DETAILED ACTION
Applicant' s arguments, filed 07/31/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/26/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-20 are hereby the present claims under consideration.
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 .
Drawings
Applicant’s replacement drawings have been accepted, the previously presented objection is withdrawn.
Specification
Applicant’s amendment to the specification have been accepted, the previously presented objection has been withdrawn.
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1 and 16 are objected to because of the following informalities:
Claim 1 lines 19-20 it appears that “through first source” should read “through the first source”
Claim 1 lines 23-24 it appears that “through second source” should read “through the second source”
Claim 16 line 15 it appears that “through first source” should read “through the first source”
Claim 16 line 18 it appears that “through second source” should read “through the second source”
Appropriate correction is required.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lash US Patent Application Publication Number US 20070055119 A1 hereinafter Lash in view of Shadgan US Patent Number US 12514474 B2 hereinafter Shadgan in view of Mao US Patent Application Publication Number US 20090326354 A1 hereinafter Mao further in view of Thomas US Patent Application Publication Number US 20240074677 A1 hereinafter Thomas.
Regarding claim 1, Lash discloses a device (Abstract) comprising:
a first enclosure of an oximeter (Paragraph 0036: the sensor head; Fig. 2A reference 200) comprising:
a first source and a second source arranged on a first line on a first planar surface of the first enclosure (Paragraphs 0036 and 0039: the optical fibers that connect the emitters to the ports in the probe head; Fig. 2B references 224a, 224b, S1 and S2 form a line on the surface of probe head 220),
wherein the first source comprises a first source side, inside the device, and a second source side, outside of the first enclosure (Paragraphs 0033- 0036: the optical fibers have an end connected to the light sources located in the device and an end that interfaces with tissue, or is outside the first enclosure), and
the second source comprises a third structure side, inside the device, and a fourth source side, outside of the first enclosure (Paragraphs 0033-0036: the optical fibers have an end connected to the light sources located in the device and an end that interfaces with tissue, or is outside the first enclosure);
a first emitter circuit, wherein the first emitter circuit emits light having a first wavelength, and the first emitter circuit is associated with the first source (Paragraphs 0045-0046: the laser diode 302a. The light from 302a and 302b are associated with one optical fiber which connects to one source structure; Fig. 3 reference 302a);
a second emitter circuit, wherein the second emitter circuit emits light having a second wavelength, which is different from the first wavelength, and the second emitter circuit is associated with the first source (Paragraphs 0045-0046: the laser diode 302b. The light from 302a and 302b are associated with one optical fiber which connects to one source structure; Fig. 3 reference 302b);
a third emitter circuit, wherein the third emitter circuit emits light having the first wavelength, and the third emitter circuit is associated with the second source (Paragraphs 0045-0046: the laser diode 306a. The light from 306a and 306b are associated with one optical fiber which connects to one source structure; Fig. 3 reference 306a);
a fourth emitter circuit, wherein the fourth emitter circuit emits light having the second wavelength, and the fourth emitter circuit is associated with the second source (Paragraphs 0045-0046: the laser diode 306b. The light from 306a and 306b are associated with one optical fiber which connects to one source structure; Fig. 3 reference 306b),
the first and second emitter circuits are positioned within the device such that light emitted by either the first emitter circuit or the second emitter circuit will pass through first source from the first source side to the second source side in a direction away from the first planar surface (Paragraphs 0033-0036: the light travels from the laser diode, or emitter circuits, into the fiber optic, or source structures, and then out of the fiber optics into the tissue, which is in a direction away from the first planar surface; Fig. 1B the path of light as illustrated by the arrows; Fig. 3 references 302a and 302b are considered the first and second emitter circuits respectively; reference 312 is considered the second source structure), and
the third and fourth emitter circuits are positioned within the device such that light emitted by either the third emitter circuit or the fourth emitter circuit will pass through second source from the third source side to the fourth source side in a direction away from the first planar surface (Paragraphs 0033-0036: the light travels from the laser diode, or emitter circuits, into the fiber optic, or source structures, and then out of the fiber optics into the tissue, which is in a direction away from the first planar surface; Fig. 1B the path of light as illustrated by the arrows; Fig. 3 references 306a and 306b are considered the first and second emitter circuits respectively; reference 316 is considered the second source structure);
a first detector and a second detector (Paragraph 0039: the detectors; Fig. 3 references 324: the fiber optics connected to the photodetectors) arranged on a second line on the first planar surface of the first enclosure, where the second line is not collinear or parallel with the first line (Fig. 2B the line formed through the photodetectors D1-D4 is not colinear or parallel with the line formed through S1 and S2);
a first detector circuit, wherein the first detector circuit receives light that passes through the first detector and not the second detector (Paragraph 0046: the photodetectors; Fig. 3 references 318 and 324: the photodetectors each have their own optic fiber);
a second detector circuit, wherein the second detector circuit receives light that passes through the second detector and not the first detector (Paragraph 0046: the photodetectors; Fig. 3 references 318 and 324: the photodetectors each have their own optic fiber); and
a second enclosure of the oximeter, wherein the second enclosure is a separate and independent enclosure from the first enclosure (Paragraph 0030: the unit; Fig. 1B reference 104), the second enclosure comprises:
a processor (Paragraph 0050: a processor is implicitly disclosed by the execution of software to carry out the recited measurement);
a memory, coupled to the processor (Paragraph 0050: a memory connected to the processor is implicitly disclosed by the execution of software to carry out the recited measurement);
a cable, extending externally between the first and second enclosures, wherein the cable couples the component of the first enclosure to the components of the second enclosure (Paragraphs 0030: a cable connector between the unit and probe).
Lash fails to further disclose the device wherein the source structures, emitter circuitry, detector structures, and detector circuits are within the first enclosure of the oximetry probe, and the cable being an electrical cable.
An obvious variation of Lash would be to position the source structures, emitter circuitry, detector structures, detector circuits, and associated beam combiner within the first enclosure of the sensor probe. Such a variation is obvious because it is a mere rearrangement of parts with no effect on the operation of the device of Lash. Additionally, such a rearrangement would necessarily include an electrical connection from the unit which performs the data processing to the probe head to send signals and power necessary for the activation of the light sources. Thus, such a variation also implicitly teaches the cable being an electrical cable. It is noted that Lash explicitly contemplates the sensor probe head being a variety of sizes and configurations in paragraphs 0036 and 0040 and thus any resultant increase in size or change in shape of the probe head of Lash to accommodate the moved light sources and detectors would not render the device of Lash as inoperable or unusable for its intended purpose. One of ordinary skill in the art would have a reasonable expectation of success because all of the components of Lash are still used for their recited purpose, simply in a new location.
Lash fails to further teach the device comprising: in the first enclosure: a printed circuit board (PCB), wherein the first, second, third, and fourth emitter circuits are coupled to a first surface of a second surface of the PCB; and a front-end circuit, coupled to the first surface or the second surface of the PCB and coupled to the first, second, third, and fourth emitter circuits and the first and second detector circuits; and in the second enclosure: a first wireless communication circuit, coupled to the processor and memory; and a battery holder comprising positive and negative battery terminals, wherein the battery terminals are coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery terminals of the second enclosure
Shadgan teaches a system for performing near infrared spectroscopy (NIRS) monitors tissue oxygenation and/or hemodynamics (Abstract). Thus, Shadgan falls within the same field of endeavor as Applicant’s invention.
Shadgan teaches a front-end circuit, coupled to the first and second emitter circuits and the first and second detector circuits (Col 17 lines 12-23: the analog module which controls the light sources and receives signals from the detectors). Shadgan further teaches that light sources, photodetectors, and other electronics of the sensor may be mounted on a flexible printed circuit board in the head of the sensor (Col 19 lines 1-13). The sensor head may be connected to other equipment via a cable and the sensor head may have a plurality of different arrangements of detectors and emitters (Col 19 line 53 - Col 20 line 16).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the analog module and the incorporation of the first enclosure components onto a surface of a PCB as taught by Shadgan into the device of Lash because Shadgan teaches that such a module may control the light source and perform initial signal conditioning and/or low level processing of the receives signals. The module may perform filtering on the receives signals and thus would be beneficial as it provides a single module for light source control and pre-processing of the received signals prior to their processing to produce the oxygen saturation. Additionally, it would be obvious to implement such a module in the first enclosure and on the PCB because its particular location is a matter of routine optimization and experimentation and/or a mere rearrangement of parts. The particular location of the module does not affect its function and mounting all of the components onto a PCB may reduce the overall size of the device which may make it easier to use.
Lash in view of Shadgan fails to further teach the device comprising: in the second enclosure: a first wireless communication circuit, coupled to the processor and memory; and a battery holder comprising positive and negative battery terminals, wherein the battery terminals are coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery terminals of the second enclosure
Mao teaches a flexible sensor pad includes a cavity to hold a sensor unit with an attached cable (Abstract). Thus Mao falls within the same field of endeavor as Applicant’s invention.
Mao teaches a first wireless communication circuit, coupled to the processor and memory (Paragraph 0059: the system may be part of a wireless network to share information; Paragraphs, 0084 0088, and 0093-0094: wireless data transfer); and a battery coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure (Paragraphs 0051-0052 and 0074-0076: the system may be battery operated and thus the elements may be supplied power via the battery. Batteries supply DC voltage and thus the use of a battery implicitly discloses a positive and negative battery terminal).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the battery and wireless communication circuitry as taught by Mao into the device of Lash in view of Shadgan because the device being battery operated permits the device to be portable and usable in a greater variety of locations and the wireless communication circuitry allows the device to communicate with network to send patient data to different locations where it may be desired. It is further noted that the limitation of “the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure” is considered to be taught by the above presented combination of Lash in view of Shadgan further in view of Mao as the electric cable of the obvious variation of Lash would connect the front end controller implemented by Shadgan to the processor and memory implicitly taught by Lash and the wireless communication circuitry and battery as taught by Mao.
Lash in view of Shadgan further in view of Mao fails to further teach a device including a battery holder comprising positive and negative battery terminals.
Thomas teaches a monitoring apparatus and method includes a monitor, a sensor comprising a wireless connection with the monitor, and an adapter comprising the wireless connection with the monitor and a wired or wireless connection with a remote monitoring station (Abstract). Thus, Thomas is reasonably pertinent to the problem at hand.
Thomas teaches a battery holder for holding a battery and having positive and negative holder electrodes, or terminals, that supply power to the device (Paragraph 0035)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the battery holder taught by Thomas into the device of Lash in view of Shadgan further in view of Mao because such a holder provides a secure location to place the battery for operating the device wirelessly without risk of the battery becoming dislodged from the contacts and preventing normal operations.
Examiner’s Note: All dependent claims are rejected with the understanding that modified Lash as presented above teaches the emitters, photodetectors, beam combiner, and their respective structures are within the first housing and connected to the second housing via an electronic cable that communicates with the front end circuit.
Regarding claim 2, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein a first distance is between the first source and the first detector, a second distance is between the first source and the second detector, a third distance is between the second source and the first detector, and a fourth distance is between the second source and the second detector, and the first, second, third, and fourth distances are different from each other (Paragraph 0038; Fig. 2B reference D1 is considered the first detector structure, reference D4 is considered the second reference structure, references S1 and S2 are considered the first and second source structures respectively, the distances Y1 and Y2 between the first source structure and the first detector structure is different from the distance between the second source structure and the second detector structure. The distances between the first source and second detector and the distance from the second source to the first detector are all different.).
Regarding claim 3, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein the first enclosure further comprises a third detector and a fourth detector arranged on the second line on the exterior planar surface of the first enclosure (Paragraph 0039: four detectors; Fig. 2B reference D2 is considered the third detector structure and reference D3 is considered the fourth detector structure; Fig. 3: the detector structures are the connecting fiber optics 324).
Regarding claim 4, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein between the first source and the first detector, there are no intervening source or detector, between the first source and the second detector, there are no intervening source or detector, between the second source and the first detector, there are no intervening source or detector, and between the second source and the second detector, there are no intervening source or detector (Fig. 2B references S1, S2, D1, and D4: there are no intervening structures between any of these elements with the exception of D1 and D4 which is not required by the claim).
Regarding claim 5, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein on a line between the first source and the first detector, there are no intervening source or detector, on a line between the first source and the second detector, there are no intervening source or detector, on a line between the second source and the first detector, there are no intervening source or detector, and on a line between the second source and the second detector, there are no intervening source or detector (Fig. 2B references S1, S2, D1, and D4: there are no intervening structures between any of these elements with the exception of D1 and D4 which is not required by the claim).
Regarding claim 6, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein the first and second source and the first and second detector comprise circular cross sections (Fig. 2B: references S1, S2, D1, and D4 have circular cross sections).
Regarding claim 8, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein the first and second source and the first and second detector comprise optical fibers (Paragraph 0036: the detector and source structures are optical fibers).
Regarding claim 9, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device comprising: a beam combiner, comprising a first input, second input, and an output, wherein the first input of beam combiner is optically coupled to the first emitter circuit, the second input of the beam combiner is optically coupled to the second emitter circuit, and the output of the beam combiner is optically coupled to the first source (Paragraphs 0032 and 0035: the outputs of the first optical source 152a and 152b are combined in a beam combiner into one optical fiber 152C and delivered to the probe head, thus the beam combined contains two inputs and one output that is coupled to the first source structure; Fig. 1B references 152a-c and 124; Paragraph 0045 and Fig. 3: the first light source may include two laser diodes, or the first and second emitter circuits).
Modified Lash fails to explicitly disclose the beam combiner located in the first enclosure.
An obvious variation of modified Lash would be to place the beam combiner in the first enclosure with the rest of the emitting and detecting circuitry because it is a mere rearrangement of parts as described in the above rejection of claim 1 and does not alter the function of the beam combiner.
Regarding claim 10, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein the first and second emitter circuits are positioned within the first enclosure such that while light emitted by either the first emitter circuit or the second emitter circuit is passing through the first source, that light will not pass through second source (Paragraphs 0032, 0035, and 0045-0046: the outputs of the first optical source 152a and 152b are combined into one optical fiber 152C and delivered to the probe head, thus the delivered light passes through only one of the source structures from one grouping of the light source circuits; Fig. 1B references 152a-c and 124; Fig. 3 references 302a-b, 306a-b, 310, 312, and 316).
Regarding claim 11, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 10. Modified Lash further teaches the device wherein the third and fourth emitter circuits are positioned within the first enclosure such that while light emitted by either the third emitter circuit or the fourth emitter circuit is passing through the second source, that light will not pass through first source (Paragraphs 0032, 0035, and 0045-0046: the outputs of the second optical source 156a and 156b are combined into one optical fiber 156C and delivered to the probe head, thus the delivered light passes through only one of the source structures from one grouping of the light source circuits; Fig. 1B references 156a-c and 124; Fig. 3 references 302a-b, 306a-b, 310, 312, and 316).
Regarding claim 12, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash fails to further teach the device wherein the second enclosure further comprises a battery compartment, comprising the battery holder, and a battery cover, which removably interlocks with the second enclosure to cover the battery compartment.
Thomas teaches wherein the second enclosure comprises a battery compartment, comprising the battery holder, and a battery cover, which removably interlocks with the second enclosure to cover the battery compartment (Paragraph 0035: the battery holder is located within the hollow interior, or battery compartment. The battery cover is provided to selectively expose or cover the opening which at least suggests that it is removable and reattachable; Fig. 13 reference 260 )
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the battery compartment of modified Lash to be structured similarly to Thomas because such a holder provides a secure location to place the battery for operating the device wirelessly without risk of the battery becoming dislodged from the contacts and preventing normal operations.
Regarding claim 13, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash fails to further teach the device wherein the battery holder comprises a first receptacle for a first battery cell and a second receptacle for a second battery cell, and the first and second holders comprise electrical connections that will couple the first battery cell and second battery cell together in series.
Thomas teaches wherein the second enclosure comprises a battery compartment, comprising the battery holder, which may hold up to four AA batteries, and a battery cover, which removably interlocks with the second enclosure to cover the battery compartment (Paragraph 0035: the battery holder is located within the hollow interior, or battery compartment and can accommodate 4 AA batteries, the respective slots for each of the batteries are considered a first through fourth battery holder. The battery cover is provided to selectively expose or cover the opening which at least suggests that it is removable and reattachable. The batteries may be connected in series; Fig. 13 reference 260 )
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the battery compartment of modified Lash to be structured similarly to Thomas because such a holder provides a secure location to place the battery for operating the device wirelessly without risk of the battery becoming dislodged from the contacts and preventing normal operations.
Regarding claims 14 and 15, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash fails to further discloses a system comprising:
the device of claim 1; and
a console comprising a processor, memory, screen, and second wireless communication circuit, wherein via the second communication circuit, the console wirelessly connects to the first communication circuit to establish a wireless communication link, the first communication circuit transmits oxygen saturation information over the wireless communication link, and the console device displays a graph on the screen based at least in part on the oxygen saturation information received from the device, and wherein the console comprises a tablet device.
Mao teaches a system which measured and displays oxygen saturation information (Paragraphs 0041-0042). Mao teaches that the display may be numbers, text, graphics, and graphical trends in color (Paragraphs 0085-0086: The graphics and graphical trends are considered to teach the display of a graph). Mao further teaches that the collected data may be transmitted to a separate receiving location (Paragraph 0088) and that the device which receives the data may be a variety of different types of devices such as mobile devices, monitoring consoles, monitoring stations, phones, pagers, laptops, or other devices (Paragraphs 0060 and 0091: The variety of different devices including mobile devices is considered to teach a tablet which includes a processor, memory, display, and second wireless communication circuitry since all of these components are present in generic computing devices). The transmitted data which includes the oxygen saturation information (Paragraph 0082) may be reviewed by a nurse or physician at the remote location (Paragraph 0094)
Mao further at least suggests that the console, or tablet, displays a graph on the screen based at least in part on the oxygen saturation information received from the device. This limitation is suggested by a combination of paragraphs 0060, 0085-0086, 0088, 0091 and 0094 which teach that the unit attached to the sensor may display such graphs and that the unit may transmit data to an external device for review by a clinician. The recitation that the data that is transmitted to the console is reviewed by a clinician teaches that some form of the data is displayed or otherwise presented to the clinician. This teaching in combination with the teaching that the unit may display graphs to communicate data at least suggests that the external console may present the same or similar graphs to allow the clinician to review the received data. Thus, Mao is considered to at least suggest that the external console presented the same or similar graphical display as the unit.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the wireless transmission of data to an external console to be reviewed by a clinician as taught or at least suggested by Mao into the system of modified Lash because Mao teaches that such data transmission allows a clinician to review the data at a remote location and make decisions based on the received data such as dispatching an ambulance (Mao: Paragraph 0094).
Regarding claim 16, Lash discloses a device (Abstract) comprising:
a first enclosure of an oximeter (Paragraph 0036: the sensor head; Fig. 2A reference 200) comprising:
a first source and a second source arranged on a first line on a first planar surface of the first enclosure (Paragraphs 0036 and 0039: the optical fibers that connect the emitters to the ports in the probe head; Fig. 2B references 224a, 224b, S1 and S2 form a line on the surface of probe head 220), wherein the first source comprises a first source side, inside the device, and a second source side, outside of the first enclosure, and the second source comprises a third source side, inside the device, and a fourth source side, outside of the first enclosure (Paragraphs 0033-0036: the optical fibers have an end connected to the light sources located in the device and an end that interfaces with tissue, or is outside the first enclosure);
a first emitter circuit, wherein the first emitter circuit emits light having a first wavelength or a second wavelength, the first wavelength is different from the second wavelength, and the first emitter circuit is associated with the first source (Paragraph 0031: the first light source emits light of two different wavelengths; Fig. 1B references 116 and 152a-b; Paragraphs 0032 and 0035: The light from the first source is combined by the beam combiner and provided to one of the source structures since it is combined into a single optical fiber; Fig. 1B references 152a-c);
a second emitter circuit, wherein the second emitter circuit emits light having the first wavelength or the second wavelength, and the second emitter circuit is associated with the second source (Paragraph 0031: the second light source emits light of two different wavelengths; Fig. 1B references 120 and 156a-b; Paragraphs 0032 and 0035: The light from the second source is combined by the beam combiner and provided to one of the source structures since it is combined into a single optical fiber; Fig. 1B references 156a-c),
the first emitter circuit is positioned within the device such that light emitted by the first emitter circuit will pass through first source from the first source side to the second source side in a direction away from the first planar surface (Paragraphs 0033-0036: the light travels from the laser diode, or emitter circuit, into the fiber optic, or source structures, and then out of the fiber optics into the tissue, which is in a direction away from the first planar surface; Fig. 1B the path of light as illustrated by the arrows; Fig. 1B reference 116: the first source structure emits light 152a-b which is combined into a single fiber optic provided to one of the source structures 152c; Fig. 3 reference 312 is considered the first source structure), and
the second emitter circuit is positioned within the device such that light emitted by the second emitter circuit will pass through second source from the third source side to the fourth source side in a direction away from the first planar surface (Paragraphs 0033-0036: the light travels from the laser diode, or emitter circuit, into the fiber optic, or source structures, and then out of the fiber optics into the tissue, which is in a direction away from the first planar surface; Fig. 1B the path of light as illustrated by the arrows; Fig. 1B reference 120: the second source structure emits light 156a-b which is combined into a single fiber optic provided to one of the source structures 156c; Fig. 3 reference 316 is considered the second source structure);
a first detector and a second detector (Paragraph 0039: the detectors; Fig. 3 references 324: the fiber optics connected to the photodetectors) arranged on a second line on the first planar surface of the first enclosure, where the second line is not collinear or parallel with the first line (Fig. 2B the line formed through the photodetectors D1-D4 is not colinear or parallel with the line formed through S1 and S2);
a first detector circuit, wherein the first detector circuit receives light that passes through the first detector and not the second detector (Paragraph 0046: the photodetectors; Fig. 3 references 318 and 324: the photodetectors each have their own optic fiber);
a second detector circuit, wherein the second detector circuit receives light that passes through the second detector and not the first detector (Paragraph 0046: the photodetectors; Fig. 3 references 318 and 324: the photodetectors each have their own optic fiber); and
a second enclosure of the oximeter, wherein the second enclosure is a separate and independent enclosure from the first enclosure (Paragraph 0030: the unit; Fig. 1B reference 104), the second enclosure comprises:
a processor (Paragraph 0050: a processor is implicitly disclosed by the execution of software to carry out the recited measurement);
a memory, coupled to the processor (Paragraph 0050: a memory connected to the processor is implicitly disclosed by the execution of software to carry out the recited measurement);
a cable, extending externally between the first and second enclosures, wherein the cable couples the components of the first enclosure to the components of the second enclosure (Paragraphs 0030: a cable connector between the unit and probe)).
Lash fails to further disclose the device wherein the source structures, emitter circuitry, detector structures, and detector circuits are within the first enclosure of the oximeter, and the cable being an electrical cable.
An obvious variation of Lash would be to position the source structures, emitter circuitry, detector structures, detector circuits, and beam combiner within the first enclosure of the sensor probe. Such a variation is obvious because it is a mere rearrangement of parts with no effect on the operation of the device of Lash. Additionally, such a rearrangement would necessarily include an electrical connection from the unit which performs the data processing to the probe head to send signals and power necessary for the activation of the light sources. Thus, such a variation also implicitly teaches the cable being an electrical cable. It is noted that Lash explicitly contemplates the sensor probe head being a variety of sizes and configurations in paragraphs 0036 and 0040 and thus any resultant increase in size or change in shape of the probe head of Lash to accommodate the moved light sources and detectors would not render the device of Lash as inoperable or unusable for its intended purpose. One of ordinary skill in the art would have a reasonable expectation of success because all of the components of Lash are still used for their recited purpose, simply in a new location.
Lash fails to further teach the device comprising: in the first enclosure: a printed circuit board (PCB), wherein the first and second detector circuits are coupled to a first surface of a second surface of the PCB; and a front-end circuit, coupled to the first surface or the second surface of the PCB coupled to the first, second, third, and fourth emitter circuits and the first and second detector circuits; and in the second enclosure: a first wireless communication circuit, coupled to the processor and memory; and a battery holder comprising positive and negative battery terminals, wherein the battery terminals are coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure
Shadgan teaches a front-end circuit, coupled to the first and second emitter circuits and the first and second detector circuits (Col 17 lines 12-23: the analog module which controls the light sources and receives signals from the detectors). Shadgan further teaches that light sources, photodetectors, and other electronics of the sensor may be mounted on a flexible printed circuit board in the head of the sensor (Col 19 lines 1-13). The sensor head may be connected to other equipment via a cable and the sensor head may have a plurality of different arrangements of detectors and emitters (Col 19 line 53 - Col 20 line 16).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the analog module and the incorporation of the first enclosure components onto a surface of a PCB as taught by Shadgan into the device of Lash because Shadgan teaches that such a module may control the light source and perform initial signal conditioning and/or low level processing of the receives signals. The module may perform filtering on the receives signals and thus would be beneficial as it provides a single module for light source control and pre-processing of the received signals prior to their processing to produce the oxygen saturation. Additionally, it would be obvious to implement such a module in the first enclosure and on the PCB because its particular location is a matter of routine optimization and experimentation and/or a mere rearrangement of parts. The particular location of the module does not affect its function and mounting all of the components onto a PCB may reduce the overall size of the device which may make it easier to use.
Lash in view of Shadgan fails to further teach the device comprising: in the second enclosure: a first wireless communication circuit, coupled to the processor and memory; and a battery holder comprising positive and negative battery terminals, wherein the battery terminals are coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure
Mao teaches a first wireless communication circuit, coupled to the processor and memory (Paragraph 0059: the system may be part of a wireless network to share information; Paragraphs, 0084 0088, and 0093-0094: wireless data transfer); and a battery coupled to the processor, memory, and first wireless communication circuit via a connection to the second enclosure; and the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure (Paragraphs 0051-0052 and 0074-0076: the system may be battery operated and thus the elements may be supplied power via the battery. Batteries supply DC voltage and thus the use of a battery implicitly discloses a positive and negative battery terminal).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the battery and wireless communication circuitry as taught by Mao into the device of Lash in view of Shadgan because the device being battery operated permits the device to be portable and usable in a greater variety of locations and the wireless communication circuitry allows the device to communicate with network to send patient data to different locations where it may be desired. It is further noted that the limitation of “the electrical cable coupling the front-end circuit of the first enclosure to the processor, memory, wireless communication circuit, and battery-holder battery terminals of the second enclosure” is considered to be taught by the above presented combination of Lash in view of Shadgan further in view of Mao as the electric cable of the obvious variation of Lash would connect the front end controller implemented by Shadgan to the processor and memory implicitly taught by Lash and the wireless communication circuitry and battery as taught by Mao.
Lash in view of Shadgan further in view of Mao fails to further teach a device including a battery holder comprising positive and negative battery terminals.
Thomas teaches a battery holder for holding a battery and having positive and negative holder electrodes, or terminals, that supply power to the device (Paragraph 0035)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the battery holder taught by Thomas into the device of Lash in view of Shadgan further in view of Mao because such a holder provides a secure location to place the battery for operating the device wirelessly without risk of the battery becoming dislodged from the contacts and preventing normal operations.
Examiner’s Note: All dependent claims are rejected with the understanding that modified Lash as presented above teaches the emitters, photodetectors, beam combiner, and their respective structures are within the first housing and connected to the second housing via an electronic cable that communicates with the front end circuit.
Regarding claim 17, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 16. Modified Lash further teaches the device wherein a first distance is between the first source and the first detector, a second distance is between the first source and the second detector, a third distance is between the second source and the first detector, and a fourth distance is between the second source and the second detector, and the first, second, third, and fourth distances are different from each other (Paragraph 0038; Fig. 2B reference D1 is considered the first detector structure, reference D4 is considered the second reference structure, references S1 and S2 are considered the first and second source structures respectively, the distances Y1 and Y2 between the first source structure and the first detector structure is different from the distance between the second source structure and the second detector structure. The distances between the first source and second detector and the distance from the second source to the first detector are all different.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lash US Patent Application Publication Number US 20070055119 A1 hereinafter Lash in view of Shadgan US Patent Number US 12514474 B2 hereinafter Shadgan in view of Mao US Patent Application Publication Number US 20090326354 A1 hereinafter Mao in view of Thomas US Patent Application Publication Number US 20240074677 A1 hereinafter Thomas as applied to claim 1 above and further in view of McDaniel US Patent Application Publication Number US 20180364098 A1 hereinafter McDaniel.
Regarding claim 7, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash further teaches the device wherein the first and second source and the first and second detector comprise a polymer material.
McDaniel teaches an optical element is provided which includes an optical fiber, and a plurality of fluorophores disposed inside the optical fiber (Abstract). Thus, McDaniel is reasonably pertinent to the problem at hand.
McDaniel teaches that fiber optics are typically comprised of glass, acrylic polymers, vinyls, ionoplasts, and silicones (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the fiber optics of modified Lash to be comprised of a polymeric material such as an acrylic polymer as taught by McDaniel because McDaniel teaches that such a material is typical for the construction of fiber optics and thus it is a simple substitution of one known element (the material used for fiber optics in Lash) for another known element (the acrylic polymer fiber optic taught by McDaniel) with no surprising technical effect.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lash US Patent Application Publication Number US 20070055119 A1 hereinafter Lash in view of Shadgan US Patent Number US 12514474 B2 hereinafter Shadgan in view of Mao US Patent Application Publication Number US 20090326354 A1 hereinafter Mao in view of Thomas US Patent Application Publication Number US 20240074677 A1 hereinafter Thomas as applied to claim 1 above and further in view of Lonsinger US Patent Application Publication Number US 20170303833 A1 hereinafter Lonsinger.
Regarding claim 18, Lash in view of Shadgan in view of Mao further in view of Thomas teaches the device of claim 1. Modified Lash fails to further disclose a kit comprising: a battery that is compatible with the battery holder of the second enclosure, wherein as part of the kit, the battery is not installed in the battery holder.
Lonsinger teaches a handheld oximeter probe (Abstract). Thus Lonsinger falls within the same field of endeavor as Applicant’s invention.
Lonsinger teaches that a device may come in a kit with batteries that may not be in the battery compartment when the kit is sold and an instruction manual (Paragraph 0124).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of modified Lash to come in a kit and batteries that are not installed in the battery holder as taught by Lonsinger because including batteries would improve the usability of the device by providing everything required to operate the system.
Regarding claim 20, Lash in view of Shadgan in view of Mao in view of Thomas further in view of Lonsinger teaches the kit of claim 18. Modified Lash fails to further disclose the kit wherein the battery comprises at least two AA batteries and an end user installs the battery into the battery holder.
Thomas teaches a device may operate using four AA batteries in series (Paragraphs 0035).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of modified Lash to operate using at least two AA batteries as taught by Thomas because such batteries are readily available and would improve the usability of the device since they can be readily replaced when empty. Furthermore, it would be obvious to one of ordinary skill in the art that the user would need to install the batteries to operate the device since Lash in view of Shadgan in view of Mao in view of Thomas further in view of Lonsinger as presented in claim 18 above teach that the batteries do not come pre-installed.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lash US Patent Application Publication Number US 20070055119 A1 hereinafter Lash in view of Shadgan US Patent Number US 12514474 B2 hereinafter Shadgan in view of Mao US Patent Application Publication Number US 20090326354 A1 hereinafter Mao in view of Thomas US Patent Application Publication Number US 20240074677 A1 hereinafter Thomas in view of Lonsinger US Patent Application Publication Number US 20170303833 A1 hereinafter Lonsinger as applied to claim 18 above and further in view of Butler US Patent Application Publication Number US 20080007210 A1 hereinafter Butler.
Regarding claim 19, Lash in view of Shadgan in view of Mao in view of Thomas further in view of Lonsinger teaches the kit of claim 18. Modified Lash fails to further disclose the kit comprising: a user guide, wherein the user guide provides instructions on how to install the battery into the battery holder.
Lonsinger teaches the inclusion of an instruction manual in the kit (Paragraph 0124).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of modified Lash to come in a kit with an instruction manual so that the user will know how to operate the device.
Modified Lash fails to further disclose the device wherein the user guide provides instructions on how to install the battery into the battery holder.
Butler teaches a rechargeable battery backup for a barrier movement operator (Abstract). Thus Butler is reasonably pertinent tot eh problem at hand.
Butler teaches a kit with a set of instructions and the instructions include instructions of how to insert a battery into a device (Paragraph 0035).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of modified Lash to include instructions on how to insert the batter because such instructions would enable the user to use the device by supplying it with the necessary power components.
Response to Arguments
Applicant's arguments filed 07/31/2026 have been fully considered but they are not persuasive. In particular, the newly added limitations are rejected over the prior art.
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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