Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 28-36 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.
Claim 28 recites the following limitations:
“generating a laser signal from each of a plurality of laser devices disposed on a cart;
generating an output from one or more additional devices disposed on the cart”;
“combining the plurality of laser signals into a single conducting medium
combining an output from the single conducting medium and the output of the one or more additional devices at a treatment head; and”
None of the bolded structures “a plurality of laser devices”, “a cart”, “one or more additional devices”, “a single conducting medium” in these limitations are positively recited. This raises questions, are these structures required and if so, which structures (if not all) are being claimed. For this examination, the interpretation taken is that all the structures are required as this appears to be the intended interpretation. Regardless the claims should make clear what is being claimed here. Claims 29-36 are rejected based on dependency to claim 28.
Also claim 29 recites
“providing one or more user controls to modify the delivery of the plurality of laser signals from a user interface device”
The user interface device is not positively claimed. It is not clear if the user interface device is being claimed or not. For this examination, the interpretation taken is that the user interface device is required. Regardless the claims should make clear what is being claimed here.
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.
Claim(s) 19-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daly et al (US 20180140866) hereafter known as Daly in view of Quisenberry et al (US 20100192596) hereafter known as Quisenberry.
Independent claim
Regarding claim 19:
Daly discloses
A laser treatment system [see Fig. 1 and para 37…“Referring now to FIG. 1, a multifunction aesthetic system 10 can be provided for performing a variety of aesthetic procedures in a single medical device.” And para 35… “the systems of the present disclosure can include at least two electromagnetic radiation (EMR) sources”] comprising:
a plurality of laser devices [see Fig. 1 elements 203 and para
46… “The laser sources 203, in some embodiments, can include one or more fiber coupled lasers. For example, in accordance with various embodiments, the laser sources 203 can include one or more fiber coupled diode lasers and/or flashlamp or diode pumped lasers such as Er:YAG, Er,Cr:YSGG, Nd:YAG, Nd:glass; Er:glass, or any other suitable fiber coupled EMR source.”] disposed on a cart [see Fig. 1 elements 100 and 105…. “the housing 100 can include one or more wheels 105 to provide mobility of the system 10.”];
one or more additional devices disposed on the cart [see Fig. 1 element 500 and para 69… “Referring again to FIG. 1, the system 10 can also include one or more cooling systems 500 for removing heat produced by the electromagnetic array 200 and the power and control electronics 400 and for delivering cold air for cooling of a patient's skin during a procedure.”], each configured to generate an output [see para 77… “the device 950 used for emitting the EMR beams for treatment.” (i.e. output for laser) and para 69… “for delivering cold air for cooling of a patient's skin during a procedure” (i.e. output for additional device)];
a combiner coupled to the plurality of laser devices, the combiner configured to combine a plurality of laser signals from the plurality of laser devices into a single conducting medium into a point of treatment [see Figs. 1-2 and elements 209 and 207 para 46… “The laser sources 203, in some embodiments, can include one or more fiber coupled lasers.” And para 57… “The beam combiner 207 can then output the combined beam to a common output cable 209 coupled to the beam combiner 207 for transmitting or relaying the EMR (also referred to as “treatment energy” or “beam”) combined in the beam combiner 207. Advantageously, the common output cable 209 can permit the different beams produced by the laser sources 203 to be emitted through a single optical device.”]
a treatment head, the treatment head configured to deliver the plurality of laser signals to a predetermined location [see Figs. 1 and 9 element 950 and para 77… “positioning of the device 950 used for emitting the EMR beams for treatment” and “scanning the device 950 across large areas during treatment to provide uniform heating of the target treatment area”]
However, Daly fails to disclose a combiner that couples and combines both the output of the plurality of laser signals and the output of the one or more additional devices into a point of treatment. Thus Daly fails to fully disclose “a combiner coupled to the plurality of laser devices and the one or more additional devices, the combiner configured to combine a plurality of laser signals from the plurality of laser devices into a single conducting medium and the output of the one or more additional devices into a point of treatment” and fails to fully disclose “a treatment head coupled to the combiner through at least the conducting medium, the treatment head configured to deliver the plurality of laser signals and the output of the one or more additional devices to a predetermined location.”
Quisenberry discloses in the analogous art of laser devices used in dermatology [see para 2… “The present invention relates to gas cooling and, more particularly, but not by way of limitation to methods of and systems for providing cooled gas for dermatological applications.” And para 32… “the hand tool 104 may also include a laser used for laser dermatological applications or other tools used in dermatological applications.”] connecting both a laser and cooling system to a hand tool (i.e. treatment head) with a hose through which gases flow to the hand tool and with an exit of hand tool outputting cooling for the purpose of helping direct the cooling to the treated area [see Figs. 1-2 element 104 is hand tool and element 206 is exit and Para 32… “Still referring to various embodiments related to the hand tool 104, a coolant output may be used to provide additional topical anesthetic effect via, for example, evaporative cooling” and “the hand tool 104 may also include a laser used for laser dermatological applications or other tools used in dermatological applications.” And Para 40… “The system 200 has a control unit 202 with a delivery hose 204 connected thereto. The control unit 202 cools a gaseous medium that then flows through the delivery hose 204 to an exit 206. The exit 206 may be connected to a hand unit (not shown) for assisting a user in controlling and directing the airflow out of the exit 206.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Daly by connecting the output of the coolant system using a hose to the treatment head similarly to that disclosed by Quisenberry as this would allow for better control of placement of coolant relative to the treatment area.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Daly in view of Quisenberry by integrating the laser conducting medium and gases into a single conducting medium together (i.e. a combiner as claimed and a treatment head as claimed) because absent unpredictable results such a modification has been ruled by the court to be a mere matter of obvious engineering choice [In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)].
Independent claim
Regarding claim 28:
A method of laser treatment [see Fig. 1 and para 8…. “a method for aesthetic treatment using a multifunctional system is provided. The method includes operating, by a controller in electronic communication with an electromagnetic array situated in a housing, two or more electromagnetic radiation (EMR) sources of the array to direct an EMR beam generated by each EMR source”] comprising:
generating a laser signal [see para 10… “the method also includes directing the EMR beam along an EMR pathway onto the treatment area”] from each of a plurality of laser devices disposed on a cart [see Fig. 1-2 elements 203 (i.e. laser devices) and elements 100 and 105 (i.e. cart) and para 46… “The laser sources 203, in some embodiments, can include one or more fiber coupled lasers. For example, in accordance with various embodiments, the laser sources 203 can include one or more fiber coupled diode lasers and/or flashlamp or diode pumped lasers such as Er:YAG, Er,Cr:YSGG, Nd:YAG, Nd:glass; Er:glass, or any other suitable fiber coupled EMR source.” and para 105… “the housing 100 can include one or more wheels 105 to provide mobility of the system 10.”];
generating an output [see para 11… “the method also includes directing, via the device, a cooling airflow onto the treatment area without disrupting the EMR beam.”] from one or more additional devices disposed on the cart [see Fig. 1 element 500 and para 69… “Referring again to FIG. 1, the system 10 can also include one or more cooling systems 500 for removing heat produced by the electromagnetic array 200 and the power and control electronics 400 and for delivering cold air for cooling of a patient's skin during a procedure.”];
combining the plurality of laser signals into a single conducting medium [see Figs. 1-2 and elements 209 and 207 and para 46… “The laser sources 203, in some embodiments, can include one or more fiber coupled lasers.” And para 57… “The beam combiner 207 can then output the combined beam to a common output cable 209 coupled to the beam combiner 207 for transmitting or relaying the EMR (also referred to as “treatment energy” or “beam”) combined in the beam combiner 207. Advantageously, the common output cable 209 can permit the different beams produced by the laser sources 203 to be emitted through a single optical device.”];
delivering the plurality of laser signals at a treatment head [see Figs. 1 and 9 element 950 and para 77… “positioning of the device 950 used for emitting the EMR beams for treatment” and “scanning the device 950 across large areas during treatment to provide uniform heating of the target treatment area”]
However, Daly fails to disclose delivering both the laser signals and the output of the one or more additional devices using the treatment head. Thus, Daly fails to fully disclose “combining an output from the single conducting medium and the output of the one or more additional devices at a treatment head” and “delivering the plurality of laser signals and the output of the one or more additional devices to a predetermined location using the treatment head.”
Quisenberry discloses in the analogous art of laser devices used in dermatology [see para 2… “The present invention relates to gas cooling and, more particularly, but not by way of limitation to methods of and systems for providing cooled gas for dermatological applications.” And para 32… “the hand tool 104 may also include a laser used for laser dermatological applications or other tools used in dermatological applications.”] connecting both a laser and cooling system to a hand tool (i.e. treatment head) with a hose through which gases flow to the hand tool and with an exit of hand tool outputting cooling for the purpose of helping direct the cooling to the treated area [see Figs. 1-2 element 104 is hand tool and element 206 is exit and Para 32… “Still referring to various embodiments related to the hand tool 104, a coolant output may be used to provide additional topical anesthetic effect via, for example, evaporative cooling” and “the hand tool 104 may also include a laser used for laser dermatological applications or other tools used in dermatological applications.” And Para 40… “The system 200 has a control unit 202 with a delivery hose 204 connected thereto. The control unit 202 cools a gaseous medium that then flows through the delivery hose 204 to an exit 206. The exit 206 may be connected to a hand unit (not shown) for assisting a user in controlling and directing the airflow out of the exit 206.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Daly by connecting the output of the coolant system using a hose to the treatment head similarly to that disclosed by Quisenberry (i.e. thereby fully reciting the steps of “combining an output from the single conducting medium and the output of the one or more additional devices at a treatment head” and “delivering the plurality of laser signals and output of the one or more additional devices to a predetermined location using the treatment head as claimed”) as this would allow for better ability to position the coolant relative to the treatment area
Dependent claims:
Regarding claims 20 and 29, see Fig. 1 element 101 and para 38 of Daly [see “a user interface 101 mounted to the housing 100 for receiving a user input. The user interface 101 can include, for example, an electronic display, a touch-screen monitor, a keyboard, a mouse, any other device or devices capable of receiving input from a user, or combinations thereof. The user input can include, for example, patient data such as height, weight, skin type, age, etc. as well as procedural parameters such as desired beam power, procedure type, wavelength or wavelengths to be applied, pulse duration, treatment duration, beam pattern, etc.”]
Regarding claims 21-23 and 27, Fig. 1 element 107 (i.e. controller), elements 1000, 1001, 1003 (i.e. sensors) and para 39 of Daly [see “the system 10 can also include a computing device 107 for receiving and storing the user input from the user interface 101, for storing and executing appropriate procedure protocols according to the user input, for providing control instruction to various components of the system 10, and receiving feedback from the various components of the system 10.”] and para 71 of Daly [see… “the cooling system 500 can be provided with a temperature adjustment feature for permitting responsive adjustment of the coolant temperature depending on operational conditions and/or sensor feedback as needed to maintain therapeutically acceptable temperatures in the treatment area consistent with procedure requirements and to maintain operationally acceptable temperatures within the system 10 consistent with equipment requirements.”] and para 109 of Daly [see “The computer system 107 can then adjust one or more operating parameters such as pulse length, EMR source activation, EMR source power, treatment duration, cooling airflow, scanning speed of the positioning apparatus, etc. to manage the temperature in response to the sensor 1000 feedback. Although shown as including both a temperature sensor 1001 and a heat flux sensor 1003, it will be apparent in view of this disclosure that, in some embodiments, the sensors 1000 may include only a temperature sensor 1001 or only a heat flux sensor 1003.”] which disclose a controller and sensors with the sensors providing feedback to the controller which then adjusts the treatment parameters including the laser parameters and cooling treatment parameters (i.e. the one or more additional devices) in response to the feedback provided by the sensors.
Regarding claims 24 and 33:
Daly in view of Quisenberry discloses the invention substantially as claimed including all the limitations of claims 19 and 28. Additionally Daly in view of Quisenberry discloses “a controller coupled to the laser devices, the one or more additional devices and one or more sensor inputs” as recited by claim 24 [see Fig. 1 element 107 (i.e. controller), elements 1000, 1001, 1003 (i.e. sensors) and para 39 of Daly see “the system 10 can also include a computing device 107 for receiving and storing the user input from the user interface 101, for storing and executing appropriate procedure protocols according to the user input, for providing control instruction to various components of the system 10, and receiving feedback from the various components of the system 10.” and para 71 of Daly… see “the cooling system 500 can be provided with a temperature adjustment feature for permitting responsive adjustment of the coolant temperature depending on operational conditions and/or sensor feedback as needed to maintain therapeutically acceptable temperatures in the treatment area consistent with procedure requirements and to maintain operationally acceptable temperatures within the system 10 consistent with equipment requirements.” and para 109 of Daly…see “The computer system 107 can then adjust one or more operating parameters such as pulse length, EMR source activation, EMR source power, treatment duration, cooling airflow, scanning speed of the positioning apparatus, etc. to manage the temperature in response to the sensor 1000 feedback. Although shown as including both a temperature sensor 1001 and a heat flux sensor 1003, it will be apparent in view of this disclosure that, in some embodiments, the sensors 1000 may include only a temperature sensor 1001 or only a heat flux sensor 1003.” which disclose a controller and sensors with the sensors providing feedback to the controller which then adjusts the treatment parameters including the laser parameters and cooling treatment parameters (i.e. one or more additional devices)]
However, Daly in view of Quisenberry fails to disclose any discussion of suction or sensing suction. Therefore, Daly in view of Quisenberry fails to disclose “wherein the controller is configured to modify one or more suction treatment parameters in response to the one or more sensor inputs” recited by claim 24 or “modifying one or more suction treatment parameters in response to one or more sensor inputs” as recited by claim 28.
Quisenberry further discloses the hand tool (i.e. treatment head) as being connected to a vacuum and an output sensor and controller to remove gaseous medium and to reduce energy consumption [see Fig. 1 element 104 (i.e. hand tool), element 108 (i.e. controller), element 118 (i.e. vacuum) and element 126 (i.e. output sensor) and para 30…. “a vacuum 118 interoperably connected to the hand tool 104 for removing the gaseous medium provided, ambient air disposed near the cooled area, and any debris on or near the area. In some embodiments, the input chamber 116 and the filter 120 may be used in conjunction with the vacuum 118. Additionally, a waste canister 134 may also be used to collect the debris from the hand tool 104, for example, from a patient's skin during a micro-dermabrasion or laser peel procedure. In some embodiments, a reduced amount of energy is consumed when the cooled gaseous medium is reclaimed after delivery to the patient.” And para 33… “a output sensor 126 is disposed between the cooling engine 102 and the hand tool 104 to monitor the temperature and pressure of the gaseous medium after cooling. The output sensor 126 may be located near the cooling engine 102 and adapted to provide temperature and pressure information for use in determining the temperature of the gaseous medium at a remote location, such as at the exit of the hand tool 104.” And para 37… “The controller 108 may use information, such as temperature and pressure, monitored by the output sensor 126 along with other information in an algorithm to make determinations”]
It would have been obvious to further modify Daly in view of Quisenberry by including a vacuum connected to the treatment head and an output sensor that provides feedback and that are controlled/ communicate with a controller similar to that described by Quisenberry (i.e modify/modifying one or more suction treatment parameters in response to the one or more sensor inputs) to help aid in removal of debris and to reduce energy consumption.
Regarding claim 25-26, see Fig. 1 elements 1000 (i.e. proximity sensor and/or treatment tracking sensor) and element 107 (i.e. controller) of Daly and para 81 of Daly [see… “Still further, sensors 1000 can be included to detect a position of the device 950 relative to the surface to be treated. In such embodiments, the positioning apparatus 900 can responsively adjust a position or orientation of the device 950 relative to the surface to be treated according to the sensor 1000 feedback. For example, in some embodiments, the positioning apparatus 900 can maintain a prescribed separation height between the device 950 and the surface to be treated.”] and para 71 of Daly [see… “the cooling system 500 can be provided with a temperature adjustment feature for permitting responsive adjustment of the coolant temperature depending on operational conditions and/or sensor feedback as needed to maintain therapeutically acceptable temperatures in the treatment area consistent with procedure requirements and to maintain operationally acceptable temperatures within the system 10 consistent with equipment requirements.”]
Regarding claims 30-32 and 36, Fig. 1 element 107 (i.e. controller that modifies), elements 1000, 1001, 1003 (i.e. sensors that provide sensor inputs) and para 39 of Daly [see “the system 10 can also include a computing device 107 for receiving and storing the user input from the user interface 101, for storing and executing appropriate procedure protocols according to the user input, for providing control instruction to various components of the system 10, and receiving feedback from the various components of the system 10.”] and para 71 of Daly [see… “the cooling system 500 can be provided with a temperature adjustment feature for permitting responsive adjustment of the coolant temperature depending on operational conditions and/or sensor feedback as needed to maintain therapeutically acceptable temperatures in the treatment area consistent with procedure requirements and to maintain operationally acceptable temperatures within the system 10 consistent with equipment requirements.”] and para 109 of Daly [see “The computer system 107 can then adjust one or more operating parameters such as pulse length, EMR source activation, EMR source power, treatment duration, cooling airflow, scanning speed of the positioning apparatus, etc. to manage the temperature in response to the sensor 1000 feedback. Although shown as including both a temperature sensor 1001 and a heat flux sensor 1003, it will be apparent in view of this disclosure that, in some embodiments, the sensors 1000 may include only a temperature sensor 1001 or only a heat flux sensor 1003.”] which disclose a controller and sensors with the sensors providing feedback (sensor input) to the controller which then adjusts the treatment parameters including the laser parameters and cooling treatment parameters (i.e. one or more additional device) in response to the feedback (input) provided by the sensors.
Regarding claims 34-35:
see Fig. 1 elements 1000 (i.e. proximity sensor and/or treatment tracking sensor) and element 107 (i.e. controller) of Daly and para 81 of Daly [see… “Still further, sensors 1000 can be included to detect a position of the device 950 relative to the surface to be treated. In such embodiments, the positioning apparatus 900 can responsively adjust a position or orientation of the device 950 relative to the surface to be treated according to the sensor 1000 feedback. For example, in some embodiments, the positioning apparatus 900 can maintain a prescribed separation height between the device 950 and the surface to be treated.”] and para 71 of Daly [see… “the cooling system 500 can be provided with a temperature adjustment feature for permitting responsive adjustment of the coolant temperature depending on operational conditions and/or sensor feedback as needed to maintain therapeutically acceptable temperatures in the treatment area consistent with procedure requirements and to maintain operationally acceptable temperatures within the system 10 consistent with equipment requirements.”]
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792