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 .
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-6) in the reply filed on 25 June 2026 is acknowledged. The traversal is on the ground(s) that Invention I and II share a special technical feature. This is not found persuasive because the restriction is based on US restriction practice not the unity of invention standard. Invention I and II are distinct inventions under US restriction practice as outlined in the restriction requirement mailed 30 April 2026. Claims 7-15 are withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because the graphics and text of Figures 1-3B are not of sufficient quality such that all details in the drawings are reproducible in the printed patent [see MPEP §608.02 V-VII]. For example, in Figure 1 the text and lines are blurry and some of the text overlaps the lines. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the moving piece is referenced using #82 rather #81 in paragraph [0069].
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “the drive control circuit… controls the … convex lens” is not sufficiently supported by the original disclosure. The applicant’s specification indicates the convex lens maintains a constant working distance [par. 0052]. The fiber optic moves relative to the convex lens. There is no disclosure of any powered elements or circuits involving the convex lens that could be controlled by the drive control circuit.
Claims 2-6 are rejected for depending from claim 1.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (US 6,110,195) in view of Liu et al. (US 2014/0214136), in view of Shurgalin et al. (US 9,063,299), in view of Rhodes et al. (US 2016/0346565), and further in view of Li (US 2012/0157979).
[Claim 1] Xie discloses a multi-wavelength laser treatment device [abstract] for trichophyton rubrum induced onychomycosis, comprising:
a drive control circuit (control circuit, Fig. 4 #14”),
a power supply (Fig. 4 #13”),
an optical system (components within an enclosure, Fig. 4 #11”),
an air-cooled heat sink (thermoelectric cooling/heat transfer system, see Fig. 4),
an output fiber optic (optical fiber, Fig. 4 #31”), and
a hand tool (handpiece, Fig. 4 #32”);
wherein,
the hand tool includes a moving piece (scanner device for moving the beam in a pattern), a convex lens (focusing optics to create a high energy density, or defocusing optics for a broad dispersal of the laser energy) [col. 4, lines 8-21],
the drive control circuit is powered by the power supply and controls the optical system, air-cooled heat sink, moving piece, and convex lens [col. 3, lines 49-56; col. 4 lines 16-21; col. 5, lines 54-62],
the optical system includes a first laser chip (laser diode λ1, #12”), a second laser chip (laser diode λ2, #12”), a third laser chip (laser diode λn, #12”), a first optical mirror (dichroic mirror, Fig. 4 #51a), a second optical mirror (dichroic mirror, Fig. 4 #51b), and a coupler (external connector, Fig. 4 #29”),
a light beam is coupled to the output fiber optic through the coupler and emits light from the light emitting end face of the hand tool (see light beam path shown in Figure 4).
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Xie discloses a cooling system but does not specify an air-cooled heat sink.
Liu discloses an analogous phototherapy device comprising a laser unit (Fig. 2 #14) with a heat sink (Fig. 2 #16) cooled by a fan (Fig. 2 #34) [par. 0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the air-cooled heat sink of Liu as the thermoelectric cooler in Xie in order to predictably dissipate heat from the laser chips.
Xie discloses a handpiece including optics but does not specify a convex lens or a bracket that serves as a light emitting end face for fitting to the skin.
Shurgalin discloses an analogous handpiece (Fig. 1A #140) comprising a lens for focusing a laser beam and bracket (stand off tip, Fig. 1A #144) serving as a light emitting end face for fitting to the skin [col. 5, line 62 – col. 6, line 6].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the handpiece of Xie to include a convex lens and bracket at taught by Shurgalin in order to focus the light beam to the desired spot size while maintaining a desired distance between the laser beam output and the target tissue.
Xie discloses using multiple wavelengths but does not specify the first laser chip, the second laser chip and the third laser chip have a light emitting wavelength of 405 nm, 1064 nm or 632 nm respectively, for emitting light beams of 405 nm, 1064 nm and 632 nm wavelengths in turn; the 405nm is used for disinfection and sterilization of bacteria and viruses attached to a surface of and around the onychomycosis, the 1064nm is used to treat the trichophyton rubrum induced onychomycosis, and the light beam of 632 nm wavelength is used for rehabilitation.
Rhodes discloses a device for delivering therapeutic radiation to a body surface comprising wavelengths of 405 nm, about 633 nm (which is considered to read on 632 nm), and 1064 nm in order to sterilize one or more target organisms and/or to promote healthy cell growth and healing [pars. 0011, 0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use lasers in the device emitting wavelengths of 405 nm, 632 nm and 1064 nm as taught by Rhodes in order to sterilize and promote healing of a target tissue. Since the wavelengths rendered obvious are the same as applied by the applicant, the wavelengths would provide the same effects including treating trichophyton rubrum induced onychomycosis.
Xie does not disclose the moving piece is used to fix a light emitting end of the output fiber optic and can switch between a converging position and a diverging position; when the moving piece is in the converging position, a distance L from the light emitting end of the output fiber optic to an optical center of the convex lens satisfies: f＜L＜2f; when the moving piece is in the diverging position, the distance L from the light emitting end of the output fiber optic to the optical center of the convex lens satisfies: L<f.
Li discloses an analogous laser assembly for controlling convergence/divergence of a laser beam by adjusting the distance between a first lens (#10) connected to the distal end of an optical fiber (#5, #102) and second lenses (#12). Lens characteristics, such as focal length and separation distances between multiple lenses, may be factors in determining spot size and intensity [par. 0032]. The distance between the first and second lenses may be altered by relative movement between the optical fiber and a sheath (#6). In one embodiment, for example, the sheath may be distally advanced to increase the distance between the first and second lenses and may be proximally retracted to decrease the distance between the first and second lenses 10, 12, as depicted by double-headed arrow 22. In another embodiment, the optical fiber may be distally advanced or proximally retracted, while the sheath is kept stationary [par. 0033]. The laser assembly may also include a moving piece (positioning mechanism, #105) for moving and setting a relative position between the sheath and the optical fiber 102. The positioning mechanism 105 may include, for example, a threaded screw-nut configuration [par. 0038]
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device to include a moving piece for moving the output end of the optical fiber to a converging position and diverging position as taught by Li in order to provide the desired laser beam properties for treatment. Setting a distance L from the light emitting end of the output fiber optic to an optical center of the convex lens satisfies: f＜L＜2f to achieve a converging position, and setting the distance L from the light emitting end of the output fiber optic to the optical center of the convex lens satisfies: L<f to achieve a diverging position is an intended use that could be performed by the system.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (US 6,110,195) in view of Liu et al. (US 2014/0214136), in view of Shurgalin et al. (US 9,063,299), in view of Rhodes et al. (US 2016/0346565), in view of Li (US 2012/0157979) as applied to claim 1 above, and further in view of Papac et al. (US 8,662,670).
[Claim 2] The previously applied references disclose using mirrors to combine the beams of the three laser chops but do not disclose the second laser chip and the third laser chip are both located between the first laser chip and the coupler, a light emitting direction of the first laser chip passes through an optical center of the coupler and is aligned with a centerline of the output fiber optic, a light emitting direction of the second laser chip and the third laser chip is perpendicular to the light emitting direction of the first laser chip, and the third laser chip is closer to the coupler compared with the second laser chip.
Papac discloses an analogous device comprising the applicant’s claimed configuration combining the beams of a first, second and third light source as shown by the annotated figure below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to replace the configuration of the first, second, third laser chips and coupler taught by Xie with the configuration taught by Papac in order to predictably provide the beams from the laser chips to the optical fiber. The two arrangements would yield the same end result and are therefore obvious substitutions of one another.
[Claim 3] As shown in the annotated Figure above, the optical center of the first optical mirror is located in the light emitting direction of the first laser chip, and the first optical mirror is tilted relative to the light emitting direction of the first laser chip.
[Claim 4] Papac discloses the first optical mirror is a dichroic mirror wherein an incident surface of the first optical mirror towards the first laser chip is coated with an antireflective film to transmit emitted light of the first laser chip; an exit surface of the first optical mirror towards the coupler is coated with a reflective film to reflect emitted light of the second laser chip [col. 2, line 43 – col. 3, line 13]. The examiner takes Official Notice that antireflective films are well-known components of dichroic mirrors.
[Claim 5] As shown in the annotated Figure above, the optical center of the second optical mirror is located in the light emitting direction of the first laser chip, and the second optical mirror is tilted relative to the light emitting direction of the first laser chip.
[Claim 6] Papac discloses the second optical mirror is a dichroic mirror wherein: an incident surface of the second optical mirror towards the first laser chip is coated with an antireflective film to transmit a light beam from the first laser chip and a light beam from the second laser chip; an exit surface of the second optical mirror towards the coupler is coated with a reflective film to reflect a light beam from the third laser chip [col. 3, lines 14-47]. The examiner takes Official Notice that antireflective films are well-known components of dichroic mirrors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(1) Takimura et al. (US 2012/0283576) discloses an analogous probe for controlling convergence and divergence of light emitted from a light source comprising a moving mechanism section (Fig. 1 #25) that moves the objective optical system (Figs. 2a-c #4) or an optical fiber group (Figs. 2a-c #3) [pars. 0023, 0044].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 1 August 2026
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