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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The independent claims 1, 17, 19 and 20 now recited “when the band strap is worn around a limb” which encompasses the limb and thus the human body.
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.
Claim(s) 1-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. US 2007/0279852.in view of Oz et al. US 2016/0270670.
Regarding claim 1, Daniel discloses a physiological signal measurement device, comprising:
a band strap ([¶58] strap 2 with its clasp);
a rack engaging with the band strap, the rack comprising a first end and a second end opposite to the first end, such that when the band strap is worn around the limb of a user, the first end of the rack is proximal to a trunk of the user while the second end of the rack is distal to the trunk of the user ([¶32,56-58] sensing modules 8. When the arm is oriented across the body technically the first end and second end are proximal and distal to the trunk respectively);
a first sensor disposed on the first end of the rack, the first sensor configured to detect a first vessel-related signal of the user at a first point on the limb ([FIG1]); and
a second sensor disposed on the second end of the rack, the second sensor configured to detect a second vessel-related signal of the user at a second point on the limb ([FIG1] the various modules which are considered the rack have several sensors),
wherein the first end has a first stiffness, the second end has a second stiffness, and the first stiffness is higher than the second stiffness ([¶58] the rack has varying stiffness based on the structure of the sensor and circuit board. [¶70] in a third embodiment useable with the embodiment of ¶58 has varying rigidity in the rack as well).
Daniel does not specifically disclose the signals sensed are vessel-related. Oz teaches a similar physiological monitoring strap with sensors where the sensors are acoustic sensors ([¶217,285] pulse signals are determined). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Regarding claim 7, Daniel discloses a frame part detachably engaging the rack with the band strap, wherein the band strap is configured to secure the frame part to the limb of the user ([¶58] layer 13 of strap 2), and the fixing part is configured to secure the frame part to the limb of the user ([¶59]).
Regarding claim 8, Daniel discloses wherein the frame part of the fixing element comprises a through-hole structure, and the through-hole structure corresponds to the first sensor and the second sensor when the rack engages the frame part of the fixing element ([¶58] through holes 30).
Regarding claim 10, Daniel discloses a host module comprising a controller and a first connection interface coupled to the controller ([¶28,58,61] one of the modules can be a processor and all modules have connections), wherein the rack further comprises a second connection interface coupled to the first sensor and the second sensor, and the second connection interface is configured to electrically connect to the first connection interface to allow the controller to acquire signals from the first sensor and the second sensors ([¶28,58,61] the modules are connected together through 14 and to a processing module or device via connector 19).
Regarding claim 11, Daniel discloses the host module further comprises: a housing configured to accommodate the controller and comprising a latch, wherein the latch is configured to detachably engage the rack ([¶58,62][FIG6b] all modules are latched to the bar 51).
Regarding claim 20, Daniel discloses a physiological signal measurement device, comprising:
a band strap ([¶58] strap 2 with its clasp);
a rack engaging with the band strap, the rack comprising a first end and a second end opposite to the first end, such that when the band strap is worn around the limb of a user, the first end of the rack is proximal to a trunk of the user while the second end of the rack is distal to the trunk of the user ([¶32,56-58] sensing modules 8);
a first sensor disposed on the first end of the rack, the first sensor configured to detect a first vessel-related signal of the user at a first point on the limb ([FIG1]); and
a second sensor disposed on the second end of the rack, for detecting a second vessel-related signal, such that when the band strap is worn around a limb of a user, the first end of the rack is proximal to a truck of the user while the second end of the rack is distal to the trunk of the user ([FIG1] the various modules which are considered the rack have several sensors), with varying stiffness ([¶58] the rack has varying stiffness based on the structure of the sensor and circuit board. [¶70] in a third embodiment useable with the embodiment of ¶58 has varying rigidity in the rack as well. When the arm is oriented across the body technically the first end and second end are proximal and distal to the trunk respectively).
wherein the first end of the rack comprises a first spring, the second end of the rack comprises a second spring, and a spring constant of the first spring is larger than a spring constant of the second spring ([¶62,75] the modules have several spring elements for locking them in place on the band. These are of varying shapes and sizes so they would have different spring constants).
Daniel does not specifically disclose the signals sensed are vessel-related. Oz teaches a similar physiological monitoring strap with sensors where the sensors are acoustic sensors ([¶217,285] pulse signals are determined). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Regarding claim 2, Daniel does not specifically disclose that each of the first sensor and the second sensor comprises an acoustic wave sensor. Oz teaches a similar physiological monitoring strap with sensors where the sensors are acoustic sensors ([¶217,285]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Regarding claim 3, Daniel discloses the first point is located at a position proximal to the trunk of the user, and the second point is located at a position distal to the trunk of the user ([FIG3a] the sensor modules are spread across different locations on the limb. When the arm is oriented across the body technically the first end and second end are proximal and distal to the trunk respectively).
Regarding claim 4 and 5, Daniel does not disclose the band has a first perimeter of the ring is longer than a second perimeter of the ring. Oz teaches a similar physiological monitoring strap that has different perimeters or circumferences on top and bottom and wherein the first perimeter of the ring is on a same side as the first end of the rack, and the second perimeter of the ring is on a same side as the second end of the rack ([FIG3,4]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Regarding claim 6, Oz teaches the band strap has an arc shape ([FIG3,4]).
Regarding claim 12, Daniel does not specifically disclose the vibration sensors. Oz teaches a similar device for physiological sensing that has a vibration collection structure corresponding to one of the first sensor or the second sensor, wherein the vibration collection structure comprises a rigid part and a rubber part covering the rigid part, the corresponding one of the first sensor or the second sensor is located at a center of the rigid part, and the rubber part is configured to contact skin of the user ([¶287-292] flexible membrane connected to the rigid portion 12 and 13).
Regarding claim 13, Oz teaches the rigid part comprises a cone-shaped structure configured to collect mechanical waves detectable by the corresponding one of the first sensor or the second sensor ([FIG22,23]).
Regarding claim 14, Oz teaches rubber part comprises an innermost portion, at least one middle portion, and an outermost portion, and the innermost portion and the outermost portion are in contact with the rigid part and the at least one middle portion is not in contact with the rigid part ([¶335,287] the middle part of the membrane does not touch the cone structure).
Regarding claim 15, Oz teaches the rubber part but does not disclose the rubber part comprises an innermost portion, at least one middle portion, and an outermost portion, a thickness of the innermost portion and a thickness of the outermost portion are thicker than a thickness of the at least one middle portion, and the at least one middle portion forms a cavity within the rubber part. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the appropriate thickness because Applicant has not disclosed that thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the teachings of Oz at ¶338,339, and applicant' s invention, to perform equally well with either the thickness taught by Oz or the claimed thickness because both membranes or rubber parts would perform the same function of collecting the acoustic or vibrational signals equally well considering Oz teaches varying size to accommodate anatomical differences.
Therefore, it would have been prima facie obvious to modify Oz to obtain the invention as specified in claim 15 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Oz.
Regarding claim 16, Oz teaches a largest radius of the cavity is not larger than a largest radius of a cone-shaped structure of the rigid part ([FIG22,23] the cone fans out from the center section).
Regarding claim 17, Daniel discloses further comprises: a third sensor disposed on the rack and positioned between the first sensor and the second sensor, the first sensor, the second sensor, and the third sensor being arranged in a straight line on the rack; and a controller coupled to the first sensor, the second sensor, and the third sensor ([¶32,56-58] sensing modules 8).
Daniel does not disclose the third sensor being configured to detect a vessel-related signal of the user and the controller being configured to: determine whether a pulse wave is detected by both the first sensor and the second sensor; and in response to determining that the pulse wave is detected by both the first sensor and the second sensor, actuate the third sensor or start to apply the vessel-related signal detected by the third sensor for calculating an output of the physiological signal measurement device. Oz teaches a similar physiological monitoring strap with sensors where the sensors are acoustic sensors for monitoring pulse and cardiac signals ([¶217,285]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Regarding claim 18, Oz teaches each of the first sensor and the second sensor comprises an acoustic wave sensor and the third sensor comprises an optical sensor ([¶217,285] acoustic sensors [¶216] optical sensors can be included as well).
Regarding claim 19, Daniel discloses a physiological signal measurement device, comprising:
a band strap ([¶58] strap 2 with its clasp);
a rack engaging with the band strap, the rack comprising a first end and a second end opposite to the first end, such that when the band strap is worn around the limb of a user, the first end of the rack is proximal to a trunk of the user while the second end of the rack is distal to the trunk of the user ([¶32,56-58] sensing modules 8. When the arm is oriented across the body technically the first end and second end are proximal and distal to the trunk respectively);
a first sensor disposed on the first end of the rack, the first sensor configured to detect a first vessel-related signal of the user at a first point on the limb ([FIG1]); and
a second sensor disposed on the second end of the rack ([FIG1] the various modules which are considered the rack have several sensors), and varying stiffness of the structure ([¶58] the rack has varying stiffness based on the structure of the sensor and circuit board. [¶70] in a third embodiment useable with the embodiment of ¶58 has varying rigidity in the rack as well).
wherein the first end of the rack comprises a first U-shaped recessed structure, the second end of the rack comprises a second U-shaped recessed structure ([FIG3a] the cut outs 30 are two U shaped sections).
Daniel does not disclose the two parallel sides of the first U-shaped recessed structure are shorter than two parallel sides of the second U-shaped recessed structure. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the appropriate length because Applicant has not disclosed that lengths provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the structure of Daniel, and applicant' s invention, to perform equally well with either the length of Daniel or the claimed length because both lengths would perform the same function of holding the sensors and collecting the acoustic or vibrational signals equally well considering Daniel teaches varying stiffness.
Daniel does not specifically disclose the signals sensed are vessel-related. Oz teaches a similar physiological monitoring strap with sensors where the sensors are acoustic sensors ([¶217,285] pulse signals are determined). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daniel with the sensors of Oz in order to monitor blood and cardiac parameters ([¶155]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel and Oz further in view of Dott US 2020/0246580.
Regarding claim 9, Daniel does not disclose a thickness of the frame part gradually diminishes from a through-hole side to a fixing part side. Dott teaches a similar limb mounted monitoring device that has a taper from the frame part to the fixing part ([FIG4]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Daneil with the teachings of Dott as it is just a simple substitution one known shape for another.
Response to Arguments
Applicant's arguments filed 12/4/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Daniel does not disclose multiple sensors let alone two sensors disposed at opposite ends of a rack, Examiner respectfully disagrees. Daniel discloses the use of multiple sensors and multiple health sensors in ¶30 and 32. Similarly, regarding the argued positioning of the sensors in relation to the user’s trunk, the device when worn on an arm and held in front of the users has the sensors and first and second positions in the claimed configuration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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