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.
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 11,20,23,24,26,27 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.
In claim 11, the recitation “controlling…as a function of pellicle hydration” newly adds “as a function of pellicle hydration”. The disclosure, as originally filed, does not provide support for this newly added limitation. This is a new matter rejection.
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.
Claim 11 is 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 11, line 2, has been amended to recite “clear polymer aligners”. Line 17 recites “the clear polymer aligner”. It is unclear which clear polymer aligner is being referred to. It is suggested that line 2 be amended to read “a clear polymer aligner”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 11,20,23,24,27 are rejected under 35 U.S.C. 103 as being unpatentable over Groves Jr. et al (US 2018/0325622, hereafter “Groves”) in view of Jiao (US 2018/0140511) as evidenced by Andreiko (US 2013/0078593).
Regarding claim 11, Groves discloses a method for treating dental surfaces of a patient undergoing orthodontic realignment, the method comprising:
Generating, using a laser arrangement, a laser beam ([0004], “a laser source for generating at least one pulse of a laser beam”;
Directing, using an optical arrangement ([0004], “at least one optic in optical communication with the laser source”), the laser beam toward exposed tooth surfaces on a plurality of teeth within an upper arch of the patient, including aesthetic surfaces on the patient’s teeth which are visible when the patient smiles, wherein the aesthetic surfaces comprise enamel; ([0084], “, the dental laser system, 100, may ablate dental hard tissues, like enamel, dentin and bone, as well as dental soft tissues at a clinically viable rate”. Tooth enamel is an exposed surface and would include aesthetic surfaces on the patient’s teeth which are visible when the patient smiles) and,
Controlling pulse energy, using a laser controller ([0004], “controller”, “pulse energy”) as a function of pellicle hydration (see paragraph 22, which discloses how the controller heats the pellicle to a temperature high enough to remove it, which inherently does so as a function of the pellicle hydration), the laser beam in order to heat at least a portion of the exposed tooth surfaces to a temperature within a range of about 100 to 400 degrees Celsius ([0009], using the laser to raise the surface temperature to a raised surface temperature in a range from 300 to 1800 degrees Celsius. i.e. encompassing applicant’s range of 100 to 400 degrees C as raising to a raised surface temperature in a range from 300 to 1800 degrees Celsius would require that surfaces are heated within that range. See MPEP 2144.05.) to remove pellicle and calculus from the exposed tooth surfaces ((0121], “During laser treatment the pellicle, plaque, and biofilm covering the dental hard tissue is ablated.”); and prevent substantial change to a mechanical property of the enamel of the portion of the exposed tooth surfaces, wherein the mechanical property includes one or more of carbonate content and acid resistance ([0021], “the controller can be further adapted to raise the surface temperature of the location during the laser pulse above a lower therapeutic threshold temperature defined as a temperature that causes at least one of (i) a minimum increase in an acid dissolution resistance of the dental hard tissue and (ii) a minimum decrease in an amount of surface carbonate of the dental hard tissue”; [0084], “, the dental laser system, 100, may ablate dental hard tissues, like enamel, dentin and bone, as well as dental soft tissues at a clinically viable rate”. As such is done at a clinically viable rate, it is construed not to damage teeth or affect a change to a mechanical property as the laser is disclosed in [0009] to heat within similar temperatures and wavelength parameters.). Groves further discloses that the laser treatment can be followed by other various treatments ([0123], “After laser treatment the enamel, which is largely free form biofilms”...the exposed enamel surface is treated”). Note also, that the Groves method is considered to be performed during a “routine dental prophylaxis appointment” inasmuch as the method is performed to prevent dental disease.
Groves fail(s) to disclose attaching a clear polymer aligner over the pellicle- and calculus-free exposed tooth surfaces of the upper arch of the patient.
Jiao teaches treating teeth prior and after to putting on orthodontic aligners ([0021], “tooth remineralization composition onto the tooth surface prior to putting on orthodontic aligner” or “directly to the space inside orthodontic aligner prior to wearing the aligner;” and rinsing with water to wash
away the tooth remineralization composition from the orthodontic aligner after taking off the orthodontic aligner’. i.e. that the orthodontic aligner is selectively removable for treatment prior/after.
Orthodontic aligners are known in the art to be clear polymer as evidenced by Andrieko [0004], “Generally, these aligners are clear or transparent polymer orthodontic devices that are removably positioned over the teeth of the maxilla and/or the teeth of the mandible.” ).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Groves, by requiring attaching the clear polymer aligners over the pellicle- and calculus-free exposed tooth surfaces of the upper arch of the patient, as taught by Jiao/Andrieko, for the purpose of preparing teeth prior to aligner treatment to provide a better tooth response to undergo the stresses of aligner treatment. The configuration of Groves/Jiao/Andrieko teaches wherein after controlling the laser beam to remove pellicle and calculus from the portion of the exposed tooth surfaces (as taught by Groves) and then following attaching a clear polymer aligner over the pellicle- and calculus removed portion of the exposed tooth surfaces of the upper arch of the patient (as Jiao teaches treating a bare tooth prior to applying a clear polymer aligner).
Regarding claim 20, The configuration of Groves/Jaio/Andrieko would result wherein prior to directing the laser beam toward the exposed surfaces, removing the clear polymer aligner that would be present in the mouth from the upper arch of the patient (as Groves teaches the lasing steps to remove pellicle/calculus and Jaio teaches using a selectively removable orthodontic aligner to allow for treatment between use of orthodontic aligners as set forth in claim 11 above).
Regarding claim 23, Groves further discloses wherein the laser beam has a wavelength of about 10.6um ([0009], “The laser beam can have a wavelength in a range from 8 to 12 microns (e.g., 9 to 10 microns or 10 to 11 microns).
Regarding claim 24, Groves further discloses wherein the exposed tooth surfaces comprise a front surface of a front tooth ([[0084], “, the dental laser system, 100, may ablate dental hard tissues, like enamel, dentin and bone, as well as dental soft tissues at a clinically viable rate”. Tooth enamel is present on all surfaces of a tooth including a front surface of a front tooth. ).
With regard to claim 27, Groves/Jiao/Andreiko do not disclose directing, using the optical arrangement, the laser beam toward non-enamel dental hard tissue; and, controlling, using a laser controller, the laser beam in order to heat at least a portion of the non-enamel dental hard tissue to a temperature within a range of 50 to 200°C. However, it is noted that Groves discloses that the laser may be used on non-enamel surfaces such as dentin or bone. See paragraph 84.
It would have been obvious to one skilled in the art, to direct the laser of Groves/Jiao/Andreiko to non-enamel hard surfaces, utilizing the laser to heat the non-enamel dental hard surfaces to a temperature within a range of about 50 to 200°C, as a matter of routine optimization, since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955), and also in view of the teaching of Groves that the laser may be used to treat non-enamel dental hard surfaces.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Groves (US 2018/0325622) in view of Jiao (US 2018/0140511) as evidenced by Andreiko (US 2013/0078593) as applied to claim 11 above, and further in view of Brahler 5380202.
With regard to claim 26, Groves/Jiao/Andreiko do not disclose a step of after controlling the laser beam to remove pellicle and calculus from the portion of the exposed tooth surfaces and before attaching the clear polymer aligner, performing dental prophylaxis polishing on the exposed tooth surfaces on the plurality of teeth.
Brahler discloses a step of performing dental prophylaxis polishing on an exposed tooth surface. See fig 6.
It would have been obvious to one skilled in the art to perform a step of dental prophylaxis polishing on the exposed tooth surfaces of Groves/Jiao/Andreiko before attaching the clear polymer aligner, in view of the teaching of Brahler that dental prophylaxis allows for polishing of exposed tooth surfaces.
Response to Arguments
Applicant's arguments filed 12/12/25 have been fully considered but they are not persuasive.
Applicant argues (response, pages 5 and 6) that neither Groves nor Jiao teach a method of performing laser cleaning on a patient undergoing treatment with clear polymer aligners.
This is not found persuasive. As outlined in the above rejection of claim 11, Jiao is cited to show that it is well known to treat teeth prior to, and after applying aligners to teeth. Andreiko was further cited to show that it is well known that aligners are clear. Therefore, the combination of Groves/Jiao/Andreiko discloses this limitation.
Applicant also argues (response, page 6, that Groves does not disclose controlling, using a laser controller, one or more of pulse energy, pulse duration, and fluence of the laser beam, as a function of pellicle hydration…This limitation has been addressed in the modified grounds of rejection of claim 11 above. The limitation of “during a routine dental prophylaxis appointment in lieu of mechanical scaling” has also been addressed in the modified grounds of rejection of claim 11 above.
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 NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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, Eric Rosen can be reached at 571-270-7855. 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.
/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772