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(b)
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 19 and 22 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 19 recites, “wherein the stabilizer comprises a high thermal capacity material.” The recitation of a “high thermal capacity” is a relative term that us not defined by the language of the claim. Therefore, the metes and bounds of the claim cannot be understood.
Claim 21 recites, “wherein the compound comprises a hydrophilic and low molecular weight compound.” The recitation of a “low molecular weight compound” is a relative term that us not defined by the language of the claim. Therefore, the metes and bounds of the claim cannot be understood.
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.
Claim(s) 1-3, 10, 12-14, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manstein et al. (US 20150202007 A1, “Manstein”).
Regarding claim 1, Manstein teaches an apparatus for directing optical energy onto a sample (abstract: "Exemplary methods and devices can be provided for fractional resurfacing of skin that include formation of a plurality of small holes, e.g., having widths less than about 1 mm or 0.5 mm, using one or more pulses of ablative electromagnetic radiation (EMR), e.g., optical energy. One or more pulses of substantially non-ablative can then be directed into the ablated holes to coagulate tissue therein, followed by at least one further ablative pulse of EMR to ablate and remove some of the coagulated tissue."), comprising: a difference frequency generation (DFG) laser apparatus (para. [0018]: "For example, the apparatus can include two or more lasers, each capable or configured to produce EMR at a different wavelength, e.g., an ablative laser and a non-ablative laser." para. [0058]: "For example, one laser can provide EMR at wavelengths that typically ablate biological tissue, whereas a further laser can provide EMR at a wavelength that is more weakly absorbed by tissue and can generally heat irradiated tissue without ablating it."); a handpiece (Fig. 3; 305; para. [0052]: "The housing 305 can be provided in a shape of a handpiece.") optically coupled to at least a portion of the DFG laser apparatus by an optical fiber arrangement (Fig. 3; optical arrangement 330 is connected to 305, which includes the shape of a handpiece); and a controller (Fig. 3; 320) in operative communication with the DFG laser apparatus (para. [0055]: " The control arrangement 320 can be specifically configured to control and/or adjust properties of the EMR source 310 to provide predetermined pulse sequences of EMR as described herein.") and the handpiece (Fig. 3; control arrangement 320 is disposed on 305, which is in the shape of a handpiece), wherein the DFG laser apparatus is configured to generate both ablative and nonablative optical energy (Fig. 3; 310; para. [0053]: " For example, the EMR source 310 can include an ablative laser and a non-ablative laser."), and wherein the handpiece comprises at least one optical or micromechanical element (Fig. 3; optical arrangement 330; para. [0052]: "The exemplary apparatus 300 can include an EMR source 310, a control arrangement 320 provided in communication with the EMR source 310, and an optical arrangement 330. One or more of these components can be provided in a housing 305, e.g., as shown in FIG. 3.") configured to generate a first pulse (para. [0043]: " a beam 100 of ablative energy (e.g., one or more HA or MA pulses) can be directed onto a particular location on the surface of tissue 110 (e.g., skin) to form a hole 120 therein[…]") and a second pulse of optical energy (para. [0043]: "[…]such coagulated tissue 130 can be formed (or the amount of it increased) by directing one or more further pulses 100 of NA energy onto the same location and into the hole 120 as shown, e.g., in FIG. 2B."), wherein a first amount of at least one of ablative optical energy or nonablative optical energy in the first pulse (para. [0043]: "As shown in FIG. 2A, a beam 100 of ablative energy (e.g., one or more HA or MA pulses)[…]". The first pulse is that with energy that is highly ablative or moderately ablative) is different from a second amount of at least one of ablative optical energy or nonablative optical energy in the second pulse (para. [0043]: "[…]by directing one or more further pulses 100 of NA energy onto the same location and into the hole 120 as shown, e.g., in FIG. 2B." The second pulse directed at the hole is non-ablative, which requires a different energy than highly or moderately ablative), and wherein the controller is configured to direct the first pulse and the second pulse onto a particular location on the sample using the handpiece (para. [0059]: "In still further exemplary embodiments of the present disclosure, the control arrangement 320 can be configured or adapted to control the optical arrangement 330, e.g., to direct EMR pulses 100 from the EMR source 310 onto one or more particular locations. Such control can be adapted, for example, to provide a plurality of pulses onto a plurality of particular locations, where the pulses 100 are controlled to perform the exemplary sequence of processes illustrated in FIG. 2A-2C or 2A-2D and described herein at each location."; Control arrangement 320 is situated on 305, which is configured to be a handpiece.).
Regarding claim 2, Manstein teaches the apparatus of claim 1 (see above), wherein the first pulse comprises substantially ablative optical energy (para. [0043]: "As shown in FIG. 2A, a beam 100 of ablative energy (e.g., one or more HA or MA pulses)[…]". The first pulse is that with energy that is highly ablative or moderately ablative) and the second pulse comprises substantially nonablative optical energy (para. [0043]: "[…]by directing one or more further pulses 100 of NA energy onto the same location and into the hole 120 as shown, e.g., in FIG. 2B." The second pulse directed at the hole is non-ablative, which requires a different energy than highly or moderately ablative).
Regarding claim 3, Manstein teaches the apparatus of claim 1 (see above), wherein the handpiece is configured to direct a plurality of pulses of energy onto a particular location on the sample (para. [0059]: "In still further exemplary embodiments of the present disclosure, the control arrangement 320 can be configured or adapted to control the optical arrangement 330, e.g., to direct EMR pulses 100 from the EMR source 310 onto one or more particular locations. Such control can be adapted, for example, to provide a plurality of pulses onto a plurality of particular locations, where the pulses 100 are controlled to perform the exemplary sequence of processes illustrated in FIG. 2A-2C or 2A-2D and described herein at each location."; Control arrangement 320 is situated on 305, which is configured to be a handpiece.), and wherein the plurality of pulses comprises at least one first pulse (para. [0043]: "As shown in FIG. 2A, a beam 100 of ablative energy (e.g., one or more HA or MA pulses)[…]". The first pulse is that with energy that is highly ablative or moderately ablative) and at least one second pulse (para. [0043]: "[…]by directing one or more further pulses 100 of NA energy onto the same location and into the hole 120 as shown, e.g., in FIG. 2B." The second pulse directed at the hole is non-ablative, which requires a different energy than highly or moderately ablative).
Regarding claim 10, Manstein teaches the apparatus of claim 1 (see above). Claim 10 does not impart further structural limitation of the apparatus of claim 1. Absent evidence of the contrary, Manstein teaches the structural limitation necessary of claim 10.
Regarding claim 12, Manstein teaches the apparatus of claim 2 (see above), wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: direct the first pulse (para. [0015]: “HA or MA pulse”) onto the particular location (para. [0015]; “the hole” (which is formed on the target tissue)) on the sample during a first time period, and direct the second pulse (para. [0015]: “NA”) onto the particular location on the sample during a second time period following the first time period. (para. [0015]: “For example, after a deep hole is ablated using an HA or predominantly ablative MA pulse, one or more NA pulses and/or predominantly coagulative MA pulses can then be directed into the hole to coagulate more tissue within the hole. A portion of this coagulated tissue can then be ablated by directing one or more MA or HA pulses into the hole. This exemplary procedure can optionally be repeated a number of times in a single hole to alternately form coagulated tissue within the hole and then remove at least a portion of it by ablation.”; para. [0016]: “[…]a plurality of MA and/or NA pulses can be directed into the ablated hole after the ablative pulses to generate more coagulated tissue therein, such that the hole can be at least partially filled with coagulated tissue.”) As disclosed, the first HA or MA pulse is directed at the target, and then followed by a second NA pulse. When the first HA or MA pulse is generated can be considered the first period, and when the second NA pulse is generated can be considered the second time period.
Regarding claim 13, Manstein teaches the apparatus of claim 2 (see above), wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: direct the first pulse (para. [0015]: “NA pulses”) onto the particular location on the sample during a first time period (the time period when NA pulses are generated), and direct the second pulse (para. [0015]: “HA or MA pulses”) onto the particular location on the sample during a second time period (when the HA or MA pulses are generated) prior to the first time period (the HA or MA pulses are generated prior to the NA pulses; Additionally, Manstein discloses generating additional NA or MA pulses after ablative pulses in para. [0015]: “This exemplary procedure can optionally be repeated a number of times in a single hole to alternately form coagulated tissue within the hole and then remove at least a portion of it by ablation. Such exemplary pulse sequences may reduce healing or recovery times, for example, by directing further pulses of energy (EMR) into each ablated hole without a significantly increase in the hole depth or width.” This means the first and second pulse can be delivered in any order at distinct times, which meets the limitations of the claim.
Regarding claim 14, Manstein teaches the apparatus of claim 2 (see above), wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: alternate directing the first pulse and the second pulse onto the particular location on the sample during different time periods (para. [0015]: “This exemplary procedure can optionally be repeated a number of times in a single hole to alternately form coagulated tissue within the hole and then remove at least a portion of it by ablation. Such exemplary pulse sequences may reduce healing or recovery times, for example, by directing further pulses of energy (EMR) into each ablated hole without a significantly increase in the hole depth or width.”; As disclosed, the fact that MA or HA and NA pulse delivery can be repeated means that the device of Manstein can alternate between MA or HA and NA pulses at different time periods.).
Regarding claim 24, Manstain teaches the apparatus of claim 1 (see above), wherein the sample comprises a biological tissue (para. [0022] gives a brief description of Fig. 1, which shows the effects of laser pulses being used on skin tissue (a type of biological tissue).)
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) in view of Zho et al. ("Continuous-Wave 3.1–3.6 μm Difference-Frequency Generation of Dual Wavelength-Tunable Fiber Sources in PPMgLN-Based Rapid-Tuning Design"; IEEE Journal of Selected Topics in Quantum Electronics; Published 11 July 2017).
Regarding claims 4-6, Manstein discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein does not disclose the various pump, seed, and combined output wavelengths of claims 4-6.
Zho, in the same field of endeavor of difference frequency generation, discloses the concept of tunable wavelengths based on adjusting input wavelengths. Zho discloses a range of different pump wavelengths, seed (signal) wavelengths, and output wavelengths (Abstract: “difference-frequency generation (DFG) source based on single-frequency wavelength-tunable polarization-maintaining ytterbium- and erbium-doped fiber master oscillator-power amplifiers (MOPAs), acting as the pump and signal source[…]the generated idler light reaches a wavelength-tuning range of close to 500 nm, from ~3117.2 to ~3598.8 nm, only by tuning the launched pump and signal wavelengths from 1040 to 1084.6 nm and from 1545.2 to 1561.4 nm, respectively, without any change of temperature or grating period of the PPMgLN.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to try experimentation with various wavelength inputs (seed and pump wavelengths) before arriving at the optimal pump, seed and output wavelengths. In trying different wavelengths, it could be determined which specific pump, seed, and output wavelengths are most effective for dermatological treatment. Zho discloses the concept of tuning the wavelenths, meaning that they can be adjusted to find an optimal combination. It would have been obvious to use this tuning method with similar wavelength ranges to find the optimal ranges of those disclosed in claims 4-6. Further, it would have been obvious after performing experimentation to include the optimal wavelengths with the apparatus of claims 1.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) in view of Dekker et al. (US 20100054284 A1, “Dekker”).
Regarding claim 7, Manstein discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein does not disclose wherein the at least one optical or micromechanical element comprises a polarizer and a polarizing beam splitter.
Dekker, in the same field of endeavor of outputting multiple wavelength laser beams, discloses a device that uses different frequency generation (DFG). Dekker discloses wherein the at least one optical or micromechanical element comprises a polarizer and a polarizing beam splitter. (para. [0376]: "The polarizer, which polarises the light resonating within the resonator cavity, may be a mechanically rotatable polariser, or it may be a Faraday rotator or an electro-optic rotator whereby selecting the polarisation is accomplished electronically."). para. [0298]: “The outputting may by means of an output reflector or of a polarizing beam splitter.”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the polarizer and polarizing beam splitter, as disclosed by Dekker, in the device of claim 1, as disclosed by Manstein, since using a polarizing beam splitter improves the device by effectively and efficiently directing each beams. In splitting the beams, the beams can be controlled more precisely. It would have been an obvious improvement to further include the polarizer and polarizing beam splitter in a device for directing different frequency lasers.
Regarding claim 8, Manstein discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein does not disclose wherein the at least one optical or micromechanical element comprises electronically-driven optical elements that include at least one of an acousto-optic modulator, an electro-optic modulator, flip/movable mirrors, electrical actuators, galvanometer scanners, rotation stages, or spinning mirror drums.
Dekker discloses wherein at least one optical or micromechanical element comprises at least one of an electronic shutter and an optical chopper [para. [0449]: "[…] the pump was chopped using a mechanical chopper in close proximity to fiber coupled diode. Using a chopper blade with a 50% duty cycle the pump was chopped at a repetition rate of approximately 200 Hz.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include an optical chopper, as disclosed by Dekker, in the device of claim 1, as disclosed by Manstein, since using an optical chopper improves the device by providing means of interrupting the optical beam. In doing so, the beams can be controlled more precisely. Specifically, the time periods of emitting each pulse frequency could be controlled. It would have been an obvious improvement to further include an optical chopper in a device for directing different frequency lasers to improve control of beam frequency delivery periods.
Regarding claim 9, Manstein discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein does not disclose wherein the at least one optical or micromechanical element comprises electronically-driven optical elements that include at least one of an acousto-optic modulator, an electro-optic modulator, flip/movable mirrors, electrical actuators, galvanometer scanners, rotation stages, or spinning mirror drums.
Dekker discloses wherein the at least one optical or micromechanical element comprises electronically-driven optical elements that include at least one of an acousto-optic modulator, an electro-optic modulator, flip/movable mirrors, electrical actuators, galvanometer scanners, rotation stages, or spinning mirror drums (para. [0421]: "Other low-loss means for causing the laser to operate unidirectionally such as acousto-optic modulators and external feedback mirrors to couple one direction back into the other are also available.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include an acousto-optic modulators, as disclosed by Dekker, in the device of claim 1, as disclosed by Manstein, since using an acousto-optic modulators improves the device by providing means more efficient control of the laser beams. In including the acousto-optic modulators, the beams can be controlled more precisely. It would have been an obvious improvement to further include an optical chopper in a device for directing different frequency lasers to improve the efficiency of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) in view of Thorhauge et al. (US 20110306955 A, “Thorhauge A”).
Regarding claim 11, Manstein discloses the apparatus of claim 1 (see 102 rejection above), and a first pulse (HA or MA pulse) and second pulse (NA pulse) directed onto a particular location (a hole in the tissue). However, Manstein does not disclose where the pulses are simultaneously directed.
Thorhauge A, in the same field of endeavor of directing multiple pulses to target tissue, discloses a different frequency wavelength device for skin treatment. Thorage A discloses wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: simultaneously direct both the first pulse and the second pulse onto the particular location on the sample. (para. [0071- 0072]: “positioning a beam delivery device in proximity to the target skin area, […] irradiating the target skin area with laser light having at least three distinct wavelengths simultaneously or in succession. By delivering more than one wavelength simultaneously or in rapid succession, an improved treatment may be achieved. The beam delivery device may, e.g. be a hand piece.")
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the controller for delivering simultaneous pulses onto a location on a sample, as disclosed by Thorhauge A, with the device of claim 1, as disclosed by Manstein. In doing so, the efficiency of delivering therapeutic effects from different frequency laser beams would be improved. Being able to irradiate different wavelengths at the same time is an obvious improvement to the device of claim 1, since Thorhauge A discloses a similar different frequency generating device for skin treatment irradiation.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) in view of Thorhauge et al. (US 20210260401 A1, “Thorhauge B.”)
Regarding claim 15, Manstein discloses the apparatus of claim 1 (see 102 rejection above), and a first pulse (HA or MA pulse) and second pulse (NA pulse) directed onto a particular location (a hole in the tissue). However, Manstein does not disclose a delay between the first and second pulses.
Thorhauge B, in the same field of endeavor of directing multiple pulses to target tissue, discloses a different frequency wavelength device for skin treatment. Thorage B discloses wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: direct the first pulse onto the particular location on the sample during a first time period, and following a delay, direct the second pulse onto the particular location on the sample during a second time period. (para. [0018]: "The control circuit may thus implement a suitable control mechanism for adjusting a relative delay between the pulses of the first and second pulse trains so as to maximize the output power of the generated third optical field.")
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the controller for delivering a first pulse onto a location on a sample, followed by a delay and then a second pulse onto a location on a sample, as disclosed by Thorhauge B, with the device of claim 1, as disclosed by Manstein. In doing so, the delay would allow for the therapeutic effects of the first pulse to continue before delivery of the second pulse. Since Thorhauge B discloses a delay between different pulses, it would have been obvious to include a controller configured to implement the delay in the apparatus of claim 1, as disclosed by Manstein.
Claims 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) in view of Hu et al. (US 20140063591 A1, “Hu”)
Regarding claims 16 and 17, Manstein discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein does not disclose applying a stabilizer to the beam, or wherein the stabilizer comprises at least one of a plate, beam, or a mask.
Hu, in the same field of endeavor using a difference frequency generation to irradiate multiple frequencies of laser beams, discloses a mask. Hu discloses wherein a controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: apply a stabilizer to the sample, and direct the first pulse and the second pulse onto the stabilizer at the particular location on the sample. (claim 16)(para. [0068]: "In other embodiments, etalon 537 is omitted and mask 536, that has one slit opening for the I.sub.I beam and one slit opening for the I.sub.S beam, is used to select the two intermediate frequencies."; Shows the beams are applied to the slit locations on the sample."; The mask is the stablizer in this scenario). Hu also discloses wherein the stabilizer comprises at least one of a plate, a film, or a mask. (claim 17) (para. [0064]: "the cavity 393 can be independently frequency tuned (using the etalons 438-439 and/or diffraction grating 412 used in conjunction with a mask having two slits (one for each of the two intermediate-frequency beams) and length tuned (using the two piezo-electric actuators) to each of the two intermediate frequency beams, if desired.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply the stabilizer to the sample, wherein the stabilizer is a mask, as disclosed by Hu, with the apparatus of claim 1, as disclosed by Manstein, since doing so would have been an obvious improvement. A mask is a known component that enables the laser to irradiate a precise target area. Using this would enhance the device by improving the precision of the irradiation.
Regarding claim 18, Manstein and Hu, in combination, disclose the apparatus of claim 16 (see above). Further, Hu discloses wherein the stabilizer comprises a mask including a plurality of openings therein (above), and wherein the controller ([0064]; The two pizo-electric actuators), when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: direct the first pulse and the second pulse onto the particular location on the sample (para. [0064]: "[…] wherein the two piezo-electric actuators allow independent adjustment of the lengths of the cavity 393 as seen by each intermediate beam, for tuning purposes."; para. [0064]: "[…]used in conjunction with a mask having two slits (one for each of the two intermediate-frequency beams) and length tuned (using the two piezo-electric actuators) to each of the two intermediate frequency beams, if desired.") through at least one of the plurality of openings in the mask (para. [0068]: "In other embodiments, etalon 537 is omitted and mask 536, that has one slit opening for the I.sub.I beam and one slit opening for the I.sub.S beam, is used to select the two intermediate frequencies."; Shows the beams are directed through the slits).
It would have been It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include a plurality of openings in a mask and directing the pulses to the openings, as disclosed by Hu, with the device of claim 16. As Hu discloses, a mask with slits is a known component that precisely directs the pulses to a target area. Including a mask with slits would allow the device to better control which area of tissue is irradiated.
Claims 19 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein”) Hu et al. (US 20140063591 A1, “Hu”), and Mirov et al. (US 7606274 B2).
Regarding claim 19, the combination of Manstein and Hu disclose the apparatus of claim 16 (see above). However, they do not disclose wherein a stabilizer comprises a high thermal capacity material.
Mirov, in the same field of endeavor of stabilizing difference frequency generator (DFG) laser beams, discloses a material for stabilizing the laser beams. Mirov discloses wherein a stabilizer comprises a high thermal capacity material (para. (59): "finally, to provide the laser thermal and mechanical stability, its temperature will be stabilized with mK precision by a set of thermoelectric coolers (TEC)."). The examiner notes that the claim is given its broadest reasonable interpretation due to the indefiniteness of the claim language. As a result, the claim is interpretated as any material included that is meant to withstand the temperature from the laser and prevent overheating the stabilizer.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the thermoelectric coolers with high thermal capacity, as disclosed by Mirov, with the apparatus of claim 16, as disclosed by the combination of Manstein and Hu. In doing so, the stabilizer would be comprised of means for withstanding high temperatures that are consequential of the laser pulses. It would have been an obvious improvement to include a high thermal capacity material in the stabilizer, as Mirov discloses this concept.
Regarding claim 20, the combination of Manstein and Hu disclose the apparatus of claim 16 (see above). However, neither Manstein nor Hu disclose wherein a stabilizer comprises a cooling system.
Mirov discloses wherein a stabilizer comprises a cooling system (para. (59): "finally, to provide the laser thermal and mechanical stability, its temperature will be stabilized with mK precision by a set of thermoelectric coolers (TEC).")
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the cooling system in a stabilizer, as disclosed by Mirov, with the apparatus of claim 16, as disclosed by the combination of Manstein and Hu. In doing so, thermal stability would be provided to the system to stabilize the temperature. The stabilizer would get hot during laser treatment and require means for reducing the temperature. Mirov solves this problem by including the cooling system. Therefore, it would have been an obvious improvement to include the cooling system of Mirov to the apparatus of claim 16.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein A”) in view of Manstein (US 10092354 B2, “Manstein B”).
Regarding claim 21, Manstein A discloses the apparatus of claim 1 (see 102 rejection above). However, Manstein A does not disclose wherein the particular location on the sample comprises a compound applied thereto.
Manstein B, in the same field of endeavor of dermatological treatment using laser devices, discloses wherein the particular location on the sample comprises a compound applied thereto. (para. (30): " For example the film 100 can be formed of a compound that includes one or more therapeutic substances."; Also see para. (24) and (18), which mention the holes are formed in the tissue where stabilizing films are provided.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include where the sample comprises a compound applied to the location, as disclosed by Manstein B, with the apparatus of Manstein A. By doing so, the treatment of the patient’s skin would be improved in that drug delivery capabilities would be improved for the apparatus of claim 1. Manstein B suggests using a similar laser treatment apparatus for drug delivery. . Therefore, it would have been an obvious improvement to include the compound applied to the sample location.
Regarding claim 23, Manstein A and B, in combination, disclose the apparatus of claim 21 (see above). Manstein B further discloses wherein the controller, when directing the first pulse and the second pulse onto a particular location on the sample, is further configured to: image the sample using an imaging arrangement associated with the apparatus (para. [0089]: "[…]," the sensor includes a camera configured to capture images of the target area during treatment, and the medical laser system may be configured to process one or more images captured by the camera so as to determine an effect of the laser output on the target area."), adjust a position of the apparatus relative to the sample using a position controller (para. [0136]: "The mirror selector is configured, responsive to a control signal from control circuit 130 to position a chosen selection mirror to intersect the first optical axis, second optical axis and third optical axis."), and direct the first pulse and the second pulse onto the particular location on the sample. (para. [0038]: "by moving one or more optical components e.g. a mirror, so as to direct the output of the medical laser system to a new target location within the target area.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the imaging, positioning, and laser direction onto the sample, as disclosed by Manstein B, with the apparatus of claim 21, as disclosed by Manstein A and B in combination. Including these particular components would be an obvious improvement to the apparatus of claim 21 since they would allow the device to image the treatment site and adjust the position of the treatment. This would allow for more accurate application of laser pulses. It would be an obvious improvement to include these features in the apparatus of claim 21.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Manstein et al. (US 20150202007 A1, “Manstein A”), Manstein et al. (US 10092354 B2, “Manstein B”), and Tankovich et al. (US 6050990 A, “Tankovich”).
Regarding claim 22, the combination of Manstein A and B disclose the apparatus of claim 21 (see above). However, neither reference discloses wherein the compound comprises a hydrophilic and low molecular weight compound.
Tankovich, in the same field of endeavor of treating the skin, discloses a method for applying laser light and a compound to the treatment site. Tankovich discloses wherein a compound comprises a hydrophilic and low molecular weight compound (para. (132): “hydrogels suitable for use in making the thin film 24 of the composite hydrogel include elastomeric polymers, such as polyurethane, having hydrophilic sites in the polymer molecule of polyethylene glycol and a molecular weight of less than about 1,000 units, for example from about 400 to about 600 units.”). The examiner notes that the claim is given its broadest reasonable interpretation due to the indefiniteness of the claim. The claim is interpreted that a low molecular weight could be anything that’s used with a hydrophilic material for a film.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include a hydrophilic and low molecular weight material in the compound applied to the treatment site since doing so would improve the therapeutic benefits by retaining and attracting water, which prevents the film from drying out. Further, the low molecular weight would allow the film to deform to the contours of the treatment site. Since Tankovich discloses a low molecular weight and hydrophilic compound applied to the treatment site, as well as the benefits of doing so, it would have been obvious to include this in the apparatus of claim 21 and 1, as disclosed in the Manstein A and B combination.
Conclusion
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/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796