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 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 1-15 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.
In claims 1 and 14, the limitation “a distance…of the current treatment area from a previous treatment area” is unclear because a distance between two-dimensional areas is indefinite without defining specific points between which to measure the distance. For example, it is unclear whether a distance of zero describes two fully overlapping areas (that is, the distance from the center of the current treatment area to the center of the previous treatment area is zero), two adjacent areas with abutting edges (that is, the distance from a leading edge of the previous treatment area to a lagging edge of the current treatment area is zero), or another distance measured between any two points within the two treatment areas. For examination purposes, this limitation will be read as wherein the distance from a leading edge of the previous treatment area to a lagging edge of the current treatment area is zero.
Dependent claims 2-11, 13, and 15 are necessarily rejected as depending upon rejected base claims.
Regarding claims 4, 7, 8, 11, and 13, the term “and/or” renders the claim indefinite because it is unclear whether the limitations preceding and following the phrase are part of the claimed invention. For examination purposes, the term will be read as --or-- in all instances.
Claim 12 recites the limitation “the pre-set speed” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-3, 5-7, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Reichert et al. (US PGPub No. 2013/0030423), hereinafter Reichert, in view of Kalev et al. (US PGPub No. 2014/0121730), hereinafter Kalev.
Regarding claims 1 and 14, Reichert teaches an apparatus and computer-implemented method configured to control a treatment device configured to perform a treatment operation on a body part of a subject (par. 0008: “radiation-based dermatological treatment devices and methods”),
wherein the treatment device is configured to apply light pulses to skin of the body part to perform the treatment operation, wherein a light pulse applied to the skin treats a treatment area of the skin (par. 0010: “one or more radiation sources that radiate energy in the form of one or more beams to produce one or more irradiated areas on the skin that provide a dermatological treatment”),
the treatment area having a known or estimated width in a movement direction of the treatment device (Fig. 5B and par. 0111: “a ‘treatment spot’ means a contiguous area of skin irradiated by a radiation source--during a delivered pulse (as defined above) --to a degree generally sufficient to provide a desired treatment in the skin at that location. For some types of radiation source, including laser radiation sources for example, the boundaries of the treatment spot are defined by the ‘1/e2 width,’ i.e., the treatment spot includes a contiguous area of the skin surface that is irradiated by a radiation intensity equal to at least 1/e2 (or 0.135) times the maximum radiation intensity at any point on the skin surface”),
the apparatus comprising a processing unit (Fig. 4: control electronics 30; par. 0116: “Control electronics 30 may include one or more processors and memory devices for storing logic instructions or algorithms or other data”) configured to: estimate a position of a current treatment area corresponding to an area of skin that the treatment device would apply a light pulse to while at a current treatment position;
determine a distance, in the movement direction of the treatment device, of a lagging edge of the current treatment area from a leading edge of a previous treatment area corresponding to an area of skin that the treatment device applied a previous light pulse to while at a previous treatment position;
determine if the distance is zero;
and generate a pulse control signal for controlling the treatment device to generate and apply a light pulse to the current treatment area of the skin if the distance has been determined to be zero (par. 0188: “adjacent treatment spots in the scan direction may abut each other edge-to-edge, or may overlap each other, in order to provide contiguous rows of irradiated areas. Such contiguous rows […] may abut each other edge-to-edge;” par. 0492: “control systems 18, including displacement-based control system 132, controls operational aspects of device 10 (e.g., operational aspects of treatment radiation source 14) based on the displacement of device 10 across the skin […] beams 114 are delivered only if sufficient distance has been translated relative to the delivery of a particular prior beam 114 or some other predetermined event”).
Reichert does not explicitly teach wherein the processing unit is further configured to determine if the distance is an integer multiple of the width of the treatment area and generate the pulse control signal for controlling the treatment device to generate and apply a light pulse to the current treatment area of the skin if the distance has been determined to be said integer multiple of the width of the treatment area. However, in an analogous art, Kalev teaches an apparatus and computer-implemented method for laser skin treatment with a processing unit (par. 0011: “A controller controls the application of laser application spots”) configured to determine if the distance is an integer multiple of a distance between adjacent application spots and generate the pulse control signal for controlling the treatment device to generate and apply a light pulse to the current treatment area of the skin if the distance has been determined to be said integer multiple of the distance between adjacent application spots (Figs. 2A-2C and par. 0010: “after an application spot has received laser energy, the laser apparatus skips N number of application spots prior to activating the next laser beam application”), in order to lessen thermal damage to the surrounding tissue of each spot (Abstract: “In order to lessen thermal damage to the surrounding tissue of the spot, a controller will cause the laser or the energy application device to skip around the area to be treated rather than to apply the laser beam in a sequential, raster-like fashion to each of the points;” par. 0019: “spots are skipped so as to lessen the damage to the skin surface yet provide total coverage of the area scanned”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus and computer-implemented method of Reichert by configuring the processing unit to determine if the distance is an integer multiple of a distance between adjacent application spots (that is, the width of Reichert’s abutting treatment spots) and generate the pulse control signal for controlling the treatment device to generate and apply a light pulse to the current treatment area of the skin if the distance has been determined to be said integer multiple of the distance between adjacent application spots, as taught by Kalev, in order to lessen thermal damage to the surrounding tissue of each spot, as taught by Kalev.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Reichert further teaches wherein the processing unit is configured to determine a minimum threshold distance (that is, the integer multiple of the combined reference) based on an initial movement speed of the treatment device, in particular a measured or pre-set movement speed of the treatment device, and the known or estimated width of the treatment area (par. 0012: “the automated scan rate and/or the pulse rate may be set and/or controlled based on various factors, such as a typical or expected speed at which the device is manually moved or glided across the skin. In particular, the automated scan rate and/or the pulse rate may be set and/or controlled such that for a range of typical or expected manual (or mechanically-driven) glide speeds, adjacent treatment spots or adjacent rows of treatment spots are generally physically separated from each other by areas of non-treated skin (i.e., fractional treatment is provided)”).
Regarding claim 3, the combination teaches the device of claim 2 as described previously. Reichert further teaches wherein the processing unit is further configured to determine a number of strokes needed to treat a first portion of skin (par. 0517: “the glide speed may influence the number of times device 10 must be glided across the skin 40 to complete the treatment session”).
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Reichert further teaches wherein the processing unit is further configured to avoid overlapping the current treatment area with the previous treatment area before applying a light pulse (par. 0656: “techniques that individually or in combination provide over-treatment protection, e.g., to prevent pulse stacking, firing on the same area(s), an excessive treatment spot 70 density, or other non-desirable treatment conditions. For example, in some embodiments, device 10 ceases to operate (e.g., generate or deliver beams) when stationary condition of device 10 is detected”).
Regarding claim 6, the combination teaches the device of claim 1 as described previously. Reichert further teaches wherein the processing unit is further configured to evaluate readiness of the device’s radiation source before applying a light pulse (Fig. 56 and par. 0633: “at step 816, secondary controller 144B may provide an independent check of various laser parameters (e.g., pulse duration, current, and voltage) to monitor for laser over-pulse-duration, laser over-current, or degraded laser (based on laser diode voltage), for example. If any of the fault conditions are detected at step 814 or 816, the laser pulsing will stop immediately and the device will report an error condition on the display user interface, as indicated at 816”).
Regarding claim 7, the combination teaches the device of claim 1 as described previously. Reichert further teaches wherein the processing unit is configured to generate a guidance signal for a feedback unit, wherein the guidance signal is configured to cause the feedback unit to generate guidance indicating into which direction or at which treatment area the treatment device shall be moved (par. 0692: “To facilitate uniform treatment of the target area, device 10A may provide feedback to the user indicating when to move from one region of the target area to another, e.g., after a predetermined fraction of the total treatment spots for the session have been generated on the target area”).
Regarding claim 11, the combination teaches the device of claim 1 as described previously. Reichert further teaches wherein the processing unit is configured to: receive a first measurement signal from a sensor, the first measurement signal comprising information about positions or movements of the treatment device over time (Fig. 38: displacement sensor 200; par. 0173: “Displacement sensor 200 may monitor the lateral displacement of device 10 relative to the skin, e.g., as device 10 is moved across the skin”); for a light pulse previously applied by the treatment device to the body part during the treatment operation, process the first measurement signal to estimate the previous treatment position as a position of the treatment device relative to the body part when the light pulse was generated; for the previously applied light pulse and based on the estimated previous treatment position, estimate the position of the previous treatment area; process the first measurement signal to estimate the current position of the treatment device relative to the body part; and based on the estimated current position of the treatment device, estimate the position of the current treatment area (par. 0439: “displacement-based control system 132 may analyze signal 360 to identify and count surface features 74 in the skin (e.g., in embodiments utilizing a single-pixel displacement sensor 200 (e.g., sensors 200A, 200B, or 200C discussed below)), or compare images scanned at different times (in embodiments utilizing a multi-pixel displacement sensor 200 (e.g., sensor 200D discussed below)), as device 10 is moved across the skin (e.g., in a gliding mode, during and/or after the generation of the first array of treatment spots; or in a stamping mode, after the generation of the first array of treatment spots). System 130 may begin the first monitoring process at the initiation of the first scan or upon any other predefined event or at any predetermined time”).
Regarding claim 12, Reichert teaches an apparatus configured to control a treatment device configured to perform a treatment operation on a body part of a subject (par. 0008: “radiation-based dermatological treatment devices and methods”),
wherein the treatment device is configured to apply light pulses to skin of the body part to perform the treatment operation, wherein a light pulse applied to the skin treats a treatment area of the skin (par. 0010: “one or more radiation sources that radiate energy in the form of one or more beams to produce one or more irradiated areas on the skin that provide a dermatological treatment”),
the treatment area having a known or estimated width in a movement direction of the treatment device (Fig. 5B and par. 0111: “a ‘treatment spot’ means a contiguous area of skin irradiated by a radiation source--during a delivered pulse (as defined above)--to a degree generally sufficient to provide a desired treatment in the skin at that location. For some types of radiation source, including laser radiation sources for example, the boundaries of the treatment spot are defined by the ‘1/e2 width,’ i.e., the treatment spot includes a contiguous area of the skin surface that is irradiated by a radiation intensity equal to at least 1/e2 (or 0.135) times the maximum radiation intensity at any point on the skin surface”),
the apparatus comprising a processing unit (Fig. 4: control electronics 30; par. 0116: “Control electronics 30 may include one or more processors and memory devices for storing logic instructions or algorithms or other data”) configured to:
determine a distance, in the movement direction of the treatment device, that the treatment device has moved; and generate, based on a speed of the treatment device, a pulse control signal for controlling the treatment device to generate and apply a light pulse if the determined distance corresponds to the width of the treatment area (par. 0026: “the device may monitor the speed or displacement of the device relative to the skin and control the radiation source accordingly, e.g., by turning off the radiation source, reducing the pulse rate, etc. upon detecting that the device has not been displaced on the skin a minimum threshold distance from a prior treatment location;” examiner notes that if the device has been displaced a minimum threshold distance from a prior treatment location, as measured using speed, a light pulse is applied).
Reichert does not explicitly teach wherein the processing unit is further configured to: set an integer multiple of the width of the treatment area based on the pre-set speed of the treatment device, wherein said integer multiple is at least two; and generate the pulse control signal for controlling the treatment device to generate and apply a light pulse if the determined distance corresponds to the set integer multiple of the width of the treatment area. However, Reichert in view of Kalev teaches these limitations for the same reasons set forth in the rejection of claim 1.
Regarding claim 13, the combination teaches the device of claim 1 as described previously. Reichert further teaches a system, comprising: a treatment device comprising one or more light sources for generating light pulses for application to skin of the body to perform a treatment operation (Fig. 1: device 10, radiation source 14); a sensor for outputting a first measurement signal comprising information about positions or movements of the treatment device over time (Fig. 1: sensors 26; par. 0118: “sensors 26 may include one or more of the following types of sensors: (a) one or more displacement sensor for determining the displacement of device 10 relative to the skin, (b) one or more motion/speed sensor for determining the speed, rate, or velocity of device 10 moving ("gliding") across the skin”); and an apparatus as claimed in claim 1 (Fig. 1: control electronics 30).
Regarding claim 15, the combination teaches the method of claim 14 as described previously. Reichert further teaches a computer program comprising program code means for causing a computer to carry out the steps of the method as claimed in claim 14 when said computer program is carried out on the computer (par. 0116: “Control electronics 30 may include one or more processors and memory devices for storing logic instructions or algorithms or other data […] Logic instructions or algorithms may be implemented as software, firmware, or any combination thereof. Processors may include any one or more devices, e.g., one or more microprocessors and/or microcontrollers, for executing logic instructions or algorithms to perform at least the various functions of device 10 discussed herein”).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Reichert in view of Kalev and further in view of DeBenedictis et al. (US PGPub No. 2007/0093798), hereinafter DeBenedictis.
Regarding claim 4, Reichert in view of Kalev teaches the device of claim 2 as described previously. The combination does not explicitly teach wherein the processing unit is further configured to adjust the integer multiple or the number of strokes upon determining that a current movement speed of the treatment device is different from the initial movement speed. However, in an analogous art, DeBenedictis teaches a laser treatment system with a processing unit configured to adjust the rate of laser firing (analogous to the integer multiple) according to the real-time velocity of the treatment device (par. 0060: “The positional sensor 280 and the dosage evaluation sensor 260 communicate with the controller 215. In response to the measurements, the controller 215 adjusts the optical treatment parameters in real time to materially affect the photothermal treatment. For example, the rate of laser firing can be adjusted to be proportion to the velocity of the handpiece 200 to create a predefined treatment pattern or a uniform treatment”), which helps prevent over- or under-treatment if the device is being used by an unskilled operator (par. 0007: “Other laser treatment systems fire identical pulses at a constant pulse repetition rate as the user moves the handpiece across the tissue. This system requires skill and increases the risks of over- or under-treatment in the hands of an unskilled operator. Therefore, there is also a need for an approach to electromagnetic treatment that provides controlled dosage and adjusts the dosage level in real time to prevent over- and/or under-treatment”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by configuring the processing unit to adjust the integer multiple according to the real-time velocity of the device, as taught by DeBenedictis, in order to help prevent over- or under-treatment if the device is being used by an unskilled operator, as taught by DeBenedictis.
Regarding claim 10, Reichert in view of Kalev teaches the device of claim 7 as described previously. The combination does not explicitly teach wherein the processing unit is configured to: compute a map indicating treated treatment areas to which a light pulse has been previously applied and untreated treatment areas to which a light pulse has not been previously applied; and generate the guidance signal for the feedback unit based on the computed map. However, DeBenedictis further teaches computing a map indicating treated treatment areas to which a light pulse has been previously applied and untreated treatment areas to which a light pulse has not been previously applied, and generating a guidance signal based on the computed map (par. 0064: “a treatment status map is displayed on a monitor (not shown) for the user or the patient to observe […] a map can display which parts of the treatment region have been treated and how each part of the treatment region has responded to treatment. The user can take the information on this map to make treatment uniform over the entire treatment region or to have treatment vary in a desirable manner such as treating area with deep wrinkles more heavily than less wrinkled areas. Alternatively, the system can be configured to automatically reduce or disable treatment in the regions that have already been adequately treated as the user continues to move the handpiece over the treatment region”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by configuring the processing unit to compute a map indicating treated and untreated areas, as taught by DeBenedictis, in order to make treatment uniform over the entire treatment region or to have treatment vary in a desirable manner, as taught by DeBenedictis.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Reichert in view of Kalev and further in view of Karni et al. (US PGPub No. 2014/0005644), hereinafter Karni.
Reichert in view of Kalev teaches the device of claim 1 as described previously. Kalev further teaches wherein the processing unit is configured to determine if, after a first stroke of the treatment device over a first portion of the skin, there are untreated treatment areas between treated treatment areas, and generate the guidance signal for the feedback unit, wherein the guidance signal is configured to cause the feedback unit to generate guidance indicating: that the treatment device shall be moved in a second stroke over the same first portion of the skin but in the opposite direction if there are untreated treatment areas between treated treatment areas in the first portion of the skin (Figs. 2A-2C: passes 1-3 traveling in alternating directions; 0017: “In FIG. 2a, noted as "Pass 1", the dark circles illustrate the sequence of laser beam application to the skin tissue in this first pass. After the first pass, as illustrated in FIG. 2b, the laser beam again applies beams to other portions of the skin tissue without repeating an application on the same spot previously made in pass 1. Finally, in pass 3, illustrated FIG. 2c, the remaining spots that have not been previously had laser application applied to them have a laser beam applied”),
but the combination does not explicitly teach wherein the guidance signal is configured to cause the feedback unit to generate guidance indicating: if there are no untreated treatment areas between treated treatment areas in the first portion of the skin, that the treatment of the first portion of the skin is finished or that the treatment device shall be moved in a second stroke over a second portion of the skin different from the first portion and that is parallel and adjacent to the first portion of the skin.
However, in an analogous art, Karni teaches treating large areas of skin by applying light in parallel and adjacent strips (par. 0074: “To treat a large surface area, in some embodiments the device is moved in a prescribed direction as described above to treat a first strip of skin, and then relocated and moved in substantially the same way to treat a following strip of skin parallel to the first strip of skin”). Karni teaches that this technique provides a simpler way of ensuring that portions of skin are not overtreated or left untreated (par. 0075: “In stamping methods, it is difficult to ensure that any two treated areas exactly abut, so often a significant portion of the skin is left untreated, or a portion of the skin is treated twice, potentially causing overexposure to light and possible damage. Generally, it is simpler to ensure that any two strips of skin treated in accordance with the teachings herein are parallel and abut”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by configuring the guidance signal to cause the feedback unit to generate guidance that the treatment device shall be moved in a second stroke over a second portion of the skin different from the first portion and that is parallel and adjacent to the first portion of the skin, as taught by Karni, in order to treat large areas of skin while ensuring that portions of skin are not overtreated or left untreated, as taught by Karni.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794
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