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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/01/2025 has been considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 16 of copending Application No. 18/738,587 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending Application are narrower in scope than the claims of the current invention, and encompass the subject matter of the current claims. Therefore, any reference meeting the limitations set forth in claims 6 and 16 of the copending Application would also meet the requirements set forth in claim 1 of the current invention.
Claim Objections
Claims 3, 6, 8-13, 16, and 18-20 are objected to because of the following informalities:
Claim 3 recites “sensors arranged with different density distribution” in line 2. This should read “sensors arranged with different density distributions”.
Claim 6 recites “sensors arranged with different density distribution” in line 2. This should read “sensors arranged with different density distributions”.
Claim 8 recites “Infrared sensing layer” in line 1. This should read “infrared sensing layer”.
Claim 9 recites “sensing module provides program or algorithm” in line 1. This should read “sensing module provides a program or algorithm”.
Claim 10 recites “GPS data” in line 2. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. This reads “Global Positioning System (GPS) data”.
Claim 11 recites “Infrared sensing layer” in line 11. This should read “infrared sensing layer”.
Claim 12 recites “Infrared sensing layer” in line 2. This should read “infrared sensing layer”.
Claim 13 recites “sensors arranged with different density distribution” in line 2. This should read “sensors arranged with different density distributions”.
Claim 16 recites “sensors arranged with different density distribution” in line 2. This should read “sensors arranged with different density distributions”.
Claim 18 recites “GPS data” in line 2. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. This reads “Global Positioning System (GPS) data”.
Claim 19 recites “Infrared sensing layer” in line 1. This should read “infrared sensing layer”.
Claim 20 recites “WiFi (Wireless Fidelity) data” in line 2. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. This reads “Wireless Fidelity (Wi-Fi) data”.
Appropriate correction is required.
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 1-20 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.
Regarding claims 1 and 11, claim 1 recites “a pressure sensing layer arranged inside said insole” in line 2. There is insufficient antecedent basis for this limitation in the claim. A similar recitation is present in lines 2 of claim 11.
For the purposes of examination, the claims are interpreted as “a pressure sensing layer arranged inside an insole”.
Regarding claims 4 and 14, claim 4 recites “wherein said pressure sensing layer comprises a plurality of resistive pressure sensors” in lines 1-2. It is unclear whether this plurality of pressure sensors is the same plurality of pressure sensors as recited in claim 3, or a different plurality of pressure sensors. A similar recitation is present in lines 1-2 of claim 14. Clarification is requested.
For the purposes of examination, the claims are interpreted as “wherein the plurality of pressure sensors of said pressure sensing layer are resistive pressure sensors”.
Regarding claims 10 and 18, claim 10 recites “further comprising an accelerometer used to detect direction changes, GPS data…” in lines 1-2. An accelerometer is capable of detecting linear acceleration in three directions relative to the sensor. Therefore, it is unclear how an accelerometer is capable of detecting GPS data. A similar recitation is present in lines 1-2 of claim 18. Clarification is requested.
For the purposes of examination, the claims are not interpreted such that the accelerometer is not used to detect GPS data.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claims 1, 3-5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2020/0253320 by Guard et al., – cited by Applicant, hereinafter “Guard”.
Regarding claim 1, Guard teaches a foot sensor and analysis device (Figs. 1-3, 5-6; smart footwear article 100), comprising: a pressure sensing layer arranged inside said insole (See Figs. 4-5, layer including element 340 and the force sensors 120, which create pressure data across the foot as shown in Fig. 4C ([0188])); a sensing module installed inside said insole, said sensing module electrically coupled with said pressure sensing layer for receiving and processing detected electronic signals (Figs. 5 and 31, [0220-0221], Printed circuit board enclosure 202 includes a microprocessor connected to the circuit board 340 and collects sensor data); wherein said sensing module includes an inductance coil to perform wireless charging to a battery of said sensing module (Fig. 27, [0212]; the wireless charging receiver coil 330 is on top and bottom of the PCB enclosure 202. PCB enclosure 202 also contains a rechargeable battery) wherein said pressure sensing layer and said sensing module are inside said insole (Fig. 6 shows all of the layers of smart footwear system 100 together). It is noted that Guard uses a plurality of force sensors to determine pressure, therefore, the force sensors can be considered pressure sensors as they output a pressure measurement.
Guard does not teach wherein said pressure sensing layer and said sensing module are integrally formed inside said insole.
The courts have held that the use of a one-piece construction is merely a matter of obvious engineering choice. See MPEP 2144-V-B. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensing layer and said sensing module taught by Guard to be a single, integral piece inside the insole, as a matter of engineering choice.
The term “formed” of the phrase “integrally formed” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, even though Guard is silent as to the process used to create the insole in a single piece, the device taught by modified Guard would be the same or similar as that claimed.
Regarding claim 3, Guard teaches the device of claim 1, wherein said pressure sensing layer includes a plurality of pressure sensors arranged with different density distributions (Fig. 2 shows the distribution of force sensors in the pressure sensing layer, wherein there is a greater density of sensors in the forefoot compared to the other areas), which are arranged on a forefoot area, a lateral arch area and a heel area in said insole (Fig. 6, there are most sensors in the forefoot (highest density), and a single long sensor in the lateral arch area (low density) and a single round sensor in the heel area (low density)).
Regarding claim 4, Guard teaches the device of claim 3, but does not teach wherein said pressure sensing layer comprises a plurality of resistive pressure sensors.
Guard further teaches an embodiment wherein the smart footwear system includes force sensitive resistors and/or load sensors under the foot ([0231]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Guard such that the pressure sensors comprise resistive pressure sensors, as taught by Guard. This combination merely comprises a simple substitution of one known element for another to obtain predictable results. See MPEP 2143-I-B.
Regarding claim 5, Guard teaches the device of claim 4, wherein said pressure sensing layer is flexible (Fig. 6, [0190]; Flexible circuit 340 includes at least one force sensor 120).
Regarding claim 9, Guard teaches the device of claim 1, wherein said sensing module provides program or algorithm to control collection and storage of data (Fig. 30 [0220, 0266], shows a diagram wherein software is executed by a processor to relay sensor data to an application, where the data can then be stored in a server. Fig. 33A-B also teaches that the system is configured to be able to analyze the data before transmission to the mobile device. In this case, the data must be stored within PCB 202.).
Regarding claim 10, Guard teaches the device of claim 9, further comprising an accelerometer (Fig. 31, [0221]; an accelerometer and IMU are included in printed circuit board enclosure 202 and is included in smart footwear article) used to detect direction changes, GPS data, acceleration output data, angular orientation related data, and angular orientation changes during the user's walking, for detecting information including speed/distance, and to correlate with sensed pressure data for cross reference and correction. It is noted that the output of the accelerometer as taught by Guard is capable of being used for all of the uses listed above.
Claims 2, 8, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Guard in view of Korean Patent Publication 102214513 B1 by Chong, hereinafter “Chong”, in view of US Patent Publication 2017/0153761 by Park, hereinafter “Park”.
Regarding claims 2 and 8, Guard teaches the device of claim 1, but does not teach the device further comprising an infrared sensing layer disposed inside said insole and electrically connected to said sensing module to transmit electronic signals detected by said infrared sensing layer, wherein said infrared sensing layer is integrally formed inside said insole, or wherein the infrared sensing layer is flexible.
Chong teaches a smart insole sensor comprising a pressure sensing layer and another layer (130) containing blood flow sensors 131 for detecting information about the blood flow information of the individual (Page 5, par. 5). The blood flow information is transferred to a wireless communication module 200 to be transmitted to the smart terminal 300 for further analysis. The blood flow sensors are thin films (Page 5, par. 6). The blood flow information can be used to identify abnormalities that may be signs of vascular disease (Page 2, Technical Field; Page 3, par. 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device as taught by Guard to include a sensing layer disposed inside said insole and electrically connected to said sensing module to transmit electronic signals detected by said sensing layer, in order to determine blood flow information and identify abnormalities that may be signs of vascular disease, as taught by Chong.
Guard in view of Chong does not teach the sensing layer being an infrared sensing layer, or wherein the infrared sensing layer is flexible.
Park teaches an infrared thin film transistor 122 that is a part of a touch sensing device configured to determine the body temperature, blood flow rate, blood pressure and blood oxygen ratio. The touch sensing device can comprise a flexible sensor array and can be disposed on a flexible substrate ([0050]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the sensing layer of the device taught by Guard in view of Chong to be an infrared sensing layer, wherein the infrared sensing layer is flexible, in order to collect more blood information data such as blood pressure and blood oxygen ratio, generating a more comprehensive amount of blood information, as taught by Park.
It is noted that Guard teaches that the device is configured to transmit all sensor data to the external device, therefore in the combination of Guard, Chong, and Park would include the infrared sensing layer being connected to the sensing module to transmit electronic signals detected by the infrared sensing layer.
The combination of Guard, Chong, and Park does not teach the infrared sensing layer being integrally formed inside said insole.
The courts have held that the use of a one-piece construction is merely a matter of obvious engineering choice. See MPEP 2144-V-B. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the infrared sensing layer as taught by the combination of Guard, Chong, and Park to be a single, integral piece inside the insole, as a matter of engineering choice.
The term “formed” of the phrase “integrally formed” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, even though the combination of Guard, Chong, and Park is silent as to the process used to create the insole in a single piece, the device taught by the combination of Guard, Chong, and Park would be the same or similar as that claimed.
Regarding claim 11, the combination of Guard, Chong, and Park teaches a foot sensor and analysis device (See the rejection of claim 1), comprising: a pressure sensing layer arranged inside said insole (See the rejection of claim 1); an infrared sensing layer configured within said insole (See the rejection of claims 2 and 8); a sensing module (See the rejection of claim 1), configured in an arch support integrated with said insole (Guard, Figs 3 and 5, the printed circuit board enclosure 202 is located in the inner arch support), coupled to said pressure sensing layer and said infrared sensing layer for receiving and processing electronic signals sensed by said pressure sensing layer and said infrared sensing layer (Guard, Figs. 30-31, [0221]; Printed circuit board enclosure 202 includes a microprocessor, transceiver, and other components, and is configured to transmit the data from all sensors from the footwear to an external device.); wherein said pressure sensing layer, said infrared layer and said sensing module are integrally formed inside said insole (See the rejection of claim 1); wherein said sensing module includes: a processing unit to collect and analyze said electrical signals sensed by said pressure sensing layer and said infrared sensing layer to convert said electrical signals to a corresponding foot pressure distribution and a blood circulation information (Guard, [0223]; The system is configured to analyze the user data before it is sent to the API (i.e., remote device). Therefore, the system must be configured to analyze the data on the microprocessor before it is transferred to the remote device.); a memory coupled to said processing unit to store said corresponding foot pressure distribution and said blood circulation information (Guard, [0179]; The microprocessor includes a read-only memory (ROM), random-access memory (RAM) (e.g., static random-access memory (SRAM)) and/or flash memory. It is noted that the sensor data must be stored if it is to be analyzed prior to transmission to an external device); a wireless data transmission/receiving device coupled to said processing unit to transmit said corresponding foot pressure distribution and said blood circulation information to an external electrical device (Guard, Fig. 30-31, [0221]; the printed circuit board enclosure 202 comprises a transceiver configured to wirelessly send sensor data from the smart footwear device to an external device).
Regarding claim 12, the combination of Guard, Chong, and Park teaches the device of claim 11, further comprising a power supply unit (Guard, [0176, 0189]; battery included in PCB enclosure 202) to provide power to said pressure sensing layer, said infrared sensing layer, said processing unit, said memory and said wireless data transmission/receiving device (Although not explicitly stated, the device requires power and the battery is the only source of power in this embodiment, therefore it would be obvious that this battery would power all electrical components in the device).
Regarding claim 13. the combination of Guard, Chong, and Park teaches the device of claim 11, wherein said pressure sensing layer includes a plurality of pressure sensors arranged with different density distributions (See the rejection of claim 3), which are arranged on a forefoot area, a lateral arch area and a heel area in said insole (See the rejection of claim 3).
Regarding claim 14, the combination of Guard, Chong, and Park teaches the device of claim 13, wherein said pressure sensing layer comprises a plurality of resistive pressure sensors (See the rejection of claim 4).
Regarding claim 15, the combination of Guard, Chong, and Park teaches the device of claim 14, wherein said pressure sensing layer is flexible (See the rejection of claim 5).
Regarding claim 18, the combination of Guard, Chong, and Park teaches the device of claim 11, further comprising accelerometer used to detect direction changes, GPS data, acceleration output data, angular orientation related data, and angular orientation changes during the user's walking, for detecting information including speed/distance, and to correlate with sensed pressure data for cross reference and correction (See the rejection of claim 10).
Regarding claim 19, the combination of Guard, Chong, and Park teaches the device of claim 11, wherein said infrared sensing layer is flexible (See the rejection of claim 8).
Regarding claim 20, the combination of Guard, Chong, and Park teaches the device of claim 11, wherein said wireless data transmission/receiving device is a Bluetooth chip or a WiFi (Wireless Fidelity) device (Guard, [0179]; the wireless communication between the remote device and the smart footwear device can include Bluetooth or WiFi. Therefore the transceiver must contain circuitry (i.e., a Bluetooth chip or WiFi device) to enable these communication modes).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Guard, as applied to claim 1, in view of US Patent Publication 2011/0054359 by Sazonov et al. – cited by Applicant, hereinafter “Sazonov”.
Guard teaches the device of claim 1, wherein said pressure sensing layer includes a plurality of sensors with different density distributions, which are arranged on a forefoot area, a lateral arch area and a heel area in said insole (See the rejection of claim 3), wherein the pressure sensing layer is flexible (See the rejection of claim 5).
Guard does not teach the plurality of sensors being a plurality of capacitive sensors.
Sazonov teaches an insole configured to detect changes in the amount of pressure applied to the insole. The insole may be a flexible insole, and the pressure sensor may be a capacitive sensor or a force-sensitive resistor sensor ([0039]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensing layer taught by Guard such that the pressure sensing layer comprises capacitive pressure sensors, as taught by Sazonov. This modification merely comprises a simple substitution of one known element for another to obtain predictable results. See MPEP 2143-I-B.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Guard in view of Chong in view of Park, as applied to claim 11, in view of Sazonov.
The combination of Guard, Chong, and Park teaches the device of claim 11, wherein said pressure sensing layer includes a plurality of sensors with different density distribution, which are arranged on a forefoot area, a lateral arch area and a heel area in said insole (See the rejection of claim 13), wherein the pressure sensing layer is flexible (See the rejection of claim 15).
The combination of Guard, Chong, and Park does not teach the plurality of sensors being a plurality of capacitive sensors.
Sazonov teaches an insole configured to detect changes in the amount of pressure applied to the insole. The insole may be a flexible insole, and the pressure sensor may be a capacitive sensor or a force-sensitive resistor sensor ([0039]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensing layer taught by the combination of Guard, Chong, and Park such that the pressure sensing layer comprises capacitive pressure sensors. This modification merely comprises a simple substitution of one known element for another to obtain predictable results. See MPEP 2143-I-B.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2024/0115191 by Chung et al. teaches a diabetic foot monitoring apparatus that may comprise an insole, which may comprise a pressure measurement sensor, an infrared sensor, processor, memory, and a communication unit (i.e., transceiver).
US Patent Publication 2020/036778 by Philimis – cited by Applicant teaches a system comprising a sole of a shoe with a plurality of pressure sensors and a sensing module
US Patent Publication 2024/0149171 by Paddock et al. teaches a system that cam include an insole that may include a somatic sensor such as an infrared sensor ([0028, 0042]).
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791