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 Objections
Claims 1, 5, 7, 11, 14, and 16 are objected to because of the following informalities:
Claim 1 should be revised to recite: “1. An optical imaging apparatus comprising:…”
Claim 1 should be revised to be grammatically consistent with other recitations by reciting: “a rotational motor; a rotary joint; and a probe connection….”
Claim 5 should be revised to recite: “wherein the redundancy circuit includes two frequency comparators, wherein one comparator is a positive comparator, and the other comparator is a negative comparator.”
Claim 7 should be revised to depend from claim 6 to correct the antecedent basis issue with respect to “threshold.”
Claim 11 recites a method claim but appears to add an element as a method step. Based on claim 10, claim 11 should be revised to recite: “The method of Claim 10, wherein the optical imaging apparatus further comprises an interlock circuit….”
Claim 14 should be revised to recite: “wherein the redundancy circuit includes two frequency comparators, wherein one comparator is a positive comparator, and the other comparator is a negative comparator.”
Claim 16 should be revised to depend from claim 15 to correct the antecedent basis issue with respect to “threshold.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 1, 2, 6, 11, and 15 recites that the “laser light” is functional or has a functionality. Laser light is not typically thought of being functionally controllable. Based on Applicant’s disclosure, it is Examiner’s understanding that the delivery (i.e., emission) of the laser light is controlled for safety purposes. (see, e.g., [0031]-[0033], [0042]). However, the claims do not recite controlling the delivery or emission of the laser light. As such, the scope of the claims are not clear to one having ordinary skill in the art.
For the purposes of a compact prosecution, Examiner is interpreting:
The relevant portion of claim 1 as follows: “…wherein the laser light is emitted only when the probe is rotating.” (see, e.g., Abstract and [0031]-[0033], [0042] of Applicant’s disclosure).
The relevant portions of claims 2 and 11 are being interpreted as follows: “…an interlock circuit for controlling emission of the laser light.”
The relevant portion of claims 6 and 15 as follows: “…wherein the laser light emitted only when the probe is rotating above a threshold.
Claim 10 recites “terminating the laser light once a disturbance of the probe occurs.” The phrase “disturbance of the probe” is unclear. For example, a disturbance of the probe could be anything that prevents the probe from operating as intended, including internal malfunctions or external objects. Based on Applicant’s disclosure, the “disturbance of the probe” relates to the probe’s rotation.
For the purposes of a compact prosecution, Examiner is interpreting the relevant portion of claim 10 as follows: “…terminating the laser light in response to detecting that a rotating speed of the probe is not above a threshold.” (see, e.g., Abstract and [0040]-[0044] of Applicant’s disclosure).
Claim 12 recites “wherein the disturbance of the probe occurs when a frequency comparator to generate the laser light on and off states, which depends on the rotating speed of the rotational motor, reaches or exceeds a threshold.” As explained above with respect to claim 10, the phrase “disturbance of the probe” is indefinite.
There are two additional issues with claim 12. Claim 12 recites that the disturbance occurs when the “frequency comparator…reaches or exceeds a threshold.” First, a frequency comparator cannot reach or exceed a threshold, only the output of the frequency comparator can reach or exceed a threshold. Second, based on Applicant’s disclosure, the disturbance occurs when the rotating speed is not above a threshold.
For the purposes of a compact prosecution, Examiner is interpreting the relevant portion of claim 12 as follows: “wherein the detecting that the rotating speed is not above the threshold is determined by a frequency comparator.” (see, e.g., Abstract and [0040]-[0044] of Applicant’s disclosure).
Claims 2-9 and claims 11-18 depend directly or indirectly from claims 1 and 10, respectively. Based on their dependencies, claims 2-9 and 11-18 are also indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2009/0073455 A1 (hereinafter “ONIMURA”).
ONIMURA discloses an optical coherent tomography (OCT) catheter that is used for medical imaging procedures (e.g., to diagnose arteriosclerosis). ([0003]). The OCT catheter has a rotating light for imaging. ([0004]). Increasing the intensity of this light is desirable. However, increased intensity generally requires “a certain amount of time for the start-up.” ([0008]). “[W]hen inserting the catheter into the blood vessel, it is in a state in which the measuring light is already being emitted from the distal portion thereof and so it happens on the occasion of diagnosis that the measuring light is illuminated continuously at the periphery of the apparatus.” ([0008]). “Here, the measuring light used in the optical coherent tomography diagnosis apparatus is generally a near-infrared ray and is invisible to human eyes, so if an individual (i.e., the eyes of an individual) is subjected to the illumination, it cannot be expected that the individual will react to avoid the illumination.” ([0009]).
With respect to claim 1 (and in light of the Section 112(b) rejection), ONIMURA discloses:
An optical imaging apparatus. ONIMURA discloses an optical coherent tomography (OCT) apparatus that is used for medical imaging procedures (e.g., to diagnose arteriosclerosis). ([0003]). Figure 16 is shown herein and illustrate an “optical coherent tomography diagnosis apparatus.” ([0169]).
an imaging engine having at least one laser source and a controller for controlling the laser source. ONIMURA discloses that “1608 denotes a wavelength-swept light source, with a Swept Laser preferably being used. The Swept Laser 1608 is a kind of Extended-Cavity Laser composed of a SOA 1616 (semiconductor optical amplifier).” ([0169]). With respect to a “controller,” ONIMURA discloses a “signal processing unit 1623” that cooperates with a “motor
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control unit 1624” (see, e.g., [0191]) and a “shutter control unit 1635.” (see, e.g., [0179]). Moreover, claim 1 of ONIMURA discloses “a control unit connected to the light transmission permitting and preventing device for controlling the light transmission permitting and preventing device to either permit the light at the incident port to exit out of the emission port or to prevent light at the incident port from exiting out of the emission port.”
a patient interface unit (see, e.g., [0051] “scanner/pullback unit 302” which “defines the radial operation of the optical probe in the catheter unit 301” see also Figure 16) comprising:
a rotational motor (see, e.g., [0181]: “the rotation unit side of the optical rotary joint 1603 is driven rotatingly by a radial scanning motor 1605 of a rotating drive device 1604.”;
rotary joint (see, e.g., [0181]: “optical rotary joint 1603”); and
a probe connection (see, e.g., [0178]: “a connector portion 1602 of an optical probe 1601”); and
a probe (see, e.g., [0178]: “optical probe 1601”) comprising an optical fiber (see, e.g., [0178]: “a fourth single-mode fiber 1639”) to illuminate a laser light from the at least one laser source;
wherein the probe is rotated by the rotational motor when imaging (see, e.g., [0177]-[0181]); and
wherein the laser light is emitted only when the probe is rotating. ONIMURA discloses a “shutter unit” (see, e.g., [0081]) and a “frequency shifter unit.” ([0094]). Each of these is also referred to as a “light transmission permitting and preventing device.” ([0081] and [0094], respectively). Claim 1 summarizes its purpose and operation. A control unit controls “the light transmission permitting and preventing device to either permit the light at the incident port to exit out of the emission port or to prevent light at the incident port from exiting out of the emission port.” (see, e.g., [0195]-[0207] describing the construction and operation of the shutter unit and [0210]-[0220] describing the construction and operation of the frequency shifter unit).
With respect to the only when the probe is rotating limitation, ONIMURA teaches “[I]n the signal processing unit 1623, a shutter opening and closing process is executed during a period when the wavelength-swept light source 1608 is driven, and the measuring light is emitted only during a period when the catheter unit 301 is connected and also the optical probe rotates….” ([0232]). ONIMURA discloses this feature for both the shutter unit (see, e.g., [0232]-[0233]) and the frequency shifter unit. (see, e.g., [0234]-[0235]).
With respect to claim 2 (and in light of the Section 112(b) rejection), ONIMURA discloses further comprising an interlock circuit for controlling emission of the laser light. NOTE: “Interlocks” are “safety devices for automatically switching off a laser power or interrupting a laser beam.” (see R. Paschotta, article on “Interlocks” in the RP Photonics Encyclopedia, retrieved 2026-07-26, https://doi.org/10.61835/txg). In ONIMURA, each of the shutter unit and the frequency shifter unit, combined with the control unit, disclose an “interlock circuit” as discussed above with respect to claim 1. (see, e.g., [0195]-[0207] describing the construction and operation of the shutter unit and [0210]-[0220] describing the construction and operation of the frequency shifter unit).
With respect to claim 10 (and in light of the Section 112(b) rejection), ONIMURA discloses:
A method for operating an optical imaging apparatus (see, e.g., [0016] AND claims 14 and 15 of ONIMURA), the optical imaging apparatus comprising:
an imaging engine having at least one laser source and a controller for controlling the laser source. ONIMURA discloses that “1608 denotes a wavelength-swept light source, with a Swept Laser preferably being used. The Swept Laser 1608 is a kind of Extended-Cavity Laser composed of a SOA 1616 (semiconductor optical amplifier).” ([0169]). With respect to a “controller,” ONIMURA discloses a “signal processing unit 1623” that cooperates with a “motor control unit 1624” (see, e.g., [0191]) and a “shutter control unit 1635.” (see, e.g., [0179]). Moreover, claim 1 of ONIMURA discloses “a control unit connected to the light transmission permitting and preventing device for controlling the light transmission permitting and preventing device to either permit the light at the incident port to exit out of the emission port or to prevent light at the incident port from exiting out of the emission port.”
a patient interface unit (see, e.g., [0051] “scanner/pullback unit 302” which “defines the radial operation of the optical probe in the catheter unit 301” see also Figure 16) comprising:
a rotational motor (see, e.g., [0181]: “the rotation unit side of the optical rotary joint 1603 is driven rotatingly by a radial scanning motor 1605 of a rotating drive device 1604.”;
rotary joint (see, e.g., [0181]: “optical rotary joint 1603”); and
a probe connection (see, e.g., [0178]: “a connector portion 1602 of an optical probe 1601”); and
a probe (see, e.g., [0178]: “optical probe 1601”) comprising an optical fiber (see, e.g., [0178]: “a fourth single-mode fiber 1639”) to illuminate a laser light from the at least one laser source;
the method comprising:
rotating the probe using the rotational motor (see, e.g., [0177]-[0181]);
illuminating the laser light when the probe is rotating to capture an image. “[I]t becomes in a state in which the catheter unit 301 is connected to the scanner/pullback unit 302 and the measuring light is to be emitted when the rotation of the optical probe is started.” ([0228]). With respect to the capture an image limitations, see [0180] and [0190].
terminating the laser light in response to detecting that a rotating speed of the probe is not above a threshold. “In step S2305, it is judged whether or not the rotation of the optical probe 1601 is stopped based on the output of the encoder unit 1606. In step S2305, in a case in which it is judged that the optical probe 1601 does not rotate, the flow proceeds to step S2306 and the shielding body 1801 is rotated to the close position by outputting a close command with respect to the shutter control unit 1635.” ([0229]; see also [0241] with respect to the frequency shifter embodiment.
wherein the laser light is emitted only when the probe is rotating. ONIMURA discloses a “shutter unit” (see, e.g., [0081]) and a “frequency shifter unit.” ([0094]). Each of these is also referred to as a “light transmission permitting and preventing device.” ([0081] and [0094], respectively). Claim 1 summarizes its purpose and operation. A control unit controls “the light transmission permitting and preventing device to either permit the light at the incident port to exit out of the emission port or to prevent light at the incident port from exiting out of the emission port.” (see, e.g., [0195]-[0207] describing the construction and operation of the shutter unit and [0210]-[0220] describing the construction and operation of the frequency shifter unit).
With respect to the only when the probe is rotating limitation, ONIMURA teaches “[I]n the signal processing unit 1623, a shutter opening and closing process is executed during a period when the wavelength-swept light source 1608 is driven, and the measuring light is emitted only during a period when the catheter unit 301 is connected and also the optical probe rotates….” ([0232]). ONIMURA discloses this feature for both the shutter unit (see, e.g., [0232]-[0233]) and the frequency shifter unit. (see, e.g., [0234]-[0235]).
With respect to claim 11 (and in light of the Section 112(b) rejection), ONIMURA discloses further comprising an interlock circuit for controlling emission of the laser light. NOTE: “Interlocks” are “safety devices for automatically switching off a laser power or interrupting a laser beam.” (see R. Paschotta, article on “Interlocks” in the RP Photonics Encyclopedia, retrieved 2026-07-26, https://doi.org/10.61835/txg). In ONIMURA, each of the shutter unit and the frequency shifter unit, combined with the control unit, disclose an “interlock circuit” as discussed above with respect to claim 1. (see, e.g., [0195]-[0207] describing the construction and operation of the shutter unit and [0210]-[0220] describing the construction and operation of the frequency shifter unit).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 4, 6, 8, 12, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2009/0073455 A1 (hereinafter “ONIMURA”) in view of U.S. Patent No. 4,709,195 A (hereinafter “HELLEKSON”).
With respect to claim 3 (depending from claim 2), ONIMURA does not explicitly teach wherein the interlock circuit further comprises a frequency comparator to generate the laser light on and off states depending on the rotating speed of the rotational motor.
HELLEKSON teaches a laser scanner having a rotating mirror. Although the laser scanner is described as being used in supermarkets, HELLEKSON addresses the problem of having a laser scanner that rotates too slowly. “A safety requirement for laser scanning devices is that the laser beam must not be operative when the scanner motor is stopped, or rotating below a certain speed which will assure that retina exposure will be of sufficiently short duration to be safe for persons positioned nearby. Thus, if a scanner motor failed or was below speed, the safety requirement has been that the laser beam must be immediately shut off.” (Col. 1, lines 21-28). Accordingly, HELLEKSON is analogous art because “the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).” (MPEP 2141.01(a), I).
HELLEKSON teaches “a hall effect motor speed signal which is used for monitoring and safety features in association with the scanner.” (Abstract). Hall effect switch or switches are configured for “monitoring of motor speed, as to underspeed and overspeed conditions, for meeting safety requirements.” (Col. 2, lines 26-29). “Thus, if the motor is stopped or rotating below a permissible range of operating speed, there could potentially be a threat of retina damage to persons encountering the laser beam of the scanner, since the scanning beam is not moving as fast as it is supposed to be. Under such a condition the system of the invention generates a signal which is used by other associated circuitry to shut down power to the laser.” (Col. 2, lines 30-37).
Notably, “the output signal from one of the hall effect switches of the motor is used as an input to motor detector circuitry of the invention. The motor detector circuitry receives a pulse train signal from the hall effect switch, derives a voltage proportional to frequency (i.e. speed of the motor), compares the derived voltage to a reference voltage representative of a minimum permissible operating speed, and outputs a voltage signal which indicates either up to speed, i.e. within a permissible speed range, or not up to speed. This signal or signals is then used for safety and other control functions as described above.” (Col. 2, line 61 to Col. 3, line 5). Accordingly, the “motor control circuitry” of HELLEKSON operates as a frequency comparator that generates on and off states of the laser light depending on the rotating speed of the rotational motor.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus to include an interlock circuit having a frequency comparator that generates the laser light on and off states depending on the rotating speed of the rotational motor. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to include a frequency comparator and cooperate with one another to permit emission of the laser light only when the threshold is reached.
With respect to claim 4 (depending from claim 2), ONIMURA does not explicitly teach wherein the interlock circuit is a redundancy circuit.
However, HELLEKSON teaches a “motor sense/control circuitry,” as shown in Figure 5, that “generates the up-to-speed and overspeed signals….” (cite). As discussed above with respect to claim 3, “The motor detector circuitry receives a pulse train signal from the hall effect switch, derives a voltage proportional to frequency (i.e. speed of the motor), compares the derived voltage to a reference voltage representative of a minimum permissible operating speed, and outputs a voltage signal which indicates either up to speed, i.e. within a permissible speed range, or not up to speed. This signal or signals is then used for safety and other control functions as described above.” (Col. 2, line 61 to Col. 3, line 5).” These signals are communicated through the UP2SD1 and the UP2SD2/OVRSPD lines shown in Figure 5. “As outlined above, both UP2SPD1 and UP2SPD2/OVRSPD circuits are completely separate and ultimately redundant. / As also mentioned above, the laser control circuitry may consist of three optically isolated control switches. Two of the switches disable the entire laser supply when activated. Both of these switches are enabled and disabled by the UP2SPD1 and UP2SPD2/OVRSPD signals, which, again are separate and redundant.”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus to include an interlock circuit that includes redundant circuitry. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, one having ordinary skill in the art would configure the interlock circuit to include redundant circuitry to assure that the laser would be shut down if the threshold speed is not met.
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With respect to claim 6 (and in light of the Section 112(b) rejection), ONIMURA does not explicitly teach wherein the laser light is emitted only when the probe is rotating above a threshold. However, as discussed above, ONIMURA teaches that the laser light is emitted only when the probe is rotating (i.e., regardless of a threshold). More specifically, ONIMURA teaches “…in the signal processing unit 1623, a shutter opening and closing process is executed during a period when the wavelength-swept light source 1608 is driven, and the measuring light is emitted only during a period when the catheter unit 301 is connected and also the optical probe rotates….” ([0232]).
HELLEKSON teaches a laser scanner having a rotating mirror. Although the laser scanner is described as being used in supermarkets, HELLEKSON addresses the problem of having a laser scanner that rotates too slowly. “A safety requirement for laser scanning devices is that the laser beam must not be operative when the scanner motor is stopped, or rotating below a certain speed which will assure that retina exposure will be of sufficiently short duration to be safe for persons positioned nearby. Thus, if a scanner motor failed or was below speed, the safety requirement has been that the laser beam must be immediately shut off.” (Col. 1, lines 21-28).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus such that the laser light is emitted only when the probe is rotating above a threshold. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to cooperate with one another to permit emission of the laser light only when the threshold is reached.
With respect to claim 8, ONIMURA discloses wherein the rotational motor has an encoder to generate spinning signals for calculating rotating speed. However, ONIMURA teaches that an encoder unit 1606 detects the rotation angle of the radial scanning motor 1605. ([0181]). An output from the encoder unit is received by the signal processing unit 1623. “The apparatus is constructed such that the presence or absence of the rotation of the optical probe 1601 is judged by the signal processing unit 1623 which received the output of the encoder unit 1606 through the motor control circuit 1624.” ([0223]). “In step S2305, it is judged whether or not the rotation of the optical probe 1601 is stopped based on the output of the encoder unit 1606.” ([0229]).
HELLEKSON teaches “a hall effect motor speed signal which is used for monitoring and safety features in association with the scanner.” (Abstract). Hall effect switch or switches are configured for “monitoring of motor speed, as to underspeed and overspeed conditions, for meeting safety requirements.” (Col. 2, lines 26-29). “Thus, if the motor is stopped or rotating below a permissible range of operating speed, there could potentially be a threat of retina damage to persons encountering the laser beam of the scanner, since the scanning beam is not moving as fast as it is supposed to be. Under such a condition the system of the invention generates a signal which is used by other associated circuitry to shut down power to the laser.” (Col. 2, lines 30-37).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus such that the encoder generates spinning signals for calculating rotating speed. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the encoder generated spinning signals for calculating rotating speed to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to cooperate with one another to permit emission of the laser light only when the threshold is reached. The control unit would calculate the rotating speed based on the signals from the encoder as taught in HELLEKSON.
With respect to claim 12 (and in view of the Section 112(b) rejection), ONIMURA does not explicitly teach that a frequency comparator detects that the rotating speed is not above the threshold. HELLEKSON teaches a laser scanner having a rotating mirror. Although the laser scanner is described as being used in supermarkets, HELLEKSON addresses the problem of having a laser scanner that rotates too slowly. “A safety requirement for laser scanning devices is that the laser beam must not be operative when the scanner motor is stopped, or rotating below a certain speed which will assure that retina exposure will be of sufficiently short duration to be safe for persons positioned nearby. Thus, if a scanner motor failed or was below speed, the safety requirement has been that the laser beam must be immediately shut off.” (Col. 1, lines 21-28).
HELLEKSON teaches “a hall effect motor speed signal which is used for monitoring and safety features in association with the scanner.” (Abstract). Hall effect switch or switches are configured for “monitoring of motor speed, as to underspeed and overspeed conditions, for meeting safety requirements.” (Col. 2, lines 26-29). “Thus, if the motor is stopped or rotating below a permissible range of operating speed, there could potentially be a threat of retina damage to persons encountering the laser beam of the scanner, since the scanning beam is not moving as fast as it is supposed to be. Under such a condition the system of the invention generates a signal which is used by other associated circuitry to shut down power to the laser.” (Col. 2, lines 30-37).
Notably, “the output signal from one of the hall effect switches of the motor is used as an input to motor detector circuitry of the invention. The motor detector circuitry receives a pulse train signal from the hall effect switch, derives a voltage proportional to frequency (i.e. speed of the motor), compares the derived voltage to a reference voltage representative of a minimum permissible operating speed, and outputs a voltage signal which indicates either up to speed, i.e. within a permissible speed range, or not up to speed. This signal or signals is then used for safety and other control functions as described above.” (Col. 2, line 61 to Col. 3, line 5). Accordingly, the “motor control circuitry” of HELLEKSON operates as a frequency comparator that generates on and off states of the laser light depending on the rotating speed of the rotational motor.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA method to use a frequency comparator to detect that the rotating speed is not above the threshold. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” using a frequency comparator as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to include a frequency comparator and cooperate with one another to permit emission of the laser light only when the threshold is reached.
With respect to claim 13 (depending from claim 11), ONIMURA does not explicitly teach wherein the interlock circuit is a redundancy circuit.
However, HELLEKSON teaches a “motor sense/control circuitry,” as shown in Figure 5, that “generates the up-to-speed and overspeed signals….” (cite). As discussed above with respect to claim 3, “The motor detector circuitry receives a pulse train signal from the hall effect switch, derives a voltage proportional to frequency (i.e. speed of the motor), compares the derived voltage to a reference voltage representative of a minimum permissible operating speed, and outputs a voltage signal which indicates either up to speed, i.e. within a permissible speed range, or not up to speed. This signal or signals is then used for safety and other control functions as described above.” (Col. 2, line 61 to Col. 3, line 5).” These signals are communicated through the UP2SD1 and the UP2SD2/OVRSPD lines shown in Figure 5. “As outlined above, both UP2SPD1 and UP2SPD2/OVRSPD circuits are completely separate and ultimately redundant. / As also mentioned above, the laser control circuitry may consist of three optically isolated control switches. Two of the switches disable the entire laser supply when activated. Both of these switches are enabled and disabled by the UP2SPD1 and UP2SPD2/OVRSPD signals, which, again are separate and redundant.”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus to include an interlock circuit that includes redundant circuitry. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, one having ordinary skill in the art would configure the interlock circuit to include redundant circuitry to assure that the laser would be shut down if the threshold speed is not met.
With respect to claim 15 (and in light of the Section 112(b) rejection), ONIMURA does not explicitly teach wherein the laser light is emitted only when the probe is rotating above a threshold. However, as discussed above, ONIMURA teaches that the laser light is emitted only when the probe is rotating (i.e., regardless of a threshold). More specifically, ONIMURA teaches “…in the signal processing unit 1623, a shutter opening and closing process is executed during a period when the wavelength-swept light source 1608 is driven, and the measuring light is emitted only during a period when the catheter unit 301 is connected and also the optical probe rotates….” ([0232]).
HELLEKSON teaches a laser scanner having a rotating mirror. Although the laser scanner is described as being used in supermarkets, HELLEKSON addresses the problem of having a laser scanner that rotates too slowly. “A safety requirement for laser scanning devices is that the laser beam must not be operative when the scanner motor is stopped, or rotating below a certain speed which will assure that retina exposure will be of sufficiently short duration to be safe for persons positioned nearby. Thus, if a scanner motor failed or was below speed, the safety requirement has been that the laser beam must be immediately shut off.” (Col. 1, lines 21-28).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA apparatus such that the laser light is emitted only when the probe is rotating above a threshold. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the laser light is emitted only when the probe is rotating above a threshold to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to cooperate with one another to permit emission of the laser light only when the threshold is reached.
With respect to claim 17, ONIMURA discloses further comprising generating a spinning signal from an encoder in the rotational motor for calculating rotating speed. However, ONIMURA teaches that an encoder unit 1606 detects the rotation angle of the radial scanning motor 1605. ([0181]). An output from the encoder unit is received by the signal processing unit 1623. “The apparatus is constructed such that the presence or absence of the rotation of the optical probe 1601 is judged by the signal processing unit 1623 which received the output of the encoder unit 1606 through the motor control circuit 1624.” ([0223]). “In step S2305, it is judged whether or not the rotation of the optical probe 1601 is stopped based on the output of the encoder unit 1606.” ([0229]).
HELLEKSON teaches “a hall effect motor speed signal which is used for monitoring and safety features in association with the scanner.” (Abstract). Hall effect switch or switches are configured for “monitoring of motor speed, as to underspeed and overspeed conditions, for meeting safety requirements.” (Col. 2, lines 26-29). “Thus, if the motor is stopped or rotating below a permissible range of operating speed, there could potentially be a threat of retina damage to persons encountering the laser beam of the scanner, since the scanning beam is not moving as fast as it is supposed to be. Under such a condition the system of the invention generates a signal which is used by other associated circuitry to shut down power to the laser.” (Col. 2, lines 30-37).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA method to generate a spinning signal from an encoder in the rotational motor for calculating rotating speed. Each of HELLEKSON and ONIMURA are concerned for the safety of nearby individuals. One would have been motivated to configure the ONIMURA apparatus so that the encoder generated spinning signals for calculating rotating speed to “assure that retina exposure will be of sufficiently short duration to be safe” as taught in HELLEKSON. Specifically, the control unit and encoder in ONIMURA would be configured to cooperate with one another to permit emission of the laser light only when the threshold is reached. The control unit would calculate the rotating speed based on the signals from the encoder as taught in HELLEKSON.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2009/0073455 A1 (hereinafter “ONIMURA”) and U.S. Patent No. 4,709,195 A (hereinafter “HELLEKSON”) as applied to claims 4 and 13 above, and further in view of U.S. Patent No. 5,939,874 A (hereinafter “DULEY”).
With respect to claims 5 and 14, neither ONIMURA nor HELLEKSON teach that the redundancy circuit includes 2 frequency comparators, wherein one comparator is a positive comparator, and the other comparator is negative comparator.
However, DULEY teaches a voltage detector circuit for use with the probe may include pairs of comparators. “Each of the pairs of comparators may have mutually connected inputs with the non-inverting input of one comparator connected to the inverting pair of the other comparator. A reference voltage may be connected to one mutual connection and the voltage to be detected connected to the other.” (Abstract).
Figure 5 of DULEY illustrates one such pair. The outputs of the comparators of each pair are opposite each other such that if one comparator goes high (i.e., positive), the other comparator goes low (i.e., negative). “The inverting and non-inverting inputs are connected so that if VCC SN exceeds REF36 (e.g., 3.6 V) then the output from comparator 90a will transition to a logic high value, but the output from comparator 90b will transition to a logic low value. On the other hand, if VCC SN is less than REF36, then the output from comparator 90a will transition to a logic low value while the output from comparator 90b will transition to a logic high value.” (cite).
It would have been obvious to one having ordinary skill in the art to modify the redundant circuitry of the interlock of HELLEKSON to include two frequency comparators, wherein one comparator is a positive comparator, and the other comparator is negative comparator as described in DULEY. HELLEKSON teaches the desire to have redundant interlock circuitry to assure that the laser is properly controlled. DULEY teaches a comparator configuration in which the same detected value and the reference value are applied to produce opposite outputs. One of ordinary skill in the art could have add the comparator pair of DULEY using known methods. In combination, each element would perform the same function as it does separately while also verifying the rotating speed of the laser. Moreover, one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claims 7, 9, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2009/0073455 A1 (hereinafter “ONIMURA”) and U.S. Patent No. 4,709,195 A (hereinafter “HELLEKSON”) as applied to claims 4, 8, 13, and 17 above, and further in view of a translation of PCT Patent Appl. Publ. No. WO 2020/010649 A1 (hereinafter “SHENZHEN”).
With respect to claims 7 and 16, neither ONIMURA nor HELLEKSON teach that the threshold is greater than or equal to 1000 revolutions per minute.
However, UEHARA teaches an imaging apparatus that includes an optical coherence tomography (OCT) diagnostic apparatus. ([0004]). The OCT diagnostic part of the imaging apparatus is similar to the imaging apparatus of ONIMURA. The imaging apparatus “is directly inserted into a blood vessel, freely moves in a longitudinal direction of the blood vessel, and accommodates an imaging core that freely rotates. A distal end of the imaging core is provided with…an optical transceiver, which continuously transmits transferred light (measurement light) into the blood vessel and continuously receives the reflected light from the inside of the blood vessel” ([0024]).
“[The] motor drive unit (MDU) 201 is connected to the catheter and rotates the probe 101. In an embodiment, the MDU operates at 1,800 rpm (revolutions per minute) and outputs a pulse signal of 1,024 pulse/rev (a pulse signal having 1,024 pulses per one rotation of the imaging core) as an encoder pulse signal.” ([0031]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA-HELLEKSON apparatus to set the threshold at a number greater than or equal to 1000 revolutions per minute in view of the teachings of UEHARA. The motor in UEHARA operates at 1,800 rpm. One having ordinary skill in the art would be motivated to set the threshold at or near 1,800 rpm so that the probe is permitted to operate (i.e., laser light turned on) when the motor is operating at the designated speed. 1,800 rpm is greater than or equal to 1,000 rpm as claimed. There would have been a reasonable expectation of success as UEHARA teaches that similarly designed catheter/probes have a motor that operates at 1,800 rpm.
With respect to claims 9 and 18, neither ONIMURA nor HELLEKSON teach that the spinning signal from the encoder is greater than or equal to 100 pulses per rotation.
As discussed above with respect to claims 7 and 16, the common imaging core of UEHARA is controlled by the motor drive unit (MDU). The MDU outputs a pulse signal at 1,024 pulses/revolution. ([0031]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the ONIMURA-HELLEKSON apparatus to set the spinning signal from the encoder to be greater than or equal to 100 pulses per rotation in view of the teachings of UEHARA. The motor drive unit in UEHARA outputs at 1,024 pulses/revolution. One having ordinary skill in the art would be motivated to set the spinning signal from the encoder to be greater than or equal to 100 pulses per rotation. More specifically, for the motor operating at 1,800 rpm, the spinning signal would be set at 1,204 pulses/revolution as taught in UEHARA. There would have been a reasonable expectation of success as UEHARA teaches that similarly designed catheter/probes have a motor that operates at 1,800 rpm with a spinning signal of 1,024 pulses/revolution.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20190059734-A1 discloses an optical coherence tomographic (OCT) system that is similar in design to the pending application.
“Instructions for Use” of the ILUMIENTM OPTISTM System (2013) describes a similarly designed system for intravascular use. Page 11-9 has a section entitled “Safety Functions Built into the Ilumien Optis System.” The safety functions include disabling light output and all motors when the optical fiber stops rotating due to mechanical failure.
Conclusion
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/JASON P GROSS/ Examiner, Art Unit 3797
/ANNE M KOZAK/ Supervisory Patent Examiner, Art Unit 3797
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