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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/22/26 has been entered.
All previous claim interpretation under 35 USC 112, F is maintained herein.
Response to Arguments
Applicant's arguments filed 6/22/26 have been fully considered but they are not persuasive.
Applicant argues that Chevalier does not teach the newly added claim limitations of the acoustic emissions signals being “emitted by a material constituting the instrument when the instrument is under stress during use”. However, the Examiner disagrees. Specifically, the Examiner notes that the working tips of Chevalier are at least partially formed of the electro-responsive material and such material provides the surface acoustic wave which may be modified and/or reflected thereby (see [0028] and [0041]-[0042]; [0083]). Accordingly, the tip is constituted of the material of the electro-responsive material (at least in part, as it is part of the tip) and the material of the tip (the electro-responsive material) emits the acoustic waves, including at times when the instrument is under stress (e.g. during use). Thereby the tip of chevalier emits acoustic emission signals emitted by a material constituting the instrument when the instrument is under stress during use, meeting the limitation of the claims. Still further, the Examiner notes that Applicant’s arguments stating that the acoustic signals in Chevalier are not “passively captured as spontaneous emissions from material failure” are not commensurate with the scope of the claims. Additionally, regarding Applicant’s argument that Chevalier does not enable the detection of “failure” events, the Examiner points to and incorporates the previous response to Arguments in the action mailed 4/21/26 herein. Regarding Applicant’s arguments to the rejections under 35 USC 103, the Examiner notes that the arguments only focus on what Chevalier allegedly does not teach, and not the combinations relied on, nor the specific teachings of the secondary references which are relied on. Therefore, Applicant’s arguments have been fully considered but are not persuasive.
Claim Rejections - 35 USC § 112
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.
Claims 14-15 and 17-18 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.
Regarding claims 14 and 17, the term “consists in” is indefinite as it is unclear whether or not Applicant intends to recite the narrower transitional phrase “consisting of” or a broader transitional phrase amounting to “comprising” or the like. The Examiner notes that in the previous claim set filed 3/2/26, both claims recited “comprising” and as such will be interpreted as such. Clarification is required.
Claims 15 and 18 are rejected based on their dependency on a previously rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a method of monitoring instrument failure by capturing and analyzing acoustic signals and detecting instrument failure based on the acoustic signal analyzed. The method is within the statutory category of a process but falls into the judicial exception of an abstract idea. The claimed invention is directed to a mental process- concepts that are capable of being performed in the human mind, including observations, evaluations and judgements. More particularly the step of capturing and analyzing the signals during use, and identifying the signal when a failure occurs can be performed by a user listening to the device during use and additionally amounts to mere data gathering. This judicial exception is not integrated into a practical application because there are no structure or steps which link the judicial exception into a practical application. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited in claims 13-16.
Dependent claims 14-16 only further describe the judicial exception by describing how the detection is made (comparison of data), and identifying the type of failure (based on comparison of data). Claim 16 recites emitting a signal in response to the detection, but does not amount to significantly more or an integration of the judicial exception.
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; 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 a set of acoustic emission signals emitted by a material constituting the instrument when the instrument is under stress during the use of the instrument (see citations above and [0081], [0145], [0146], [0168]-[0180], [0210], [0230]-[0235]; instrument is constituted by electro-responsive material (at least in part as it is part of the instrument) which emits the signals when vibrating in use (under stress at least to some degree, see [0028] and citations above); 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 (consists in): 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 (consists in) 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 emitted by a material constituting the instrument when the instrument is under stress during use of the instrument (see explanation above in regards to claim 13; 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 emitted (see citations above and claim 13); 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 13), 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
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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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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