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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ohsawa (WO 2015/166888 – Previously cited) and further in view of Coppens (US 6447880 B1- Previously cited), Yang (WO 2016/205549- Previously cited), and Kimura et al. (US 20190122517- Previously cited).
Claims 1 and 5, Ohsawa discloses a wearable electronic device (See ABSTRACT and Fig. 1-3, bracelet-type device 10) comprising, a first belt portion (11) including an outer/cover layer 15 formed of a thermosetting resin and a first insert layer 11b formed of PET resin, formed of a higher tensile strength than the cover 15, and a second insert layer 11c disposed within the cover layer 15 formed of epoxy resin/thermoplastic resin (see fig. 1-2 and para. [0042-43]), that is bent along a circumferential direction of a user’s wrist (see para. [0032,0045-46] and fig. 1-2)); and a second belt portion (13) that couples to the first belt portion (11) via coupling part 3 (see fig. 1 and para. [0028-29]), wherein: the cover layer 15 is formed of thermosetting resin, the thermosetting resin is a thermosetting elastomer, and the thermosetting elastomer is one of a silicone resin or fluororesin (see para.[0046], “fluorocarbon resin having a relatively high permittivity, such as polyurethane resin or polyvinylidene fluoride” indicates that fluororesins and silicone resins are used, one skilled in the art at would understand that polyvinylidene fluoride (FDVP) is a type of fluororesin; In addition, “adding a filler for permittivity enhancement” and “he permittivity of the back surface protective layer 17 can be reduced by using a fluorocarbon resin, such as a silicone material or polytetrafluoroethylene” indicating that cover layer 15 can also be formed with silicon resin fillers for permittivity enhancement (see para. [0050])) and insert 11b is formed of PET resin which has a higher tensile strength than thermosetting resin (see para. [0045-46]).
Ohsawa fails to teach a bag shaped cuff configured to be wound around the living body, and further configured to be inflated when a fluid is supplied to an inner space of the cuff, wherein the belt is disposed on an outer side of the bag shaped cuff, and wherein the first belt portion is formed by curing the thermosetting resin forming the cover layer and softening the second insert layer by heating to a predetermined temperature.
Yang discloses a blood pressure measurement device that can be incorporated on a wearable band and further integrated in a watch device (see ABSTRACT and para. [0032,0067]), wherein the blood pressure measurement device comprises: a curler (see para. [0063] and fig. 19, inner surface member 1904) on the inner side of the belt configured to be bent around the user’s wrist; a bag shaped cuff (see para. [0007,0063] and fig. 19, expandable member 1902) located on the inner side of the curler 1904, configured to be wound around the user’s wrist, and further configured to be inflated when a fluid is supplied to an inner space of the expandable member 1904 (see para. [0032,0064]); and a fluid pump configured to be included in the band, and configured to supply air into the expandable member 1902 via a fluid flow conduit (see para. [0032,0037,0064,0068] and claims 1-3).
It would have been obvious to one of ordinary skill at the time the invention was effectively filed to have modified the watch device of Ohsawa such that it incorporates the blood pressure measurement device on a wearable band, as taught by Yang, as it would merely be applying a known technique (blood pressure measurement device) to a known device (wearable band) ready for improvement. Furthermore, the modification to Ohsawa would allow the watch device of Ohsawa to monitor blood pressure.
Ohsawa teaches a preform forming step, but does not explicitly disclose bending the preform. However, it would have been obvious to one of ordinary skill to realize in order to achieve the circumferential shape of the band as shown in Fig. 1-2 the preform would need to undergo a bending step.
Coppens discloses a method for manufacturing a bonded composited material with medical diagnostic device applications, wherein the method comprises curing a thermosetting resin and softening an amorphous thermoplastic insert material by heating (see column 3 [lines 4-20]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the manufacturing method of Ohsawa such that curing the thermosetting resin and softening the second insert material is performed via heating and then bending the preform and curing the second insert material because Coppens teaches bending first and then curing, however it would have been obvious to try heating and curing the preform before bending the preform, as it would merely be choosing from a finite number of identified, predictable solutions (a. heat and cure, then bend; b. bend, then heat and cure; c. do both simultaneously), with a reasonable expectation of success.
Furthermore, Coppens acknowledges his teachings can be used in the field of medical diagnostics (see column 4 [lines 51-52]).
Ohsawa-Yang-Coppens fails to teach wherein the high tensile material is a mesh of high-strength polyarylate fibers, and the high tensile material is disposed on the outer side of a curve of the thermoplastic resin of the thermoplastic resin of the second insert layer.
Kimura teaches a wearable device for detection of movement and physiological information, i.e., blood pressure, heart rate, oxygen, (see abstract para. [0033,0053]). The wearable device, i.e., watch, comprises an outermost layer formed of mesh polyarylate and an innermost layer (see para. [0056,0071,00074], “he protective equipment provided with the warning system is not limited to protective garment, but helmets, gloves, boots, watches, hoofs etc. may be used”, “above-mentioned fibers, long fibers or short fibers may be used. Also, two or more of the above fibers may be mixed or blended and used” “The cloth may be used in the form of a woven fabric, knitted fabric, nonwoven fabric or the like”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ohsawa-Coppens-Yang, such that the high-tensile layer is a constructed of mesh polyarylate, as taught by Kimura, as it would merely be combining prior art elements (wearable physiological information gathering devices) according to known methods (constructed with polyarylate fibers) to yield predictable results.
However, the configuration in regards to the high-tensile material disposed on the outer side of the curve of the thermoplastic resin of the second insert layer is not explicitly taught. It is noted that the device of Kimura teaches that the polyarylate fiber material of the wearable device is disposed on the outermost layer. Additionally, Ohsawa recites “The shapes, materials, and manufacturing methods of the components may be changed or replaced within the scope of the present invention” (para. [0073]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the high-tensile material layer disposed on the outer side of the second insert layer as it would not have modified the device operation of the device and is an obvious matter of design choice. Furthermore, it would have been obvious to one of ordinary skill in the art to try an configure position the high tensile material on the outer layer, as it would merely be choosing from a finite number of identified predictable solutions, e.g., (high tensile material disposed on the outside, center, or inner layers), with a reasonable expectation of success.
It follows, Ohsawa-Coppens-Yang-Kimura teach wherein the cover layer has a first side which covers one side of the first insert layer and a second side which covers side of the second insert layer (see fig. 2 of Ohsawa, layer 15 inherently comprises a first side (top) and a second side (bottom), since layer 15 is located externally to the first/second insert layer, then layer 15 partially covers both insert layers).
Ohsawa-Coppens-Yang-Kimura fail to teach wherein the first side of the cover layer, the first insert layer, the second insert layer, and the second side of the cover layer are stacked in a stacking direction in this order from the outer side of the curve. However, the combination is structured with the cover layer formed of a thermoset (15), the second insert layer (11c), a first insert layer (11b) formed of a thermoset or thermoplastic, and the cover layer (15) formed along the sides of the first/second layers thereby partially covering them (see para. [0032,0045-46] of Ohwasa). That is, the order of the first and second insert layers differ, and the cover layer (15) is not further stacked after the second insert layer. It is noted, the layer formed of the second insert layer can be of the same type as the cover layer (see para. [0032]), moreover the layer after the second insert layer (11b) can be formed of the same type of material as the cover layer (see para. [0050]). Therefore, Ohwasa teaches or at least suggests stacking layers of the same three types of materials as the present invention. As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the first side of the cover layer, the first insert layer, the second insert layer, and the second side of the cover layer by stacking in this order from the outer side of the curve as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. A).
Regarding claim 6, Ohsawa discloses manufacturing a belt/band, wherein the method of manufacturing the band shaped belt (11) comprises a preform forming step of forming the band shaped preform by insert molding, the preform comprising a first insert material (11b) disposed inside a cover layer (15) formed of a thermosetting resin, the first insert material made of PET( higher tensile material than the cover material; see para. [0053] and fig. 1-2); and wherein the preform forming step includes: disposing the thermoset resin surface cover layer 15 forming the cover layer around the first insert material and second insert material (see para. [0030-31] and fig. 1-2, insert 11a comprises the first (11b) and second (11c) insert layer made of a thermoplastic), the cover layer 15 is formed of thermosetting resin, the thermosetting resin is a thermosetting elastomer, and the thermosetting elastomer is one of a silicone resin or fluororesin (see para.[0046], “fluorocarbon resin having a relatively high permittivity, such as polyurethane resin or polyvinylidene fluoride” indicates that fluororesins and silicone resins are used, one skilled in the art at would understand that polyvinylidene fluoride (FDVP) is a type of fluororesin; In addition, “adding a filler for permittivity enhancement” and “he permittivity of the back surface protective layer 17 can be reduced by using a fluorocarbon resin, such as a silicone material or polytetrafluoroethylene” indicating that cover layer 15 can also be formed with silicon resin fillers for permittivity enhancement (see para. [0050])) and insert 11b is formed of PET resin which has a higher tensile strength than thermosetting resin (see para. [0045-46]).
Ohsawa teaches a preform forming step, but does not explicitly disclose bending the preform. However, it would have been obvious to one of ordinary skill to realize in order to achieve the circumferential shape of the band as shown in Fig. 1-2 the preform would need to undergo a bending step.
Ohsawa fails to explicitly disclose curing the thermosetting resin and softening the second insert material by heating and the bending step includes a curing step of bending the preform and curing the second insert material at a temperature lower than a temperature at which the insert molding is performed.
Coppens discloses a method for manufacturing a bonded composited material with medical diagnostic device applications, wherein the method comprises curing a thermosetting resin and softening a second insert material by heating (see column 3 [lines 4-20]), wherein the method further comprises bending the bonded composite in a shaped mold, based on the application, and letting the insert thermoplastic layer cool at a temperature lower than the temperature insert molding was performed to harden (see column 2 [lines 18-25] and column 2 [lines 43-67]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the manufacturing method of Ohsawa such that curing the thermosetting resin and softening the second insert material is performed via heating and then bending the preform and curing the second insert material because Coppens teaches bending first and then curing, however it would have been obvious to try heating and curing the preform before bending the preform, as it would merely be choosing from a finite number of identified, predictable solutions (a. heat and cure, then bend; b. bend, then heat and cure; c. do both simultaneously), with a reasonable expectation of success. Furthermore, Coppens acknowledges his teachings can be used in the field of medical diagnostics (see column 4 [lines 51-52]).
Ohsawa fails to teach joining the belt to the bag-shaped cuff so that the belt is disposed on an outer side of the bag-shaped cuff.
Yang discloses a blood pressure measurement device that can be incorporated on a wearable band and further integrated in a watch device (see ABSTRACT and para. [0032,0067]), wherein the blood pressure measurement device comprises: a curler (see para. [0063] and fig. 19, inner surface member 1904) on the inner side of the belt configured to be bent around the user’s wrist; a bag shaped cuff (see para. [0007,0063] and fig. 19, expandable member 1902) located on the inner side of the curler 1904, configured to be wound around the user’s wrist. The material of the curler is of “rigid or semi-rigid materials, including but not limited polyethylene terephthalate (PET), high density polyethylene (HDPE), polyvinyl chloride (PVC), polypropylene (PP) and polystyrene” indicting synthetic polymers, e.g., thermoplastic, thermosets, are used for the curler.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ohsawa-Coppens, such that a bag shaped-cuff is joined to the belt, as taught by Yang, as it would merely be combining prior art elements (synthetic polymer bands) according to known methods (band with bag-shaped cuff joined) to yield predictable results.
Ohsawa-Coppens-Yang fails to teach wherein the high tensile material is a mesh of high-strength polyarylate fibers, and the high tensile material is disposed on the outer side of a curve of the thermoplastic resin of the thermoplastic resin of the second insert layer.
Kimura teaches a wearable device for detection of movement and physiological information, i.e., blood pressure, heart rate, oxygen, (see abstract para. [0033,0053]). The wearable device, i.e., watch, comprises an outermost layer formed of mesh polyarylate and an innermost layer (see para. [0056,0071,00074], “he protective equipment provided with the warning system is not limited to protective garment, but helmets, gloves, boots, watches, hoofs etc. may be used”, “above-mentioned fibers, long fibers or short fibers may be used. Also, two or more of the above fibers may be mixed or blended and used” “The cloth may be used in the form of a woven fabric, knitted fabric, nonwoven fabric or the like”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ohsawa-Coppens-Yang, such that the high-tensile layer is a constructed of mesh polyarylate, as taught by Kimura, as it would merely be combining prior art elements (wearable physiological information gathering devices) according to known methods (constructed with polyarylate fibers) to yield predictable results.
However, the configuration in regards to the high-tensile material disposed on the outer side of the curve of the thermoplastic resin of the second insert layer is not explicitly taught. It is noted that the device of Kimura teaches that the polyarylate fiber material of the wearable device is disposed on the outermost layer. Additionally, Ohsawa recites “the front and back sides of the sensor sheet 11a may be reversed within the wearable touch sensor” and “The shapes, materials, and manufacturing methods of the components may be changed or replaced within the scope of the present invention” indicating that the insert layer configurations can be changes (see para. [0052,0073]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the high-tensile material layer disposed on the outer side of the second insert layer as it would not have modified the device operation of the device and is an obvious matter of design choice. Furthermore, it would have been obvious to one of ordinary skill in the art to try an configure position the high tensile material on the outer layer, as it would merely be choosing from a finite number of identified predictable solutions, e.g., (high tensile material disposed on the outside, center, or inner layers), with a reasonable expectation of success.
Ohsawa-Coppens-Yang-Kimura fail to teach wherein the first side of the cover layer, the first insert layer, the second insert layer, and the second side of the cover layer are stacked in a stacking direction in this order from the outer side of the curve. However, the combination is structured with the cover layer formed of a thermoset (15), the second insert layer (11c), a first insert layer (11b) formed of a thermoset or thermoplastic, and the cover layer (15) formed along the sides of the first/second layers thereby partially covering them (see para. [0032,0045-46] of Ohwasa). That is, the order of the first and second insert layers differ, and the cover layer (15) is not further stacked after the second insert layer. It is noted, the layer formed of the second insert layer can be of the same type as the cover layer (see para. [0032]), moreover the layer after the second insert layer (11b) can be formed of the same type of material as the cover layer (see para. [0050]). Therefore, Ohwasa teaches or at least suggests stacking layers of the same three types of materials as the present invention. As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have rearranged the first side of the cover layer, the first insert layer, the second insert layer, and the second side of the cover layer by stacking in this order from the outer side of the curve as it would not have modified the operation of the device and is an obvious matter of design choice (see MPEP 2144.04 IV. A).
Regarding claim 8, Ohsawa teaches wherein the high tensile material is in direct contact with the thermoplastic resin of the second insert layer (see para. [0052], “ the base film 11b and the resist 11c of the sensor sheet 11a are positioned to be in contact with the back surface protective layer 17 and the front surface protective layer 15, respectively, and stacked together” (emphasis added)).
Regarding claim 9, Ohsawa teaches wherein the first side of the cover layer and the second side of the cover layer are formed of the same material (see para. [0046]),
the first side of the cover layer is thicker than the second side of the cover layer in a stacking direction of the first side of the cover layer and the second side of the cover layer (see fig. 2, the first side (external) is thicker than the second side (touching 11a) due to the space required for elements 11a-c),
and the second side of the cover layer is on an inner side of the curve of the bent shape with respect to the first side of the cover layer (see figs. 1-2, the second side (side of the insert layers 11a-b) is positioned on the inner side of the curve).
Response to Arguments
Applicant's arguments filed 08/15/2025 have been fully considered but they are not fully persuasive.
Applicant contends that “It would not have been obvious to modify Ohsawa to achieve this advantage because Ohsawa and the other references do not recognize the advantage of curing the cover layer 63 and softening of the insert layer 64 in a single process”, “It would not have been obvious to modify Ohsawa to achieve this advantage because Ohsawa and the other references do not recognize that such a limitation can provide less wrinkles,” and “It would not have been obvious to modify Ohsawa to achieve this advantage because Ohsawa and the other references do not recognize that such a limitation can provide a greater accuracy by suppressing the elongation of the belt at the time of blood pressure measurement” on pages 8-9 of the Remarks.
First, the specification lacks details on the process being a “single process.” Further, one of ordinary skill in the art would require more details on the “single process” to determine whether the inventor had possession of such invention and to teach one of ordinary skill each step to the “single process.” More information is required.
Second, the wrinkles are not minimized by the stacking of each layer, rather by “disposing the first insert material 64A on the outer side of the curve of the second insert material 65A.” Ohsawa teaches the same of disposing the first insert layer adjacent to the second insert layer (see fig. 2), and therefore, would achieve the same result.
Lastly, it is the high tensile strength cover layer that provides such contention of suppression, not the stacking of each layer. In this case, Ohsawa’s cover layer is also that of a high tensile strength material (see para. [0046]), therefore would achieve the same results.
In conclusion, Applicant’s arguments have been found unpersuasive for the reasons stated above.
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791