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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 11/895,404 and 11/704,665, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed applications fail to disclose “the source comprising an ErCrYSGG laser source” as recited in claims 13 and 17. As such claims 13-14 and 17-19 are given the priority date of application 12/395,643 which is 2/28/2009.
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 2, 4-5, 7-9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubu (US 6,162,052) in view of Nakajima et al (JP-H07155335 A).
Regarding claim 2, Kokubu discloses an apparatus for treating an infected or decaying condition in a tooth (col 3, lines 10-38 disclose a laser system that sterilizes and prepares a root canal for a root canal treatment), the apparatus comprising:
a laser system (laser treatment apparatus 60) configured to irradiate a liquid within a treatment region comprising a root canal of the tooth including the infected or decaying condition and to generate sufficient energy in the liquid to remove biotic material from a canal wall within the treatment region of the tooth via the photoacoustic effect the laser system comprising (this limitation interpreted as functional language achievable by Kokubu in view of the disclosure of the structural elements of the laser system and the disclosure of a laser beam generated by the laser beam source being easily absorbed by OH groups and H20 resulting in evaporation, see col 6, lines 15-19, which in conclusion means the level of energy being generated by Kokubu is great enough to activate a liquid and the combined use of the laser beam and a water supply on an irradiation site resulting in cavitation see, col 7, lines 4-11 and col 16, lines 30- 35);
a source of a laser light beam (laser beam source 61);
an elongate optical fiber (the inner core 30 of emission fiber 12, as see in figures 3 and 4) extending along a fiber axis (optic axis c) connected to the source (col 6, lines 25-30 disclose the emission fiber being part of laser probe 10 connects to the laser beam source) and configured to transmit the laser light beam to a tip thereof (emission end portion 22, see col 7, lines 20-24 and figures 2-3), the elongate optical fiber (30) comprising a substantially cylindrical and untapered segment from adjacent a proximal end of the elongate optical fiber to adjacent the tip (where the core of the emission fiber 30 is cylindrical within the layers 31-34, see figures 2 and 3 and col 7, lines 49- 51), the tip comprising a conical outer surface (first emission face 23 of core 30, see figures 2-3) which tapers to an apex (second emission face 24, see figure 3); and
a cladding (first jacket 32 which is made of a high polymer material, the second jacket 33 that is made of a high polymer material, clad 31, and electrode 34; see col 8, lines 3-12) comprising a sheath (clad 31) that coats a portion of a length of the elongate optical fiber (see figure 3), the sheath (31) extending from adjacent the proximal end of the elongate optical fiber (see figures 2 and 3) and at least the conical outer surface (emission face 23) is uncovered by the sheath (31) to allow transmission of laser light through the at least a portion of the conical outer surface (see figure 3),
wherein the conical outer surface (23) is shaped to emit at least a portion of light from the laser light beam laterally outwardly relative to the fiber axis into the liquid, the light emanating from the conical outer surface having sufficient power to create photoacoustic waves in the liquid of sufficient vibrational energy to remove at least the biotic material from the canal wall and from locations distant from the conical outer surface, including from at least one lateral canal extending from the root canal of the tooth (where the beams A1 include a path that is lateral to the axis beam 3 and thus rendering Kokubu shaped to perform the intended use recited in this limitation including the delivery to the lateral canals extending in the root canal which are structural part of a root canal including structures beyond the interior of the canal, such as lateral channels or openings at a distance from the canal wall).
Kokubu fails to disclose the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm.
However, Nakajima teaches a laser system (irradiation laser chip 23), with an elongate optical fiber (light guide optical fiber 25) with at least a portion being substantially cylindrical and untapered (see figures 5, 6 and 10), a sheath (the sheath is chip stop member 73/stud 73 which includes two pipes 78 and 79) extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the application tip (see figure 10, where the fiber 25 extends past the end of pipes 78/79) towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm (see figure 5-6 and 10, where the terminus is the ending of pipes 78 and 79 and the cylindrical and untapered section is 75a, where page 5, par 4 discloses the fiber extending 3 mm beyond the outside of the outer pipe 78/79).
Therefore, it would be obvious to one of ordinary skill in the art to modify Kokubu to have the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm as taught by Nakajima for the purpose of exposing a desired amount of the optical wire that influences the location and desired treatment.
Regarding claim 4, the limitation “configured to generate sufficient energy in the liquid to remove infected or decaying material from the tooth at a treatment region” is being interpreted as intended use of the claimed invention which could be performed by Kokubu in view of the disclosure of all the structural elements of the claimed invention set forth above. This conclusion is further supported by the disclosure of the level of laser being generated to be absorbed by OH groups and H20 resulting in evaporation (col 6, lines 15-19), as set forth above.
Regarding claim 5, the limitation “configured to cause the liquid to expand” is being interpreted as intended use of the claimed invention which could be performed by Kokubu in view of the disclosure of all the structural elements of the claimed invention set forth above. This conclusion of this being further supported by the disclosure of the level of laser being generated to be absorbed by OH groups and H20 resulting in evaporation (col 6, lines 15-19), as set forth
Regarding claim 7, the limitation “configured to irradiate the liquid without damaging the healthy tissue of the tooth” is being interpreted as intended use of the claimed invention which could be performed by Kokubu in view of the disclosure of all the structural elements of the claimed invention set forth above. This conclusion being further supported by the disclosure of Kokubu to combine an air or water treatment to accelerate the heat generation and cooling (col 7, lines 15-17).
Regarding claim 8, Kokubu further discloses the laser system comprises a pulsed laser (col 6, lines 16-19, discloses a pulse laser beam).
Regarding claim 9, Kokubu further discloses the proximal end of the elongate optical fiber (12) is connected to the source of the laser light beam (61) wherein the tip (22) is coupled to a distal end of the elongate optical fiber (col 6, lines 21-30 discloses the attachment of the laser beam to the laser source 61 also seen in figure 1 and col 7, lines 22-30 disclose the 22 being the end portion of 12 also seen in figure 2).
Regarding claim 15, Kokubu discloses an apparatus for treating an infected or decaying condition in a tooth (col 3, lines 10-38 disclose a laser system that sterilizes and prepares a root canal for a root canal treatment), the apparatus comprising:
a laser system (laser treatment apparatus 60) configured to irradiate liquid within a treatment region comprising a root canal of the tooth including the infected or decaying condition and to generate sufficient energy in the liquid to remove organic material from a canal wall within the treatment region of the tooth via the photoacoustic effect (this limitation interpreted as functional language which is achievable by Kokubu in view of the structural elements of the laser system, the disclosure of a laser beam generated by the laser beam source being easily absorbed by OH groups and H20 resulting in evaporation, see col 6, lines 15-19, which in conclusion means the level of energy being generated by Kokubu is great enough to activate a liquid and the combined use of the laser beam and a water supply on an irradiation site for cavitation see, col 7, lines 4-11 and col 16, lines 30- 35), the laser system comprising:
a source of laser light (laser beam source 61);
an elongate optical fiber (the inner core 30 of emission fiber 12, as see in figures 3 and 4) connected to the source (col 6, lines 25-30 disclose the emission fiber being part of laser probe 10 connects to the laser beam source) extending along a fiber axis (optic axis c) and configured to transmit the laser light to a tip thereof (emission end portion 22, see col 7, lines 20-24 and figures 2-3), the elongate optical fiber (30) comprising a substantially cylindrical and untapered segment from adjacent a proximal end of the elongate optical fiber to adjacent the tip (where the core of the emission fiber 30 is cylindrical within the layers 31-34, see figures 2 and 3 and col 7, lines 49- 51), the tip comprising a conical outer surface (first emission face 23 of core 30, see figures 2-3) which tapers to an apex (second emission face 24, see figure 3); and
a cladding (first jacket 32 which is made of a high polymer material, the second jacket 33 that is made of a high polymer material, clad 31, and electrode 34; see col 8, lines 3-12) comprising a sheath (clad 31) that coats a portion of a length of the elongate optical fiber (see figure 3), the sheath (31) extending from adjacent the proximal end of the elongate optical fiber (see figures 2 and 3) and at least the conical outer surface (emission face 23) is uncovered by the sheath (31) to allow at least a portion of the laser light to propagate laterally through at least the conical outer surface during operation of the laser system (see figure 3).
Kokubu fails to disclose the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm.
However, Nakajima teaches a laser system (irradiation laser chip 23), with an elongate optical fiber (light guide optical fiber 25) with at least a portion being substantially cylindrical and untapered (see figures 5, 6 and 10), a sheath (the sheath is chip stop member 73/stud 73 which includes two pipes 78 and 79) extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the application tip (see figure 10, where the fiber 25 extends past the end of pipes 78/79) towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm (see figure 5-6 and 10, where the terminus is the ending of pipes 78 and 79 and the cylindrical and untapered section is 75a, where page 5, par 4 discloses the fiber extending 3 mm beyond the outside of the outer pipe 78/79).
Therefore, it would be obvious to one of ordinary skill in the art to modify Kokubu to have the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm as taught by Nakajima for the purpose of exposing a desired amount of the optical wire that influences the location and desired treatment.
The limitation during operation of the laser system, the at least the portion of the laser light is directed laterally outwardly relative to the fiber axis into the liquid, the at least the portion of the laser light emanating from the tip having sufficient power to create photoacoustic waves in the treatment liquid of sufficient vibrational energy to remove at least some organic material from the canal wall and from locations distant from the conical outer surface including from at least one lateral canal extending from the root canal of the tooth is considered intended use which is achievable in view of the disclosure of the beams A1 include a path that is lateral to the axis beam 3 of Kokubu and thus rendering Kokubu shaped to perform the intended use recited in this limitation including the delivery to the lateral canals extending in the root canal which are structural part of a root canal including structures beyond the interior of the canal, such as lateral channels or openings at a distance from the canal wall.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubu in view of Nakajima et al as applied to claim 15 above, and further in view of Rizoiu (US 2009/0042171).
Regarding claim 17, Kokubu/Nakajima disclose the claimed invention as set forth above in claim 15, but fails to disclose the source comprises an ErCrYSGG laser source.
However, Rizoiu teaches treating an infected or decaying condition in a tooth (abstract discloses an endodontic probe being used to disinfect the target tissues within a root canal) with a laser light source comprising an ErCrYSGG laser source (par 88 discloses the use of an ErCrYSGG solid state laser).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the Kokubu/Nakajima to have the source comprises an ErCrYSGG laser source as disclosed by Rizoiu for the purpose of providing laser power sufficient to disrupt intra-tubular bacteria while being non-destructive to non-target tissue.
Regarding claim 18-19, Kokubu/Nakajima/Rizoiu disclose the claimed invention as set forth above by claim 17. Rizoiu further teaches the ErCrYSGG laser source is configured to operate at a power level in a range of 0.1 W to 1.5 W (calculated power levels being in a range of 0.02 W to 0.6 W or 0.04 W to 1.2 W, see par 88 which discloses a repetition rate of about 10 or 20 Hz and energy per pulse from about 2 to 60 mJ, wherein the formula for power P=W/At is used for the calculation, as such the laser source is considered capable of operating in the claimed power range) for the reason set forth above. It would be further obvious to modify the pulse duration which is considered a result effective variable, which can affect the operation and response of a target tooth. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have a pulse duration which is relatively low, such as 50 microseconds to 1000 microsecond, 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).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubu in view of Rizoiu and Nakajima et al.
Regarding claim 13, Kokubu discloses an apparatus for treating an infected or decaying condition in a tooth (col 3, lines 10-38 disclose a laser system that sterilizes and prepares a root canal for a root canal treatment), the apparatus comprising:
a laser system (laser treatment apparatus 60) configured to irradiate a liquid within a treatment region comprising a root canal of the tooth including the infected or decaying condition and to generate sufficient energy in the liquid to remove organic material from a canal wall within the treatment region of the tooth via the photoacoustic effect (this limitation interpreted as functional language which is achievable by Kokubu in view of the structural elements of the laser system, the disclosure of a laser beam generated by the laser beam source being easily absorbed by OH groups and H20 resulting in evaporation, see col 6, lines 15-19, which in conclusion means the level of energy being generated by Kokubu is great enough to activate a liquid and the combined use of the laser beam and a water supply on an irradiation site for cavitation see, col 7, lines 4-11 and col 16, lines 30- 35), the laser system comprising:
a source of laser light (laser beam source 61),
an elongate optical fiber (the inner core 30 of emission fiber 12, as see in figures 3 and 4) connected to the source (col 6, lines 25-30 disclose the emission fiber being part of laser probe 10 connects to the laser beam source) extending along a fiber axis (optic axis c) and configured to transmit the laser light to a tip thereof (col 6, lines 25-30 disclose the emission fiber being part of laser probe 10 connects to the laser beam source), the elongate optical fiber (30) comprising a substantially cylindrical and untapered segment from adjacent a proximal end of the elongate optical fiber to adjacent the tip (where the core of the emission fiber 30 is cylindrical within the layers 31-34, see figures 2 and 3 and col 7, lines 49- 51), the tip comprising a conical outer surface (first emission face 23 of core 30, see figures 2-3) which tapers to an apex (second emission face 24, see figure 3); and
cladding (first jacket 32 which is made of a high polymer material, the second jacket 33 that is made of a high polymer material, clad 31, and electrode 34; see col 8, lines 3-12) comprising a sheath (clad 31) that coats a portion of a length of the elongate optical fiber (see figure 3), the sheath (31)extending from adjacent the proximal end of the elongate optical fiber (see figures 2 and 3 and at least the conical outer surface (emission face 23) is uncovered by the sheath (31) to allow at least a portion of the laser light to propagate laterally through at least the conical outer surface during operation of the laser system (see figure 3).
Kokubu fails to disclose the source comprising an ErCrYSGG laser source configured to operate at a power level in a range of 0.1 W to 1.5 W and at a pulse duration in a range of 50 microseconds to 1000 microseconds to generate laser light and the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm
However, Rizoiu teaches treating an infected or decaying condition in a tooth (abstract discloses an endodontic probe being used to disinfect the target tissues within a root canal) with a laser light source comprising an ErCrYSGG laser source (par 88 discloses the use of an ErCrYSGG solid state laser) which is configured to operate at a power level in a range of 0.1 W to 1.5W (calculated power levels being in a range of 0.02 W to 0.6 W or 0.04 W to 1.2 W, see par 88 which discloses a repetition rate of about 10 or 20 Hz and energy per pulse from about 2 to 60 mJ, wherein the formula for power P=W/At is used for the calculation, as such the laser source is considered capable of operating in the claimed power range) and configurated to have the photo-acoustic waves having different characteristics based on the target, wherein these characteristics include pulse and duration (par 81) and that adjustments can be made so that the laser may be relatively low (e.g., non-destructive to the tissue) radiation for one or more of opening soft tissue and/or making it more (a) penetrable by way for example of the application of low level light therapy and/or (b) tolerant to pain whereby tissue is just conditioned for cutting (e.g., conditioned whereby nerve path changes can raise pain threshold for an analgesic effect, such as in a cavity preparation procedure, par 85) for the purpose of providing power sufficient to disrupt intra-tubular bacteria while being non-destructive to non-target tissue (par 85).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date to modify Kokubu to have the laser light source comprising an ErCrYSGG laser source configured to operate at a power level in a range of 0.1 W to 1.5 W, as disclosed by Rizoiu for the purpose of providing power sufficient to disrupt intra-tubular bacteria while being non-destructive to non-target tissue. It would be further obvious to modify the pulse duration which is considered a result effective variable, which can affect the operation and response of a target tooth. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have a pulse duration which is relatively low, such as 50 microseconds to 1000 microsecond, 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).
Nakajima teaches a laser system (irradiation laser chip 23), with an elongate optical fiber (light guide optical fiber 25) with at least a portion being substantially cylindrical and untapered (see figures 5, 6 and 10), a sheath (the sheath is chip stop member 73/stud 73 which includes two pipes 78 and 79) extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the application tip (see figure 10, where the fiber 25 extends past the end of pipes 78/79) towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm (see figure 5-6 and 10, where the terminus is the ending of pipes 78 and 79 and the cylindrical and untapered section is 75a, where page 5, par 4 discloses the fiber extending 3 mm beyond the outside of the outer pipe 78/79).
Therefore, it would be obvious to one of ordinary skill in the art to modify Kokubu to have the sheath extending from adjacent the proximal end of the elongate optical fiber to a terminus edge spaced proximally from a distal end of the tapered tip towards the proximal end of the elongate optical fiber by a distance of no more than 10 mm as taught by Nakajima for the purpose of exposing a desired amount of the optical wire that influences the location and desired treatment.
The limitation during operation of the laser system, the at least the portion of the laser light is directed laterally outwardly relative to the fiber axis into the liquid, the at least the portion of the laser light emanating from the tip having sufficient power to create photoacoustic waves in the treatment liquid of sufficient vibrational energy to remove at least some organic material from the canal wall and from locations distant from the conical outer surface including from at least one lateral canal extending from the root canal of the tooth is considered intended use of the claimed invention, which is achievable in view of the shape of the beams and paths disclosed by Kokubu which include a path that is lateral to the axis beam and the disclosed operation values made obvious by Rizoiu and thus rendering Kokubu shaped to perform the intended use recited in this limitation including the delivery to the lateral canals extending in the root canal which are structural part of a root canal including structures beyond the interior of the canal, such as lateral channels or openings at a distance from the canal wall.
Regarding claim 14, Kokubu discloses the optical fiber has a diameter in a range of 200 microns to 400 microns (Col 7, lines 61-65 discloses the core 30 being about 200 microns).
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the prior art fails to disclose the light emanating from the conical outer surface having sufficient power to create photoacoustic waves in the liquid of sufficient vibrational energy to remove at least the biotic material from the canal wall and from locations distant from the conical outer surface, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANNEL N BELK whose telephone number is (571)272-9671. The examiner can normally be reached Mon. -Fri. 11:30 am - 3:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.N.B./ Examiner, Art Unit 3772
/EDELMIRA BOSQUES/ Supervisory Patent Examiner, Art Unit 3772