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 2-11 are objected to because of the following informalities: the phrase “The applicator of claim x” should be amended to include a comma and should recite “The applicator of claim x,”. Appropriate correction is required.
Claims 1-11 are objected to because of the following informalities: the lettered (a, b, c) bullet points and roman numeral (i, ii) bullet points should be removed. Appropriate correction is required.
Claims 1-11 are objected to because of the following informalities: the numbering of the structure correlated with the figures should be removed. Appropriate correction is required.
Claims 1 is objected to because of the following informalities: the indentation of the positioning system in comparison to the removably connected tip and identification detector should be adjusted. Appropriate correction is required.
The claims are objected to for containing periods within a claim. MPEP 601.01(m) states, “[e]ach claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i).”
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 1-11 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 1 recites the limitation "the optical element" in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the at least one optical element” to fall in line with the scope of the claim.
Claim 1 recites the limitation "the laser path" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the removable connection of the tip" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the encoder" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the other end" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the optical element" in lines 8 and 10. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the at least one optical element” to fall in line with the scope of the claim.
Claim 4 recites the limitation "the cam channel" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the optical element" in lines 1-5. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the at least one optical element” to fall in line with the scope of the claim.
Regarding claim 5, it is unclear how to “home” and “verify freedom of travel” of the optical element. It is unknown what “hom[ing]” and “verify[ing] freedom of travel” the optical element means.
Regarding claim 5, it is unclear what structure is further adapted to “home” and “verify freedom of travel” of the optical element.
Regarding claim 6, it is unclear what structure is further adapted to cooperate with a user-controlled system operation program.
Claim 6 recites the limitation "the optical element" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the at least one optical element” to fall in line with the scope of the claim.
Claim 6 recites the limitation "the working distance" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the treatment" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the user" in line 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the choice" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the selected treatment" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, it is unclear if “its” is referring to the rotation wheel or the roller. It is further unclear if the “comprising” of line 5 is referring to the rotation wheel of the roller.
Claim 7 recites the limitation "the bottom of the roller" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the skin" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the laser" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the skin" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the laser" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8, it is unclear what structure is “operable” to be rolled along the skin. It is further unclear the direction of where the laser is being fired at because the location of “passing beneath an area bounded on one side by the roller, and on the back and other side by the support” fails to define the structure, which makes it unclear what “side” and “back” is looked at.
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.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stuart et al. (US 20080154251)(Hereinafter Stuart).
Regarding claim 1, Stuart teaches An applicator (20) for delivering a laser beam (16) to mammalian skin (Abstract “A typical treatment system for use with tip embodiments includes an optical energy source, such as, for example, a laser.”), the applicator comprising:
a. a removably connected tip (24) ([0013] “Embodiments of the present invention feature a removable tip apparatus for use with a medical light energy treatment system that includes a handpiece.”) comprising:
i. at least one optical element (34) selected from the group consisting of a lens, a beam splitter, and a KTP crystal ([0044] “The optical path of sensor 180 between the target area and the converging lens 186 may include an optically transparent window 155.”); and
ii. an identifier (56) ([0063] “In the example of FIG. 5, a magnetic connector 524 is shown. Magnets may be placed on one or both sides of the interface between tip 504 and handpiece 502.”); and
b. an identification detector (58) adapted to detect the identifier upon connection of the tip to the applicator ([0048] “Controller 200 can be programmed to sample in real-time variations in the handpiece positional parameters, tip usage, tip sensor [tip sensors are magnetic sensors] readings”); and
a positioning system (30) adapted to position the optical element (34) along the laser path ([0043] “Actuator 145 [positioning system] may be a piezoelectric, galvanometer, rotating element, etc., and operates to adjust the position of deflector 146 to a position corresponding to the desired treatment intensity and pattern. Actuator 145 may be controlled in real-time by controller 200 to modify the light beam so that the microscopic treatment is delivered from handpiece 140 in a uniform or non-uniform pattern across target area 150.”).
Regarding claim 2, Stuart teaches wherein the identifier is at least one magnet and the identification detector is a magnetic sensor ([0063] “In the example of FIG. 5, a magnetic connector 524 is shown. Magnets may be placed on one or both sides of the interface between tip 504 and handpiece 502.” [0048] “Controller 200 can be programmed to sample in real-time variations in the handpiece positional parameters, tip usage, tip sensor [tip sensors are magnetic sensors] readings”).
Regarding claim 3, Stuart teaches wherein the removable connection of the tip to the applicator is by magnet (54) ([0063] “In the example of FIG. 5, a magnetic connector 524 is shown. Magnets may be placed on one or both sides of the interface between tip 504 and handpiece 502.”).
Regarding claim 6, Stuart teaches further adapted to cooperate with a user-controlled system operation program to:
a. set system operation parameter values for a default treatment defined for the tip identifier;
b. position the optical element to the working distance for the treatment;
c. notify the user which treatment has been selected, and
d. offer the user the choice to approve the selected treatment or to switch to another treatment that is possible with the tip (The limitations are intended use. Because Stuart teaches a motor rotation of the optical element, the device of Stuart would be capable of cooperating and completing steps a-d. Examiner further notes that the user-controlled system (and the operational program) is not actively claimed. Furthermore, a processor and/or memory is not used for this program.).
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.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Stuart et al. (US 20080154251)(Hereinafter Stuart) in view of Norton et al. (US 20230398634)(Hereinafter Norton) and Karni et al. (US 20170281273)(Hereinafter Karni2).
Regarding claim 4, Stuart teaches the invention of claim 1. Stuart does not teach wherein the positioning system comprises: a. a motor (32) and associated encoder (38); b. a controller (36) configured to receive motor rotation data from the encoder and to control the motor; c. a drive shaft (44) geared at one end to the motor (32) and adapted at the other end to mate with a rod (50) in the tip; d. the rod geared to a rotatable cam channel (40); and e. a cam follower (42) on the optical element, extending through the cam channel and into an axial fixed channel (52); whereby rotation of the motor is translated into linear movement of the optical element. Norton, in the same field of endeavor, teaches a laser ablation tool with a laser source producing a beam for ablation (Abstract), and further teaches wherein the positioning system comprises:
a. a motor (32) and associated encoder (38) ([0031] “These motors and stators are solely present to control the motion/rotation of the prisms and additionally an encoder may be used to increase the accuracy of control of the motion of the prisms.”);
b. a controller (36) configured to receive motor rotation data from the encoder and to … the motor ([0015] “The encoders are coupled to a controller that is coupled to the output of the laser so that the beam is only outputted at certain positions of the two respective Risley prisms.”);
c. a drive shaft (44) geared at one end to the motor (32) and adapted at the other end to mate with a rod (50) in the tip ([0034] “The drive shafts may also have a gear system to increase or decrease the speed of rotation. The driveshaft may couple to the prisms directly or via a gear drive. This driveshaft may be located parallel to the cavity containing the Risley prisms. For example, the drive shafts may pass down the borescope conduit and lie parallel to the laser fibre.”);
d. the rod geared to a rotatable cam channel (40) ([0034] “the drive shafts may pass down the borescope conduit [cam channel] and lie parallel to the laser fibre.”); and
e. a cam follower (42) on the optical element, extending through the cam channel and into an axial fixed channel (52) ([0034] “the motor may be located outside of the ablation head and move the mirrors [cam follower] through the use of a drive shaft…The driveshaft may couple to the prisms directly [axial fixed channel] or via a gear drive. This driveshaft may be located parallel to the cavity containing the Risley prisms.”);
whereby rotation of the motor is translated into linear movement of the optical element (The limitation is intended use. Because Norton teaches a motor rotation of the optical element, the device of Norton would be capable of translating linearly.) to control a region of ablation ([0033]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart, with the positioning system comprises: a. a motor (32) and associated encoder (38); b. a controller (36) configured to receive motor rotation data from the encoder and to control the motor; c. a drive shaft (44) geared at one end to the motor (32) and adapted at the other end to mate with a rod (50) in the tip; d. the rod geared to a rotatable cam channel (40); and e. a cam follower (42) on the optical element, extending through the cam channel and into an axial fixed channel (52); whereby rotation of the motor is translated into linear movement of the optical element of Norton, because such a modification would allow to control a region of ablation.
However, Norton does not teach the controlling of the motor based on the motion. Karni2, in the same field of endeavor, teaches a laser treatment applicator (Abstract), and further teaches a controller for controlling the motor based on motion ([0030] “a motor rotates the sleeve, sensors measure at least one of the linear and rotational position of the deflector, and a controller processes the sensor data to operate the laser or the motor.”) to optimize motor usage ([0030]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart in view of Norton, with the controlling of the motor based on the motion of Karni2, because such a modification would allow to optimize motor usage.
Regarding claim 5, Stuart teaches further adapted to home the optical element and to verify freedom of travel of the optical element, by
a. fully retracting the optical element to a home position; then
b. running the optical element out to a defined end point; then
c. running the optical element back to the home position (The limitations are intended use. Because Norton teaches a motor rotation of the optical element, the device of Stuart in view of Norton would be capable of completing steps a-c. Examiner further notes that the claim fails to even recite structure associated with the function.).
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Stuart et al. (US 20080154251)(Hereinafter Stuart) in view of Karni et al. (US 20140005644)(Hereinafter Karni) and Yamazaki (US 12207867)(Hereinafter Yamazaki).
Regarding claim 7, Stuart teaches the invention of claim 1. Stuart does not teach a. a removably connected roller contact (70), comprising: i. a roller (76) adapted to be rolled across the tissue in a linear direction of travel (64); ii. a rotation wheel (78) geared to the roller, comprising magnets arranged around its perimeter; and iii. a support (72) extending perpendicular and parallel to the roller and having a support contact surface (74) coplanar with the bottom of the roller, wherein the support is adapted to support the applicator on the skin and to support maintaining the applicator a defined angle of incidence coplanar with the direction of travel; and b. a magnetic rotation sensor (80) adapted to trigger the laser when the rotation wheel rotates a defined distance. Karni, in the same field of endeavor, teaches laser therapy device directing the produced short-duration pulse of light at a skin surface (Abstract), and further teaches further comprising:
a. a removably connected roller contact (70) ([0173] “roller 22 including contact surface 24 is configured to be user-replaceable.”), comprising:
i. a roller (76) adapted to be rolled across the tissue in a linear direction of travel (64) ([0173] “roller 22 including contact surface 24 is configured to be user-replaceable.”);
ii. a rotation wheel (78) geared to the roller, comprising … arranged around its perimeter ([0173] “As seen in FIGS. 1E and 1F, roller 22 is reversibly mounted on axle 38 [rotation wheel].”); and
iii. a support (72) extending perpendicular and parallel to the roller and having a support contact surface (74) coplanar with the bottom of the roller, wherein the support is adapted to support the applicator on the skin and to support maintaining the applicator a defined angle of incidence coplanar with the direction of travel ([0174] “Axle 38 is rotatably mounted near the distal end of spacer arm 20 [support] through bearing 44. Fixedly secured to axle 38 is perforated disk 46 (FIGS. 1H and 1I), a 0.3 mm thick stainless steel disk having 48 perforations 48 arranged near the periphery thereof.” [0176] “as contact surface 24 is made up of two spaced-apart surfaces 24a and 24b, contact surface 24 assists in preventing tilting (in a plane perpendicular to the prescribed direction) of light director aperture 18 relative to the skin surface.”); and
b. a … rotation sensor (80) adapted to trigger the laser when the rotation wheel rotates a defined distance ([0204] “a distance measurer 36 [rotation sensor, “optoelectronic sensor 72” of [0199]] of device 72, and a dummy spacer arm 76 to which distal end is attached a 4 mm radius dummy wheel 78. Device 72 is configured so that the view to where the light beams impinge on a skin surface is unobscured by device 72 and that device 72 does not come in physical contact with where the light beams impinge on the skin surface.” [0206] “the seven individual light beams impinge on skin surface 58 perpendicularly as seven illuminated points (200 micrometer diameter) spaced from one another (1 mm center-to-center) along a line between first location 84 and second location 86 of skin surface 58.”) to measure the distance traveled ([0175]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart in view of Karni, with the a. a removably connected roller contact (70), comprising: i. a roller (76) adapted to be rolled across the tissue in a linear direction of travel (64); ii. a rotation wheel (78) geared to the roller, comprising magnets arranged around its perimeter; and iii. a support (72) extending perpendicular and parallel to the roller and having a support contact surface (74) coplanar with the bottom of the roller, wherein the support is adapted to support the applicator on the skin and to support maintaining the applicator a defined angle of incidence coplanar with the direction of travel; and b. a magnetic rotation sensor (80) adapted to trigger the laser when the rotation wheel rotates a defined distance of Karni, because such a modification would allow to measure the distance traveled.
However, Stuart in view of Karni does not teach magnets on the perimeter of the of the wheel and using a magnetic rotation sensor for measuring distance. Yamazaki, in the same field of endeavor, teaches an irradiation device including rollers for irradiating the skin (Abstract), and further teaches magnets on the perimeter of the of the wheel and using a magnetic rotation sensor for measuring distance (Col. 7 lines 10-20.) to control the light emission (Col. 7 lines 21-25). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart in view of Karni, with the magnets on the perimeter of the of the wheel and using a magnetic rotation sensor for measuring distance of Yamazaki, because such a modification would allow to control a region of ablation.
Regarding claim 8, Stuart teaches the invention of claim 1. Stuart does not teach operable to be rolled along the skin, firing the laser at predefined distance intervals onto an area of skin (66) passing beneath an area bounded on one side by the roller, and on the back and other side by the support. Karni, in the same field of endeavor, teaches laser therapy device directing the produced short-duration pulse of light at a skin surface (Abstract), and further teaches operable to be rolled along the skin, firing the laser at predefined distance intervals onto an area of skin (66) passing beneath an area bounded on one side by the roller, and on the back and other side by the support ([0073] “as the device is moved in a prescribed direction relative to the skin surface, the light source is repeatedly triggered to produce a pulse of light at prescribed distance intervals.” The claim limitation is intended use, and capable to be done by the roller of Karni.) to measure the distance traveled ([0175]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart in view of Karni, with the operable to be rolled along the skin, firing the laser at predefined distance intervals onto an area of skin (66) passing beneath an area bounded on one side by the roller, and on the back and other side by the support of Karni, because such a modification would allow to measure the distance traveled.
Regarding claims 9-11, Stuart teaches the invention of claim 1. Stuart does not teach wherein the angle of incidence is between 10 degrees and 40 degrees, 15 degrees and 25 degrees, and 19 degrees and 21 degrees. Karni, in the same field of endeavor, teaches laser therapy device directing the produced short-duration pulse of light at a skin surface (Abstract), and further teaches wherein the angle of incidence is between 10 degrees and 40 degrees, 15 degrees and 25 degrees, and 19 degrees and 21 degrees ([0212] “a device is configured for preferably directing a plurality of individual light beams to impinge on a skin surface at a preferred angle between about 5.degree. and about 60.degree., in some embodiments of between about 25.degree. and about 50.degree., from perpendicular to a skin surface.”) to optimize the preferred angle ([0212]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Stuart in view of Karni, with the wherein the angle of incidence is between 10 degrees and 40 degrees, 15 degrees and 25 degrees, and 19 degrees and 21 degrees of Karni, because such a modification would allow to optimize the preferred angle.
Although Karni teaches the angle of incidence between 5-60 degrees, Karni does not explicitly teach the specific angles claimed. Since the angles can be preferred by the user, each angle can be selected to optimize the laser application. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have angle of incidence is between 10 degrees and 40 degrees, 15 degrees and 25 degrees, and 19 degrees and 21 degrees, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796