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 Status: Claims 1-20 are pending.
Response to Arguments
Re 35 U.S.C. 103 rejection, Applicant's arguments filed August 8, 2025 have been fully considered but they are not persuasive.
On page 7 of the Remarks, Applicant made an argument that Lee does not disclose multifunctional measuring device comprising a housing.
This argument has been considered but is not persuasive.
Lee discloses a multiple function of optical module, ECG, motion measuring, and temperature measuring as shown in fig. 1B and para. [0020] where different sensors are mounted on the housing 102, 104, 402 (fig. 4A-C, fig. 5). Further, Applicant’s argument rather supports that Lee has a housing. Applicant stated that “Lee’s device 102 comprises a housing 104” and “[t]hat hosing 104 includes structural elements for selectively mating adaptor 402 … to be clipped to a person’s finger or clothes”.
On page 8 of the Remarks, Applicant stated that adaptor 402 provides an interface between such flat-mounted sensors of device 102 and a person’s finger and that Lee contemplates passive, continuous physiological measurement or monitoring using flat-mounted sensors embedded in wearable surfaces. Applicant argued that modification of Lee to incorporate a hinged housing with finger-receiving cavities, as taught by Yu, would not be a design choice, but rather a fundamental departure from its core teaching. Applicant made an argument that the motivation of modification of Lee’s structure with Yu’s structure is unclear.
This argument has been considered but is not persuasive.
Examiner notes that Lee already discloses a hinged housing with finger-receiving cavities (para. [0004], “the adaptor includes a base, a lever, and a hinge”. “The base includes an opening sized and positioned to enable a distal portion of a person's finger to extend through the opening and contact the device when the adaptor is mated to the device and the device is clipped to a person's finger”.).
Yu also discloses a hinged housing with finger-receiving cavities (English translation copy, page 4, first paragraph, “the finger cavity can be a finger-clip structure”, “you also need to set a finger cavity for the oximeter (of course, you can also set a cavity or clip for measuring parts such as the earlobe)”, page 4, fifth paragraph, “a pivot 3 that connects the upper/lower housings”), the cavities being different shape from those of Lee’s device.
When the structure of adaptor 402 of Lee’s device is modified to form cavities as shown in Yu’s device in fig. 2B, it would not change the principle of operation of Lee’s device. The adaptor 402 may be detached in the case that device 102 has to be strapped to a person’s wrist. Simply, the shape of the adaptor 402 would be modified to receive the person’s finger into cavities as shown in Yu’s figure 2B.
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It would have been obvious to one of ordinary skill in the art to modify the housing having an upper shell and a lower shell which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger, as taught by Lee’s fig. 4A-C and fig. 5 to include the housing having an upper shell and a lower shell which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger as taught by Yu’s figure 2B because such a modification is the result of combining prior art elements according to known methods to yield predictable results. More specifically, Lee’s housing as modified by Yu’s housing can yield a predictable result of being clipped to a human finger for measurement of physiological parameters. Thus, a person of ordinary skill would have appreciated including in Lee’s detachable adaptor housing the ability to provide cavities that correspond to one another to form a chamber for receiving a human finger since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8046059 in view of Lee (US 2016/0022213), Yu et al. (WO 2011/143823), and Iwabuchi (US 6,360,124)
Claim 1 of patent ‘059 discloses the optical measuring unit, at least one electrical measuring unit, and means for data evaluation and/or data transfer.
Claim 1 of patent ‘059 is silent regarding the specific structures claimed for the housing.
However, Lee discloses a multifunctional measuring device, comprising:
a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger (fig. 8, para. [0043], the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand; para. [0004], a hinge).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the patented claim, by adding to the housing an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger, as taught by Lee, for the purpose of positioning the measuring device on the patient’s finger (para. [0043], [0004]).
Claim 1 of patent ‘059 is silent regarding a temperature sensor (8) is also located on one of the sides.
However, Yu discloses an oximeter capable of measuring body temperature (abstract) with a finger-clip structure (fig. 2a and fig. 2b, page 4) and teaches that temperature sensor 6 is disposed in the upper casing 1 as shown in fig. 2b (page 4). Yu further discloses that the position of the temperature sensor can be set on any one of the outer end faces of the upper casing 1 or the lower casing 2 according to actual needs (page 4).
Additionally, should applicant disagree with Lee disclosing “a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger”, Yu teaches a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger (fig. 2b, page 4, upper housing 1, lower housing 2, pivot 3 that connects the upper and lower housings, finger cavity 7).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claim as modified by Lee, by configuring the housing to have an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger, as taught by Yu, for the purpose of inserting the finger for physiological measurement (page 4); and to modify patented claim as modified by Lee, by configuring a temperature sensor to be located on one of the sides, as taught by Yu, for the purpose of measuring body temperature from a convenient position on the device (page 4) and since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Claim 1 of patent ‘059 is silent regarding two measuring electrodes for bioimpedance and ECG measurements are located on two sides of the lower shell on the outer sides of the measuring device.
However, Iwabuchi discloses a handheld bioelectric impedance measuring apparatus (abstract) and teaches four electrodes are arranged apart with one another on both end sides of an upper and a lower side surfaces of a main body respectively (abstract, fig. 1, col. 4, electrodes A, B, C, D, two electrodes on one side and the other two on the opposite side) for measuring the body fat rate (abstract). Iwabuchi discloses that the bioelectric impedance may be measured only by gripping the electrodes to improve a convenience in operation (abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claim as modified by Lee and Yu, by adding two measuring electrodes for bioimpedance measurements located on two sides of the lower shell on the outer sides of the measuring device, wherein the two measuring electrodes located on the two sides of the lower shell are provided for electrical measurement on the index finger and thumb of a hand holding the measuring device, as taught by Iwabuchi, for the purpose of measuring body fate rate (abstract, col. 3).
Claim 1 of patent ‘059 recites a first ECG electrode configured to be touched with one hand and a second ECG with the other hand.
Claim 1 of patent ‘059 is silent regarding the measuring electrodes for ECG being located on the sides of the lower shell on the outer sides of the measuring device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claim as modified by Lee, Yu, and Iwabuchi, by configuring the measuring electrodes for ECG to be located on the sides of the lower shell on the outer sides of the measuring device, since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
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.
This application includes one or more claim limitations that use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means for data evaluation and/or data transfer” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Based on the specification, the corresponding structure for “means for data transfer” is a wireless interface (page 3).
Based on the specification, the corresponding structure for “means for data evaluation” is a microcontroller (page 3).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 6-9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213) in view of Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124).
Re Claim 1, Lee discloses a multifunctional measuring device, comprising:
a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger (fig. 8, para. [0043], the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand; para. [0004], a hinge),
wherein an optical measuring unit having an optical module, which comprises at least one light source and at least one sensor, is arranged in the chamber (para. [0021], The optical sensor 122 can include both a light source and a light detector. When operating as a PPG sensor, the light source of the optical sensor 122 emits light that is reflected or backscattered by patient tissue, and reflected/backscattered light is received by the light detector of the optical sensor 122; para. [0043], optical sensor 122), and
wherein means for data evaluation and/or data transfer are integrated in or on the housing (para. [0043], [0026], the device can determine a metric of PWV to determine the person’s blood pressure; para. [0027], fig. 2, a microcontroller 202 that includes a processor 204 and wireless interface 208, para. [0028]-[0034], signal processing circuitry),
wherein at least one electrical measuring unit is provided, comprising at least two measuring electrodes in the chamber and/or on the outside of the housing (para. [0043], FIG. 8 illustrates the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand, while a finger 802 b of the person's left hand is touching the outwardly facing ECG sensor 114. While it cannot be seen in FIG. 8, a distal portion of the finger 802 a on the person's right hand extends through the opening 412 in the base 402 of the adaptor 402 and touches the ECG sensor 124 that is on the backside of the housing 104).
Lee discloses that the temperature sensor is located in the inside of the housing (para. [0020], fig. 1B, the backside of the housing 104 includes a skin temperature sensor), but Lee is silent regarding the temperature sensor (8) is also located on one of the sides.
However, Yu discloses an oximeter capable of measuring body temperature (abstract) with a finger-clip structure (fig. 2a and fig. 2b, page 4) and teaches that temperature sensor 6 is disposed in the upper casing 1 as shown in fig. 2b (page 4). Yu further discloses that the position of the temperature sensor can be set on any one of the outer end faces of the upper casing 1 or the lower casing 2 according to actual needs (page 4).
Additionally, should applicant disagree with Lee disclosing “a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger”, Yu teaches a housing having an upper shell and a lower shell, which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger (fig. 2b, page 4, upper housing 1, lower housing 2, pivot 3 that connects the upper and lower housings, finger cavity 7).
Therefore, It would have been obvious to one of ordinary skill in the art to modify the housing having an upper shell and a lower shell which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger, as taught by Lee’s fig. 4A-C and fig. 5 to include the housing having an upper shell and a lower shell which are movable relative to one another by means of a hinge mechanism and comprise cavities which correspond to one another, wherein the cavities form a chamber accessible from the outside for receiving a human finger as taught by Yu’s figure 2B because such a modification is the result of combining prior art elements according to known methods to yield predictable results. More specifically, Lee’s housing as modified by Yu’s housing can yield a predictable result of being clipped to a human finger for measurement of physiological parameters. Thus, a person of ordinary skill would have appreciated including in Lee’s detachable adaptor housing the ability to provide cavities that correspond to one another to form a chamber for receiving a human finger since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Additionally, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee, by configuring a temperature sensor to be located on one of the sides, as taught by Yu, for the purpose of measuring body temperature from a convenient position on the device (page 4) and since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Lee is silent regarding two measuring electrodes for bioimpedance and ECG measurements are located on two sides of the lower shell on the outer sides of the measuring device.
However, Iwabuchi discloses a handheld bioelectric impedance measuring apparatus (abstract) and teaches four electrodes are arranged apart with one another on both end sides of an upper and a lower side surfaces of a main body respectively (abstract, fig. 1, col. 4, electrodes A, B, C, D, two electrodes on one side and the other two on the opposite side) for measuring the body fat rate (abstract). Iwabuchi discloses that the bioelectric impedance may be measured only by gripping the electrodes to improve a convenience in operation (abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu, by adding two measuring electrodes for bioimpedance measurements located on two sides of the lower shell on the outer sides of the measuring device, wherein the two measuring electrodes located on the two sides of the lower shell are provided for electrical measurement on the index finger and thumb of a hand holding the measuring device, as taught by Iwabuchi, for the purpose of measuring body fate rate (abstract, col. 3).
Lee discloses a measuring electrode for ECG 114 located on the outside of the housing and another measuring electrode for ECG 124 located inside of the housing (fig. 8, para. [0043], [0022], a person must complete a circuit by touching one of the ECG electrodes 114, 124 within a left portion of their body (e.g., a finger of their left hand) and touching the other one of the ECG electrodes 114, 124 with a right portion of their body (e.g., a finger of their right hand).
Lee is silent regarding the measuring electrodes for ECG being located on the sides of the lower shell on the outer sides of the measuring device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by configuring the measuring electrodes for ECG to be located on the sides of the lower shell on the outer sides of the measuring device, since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Re Claim 2, Lee discloses that at least one temperature-measuring unit is arranged in and/or on the housing (para. [0043], fig. 8, If the backside of the housing of the device 102 includes the skin temperature sensor 126, then the distal portion of the finger 702 on the person's left hand that extends through the opening 412 in the base 406 of the adaptor 402 will contact the skin temperature sensor 126 so that the device can determine the temperature of the person's skin.).
Re Claim 4, Lee discloses that the hinge mechanism is provided with a return mechanism (para. [0004], the adaptor includes a base, a lever and a hinge. The hinge connects a first end of the lever to a first end of the base and biases a second end of the lever towards a second end of the base).
Re Claim 6, Lee discloses that the means for data transfer have a wireless interface (para. [0027], fig. 2, a microcontroller 202 that includes a processor 204 and wireless interface 208).
Re Claim 7, Lee discloses that devices for positioning the individual fingers are provided such that the fingers are always in the same position during the measuring process (para. [0043], FIG. 8 illustrates the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand, while a finger 802 b of the person's left hand is touching the outwardly facing ECG sensor 114.).
Re Claim 8, Lee discloses that an accelerometer is integrated (para. [0024], motion sensor 128 can be an accelerometer).
Re Claim 9, Lee discloses that a gyroscope is integrated (para. [0024], motion sensor 128 can be a gyrometer).
Re Claim 13, Lee discloses a method for carrying out a measurement using a multifunctional measuring device according to claim 1, wherein one or more physiological parameters are determined by executing predetermined measuring programs by using and/or combining a plurality of measuring units (para. [0043], [0026], the device can determine a metric of PWV to determine the person’s blood pressure; para. [0027], fig. 2, a microcontroller 202 that includes a processor 204 and wireless interface 208, para. [0028]-[0034], signal processing circuitry).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213) as modified by Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124), and further in view of Areny (US20170035307A1).
Re Claim 5, Lee as modified by Yu and Iwabuchi discloses the claimed invention substantially as set forth in claim 1.
Lee discloses an electrode that is coupled to the lower shell and positioned within the chamber (para. [0043], FIG. 8 illustrates the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand, while a finger 802 b of the person's left hand is touching the outwardly facing ECG sensor 114. While it cannot be seen in FIG. 8, a distal portion of the finger 802 a on the person's right hand extends through the opening 412 in the base 402 of the adaptor 402 and touches the ECG sensor 124 that is on the backside of the housing 104)
Lee is silent regarding the plurality of electrodes including a first pair of measuring electrodes configured to perform bioimpedance and ECG measurements in the chamber.
Areny discloses an apparatus for ECG and bioimpedance measurement (abstract) and teaches the plurality of electrodes including a first electrode pair for ECG and bioimpedance (para. [0013], fig. 3, The first pair of electrodes 301 is on one limb and the second pair 302 is on another limb; para. [0018], The identification and combination of the predefined elements in the ECG and the IPG may be effected by a processor 340).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Bandic, by adding a first pair of measuring electrodes configured to perform bioimpedance and ECG measurements in the chamber, as taught by Areny, for the purpose of measurement of both ECG and bioimpedance (para. [0013], [0018]).
Lee and Bandic are silent regarding the second and third pairs of measuring electrodes including the two measuring electrodes located on the two sides of the lower shell, and the second and third pairs of measuring electrodes arranged such that measuring electrodes forming each corresponding pair of measuring electrodes are located on opposing outer sides of the lower shell.
However, Areny discloses an apparatus for ECG and bioimpedance measurement (abstract) and teaches the plurality of electrodes including a first electrode pair for ECG and bioimpedance and a second electrode pair for ECG and bioimpedance (para. [0013], fig. 3, fig. 4, The first pair of electrodes 301 is on one limb and the second pair 302 is on another limb; para. [0018], The identification and combination of the predefined elements in the ECG and the IPG may be effected by a processor 340).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Bandic and Areny, by configuring second and third pairs of measuring electrodes including the two measuring electrodes located on the two sides of the lower shell, and the second and third pairs of measuring electrodes arranged such that measuring electrodes forming each corresponding pair of measuring electrodes are located on opposing outer sides of the lower shell, as taught by Areny, for the purpose of measurement of ECG and IPG and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art and since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213) in view of Bandic et al. (US 2008/0194928) and Areny (US20170035307A1).
Re Claim 15, Lee discloses a multifunctional measuring device comprising:
a housing with an upper shell and a lower shell coupled to the upper shell at a first end of the housing to form a chamber with an opening at a second end of the housing that opposes the first end in a longitudinal direction, at least one of the upper shell and the lower shell movable relative the other at the first end to clamp a finger inserted via the opening into a predetermined measurement position within the chamber that is defined by chamber-facing surfaces of the upper and lower shells (fig. 8, para. [0043], the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand; para. [0004], a hinge);
a plurality of electrodes to output electrical physiological signals, the plurality of electrodes including an electrode that is coupled to the lower shell and positioned within the chamber relative to the predetermined measurement position (para. [0043], FIG. 8 illustrates the device 102 with the adapter 402 mated therewith clipped to a finger 802 a of a person's right hand, while a finger 802 b of the person's left hand is touching the outwardly facing ECG sensor 114. While it cannot be seen in FIG. 8, a distal portion of the finger 802 a on the person's right hand extends through the opening 412 in the base 402 of the adaptor 402 and touches the ECG sensor 124 that is on the backside of the housing 104); and
an optical module to output optical physiological signals, the optical module including a light source and an optical sensor that are positioned within the chamber relative to the predetermined measurement position (para. [0021], The optical sensor 122 can include both a light source and a light detector. When operating as a PPG sensor, the light source of the optical sensor 122 emits light that is reflected or backscattered by patient tissue, and reflected/backscattered light is received by the light detector of the optical sensor 122; para. [0043], optical sensor 122).
Lee is silent regarding the optical module including a light source and an optical sensor that are positioned on opposing chamber-facing surfaces of the upper and lower shells.
However, Bandic discloses a device for nail imaging and teaches a plurality of white light sensitive light-emitting diodes (LEDs), and the plurality of white light sensitive LEDs are uniformly distributed on the circuit board (fig. 4, abstract, para. [0014], a method and system for obtaining dermal biophysical properties; para. [0041], An imaging device 108 may be used to capture images of skin structures to obtain biophysical skin properties such as in a skin health test 160, a pre-diagnosis 162, remote monitoring 164, and the like. The imaging device 108 may also be adapted to capture images of non-dermal structures, such as hair, nails, teeth, eyes, internal organs and structures, and the like.; para. [0057], the illumination source is visible as a ring of LED’s around a central detection area.). Bandic also discloses sensor for capturing an image of the reflected light (para. [0018], [0019], [0047], [0063], For a known image sensor, a one-to-one mapping of pixel image distribution between the diffusion light image, corresponding to an electromagnetic signal, and reflected polarized light, corresponding to an electrical signal image, may be made with a distribution of the intensity of the spectroscopic data for the same area.)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by configuring the optical module including a light source and an optical sensor to be positioned on opposing chamber-facing surfaces of the upper and lower shells, as taught by Bandic, for the purpose of imaging biophysical properties of the nail (para. [0014], [0041]).
Lee is silent regarding the plurality of electrodes including a first electrode pair that is coupled to the lower shell and positioned within the chamber relative to the predetermined measurement position.
Areny discloses an apparatus for ECG and bioimpedance measurement (abstract) and teaches the plurality of electrodes including a first electrode pair for ECG and bioimpedance (para. [0013], fig. 3, The first pair of electrodes 301 is on one limb and the second pair 302 is on another limb; para. [0018], The identification and combination of the predefined elements in the ECG and the IPG may be effected by a processor 340).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Bandic, by configuring the plurality of electrodes including a first electrode pair that is coupled to the lower shell and positioned within the chamber relative to the predetermined measurement position, as taught by Areny, for the purpose of measurement of both ECG and bioimpedance (para. [0013], [0018]).
Re Claims 16, 17, and 18, Lee as modified by Bandic and Areny discloses the claimed invention substantially as set forth in claim 15.
Lee and Bandic are silent regarding wherein the plurality of electrodes further includes a second electrode pair coupled to the housing external to the chamber, wherein the plurality of electrodes further includes a third electrode pair coupled to the housing external to the chamber, wherein the second electrode pair is coupled to a first side of the lower shell and the third electrode pair is coupled to a second side of the lower shell that opposes the first side in a transverse direction.
However, Areny discloses an apparatus for ECG and bioimpedance measurement (abstract) and teaches the plurality of electrodes including a first electrode pair for ECG and bioimpedance and a second electrode pair for ECG and bioimpedance (para. [0013], fig. 3, fig. 4, The first pair of electrodes 301 is on one limb and the second pair 302 is on another limb; para. [0018], The identification and combination of the predefined elements in the ECG and the IPG may be effected by a processor 340).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Bandic and Areny, by configuring the plurality of electrodes further to include a second electrode pair coupled to the housing external to the chamber, wherein the plurality of electrodes further includes a third electrode pair coupled to the housing external to the chamber, wherein the second electrode pair is coupled to a first side of the lower shell and the third electrode pair is coupled to a second side of the lower shell that opposes the first side in a transverse direction, as taught by Areny, for the purpose of measurement of ECG and IPG and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art and since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Re Claim 19, Lee discloses a temperature sensor that is coupled to the housing and positioned within the chamber relative to the predetermined measurement position (para. [0020], fig. 1B, the backside of the housing 104 includes a skin temperature sensor).
Re Claim 20, Lee discloses that the temperature sensor is located in the inside of the housing (para. [0020], fig. 1B, the backside of the housing 104 includes a skin temperature sensor), but Lee is silent regarding the temperature sensor (8) that is coupled to the housing external to the chamber.
However, Yu discloses an oximeter capable of measuring body temperature (abstract) with a finger-clip structure (fig. 2a and fig. 2b, page 4) and teaches that temperature sensor 6 that is coupled to the housing external to the chamber (page 4, temperature sensor disposed in the upper casing 1 as shown in fig. 2b). Yu further discloses that the position of the temperature sensor can be set on any one of the outer end faces of the upper casing 1 or the lower casing 2 according to actual needs (page 4).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee, by configuring a temperature sensor to be coupled to the housing external to the chamber, as taught by Yu, for the purpose of measuring body temperature from a convenient position on the device (page 4) and since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213), as modified by Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124), and further in view of Bandic et al. (US 2008/0194928).
Re Claim 3, Lee as modified by Yu and Iwabuchi discloses the claimed invention substantially as set forth in claim 1.
Lee discloses that when operating as a PPG sensor, the light source of the optical sensor 122 emits light that is reflected or backscattered by patient tissue, and reflected/backscattered light is received by the light detector of the optical sensor 122 (para. [0021]).
Lee is silent regarding at least one additional optical sensor (13) and/or one additional light source arranged in the chamber (9) opposite the optical module (10).
However, Bandic discloses a device for nail imaging and teaches a plurality of white light sensitive light-emitting diodes (LEDs), and the plurality of white light sensitive LEDs are uniformly distributed on the circuit board (abstract, para. [0014], a method and system for obtaining dermal biophysical properties may comprise performing a spectral analysis of image data acquired from the degree of polarization of reflections of incident light from skin structures, wherein the property is at least one of a structure, form, concentration, number, size, state, and stage of at least one of a: melanocyte, melanin, hemoglobin, porphyrin, keratin, carotene, collagen, elastin, sebum, sebaceous gland activity, pore (sweat and sebaceous), moisture level, elasticity, luminosity, firmness, fine line, wrinkle count and stage, pore size, percent of open pores, skin elasticity, skin tension line, spot, skin color, psoriasis, allergy, red area, general skin disorder or infection, tumor, sunburn, rash, scratch, pimple, acne, insect bite, itch, bleeding, injury, inflammation, photodamage, pigmentation, tone, tattoo, percent burn/burn classification, mole (naevi, nevus), aspect of a skin lesion (structure, color, dimensions/asymmetry), melanoma, dermally observed disorder, cutaneous lesion, cellulite, boil, blistering disease, congenital dermal syndrome, (sub)-cutaneous mycoses, melasma, vascular condition, rosacea, spider vein, texture, skin ulcer, wound healing, post-operative tracking, melanocytic lesion, non-melanocytic lesion, basal cell carcinoma, seborrhoic keratosis, sebum (oiliness), nail- and/or hair-related concern, and the like; para. [0041], An imaging device 108 may be used to capture images of skin structures to obtain biophysical skin properties such as in a skin health test 160, a pre-diagnosis 162, remote monitoring 164, and the like. The imaging device 108 may also be adapted to capture images of non-dermal structures, such as hair, nails, teeth, eyes, internal organs and structures, and the like. The imaging device 108 may use an internal or external light source to provide a specific sequence of irradiation using unpolarized light, such as diffusion light, white light, monochromatic light, light of multiple single wavelengths, and the like, then polarized light in order to obtain data on skin structures.; para. [0057], the illumination source is visible as a ring of LED’s around a central detection area.). Bandic also discloses sensor for capturing an image of the reflected light (para. [0018], [0019], [0047], [0063], For a known image sensor, a one-to-one mapping of pixel image distribution between the diffusion light image, corresponding to an electromagnetic signal, and reflected polarized light, corresponding to an electrical signal image, may be made with a distribution of the intensity of the spectroscopic data for the same area.)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by configuring at least one additional optical sensor and/or one additional light source to be arranged in the chamber opposite the optical module, as taught by Bandic, for the purpose of imaging biophysical properties of the nail (para. [0014], [0041]).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213), as modified by Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124), and further in view of Gao et al. (US 2009/0069642), hereinafter “Gao”.
Re Claims 10 and 12, Lee as modified by Yu and Iwabuchi discloses the claimed invention substantially as set forth in claim 1.
Lee is silent regarding additional sensors integrated for measuring the air pressure, humidity and/or the ambient temperature and connections for additional external sensor systems arranged on the housing.
However, Gao discloses a wearable wireless electronic patient data communications and physiological monitoring device (abstract) and teaches additional sensors integrated for measuring the air pressure, humidity and/or the ambient temperature and connections for additional external sensor systems arranged on the housing (para. [0030], The patient data inputs 101 of FIG. 1A are connected to the data collectors 107. Any appropriate data input may be used. For example, a data input may be an input for a sensor 150 (e.g., a pulse oximeter, an ECG, heart rate sensor, an EEG, a blood pressure sensor, a temperature sensor, a CO.sub.2 sensor, a respiration sensor, a glucose sensor, a skin resistance sensor, anemia detector, hydration sensor, radio frequency ID sensors, global positioning system transceivers, gyroscopes, and accelerometers, digital cameras, IR cameras, ambient humidity sensors, ambient temperature sensors, ambient light sensors, ambient vibration sensors, etc.), particularly sensors to measure patient vital signs. The data inputs may be physical inputs (e.g., plugs) that are configured to mate with a sensor).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by adding additional sensors integrated for measuring the air pressure, humidity and/or the ambient temperature and connections for additional external sensor systems arranged on the housing, as taught by Gao, for the purpose of measuring ambient or environmental conditions (para. [0030]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213), as modified by Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124), and further in view of Chen et al. (US 2018/0132789), hereinafter “Chen”.
Re Claim 11, Lee as modified by Yu and Iwabuchi discloses the claimed invention substantially as set forth in claim 1.
Lee is silent regarding pressure sensors integrated for measuring the contact pressure of the finger.
Chen discloses a wearable device for healthcare (abstract) including PPG sensor on a finger used to calculate health data such as a PPG signal, heart rate, heart rate variability, and blood oxygen saturation level (para. [0039]). Chen teaches pressure sensors integrated for measuring the contact pressure of the finger (para. [0050], a bendable unit 871 with a predetermined coefficient of deformation is embedded into the main body 103 and/or the matching unit 104 for fitting with different finger sizes. When the wearable device 100 is worn on the finger 105, the bendable unit 871 will provide a clamping pressure within a proper range on the finger 105. As shown in FIG. 8b, one or more protrusions 872 are configured on the inner surface of the main body 103. In one embodiment, at least one protrusion 872 is made by an elastic material. In another embodiment, the main body 103 is, at least partially, made from an elastic material. When the wearable device 100 is worn on the different fingers with different sizes, the wearable device 100 with the protrusion(s) 872 will provide a pressure within a proper range on the finger 105. In other embodiment, the tightness of the wearable device 100 is adjustable and further comprises a pressure sensor to sense the pressure between the wearable device 100 and the finger 105. If the pressure sensor detects the pressure is higher than a first threshold or lower than a second threshold, the tightness of the wearable device 100 will be adjusted automatically or manually by the user.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by adding pressure sensors integrated for measuring the contact pressure of the finger, as taught by Chen, for the purpose of providing a clamping pressure within a proper range on the finger (para. [0050]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0022213), as modified by Yu et al. (WO 2011/143823) and Iwabuchi (US 6,360,124), and further in view of Baker (US 2007/0179369).
Re Claim 14, Lee as modified by Yu and Iwabuchi discloses the claimed invention substantially as set forth in claims 1 and 13.
Lee is silent regarding additional parameters that are otherwise not accessible to a non-invasive measurement determined from the measured signals using statistical methods and/or machine-learning methods.
However, Baker discloses system and method for automatic detection of unstable oxygen saturation of a patient using a pulse oximeter and computing at least two metrics based on statistical properties of the single time series input of the oxygen saturation values (abstract). Baker teaches additional parameters that are otherwise not accessible to a non-invasive measurement determined from the measured signals using statistical methods and/or machine-learning methods (para. [0020], at least two metrics are computed based on statistical properties of the single time series input of oxygen saturation values; para. [0022], Examples of statistical metrics that may be employed in conjunction with exemplary embodiments of the present invention include a magnitude of saturation changes over one second intervals, a magnitude of saturation changes over five second intervals, a magnitude of saturation changes over ten second intervals, or a magnitude of saturation changes over fifteen second intervals.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Lee as modified by Yu and Iwabuchi, by determining additional parameters that are otherwise not accessible to a non-invasive measurement from the measured signals using statistical methods and/or machine-learning methods, as taught by Baker, for the purpose of automatic detection of unstable oxygen saturation of a patient (para. [0020], abstract).
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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, December 20, 2025
Examiner, Art Unit 3792