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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/12/2026 has been entered.
Information Disclosure Statement
The Information Disclosure Statements filed 02/26/2026 and 03/12/2026 have been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pages 5-8, with respect to the 35 U.S.C. 103 rejection of claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The previously-held 35 U.S.C. 103 rejection was obviated by Applicant’s amendment to claim 1. Please see 35 U.S.C. 103 rejections below made in view of Bergheim, et al. (U.S. PGPub No. 2013/0040267).
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 1-2 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim, et al. (U.S. PGPub No. 2013/0040267) and Monty, et al. (U.S. PGPub No. 2015/0342703).
Regarding claim 1, Bergheim teaches (Fig. 2, # 64 – pressure wave generator, 67 – pressure waves) a system for providing a laser treatment to an endodontic canal to decontaminate, clean, and remove a smear layer of the endodontic canal (Par. [0037] – The disclosed apparatus, methods, and compositions advantageously may be used with root canal cleaning treatments, for example, to efficiently remove organic and/or inorganic matter from a root canal system and/or to disinfect the root canal system; Par. [0048] – the pressure wave generator 64 may include … an optical system that can provide optical energy to the tooth chamber 65 (e.g., an optical fiber that propagates laser light into the tooth chamber; Par. [0113] – In some embodiments, the pressure waves 67 generated in the pulp chamber 28 can be used to remove smear layer and debris in instrumented canal.), the system comprising:
a (Figs. 4D, 6A, and 7-8, # 50 – handpiece) handpiece for delivering a plurality of laser pulses of a laser beam (Par. [0107]; Par. [0138]; Par. [0157] – a handpiece 50 comprising an embodiment of a positioning member configured to deliver liquid jet 60 to a portion of the tooth. The position member comprises a guide tube 100; Par. [0169] – Thus, the guide tube 100 can be used to deliver a pressure wave generator 64 to the tooth chamber 65. Embodiments of the guide tube 100 may, but need not, be used with non-jet pressure wave generators. For example, in an optical arrangement, an optical fiber can be disposed along the lumen or channel 84 of the guide tube 100.; Par. [0102]; Par. [0203] – An electromagnetic beam of radiation (e.g., a laser beam) can propagate energy into the tooth chamber, and the electromagnetic beam energy can be transformed into pressure waves as it enters the treatment fluid.; Par. [0205] – The electromagnetic energy can be pulsed or modulated (e.g., via a pulsed laser), for example with a repetition rate in a range from about 1 Hz to about 10 kHz.) from a CO2 laser source, the laser beam having a wavelength in a range from 9 μm to 11 μm (Par. [0204] – The wavelength is in a range from … about 3 microns to about 30 microns (e.g., 9.4 microns or 10.6 microns; Par. [0206] – The laser can include one or more of a … CO2 laser), wherein the handpiece comprises a beam guidance system (Par. [0203] – The electromagnetic radiation from a radiation source (e.g., a laser) can be propagated to the tooth chamber by an optical waveguide (e.g., an optical fiber), and dispersed into the fluid at a distal end of the waveguide (e.g., a shaped tip of the fiber, e.g., a conically-shaped tip). In other implementations, the radiation can be directed to the tooth chamber by a beam scanning system.); and
an (Fig. 2, # 64 – pressure wave generator) optical element to adapt the laser beam such that the plurality of laser pulses are delivered into a treatment site at the endodontic canal (Par. [0102] – the pressure wave generator 64 may not act as a source of fluid, e.g., the pressure wave generator 64 may comprise an optical fiber delivering laser light energy to the tooth chamber 65; Par. [0203] – The electromagnetic radiation from a radiation source (e.g., a laser) can be propagated to the tooth chamber by an optical waveguide (e.g., an optical fiber) [i.e., optical element], and dispersed into the fluid at a distal end of the waveguide (e.g., a shaped tip of the fiber, e.g., a conically-shaped tip). In other implementations, the radiation can be directed to the tooth chamber by a beam scanning system.),
wherein the laser pulses include a laser irradiation energy level (Par. [0205] – The pulse energy can be in a range from about 1 mJ to about 1000 mJ), and
wherein the laser irradiation energy level creates a pressure wave and induces agitation or cavitation of irrigants in the endodontic canal (Par. [0051]; Par. [0115] – For example, in some systems where the pressure wave generator comprises a laser device, the light energy delivered from the laser may excite the nanoparticles and lead to more efficient photo-induced cavitation or pressure wave generation.; Par. [0203] – An electromagnetic beam of radiation (e.g., a laser beam) can propagate energy into the tooth chamber, and the electromagnetic beam energy can be transformed into pressure waves as it enters the treatment fluid. For example, at least some of the electromagnetic energy may be absorbed by the fluid (e.g., water) in the tooth chamber, which can generate localized heating and pressure waves that propagate in the fluid. The pressure waves generated by the electromagnetic beam can generate photo-induced or photo-acoustic cavitation effects in the fluid.; Par. [0212]).
Bergheim does not explicitly teach the limitation of instant claim 1, that is wherein the beam guidance system is comprising a first galvanometer mirror servo-mechanically controlled by a first galvanometer and a second galvanometer mirror servo-mechanically controlled by a second galvanometer.
Monty teaches a dental laser apparatus with an interchangeable hand piece (Title, Abstract, Par. [0002]). Monty teaches that lasers can be useful in several hard and soft tissue dental procedures, including: removing decay, cutting, drilling or shaping hard tissue, and removing or cutting soft tissue (Par. [0003]). Monty teaches that the enamel and dentin of a tooth are similar in composition and are roughly 85% mineral, carbonated hydroxyapatite (Par. [0004]). Monty teaches that hydroxyapatite absorbs laser light in the 9.3-9.6 μm wavelength range more efficiently than radiation in any other wavelength range (Par. [0004]). Monty teaches that the laser beam of the treatment system may include a wavelength in a range of about 9 μm to about 11.5 μm (Par. [0023]). Monty teaches the limitation of instant claim 1, that is wherein (Fig. 3A, # 5 – interchangeable hand piece, 10 – main chamber, 23 – adjustable mirrors, 25 – galvanometers; Figs. 7A-C, # 19 – first galvanometer mirror, 21 – first galvanometer, 23 – second galvanometer mirror, 25 – second galvanometer) the beam guidance system is comprising a first galvanometer mirror servo-mechanically controlled by a first galvanometer and a second galvanometer mirror servo-mechanically controlled by a second galvanometer (Par. [0064] – The laser beam is directed through the main chamber 10 toward the interchangeable hand piece 5 using one or more adjustable mirrors 23. Galvanometers 25 (servomechanisms, in general) are attached to the mirrors 23 to allow for angular movement of the mirrors and electronically controlled beam guidance.; Par. [0096] – The first galvanometer mirror is attached to a shaft of a first galvanometer 21. The angular orientation in a first axis of the first galvanometer mirror and, therefore, the laser's angle of incidence onto the first galvanometer mirror relative to the first axis is servo-mechanically controlled by the first galvanometer. The first galvanometer mirror is generally orientated so that the beam once reflected off the first galvanometer mirror is directed toward a second galvanometer mirror 23, which is attached to a shaft of a second galvanometer 25. The angular orientation in a second axis of the second galvanometer mirror and, therefore, the laser's angle of incidence onto the second galvanometer mirror relative to the second axis is servo-mechanically controlled by the second galvanometer.). It is further noted that Monty teaches (Fig. 4, # 43 – hollow wave guide) that in some embodiments, a hand piece can include a straight hollow wave guide or fiber (Par. [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented well-known galvanometers and galvanometer mirrors of Monty’s beam guidance system (i.e., including the first/second galvanometers and first/second galvanometer mirrors) into the beam scanning system of Bergheim’s system (see Par. [0203] of Bergheim) in order to provide electronically controlled beam guidance (see Par. [0064] of Bergheim). One of ordinary skill in the art would have desired electronically controlled beam guidance in order to provide precise radiation beams for the dental laser treatment procedure.
Therefore, claim 1 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 2, Bergheim, in view of Monty, renders obvious the system of claim 1, as indicated hereinabove. Bergheim also teaches the limitation of instant claim 2, that is wherein the laser treatment provides a rate of irrigation or movement of irrigants from about 1 to about 20 mm/s (Par. [0145] – flow rate can be 0.01 to 5 cc/s; It is noted that 1 millimeter/s = 0.001 cubic centimeter/s, so 0.01 cc/s is equal to 10 mm/s).
Therefore, claim 2 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 5, Bergheim, in view of Monty, renders obvious the system of claim 1, as indicated hereinabove. Bergheim also teaches the limitation of instant claim 5, that is wherein a laser pulse of the plurality of laser pulses comprises a duration from about 1 to about 100 μsec (Par. [0205] – The pulse width can be in a range from about 10 ns to about 500 μs).
Therefore, claim 5 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 6, Bergheim, in view of Monty, renders obvious the system of claim 1, as indicated hereinabove. Bergheim does not explicitly teach the limitation of instant claim 6, that is wherein the beam guidance system is adapted to direct the plurality of laser pulses to respective tissue locations in a pattern.
However, Monty teaches the limitation of instant claim 6, that is wherein the beam guidance system is adapted to direct the plurality of laser pulses to respective tissue locations in a pattern (Par. [0107] – Laser pulses are then delivered to the selected region according to a pattern such as a spiral pattern, zig-zag scanning pattern, random pattern, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the feature of Monty’s beam guidance system to direct the plurality of laser pulses to respective tissue locations in a pattern into Bergheim’s beam guidance system, because doing so would allow for the galvo/servo-mirror assembly to scan the selected region such that laser pulses are not delivered continuously to a single spot (Par. [0107] of Monty). One of ordinary skill in the art would also desired to implement this feature of Monty’s beam guidance system in order to avoid or reduce overheating and potentially harmful ablation of a spot on the tooth or gum (Par. [0107] of Monty).
Therefore, claim 6 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 7, Bergheim, in view of Monty, renders obvious the system of claim 6, as indicated hereinabove. Monty teaches the limitation of instant claim 7, that is wherein the pattern comprises a number of locations from about 15 locations to about 1500 locations (Par. [0107] – Laser pulses are then delivered to the selected region according to a pattern such as a spiral pattern, zig-zag scanning pattern, random pattern, etc. Specifically, the laser beam impinges upon several spots within the selected region according to the user selected pattern.; Par. [0114] – The laser source may also be triggered in a burst pulse pattern that includes a sequence of bursts of laser pulses).
Therefore, claim 7 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 8, Bergheim, in view of Monty, renders obvious the system of claim 6, as indicated hereinabove. Monty also teaches the limitation of instant claim 8, that is wherein the beam guidance system is adapted to repeat directing the plurality of laser pulses to respective tissue locations in the pattern (Par. [0110] – As such, the number of pulses at each location point can be controlled to control the amount of laser energy to be delivered to that location. (multiple pulses at each location, i.e., repeating pulses to respective locations); Par. [0111] – repetition rate).
Therefore, claim 8 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 9, Bergheim, in view of Monty, renders obvious the system of claim 6, as indicated hereinabove. Monty also teaches the limitation of instant claim 9, that is wherein the pattern comprises at least one tissue location, at least one location non-adjacent to the tissue location, and at least one location adjacent to the tissue location Par. [0107] – Laser pulses are then delivered to the selected region according to a pattern such as a spiral pattern, zig-zag scanning pattern, random pattern, etc. Specifically, the laser beam impinges upon several spots within the selected region according to the user selected pattern. The movement of the laser beam can be controlled by a galvo/servo-mirror assembly, which is configured to scan the selected region such that laser pulses are not delivered continuously (e.g., for a duration of a few milliseconds) to a single spot.).
Therefore, claim 9 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 10, Bergheim, in view of Monty, renders obvious the system of claim 1, as indicated hereinabove. Bergheim also teaches the limitation of instant claim 10, that is wherein (Fig. 4C and 7, # 50, 100, 120) the handpiece is adapted to form an exit orifice and operatively connected to the beam guidance system for delivering the laser beam to the treatment site (Par. [0169] – Thus, the guide tube 100 can be used to deliver a pressure wave generator 64 to the tooth chamber 65. Embodiments of the guide tube 100 may, but need not, be used with non-jet pressure wave generators. For example, in an optical arrangement, an optical fiber can be disposed along the lumen or channel 84 of the guide tube 100. The fiber can have a tip configured to radiate light energy propagating in the fiber out into the fluid in the tooth chamber 65. The tip may be disposed so that the radiating light energy can exit the tip through a window 120 in the guide tube 100.).
Therefore, claim 10 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 11, Bergheim, in view of Monty, renders obvious the system of claim 10, as indicated hereinabove. While Bergheim does teach that the radiation can be directed to the tooth chamber by a beam scanning system, Bergheim does not explicitly teach the limitation of instant claim 11, that is wherein the handpiece further comprises a focusing optic and at least one optical lens, wherein the at least one optical lens is disposed between the beam guidance system and a tip.
However, Monty teaches the limitation of instant claim 11, that is wherein (Figs. 7A-7C, # 27 – first focusing optic, i.e. lens, 29 – second focusing optic, i.e. lens) the handpiece further comprises a focusing optic and at least one optical lens, wherein the at least one optical lens is disposed between the beam guidance system and a tip (Par. [0096] – The second galvanometer mirror is generally oriented so that the beam once reflected off the second galvanometer mirror is directed along an optical axis 26, toward and through a first focusing optic 27 that is generally centered along the optical axis 26. The first focusing optic 27 generally has a concave curvature. The first focusing optic 27 defocuses the beam, increasing the beam width as the beam is directed toward and through a second focusing optic 29, that is also generally centered around the optical axis 26. The second focusing optic 29 has a generally convex curvature and may be larger in diameter than the first focusing optic 27 to allow for the increased beam width. The curvatures and locations of the first and second focusing optics are selected such that the beam is focused outside the hand piece at a selectable distance from an orifice thereof.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Monty’s focusing optic and at least one lens into Bergheim’s system, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing Monty’s focusing optic and at least one lens in order to precisely focus the beam outside of the hand piece at a selectable distance from the hand piece’s orfice for desired treatment.
Therefore, claim 11 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 12, Bergheim, in view of Monty, renders obvious the system of claim 11, as indicated hereinabove. Monty also teaches the limitation of instant claim 12, that is wherein (Figs. 7A-C, # 27 and 29) the at least one lens comprises two lenses (Par. [0096] – first focusing optic 27 and second focusing optic 29).
Therefore, claim 12 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 13, Bergheim, in view of Monty, renders obvious the system of claim 11, as indicated hereinabove. Monty also teaches the limitation of instant claim 13, that is wherein (Figs. 7A-C, # 27 and 29) the focusing optic and the at least one lens are configured to increase a diameter of the laser beam (Par. [0096] – The first focusing optic 27 defocuses the beam, increasing the beam width as the beam is directed toward and through a second focusing optic 29, that is also generally centered around the optical axis 26. The second focusing optic 29 has a generally convex curvature and may be larger in diameter than the first focusing optic 27 to allow for the increased beam width.).
Therefore, claim 13 is unpatentable over Bergheim, et al. and Monty, et al.
Regarding claim 14, Bergheim, in view of Monty, renders obvious the system of claim 11, as indicated hereinabove. Monty also teaches the limitation of instant claim 14, that is wherein (Figs. 7A-C, # 27 and 29) the focusing optic and the at least one lens are configured to generate a collimated laser beam (Par. [0096] – The curvatures and locations of the first and second focusing optics are selected such that the beam is focused (i.e., collimated laser beam) outside the hand piece at a selectable distance from an orifice thereof.).
Therefore, claim 14 is unpatentable over Bergheim, et al. and Monty, et al.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bergheim, et al. (U.S. PGPub No. 2013/0040267) and Monty, et al. (U.S. PGPub No. 2015/0342703), further in view of Groves, et al. (U.S. PGPub No. 2018/0325622).
Regarding claim 4, Bergheim, in view of Monty, renders obvious the system of claim 1, as indicated hereinabove. Bergheim does not explicitly teach the limitation of instant claim 4, that is wherein the laser irradiation energy level of a laser pulse of the plurality of laser pulses is no more than about 1 J/cm2
However, Bergheim does teach that the pulse energy can be in a range from about 1 mJ to about 1000 mJ (Par. [0205]).
Groves teaches a system and method for preventative dental hard tissue treatment with a laser (Title, Abstract). Groves teaches that a pulse duration (or pulse energy) and laser beam width are selected in order to produce a fluence profile having a maximum local fluence (located at the center of a laser beam) below a minimum melting fluence threshold (e.g. 1.1 J/cm2), while keeping some portion of the fluence profile above a lower therapeutic fluence (e.g. 0.7 J/cm2) (Par. [0101]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Groves’ teaching for the laser irradiation energy level of a laser pulse into Bergheim’s modified system, because doing so would be an example of applying a known technique to a known device ready for improvement to yield predictable results. One of ordinary skill in the art would have desired a laser irradiation energy level of a laser pulse below about 1 J/cm2 in order to avoid melting of dental hard tissue (please see at least Par. [0101] of Groves).
Therefore, claim 4 is unpatentable over Bergheim, et al., Monty, et al., and Groves, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796