarding Claim 18, Uehara the teaches method of claim 17, wherein the selected body part is a forearm, chest, upper arm, or jaw (Col. 10, L. 37-63).
Regarding Claim 19, Uehara the method of claim 17, wherein providing the brace further comprises a motion sensor that is configured to monitor a movement of the selected body part and is communicatively coupled to a transmitter (Col. 29, L. 28 – Col. 30, L. 12, movement sensor 1909 where all components of the diagram may reside in housing 1915 of the wearable device 10, Col. 17, L. 3, - Col. 18, 46, movement sensor is measuring body motion to detect if the muscle moves based on whole body movement, and communicatively coupled to communication device 1901); and
transmitting data of the movement detected by the motion sensor to an external device (Col. 29, L. 28 – Col. 30, L. 12).
Regarding Claim 20, Uehara the method of claim 17, further comprising providing a tightness indicator configured to indicate that the tension of the strap is at the operating tension (Col. 29, L. 10 – 27, measurement of belt tightness when the target muscle is relaxed acts as tightness indicator).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uehara in view of Barlow et al (US 2019/0110734) (“Barlow”).
Regarding Claim 6, Uehara teaches the bracing system of claim 1, wherein the indicator circuit is configured to indicate the relaxed state by at least a first color, and the indicator circuit is configured to indicate the flexed state by at least a second color that is different than the first color (Col. 15, L. 55 – Col. 17, L. 3, different line colors used for different muscle statuses), Uehara fails to the display includes one or more light emitting diodes (LEDs), the indicator circuit is configured to indicate the relaxed state by illuminating at least one of the one or more LEDs in a first color, and the indicator circuit is configured to indicate the flexed state by illuminating at least one of the one or more LEDs in a second color that is different than the first color.
However Barlow teaches a muscle assessment system based on pressure-sensing (Abstract) comprising a LED display for providing monitoring muscle information ([0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the display of muscle state in different colors taught by Uehara specifically utilize one or more LEDs as taught by Barlow as a specific teaching on how the display should be structured, ensuring consistency across the application of Uehara’s wearable monitoring system.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uehara in view of D’Lima et al (US 2017/0281074) (“D’Lima”).
Regarding Claim 9, while Uehara teaches the bracing system of claim 1, Uehara fails to teach wherein the strap further includes a mark positioned about the second side, wherein the mark corresponds to an anatomical feature of a user such that when the mark is aligned with the anatomical feature, the pressure sensor is aligned over the preselected body muscle.
However D’Lima teaches a wearable monitoring system that evaluates muscle activity (Abstract, [0039]-[0041]) comprising a band of the wearable system further including a mark positioned about an external side, wherein the mark corresponds to an anatomical feature of a user such that when the mark is aligned with the anatomical feature, the system is correctly aligned (Figs. 14-16, [0047]-[0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the alignment mechanism teachings of D’Lima to the wearable system of Uehara to provide a reference point for correct placement of the system and ensuring proper measuring of the desired muscle group.
Regarding Claim 12, while Uehara teaches the pressure sensing brace of claim 11, Uehara fails to teach further comprising an alignment indicator configured to provide a visual indication to a user to place the brace in a position such that the pressure sensor is correctly aligned with the preselected body muscle.
However D’Lima teaches a wearable monitoring system that evaluates muscle activity (Abstract, [0039]-[0041]) comprising an alignment indicator configured to provide a visual indication to a user to place the band in a position such that the system is correctly aligned on the preselected body part (Figs. 14-16, [0047]-[0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the alignment mechanism teachings of D’Lima to the wearable system of Uehara to provide a reference point for correct placement of the system and ensuring proper measuring of the desired muscle group.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791