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 .
Response to Amendment
This action is in response to Applicant’s amendments filed 3/2/26.
All previous claim interpretation under 35 USC 112, F is maintained herein.
Response to Arguments
Applicant's arguments filed 3/2/26 have been fully considered but they are not persuasive.
Applicant argues that Chevalier does not explicitly teach “monitoring failure” of the endodontic instrument as it does not expressly describe “failure” of the instrument and instead monitors and adjusts handpiece performance based on strain. Applicant traverses that the Examiner’s position that strain beyond a target strain does not correspond to a failure of the instrument. The Examiner disagrees for several reasons. The Examiner notes that such arguments are not commensurate with the scope of the claims, specification or broadest reasonable interpretation of the term “failure”. In other words, Applicant’s apparent argued definition or criteria defining a “failure” is too narrow, and there are no reasons of record why excessive strain applied to an instrument cannot or should not be considered a “failure” thereof. Regarding the claims, the claims do not limit what is or is not considered a “failure”. Additionally, looking to the specification, there is no special definition listed therein which would limit the term to a particular meaning. Upon further review, paragraphs [0010]-[0011] describe several “potential” failures, but such a list is not exclusive. However, said paragraphs also explicitly describe “failures” which correspond to excessive strain situations (including excessive loading and/or plastic deformation of the tool). The Examiner notes that such listings are not all encompassing under the BRI of the term and does not constitute a special definition thereof. Further, the broadest reasonable interpretation of the term “failure” encompasses definitions such as “omission of occurrence or performance”, “state of inability to perform normal function”, “abrupt cessation of normal function” and “falling short” (see Merriam Webster Dictionary). Instances of excess strain on the tool meet said definition(s). For example as strain increases beyond a target, performance would decrease, normal operation would not be performed and/or the device would fall short of its intended operation. As such, the Examiner maintains that Chevalier discloses monitoring a tool for failure, as a failure can be interpreted as measured instances of excess strain for the explained reasons above. Regarding Applicant’s arguments to the combination of Chevalier in view of Katsuda, the Examiner points to the explanation above. In order to move the Application forward, the Examiner notes that Applicant may specify the particular type of failure intended to be monitored in the claims. Therefore, Applicant’s arguments have been fully considered but are not persuasive.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13-15, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chevalier (US 2015/0150647 A1).
Regarding claim 13, Chevalier discloses a method of monitoring failure of an endodontic instrument used in endodontic treatment (see [0042], [0148], [0167] disclosing monitoring an endodontic drill) during which the instrument is driven by a handpiece (see above) and generates a set of acoustic emission signals (e.g. reflected surface acoustic wave signal; see [0028], [0082]-[0083], [0145]-[0146], [0151]-[0152], [0168]-[0180]), wherein the method comprises the steps of: capturing and analyzing the set of acoustic emission signals generated by the use of the instrument (see citations above and [0081], [0145], [0146], [0168]-[0180], [0210], [0230]-[0235]); when a failure of the instrument occurs (interpreted as strain beyond a target strain; measured by system; see [0230-[0235], [0210], [0168], [0081], [0078]), thereby generating a failure acoustic emission signal (as strain is constantly monitored, a failure signal would be monitored, see citations above), detecting said failure acoustic emission signal among the set of acoustic emission signals captured and analyzed in order to detect the occurrence of the failure (failure (excessive strain) signal would be detected in the constant monitoring of tip; see citations above). Chevalier further discloses wherein the step of detecting a failure acoustic emission signal comprises: comparing acoustic emission signal parameters with respect to predetermined thresholds (e.g. “target strain”, see [0210] and citations above; per claim 14); and wherein the method comprises, after having detected the failure (monitoring reflected signal), a step comprising identifying a failure from a list of possible failures established with reference to predetermined thresholds (see [0210] stating that possible measurements include target strains, stress or vibration of the instrument; excessive values of all may result in a ”failure”; e.g. monitoring/controlling above parameters to ensure values do not exceed targets; if any are exceeded, the appropriate “failure” of the parameter would be identified via control unit which monitors treatment; per claim 15).
Regarding claim 17, Chevalier discloses a method of controlling a handpiece driving an endodontic instrument during endodontic treatment (see citations above), the method implements the monitoring method of claim 15 (see citations above), and comprises adapting instrument dynamics parameters according to the identified failure (see [0079]-[0081], [0145]-[0146], [0169]-[0180], [0210], [0230]-[0235]).
Regarding claims 19-20, Chevalier discloses a device intended to be included in a handpiece driving an endodontic instrument (see citations above and devices/handpieces shown in Figs. 4-11), the deice being capable of implementing the method of claim 13, wherein the device comprises a sensor of a set of acoustic emissions signals which are generated by the instrumental dynamics (e.g. sensor interface of controller; see [0205], or portion of controller/transmitted/communication means which receives signal indicative of the set of acoustic emission signals generated (see citations above and claim 1); and acoustic analysis means (e.g. controller) configured to detect a failure acoustic emission signal (interpreted as excessive strain) from the set of acoustic emission signals, in order to detect the occurrence of a failure of the instrument (see citations above; per claim 19); and wherein the analysis means are configured to identify the failure from a list of possible failures established with reference to a predetermined thresholds (see explanation above in regards to claim 15; per claim 20).
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.
Claim(s) 16, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chevalier in view of Katsuda et al (US 6929476 B2).
Regarding claim 16, Chevalier discloses all the features of the claimed invention, as explained above, except wherein the method comprises, after having detected the failure, a step of emitting an alert signal as required.
Katsuda et al, however teaches a similar method of controlling an endodontic drill comprising detecting a failure in a rotary cutting tool and emitting an alert signal (see col 1, line 50 though col 2, line 2 and col 3 lines 21-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of Chevalier to include Katsuda’s teaching of emitting an alert signal in response to a detected failure, as such modification would indicate to a user when strain/forces and/or other parameters of a tool may exceed a determined value and cause damage to the tool and/or tooth, providing safer treatment for the patient.
Regarding claims 21-23, Chevalier discloses a handpiece (1/2, Fig. 4) for driving an endodontic instrument (see citations above in regards to claim 1), wherein the handpiece comprises a device according to claim 19 (see explanation regarding claim 19, above); wherein the handpiece comprises a programmable interface (controller) connected to the acoustic analysis means (see citations above), the programmable interface is configured to adapt instrument dynamic parameters as a function of the identified failure, the acoustic analysis means configured to identify the failure from a list of possible failures established with reference to predetermined thresholds (see citations and analysis above in regards to claims 15, 17, 19 and 20; per claim 22); and wherein the sensor (see above in regards to claim 19) is arranged inside a body of the handpiece (controller is located in handpiece, see citations above in regards to claim 19; per claim 23), but does not teach that the handpiece comprises a warning means as required.
Katsuda et al, however teaches a similar endodontic handpiece comprising a warning means (see col 1, line 50 though col 2, line 2 and col 3 lines 21-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the handpiece of Chevalier to include Katsuda’s warning means, as such modification would indicate to a user when strain/forces and/or other parameters of a tool may exceed a determined value and cause damage to the tool and/or tooth, providing safer treatment for the patient.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Chevalier in view of Katsuda, as combined above, further in view of Hauner-Westphal et al (US 2022/0192782 A1).
Regarding claim 24, Chevalier/Katsuda, as combined above, contemplate the use of remote sensors (see Chevalier [0182]), but does not explicitly teach that the sensor is outside a body of the handpiece and is configured to be coupled to the tooth or near the tooth as required.
Hauner-Westphal et al, however, teaches a similar endodontic monitoring system which utilizes an acoustic sensor (109) placed on or near the tooth to detect an acoustic signal (see abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Chevalier/Katsuda, as combined above, to include Hauner-Westphal’s teaching of providing the receiving sensor on or near the tooth external the handpiece, as such modification would merely involve a relocation of known parts of the device, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(VI)(C)).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chevalier in view of Nakai (US 2019/0254774 A1).
Regarding claim 18, Chevalier discloses all the features of the claimed method, as explained above in regards to claim 17, including wherein the adaptation of instrument parameters may be adjusted by weighting (see [0086], [0090]-[0092], [0150], [0213], [0223]-[0225]), but does not specifically teach adjusting the parameters according to a treatment complexity score previously captured by a practitioner as required.
Nakai, however, teaches a method of controlling an endodontic drill comprising adjusting parameters of control operations of the drill based on a treatment complexity score previously captured by a practitioner (e.g. the specific shape categorization of the root canal; see abstract, [0080]-[0085] and Figs. 5b, 9-10). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method of Chevalier to include Nakai’s teaching of adjusting control parameters based on a treatment complexity score, as such modification would aid in controlling failure of the tool and reducing tooth damage when using the device.
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 EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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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.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772