DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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.
Claims 1-12 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.
Claim 1 recites “synchronizing the digital controller to modulate the first and second laser diodes such that the blue laser and the infrared laser perform simultaneous tissue ablation and hemostasis while the third laser diode provides continuous nonthermal photobiomodulation to a treatment site; emitting light from said first, second, and third laser diodes to a the treatment site, wherein the first and second laser diodes are synchronized to perform tissue ablation and hemostasis, while the third red laser diode concurrently delivers continuous nonthermal photobiomodulation to said treatment site”.
There is no indication in the disclosure at the time of filing that the photobiomodulation occurs concurrently with the treatments performed by the other lasers. Paragraphs 110 and 111 in the specification teach using the red light for aiming and that at higher powers it can be used for photobiomodulation, but does not teach performing photobiomodulation at the same time that treatments are performed by the other lasers. While delivery of all three wavelengths simultaneously is taught, the red laser is addressed as being used as an aiming beam when used in combination with other lasers (see ¶ 107) and that a higher power would be required for using the red laser for photobiomodulation (¶ 110,111). Nor do any of the examples of particular procedures provided indicate performing photobiomodulation concurrently or simultaneously with treatments performed by the blue or infrared lasers.
Claims 2-12 are rejected due to their dependence on claim 1.
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.
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 “combining up to three light beams from the three laser diodes into a single beam on an optical table” after reciting limitations to synchronizing the three laser diodes and emitting light from the three laser diodes to the treatment site. It is unclear if this limitation of combining up to three light beams is intended to recite an additional step in the method, such that the emitted light from the three lasers to the treatment site could be three separate beams and then at another time or step the laser light beams are combined, or if it is intended to place a limitation on the emitted light to the treatment site that such emitted light be a combined single beam.
Claim 1 also recites, on the second page of the claim, the digital controller adjusting the output “required for simultaneous soft tissue cutting and tissue biostimulation”. It is unclear if soft tissue cutting is intended to be the same as tissue ablation and if tissue biostimulation is intended to be the same as photobiostimulation above. Furthermore, the next limitation recites “performing laser surgery”. It is unclear if this laser surgery is referring to the tissue ablation and hemostasis above or if it requires an additional step of laser surgery with the combined single beam. Similarly, the limitation of “performing nonthermal photobiomodulation” addresses further details of photobiomodulation and needs to be clarified if it addresses the photobiomodulation claimed to be performed simultaneously with other procedures or if it is reciting an additional step. Relatedly, it is unclear whether the sum of energy is over only the photobiomodulation step, or steps, or if it is accounting for all energy delivered by all three lasers.
For the sake of examination, the combining of the light beams will be considered to be a limitation on how the three synchronous lights are delivered, all procedures (tissue ablation vs. tissue cutting, tissue biostimulation vs. photobiomodulation, laser surgery) will be considered to be those that are part of the synchronous tissue ablations, hemostasis, photobiomodulation step, and the sum of energy will be considered to be all energy delivered by all lasers.
Claims 2-11 are rejected due to their dependence on claim 1.
Claim 4 contains the limitation “wherein: activation of the first laser diode but not the second laser diode cures bonding materials, composite cements, composite restorations, endodontic composite cores, prosthetic reline and/or repair material, sealants, splint material, veneers, and crowns via tack curing.” It is unclear whether this is intended to be a positively recited limitation to a method step or to an intended use functional limitation on the laser diodes that are provided in the first step of claim 1 (i.e. a capability of the first laser diode). Additionally, claim 1 recites that the blue laser is used for tissue ablation. If claim 4 is intended to recite an additional step in the method requiring curing of the material, it is unclear if that step occurs simultaneously with the tissue ablation required in claim 1 or if the curing is an additional step which may occur before or after the tissue ablation, hemostasis, and photobiomodulation of claim 1. For the purposes of examination, this was interpreted as an intended use (functional) limitation, therefore requiring that the laser diodes provided in claim 1 are capable of being used in such a way.
Claim 5 contains the limitations “wherein: in vivo dental composite heating is achieved when the second laser diode is operated at 0.4 to 2.0 Watts for 5 to 30 seconds with a wavelength of 800 to 1200 nanometers; and, photopolymerization of composites is achieved under control of the digital controller whereby the second laser diode is automatically deactivated and the first laser diode is automatically operated at 0.2 to 0.4 Watts for 1 to 10 seconds using a 10 to 30 Hz pulsed emission.” It is unclear whether these limitations are meant to be a positively recited limitation to a required step in the method or if these limitations are to an intended functional use limitation on the laser diodes that are provided in the first step of claim 1. For the purposes of examination, this was interpreted as an intended use (functional) limitation, therefore requiring that the laser diodes provided in claim 1 are capable of being used in such a way.
Claims 6-10 are rejected due to their dependency on claim 5.
Claim 9 also recites the limitation “the composite is additionally able to be cured through a structure of tooth enamel”. It is unclear whether this limitation is meant to be a positively recited limitation to a required step in the method (i.e. a step of curing the composite through a structure of the tooth enamel) or if these limitations are to an intended functional use limitation on the laser diodes that are provided in the first step of claim 1 (i.e. the laser diodes are capable of curing a composite through a structure of tooth enamel). For the purposes of examination, this was interpreted as an intended use (functional) limitation, therefore requiring that the laser diodes provided in claim 1 are capable of being used in such a way.
Claim 11 recites the limitation "the composite". There is insufficient antecedent basis for this limitation in the claim, because the claim depends on 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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sutter (US 2015/0140504) in view of Meniga (Meniga A, Tarle Z, Ristic M, Sutalo J, Pichlar G. “Pulsed blue laser curing of hybrid composite resins.” Biomaterials. Vol 18. Pages 1349-1354. 1997) as evidenced by Melikjan (US 10,610,331, effective filing date of March 13, 2014).
Regarding Claim 13, Sutter teaches a diode lasing method for dental oral surgery (¶ 0004, 0011) comprising the steps of:
operating a blue laser at a treatment site to perform tissue cutting (¶ 0005, 0027).
Sutter also teaches that blue lasers can be used to cure composites such as in dental fillings (¶ 0024) but does not explicitly teach a step of using a pulsing blue laser to cure or polymerize a composite.
However, Meniga, in the same field of endeavor of methods for curing composites using lasers (abstract), teaches pulsing a blue laser at a rate of 10-30 Hz to photopolymerize a composite material (abstract; Materials and Methods page 1350; Figure 3 shows successful curing of 3 colors of composite materials using pulsed laser; last paragraph on page 1353).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Sutter with the parameters for photopolymerizing dental composites taught by Meniga. Sutter teaches that it is known that blue lasers can be used to cure composites but does not teach any further details, therefore it would be obvious to apply the parameters known to cure dental composites as taught by Meniga. One would be motivated to perform both tissue cutting and composite polymerization in the same method or procedure if the patient needed both, such as a patient that needed both gingivectomy and restoration of a tooth root with a composite. For example, Melikjan teaches that a gingivectomy can be performed with endodontic treatment if needed (col 4 lines 21-23) and that after preparation of the damaged tooth a restoration or reconstruction would be implemented using a composite material (col 4 lines 44-66). Therefore it would be obvious to perform such a dental procedure that includes steps of cutting gum tissue and installing a composite material with a blue laser that is capable of both steps in order to reduce the number of different tools needed.
Response to Arguments
Applicant argues that the prior art previously relied upon does not teach photobiomodulation performed simultaneously with the additional procedures of tissue ablation and hemostasis. This argument is persuasive, based on the assertion in the disclosure that a higher power is necessary for photobiomodulation than for a red laser aiming beam. However, the applicant does not have clear support for photobiomodulation simultaneously with the other procedures but rather recites aiming with the red laser simultaneous with other lasers while performing procedures. Photobiomodulation is presented in the disclosure as a procedure that could be performed with the red laser at a higher power.
The examiner does note that the applicant’s arguments state, regarding non-thermal photobiomodulation, “While not explicitly stated in the procedures, it is at the discretion of the user to apply this inherent feature of the red laser during use.” If photobiomodulation does not require higher power than is used for an aiming beam and is considered an inherent feature of the aiming beam, then the prior art may teach such steps given that utilizing an aiming beam is well known. Recognizing a new advantage of a known method does not rebut obviousness, and it is known to utilize an aiming beam when performing laser surgery with non-visible light. Therefore that aiming beam also resulting in photobiomodulation would not render the method nonobvious. See MPEP 2145 (II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jennifer P. Connell whose telephone number is (703)756-1169. The examiner can normally be reached Monday - Friday 9 am - 3 pm ET.
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/JENNIFER P CONNELL/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772
9/3/2026
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