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 .
Examiner note: A 101 analysis was performed on the claims but concluded it was not necessary because the claimed system/structures are not well understood, routine, and conventional.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “24” has been used to designate both the biological signal, an indication of an oral position, and a position of mech stimuli. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “26” in fig. 1; “28” in fig. 1; & “30” in fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
In claim 1, “the tool” in lines 2 & 3 should recite “the oral tool”.
In claim 1, "the mouth" in line 2. should recite “a mouth”.
In claim 2, “a predetermined depth” in line 4 should recite “a pre-determined depth”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an actuation mechanism for automatically applying the stimulus” in claim 1; and “a resilient element … for providing a resistive force feedback” in claim 4.
The actuation mechanism is defined, on page 4 lines 9-17 & page 12 lines 5-7, as an electrical or pneumatic powered actuation mechanism, non-powered, elastically charged.
The resilient element is defined on page 4 lines 25-33 & page 19 lines 13-25 , as a spring member, a force limiter, a spring-mounted probe tip, a resilient biasing means, an active actuation element, a responsive material, electro-active polymer.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Doidge (US 20120053483 A1) in view of Hunter (US 5137447 A).
Regarding claim 1, Doidge discloses a system (apparatus 100, “force exertion system”, para. [0010]) comprising: a tool (motor 102, motor output member 104, tissue-contacting member 108, fig. 1) for use in applying a standardized mechanical stimulus to a tissue of a subject (exerting force … standardizable and/or reproducible”; “force … predetermined force profile”, para. [0002, 0006, 0017]), wherein the tool (motor 102, motor output member 104, tissue-contacting member 108, fig. 1) includes an actuation mechanism (motor 102 & motor controller 106, fig. 1, “pneumatic”, para. [0019]) for automatically applying the stimulus (motor 102 & motor controller 106, fig. 1, “motor 102 for generating a force … accurate control”; “self-adjusting”, para. [0018-0021, 0049-0055]); and a biological signal sensor (114, fig. 1, “video … camera”; “EEG”, para. [0027-0031]) adapted to indicate a pain response to each applied stimulus (“micro-expressions … response to a painful stimulus”; “objectively detect the subject reaction to the exerted force … EEG”, para. [0027-0031, 0034]).
Doidge further discloses that the force exerted on the subject tissue by the apparatus 100 may be used in at least one purpose related to the condition(s) of mechanical pain disorders, injuries/defects, and neuropathies, that could be at least sensitive tooth dental disorder, or other injuries/defects (para. [0035]).
Doidge does not disclose an oral tool for use in applying a standardized mechanical stimulus to an oral location in the mouth of a subject, wherein the tool includes an indicator adapted to provide feedback for guiding a manual application of the stimulus by a user, wherein the oral tool is a dental probe for probing a periodontal pocket with a probe tip, and/or the oral tool comprises a probe portion for insertion in interdental spaces and/or for application on interdental papilla.
Hunter directed to a probe for use as a clinical measuring instrument or gauge discloses an oral tool (probe 40, fig. 4) for use in applying a standardized mechanical stimulus to an oral location in the mouth of a subject (“force … standardized … 20-25 grams”, col. 7 lines 24-34 & 40-51 & col. 9 lines 44-59, fig. 5), wherein the tool includes an indicator (marks 46-47; “marks at 3.5, 5.5, 8.5 and 11.5 mm distances; mark 49, col. 7 lines 45-51 & col. 9 lines 35-44, fig. 5) adapted to provide feedback for guiding a manual application of the stimulus by a user (“indicate ... periodontal pocket depth”; “mark … selected force is applied, … aligned”, col. 7 lines 45-51 & col. 9 lines 35-44, fig. 5), wherein the oral tool is a dental probe for probing a periodontal pocket with a probe tip (“probe … periodontal pocket”, tip 109, col. 9 lines 35-44, figs. 9A & 14-15C), and/or the oral tool comprises a probe portion for insertion in interdental spaces (“toothbrush … head … bristles … interproximal area”; “probe … periodontal pocket”, tip 109, col. 5 lines 4-4 & col. 9 lines 35-44, figs. 9A & 14-15C) and/or for application on interdental papilla.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge such that the system comprises an oral tool for use in applying a standardized mechanical stimulus to an oral location in the mouth of a subject, wherein the tool includes an indicator adapted to provide feedback for guiding a manual application of the stimulus by a user, wherein the oral tool is a dental probe for probing a periodontal pocket with a probe tip, and/or the oral tool comprises a probe portion for insertion in interdental spaces and/or for application on interdental papilla, in view of the teachings of Hunter, as this would aid in indicating and determining periodontal pocket depths and the degree of gingivitis (Abstract, col. 7 lines 35-45).
Regarding claim 2, Doidge, as modified by Hunter hereinabove, discloses the system of claim 1. Doidge, as modified by Hunter hereinabove, does not disclose wherein the oral tool is a dental probe for probing a periodontal pocket with a probe tip, and wherein the indicator comprises a probing depth indicator which provides mechanical and/or visual feedback to an operator of the probe when the probe tip has been inserted to a predetermined depth in the pocket.
However, Hunter directed to a periodontal probe discloses wherein the oral tool is a dental probe (probe 40, fig. 4) for probing a periodontal pocket with a probe tip (“probe … periodontal pocket”, tip 109, col. 9 lines 35-44, figs. 9A & 14-15C), and wherein the indicator comprises a probing depth indicator (marks 46-47; “marks at 3.5, 5.5, 8.5 and 11.5 mm distances; mark 49, col. 7 lines 45-51 & col. 9 lines 35-44, figs. 4-5 & 9A) which provides mechanical and/or visual feedback to an operator of the probe when the probe tip has been inserted to a predetermined depth in the pocket (marks at 3.5, 5.5, 8.5 and 11.5 mm distances … indicate ... periodontal pocket depth”, col. 7 lines 45-51 & col. 9 lines 35-44 & col. 13 lines 20-29, figs. 9A & 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the oral tool is a dental probe for probing a periodontal pocket with a probe tip, and wherein the indicator comprises a probing depth indicator which provides mechanical and/or visual feedback to an operator of the probe when the probe tip has been inserted to a predetermined depth in the pocket, in view of the teachings of Hunter, as this would aid in indicating and determining periodontal pocket depths and the degree of gingivitis.
Regarding claim 3, Doidge, as modified by Hunter hereinabove, discloses the system of claim 2. Doidge, as modified by Hunter hereinabove, does not disclose wherein the probing depth indicator comprises a ridge or outward protrusion from a surface of the probe tip, at a height from a terminal distal point of the probe tip corresponding to the pre-determined depth in the pocket to be probed.
However, Hunter directed to a periodontal probe having needle member 101 calibrated along its length in mm divisions 108 (col. 10 lines 5-33) discloses wherein the probing depth indicator (calibrated divisions 108, figs. 6 & 9A) comprises a ridge or outward protrusion from a surface of the probe tip (110, 111, as seen in fig. 9A, widened or otherwise marked portion of the needle col. 10 lines 5-33), at a height from a terminal distal point of the probe tip (109, fig. 9A, col. 10 lines 5-33) corresponding to the pre-determined depth in the pocket to be probed (as seen in figs. 6 & 9A, “measurement of pocket depth … widened … 3.5 mm … 8.5 mm”, col. 10 lines 5-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the probing depth indicator comprises a ridge or outward protrusion from a surface of the probe tip, at a height from a terminal distal point of the probe tip corresponding to the pre-determined depth in the pocket to be probed, in view of the teachings of Hunter, as this would aid in measuring the periodontal pocket depth.
Regarding claim 6, Doidge, as modified by Hunter hereinabove, discloses the system of claim 1. Doidge, as modified by Hunter hereinabove, does not disclose wherein the mechanical stimulus comprises: application of a standard reference force to an oral surface; and/or probing a periodontal pocket to a standard reference depth.
However, Hunter discloses wherein the mechanical stimulus comprises: application of a standard reference force to an oral surface (“periodontal pocket … force … standardized … 20-25 grams”, col. 7 lines 24-34 & 40-51 & col. 9 lines 44-59, fig. 5); and/or probing a periodontal pocket to a standard reference depth (“depth of penetration … marks on the needle 41 representing depths of 3.5 mm and 5.5 mm respectively, according to CPITN”, col. 7 lines 24-34 & 40-51 & col. 9 lines 44-59, figs. 5 & 9A-9B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the mechanical stimulus comprises: application of a standard reference force to an oral surface; and/or probing a periodontal pocket to a standard reference depth, in view of the teachings of Hunter, as this would aid in determining the periodontal pocket depth and the degree of gingivitis.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Doidge in view of Hunter, as applied to claim 1 above, and further in view of Brown (US 4841987 A).
Regarding claim 1, Doidge, as modified by Hunter hereinabove, discloses the system of claim 1. Doidge, as modified by Hunter hereinabove, does not disclose wherein the oral tool comprises a dental probe for probing a periodontal pocket with a probe tip, and wherein the dental probe comprises a resilient element physically coupled with the probe tip for providing a resistive force feedback indicative of when a force with which the probe tip is being applied to an oral location by a user is equal to a pre- determined reference force.
However, Brown directed to an automatically-resetting force-sensing probe for obtaining a standardized depth measurement of a periodontal pocket discloses wherein the oral tool (probe, fig. 2) comprises a dental probe for probing a periodontal pocket with a probe tip (Abstract, tip 201, fig. 2(B)), and wherein the dental probe (fig. 2(B)) comprises a resilient element (bending beam 203 & strain gauges 206, 207, fig. 2(B), “resilient beam portion”, claim 1) physically coupled with the probe tip (as seen in fig. 2(B), col. lines 50-63) for providing a resistive force feedback indicative of when a force with which the probe tip is being applied to an oral location by a user is equal to a pre- determined reference force (“applied force … 1.5 volts … 2.7 volts … predetermined level … standardize … 3 to 130 grams …lights the fifth LED …”, col. 3 line 64 - col. 4 line 60 & col. 5 lines 18-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the oral tool comprises a dental probe for probing a periodontal pocket with a probe tip, and wherein the dental probe comprises a resilient element physically coupled with the probe tip for providing a resistive force feedback indicative of when a force with which the probe tip is being applied to an oral location by a user is equal to a pre- determined reference force, in view of the teachings of Brown, as this would aid in obtaining a standardized periodontal pocket depth measurement.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Doidge in view of Hunter, as applied to claim 1 above, and further in view of Rmaile (US 20200146435 A1).
Regarding claim 5, Doidge, as modified by Hunter hereinabove, discloses the system of claim 1, wherein the oral tool comprises a probe portion for insertion in interdental spaces (“toothbrush … head … bristles … interproximal area”; “probe … periodontal pocket”, tip 109, col. 5 lines 4-4 & col. 9 lines 35-44, figs. 9A & 14-15C) and/or for application on interdental papilla. Doidge, as modified by Hunter hereinabove, does not disclose optionally wherein the probe portion comprises a fork member with at least two prongs.
However, Rmaile directed to systems and methods for determining the size of interproximal space and dynamically adjusting an oral care routine discloses an oral tool (oral care implement 14, fig. 7A), wherein the oral tool comprises a probe portion (function head 16 comprising automated sensing and actuation mechanism 40 comprising parts 52 & 54 as seen in fig. 7A) for insertion in interdental spaces (“tip or end of moveable outer part 54 is pushed against the teeth and at least partially into an interproximal space”, para. [0047]), and/or for application on interdental papilla, and optionally wherein the probe portion comprises a fork member with at least two prongs (automated sensing and actuation mechanism 40 comprising parts 52 & 54 as seen in fig. 7A, para. [0047-0048, 0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the probe portion comprises a fork member with at least two prongs, in view of the teachings of Rmaile, as this would aid in directly or indirectly measuring the interproximal space and automatically changing a parameter of the oral care device operation in response to the measurement.
Claims 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Doidge in view of Hunter, as applied to claim 1 above, further in view of Canakci (Canakci, Varol et al. "Pain levels in patients during periodontal probing and mechanical non-surgical therapy" Clinical Oral Investigations. Jan. 2008Original Article Published June 19, 2007.Vol. 11, pages 377-383, (2007)), and further in view of Gott (US 4823809 A).
Regarding claim 7, Doidge, as modified Hunter hereinabove, discloses the system of claim 1, further comprising obtaining an indication of the subject pain response to the stimulus applied using the tool over a session (“information on subject reactions … memorialized in a computer-accessible format … one or more sessions”, para. [0053]) and generate a digital record thereof (“database”; “memorialized in a computer-accessible format”, para. [0030, 0033-0034, 0053]). Doidge further discloses that the records may be kept of the somatosensory or somatomotor characteristics of the subject across one or more sessions with the apparatus 100, for reasons including tracking progression or diagnosis of a disease/dental disorder (para. [0034-0035, 0053]).
Doidge, as modified by Hunter hereinabove, does not disclose a processor adapted to obtain an indication of the subject pain response to each of a plurality of mechanical stimuli applied using the oral tool at different locations in the mouth over a session, and to determine an oral health state indicator associated with each pain response.
However, Canakci discloses obtain an indication of the subject pain response (VAS scores, Table 4) to each of a plurality of mechanical stimuli applied using the oral tool at different locations in the mouth over a session (Table 4, page 378, Clinical examination and measurements, “force … six sites on each tooth”), and to determine an oral health state indicator associated with each pain response (page 381-382, Discussion, “VAS scores were significantly higher … 4mm deep … patients with elevated pain response”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the system is adapted to obtain an indication of the subject pain response to each of a plurality of mechanical stimuli applied using the oral tool at different locations in the mouth over a session, and to determine an oral health state indicator associated with each pain response, in view of the teachings of Canakci, in order to track the progression of dental diseases for patients with elevated pain responses for deeper periodontal pockets based on tooth types, tooth surfaces, or regions of the mouth, probing depth, and bleeding.
Doidge, as modified by Hunter and Canakci hereinabove, does not disclose a processor.
However, Gott directed to a periodontal probe system for measurement, storage, and display of periodontal pocket depth, gingival level and periodontal attachment level of the teeth discloses a processor (processor 20, fig. 1, col. 10 lines 47-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter and Canakci hereinabove, such that the system further comprises a processor, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease by storing measurement values and performing signal processing using a processor.
Regarding claim 8, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 7. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the processor is further adapted to obtain an indication of a mouth location associated with each pain response and wherein the digital record represents the oral health state indicator as a function of mouth location.
However, Gott directed to directed to a periodontal probe system for measurement, storage, and display of periodontal pocket depth, gingival level and periodontal attachment level of the teeth discloses wherein the processor (processor 20, fig. 1) is further adapted to obtain an indication of a mouth location associated with each response (“displaying the location”; “each entry … probe measurement site … respective station in the sequence”, col. 4 lines 21-26 & col. 10 line 61 – col. 12 line 5, figs. 10A-C) and wherein the digital record represents the oral health state indicator as a function of mouth location (“periodontal pocket depth, gingival level, and periodontal attachment level at each of a plurality of probe sites”; “display results of periodontal examination … ”, Abstract, col. 10 line 27 – col. 12 line 50, figs. 10A-C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the processor is further adapted to obtain an indication of a mouth location associated with each pain response and wherein the digital record represents the oral health state indicator as a function of mouth location, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease.
Regarding claim 9, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 8. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the obtaining of the indication of the position of the oral tool for a given mechanical stimulus comprises: receiving a positioning signal from a position tracker indicative of position of the oral tool; obtaining an indication of a location indicated in a prompt delivered to a user by a user interface for prompting the user to manually apply the stimulus at the indicated location; or receiving from a user interface a user-input indication of the position of the oral tool.
However, Gott discloses wherein the obtaining of the indication of the position of the oral tool for a given mechanical stimulus (figs. 10A-C, col. 4 lines 21-26 & col. 10 line 61 – col. 12 line 5) comprises: receiving a positioning signal from a position tracker indicative of position of the oral tool (“processor … marker … screen 22”, col. 11 lines 1-40); obtaining an indication of a location indicated in a prompt delivered to a user by a user interface for prompting the user to manually apply the stimulus at the indicated location (“display … number … position … strain … audible tone”, col. 11 lines 1-40); or receiving from a user interface a user-input indication of the position of the oral tool (“position … advancing the dot … keyboard commands”, col. 10 lines 40-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the obtaining of the indication of the position of the oral tool for a given mechanical stimulus comprises: receiving a positioning signal from a position tracker indicative of position of the oral tool; obtaining an indication of a location indicated in a prompt delivered to a user by a user interface for prompting the user to manually apply the stimulus at the indicated location; or receiving from a user interface a user-input indication of the position of the oral tool, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease.
Regarding claim 10, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 8. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the processor is further adapted to generate user feedback via control of a user interface device operatively coupled to the processor, the user feedback comprising a visual representation of the oral health state indicator as a function of mouth location.
However, Gott discloses wherein the processor (processor 20, fig. 1) is further adapted to generate user feedback via control of a user interface device (screen 22, fig. 1) operatively coupled to the processor (“display of a marker 105 at the next measurement site”, col. 11 lines 1-40), the user feedback comprising a visual representation of the oral health state indicator as a function of mouth location (screen 22, fig. 1 & “display … periodontal pocket depth, gingival level, and periodontal attachment level at each of a plurality of probe sites around a tooth”, Abstract, col. 11 line 1-col. 12 line 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the processor is further adapted to generate user feedback via control of a user interface device operatively coupled to the processor, the user feedback comprising a visual representation of the oral health state indicator as a function of mouth location, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease.
Regarding claim 11, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 7. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the processor is adapted to access a health record datastore, and to append the generated digital record of the oral health state indicator to the datastore, associated with subject identification information, and associated with a time- stamp.
However, Gott discloses wherein the processor (processor 20, fig. 1) is adapted to access a health record datastore (storage processor 89, figs. 7 & 11, Abstract), and to append the generated digital record of the oral health state indicator to the datastore (“digital format”, files 200, 202, 204, fig. 11, Abstract, col. 11 line 54 – col. 12 line 13), associated with subject identification information, and associated with a time- stamp (“file 220 is identified by a patient number and examination date”, col. 11 line 54 – col. 12 line 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the processor is adapted to access a health record datastore, and to append the generated digital record of the oral health state indicator to the datastore, associated with subject identification information, and associated with a time- stamp, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease.
Regarding claim 12, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 11. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the processor is adapted to access the health record datastore, to access historical records stored in the datastore for the subject of the oral health state indicator as a function of mouth location, and to compare the determined health state indicator for one or a plurality of the mouth locations with the historical values.
However, Gott discloses wherein the processor (processor 20, fig. 1) is adapted to access the health record datastore (storage processor 89, figs. 8 & 11, Abstract), to access historical records stored in the datastore for the subject of the oral health state indicator as a function of mouth location (“previously stored file of measurement signals”, col. 3 lines 29-41, fig. 11), and to compare the determined health state indicator for one or a plurality of the mouth locations with the historical values (“compares an accumulated file of measurement signals with a previously stored file of measurement signals and produces a set of differential measurement signals”, col. 3 lines 29-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the processor is adapted to access the health record datastore, to access historical records stored in the datastore for the subject of the oral health state indicator as a function of mouth location, and to compare the determined health state indicator for one or a plurality of the mouth locations with the historical values, in view of the teachings of Gott, as this would aid in diagnosing and monitoring the progress of periodontal disease.
Regarding claim 13, Doidge, as modified by Hunter, Canakci, and Gott hereinabove, discloses the system of claim 12. Doidge, as modified by Hunter, Canakci, and Gott hereinabove, does not disclose wherein the processor is adapted to generate longitudinal trend information for the oral health state indicator for one or a plurality of locations in the mouth and to output the trend information to a user interface for presentation to a user.
However, Gott discloses wherein the processor (processor 20, fig. 1) is adapted to generate longitudinal trend information for the oral health state indicator for one or a plurality of locations in the mouth and to output the trend information to a user interface for presentation to a user (fig. 10C, “construction of a historical record comprising a series of periodically-made periodontal measurements”; “pair of periodontal examination files obtained from the history … to display changes in measurement … display 22 … displays results on the occlusal map by drawing”, col. 2 lines 1-13 & col. 12 lines 35-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter, Canakci, and Gott hereinabove, such that the processor is adapted to generate longitudinal trend information for the oral health state indicator for one or a plurality of locations in the mouth and to output the trend information to a user interface for presentation to a user, in view of the teachings of Gott, as this would aid in monitoring the progress of periodontal disease.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Doidge in view of Hunter, as applied to claim 1 above, and further in view of Zuckerman-Stark (US 20170367614 A1).
Regarding claim 14, Doidge, as modified by Hunter hereinabove, discloses the system of claim 1. Doidge, as modified by Hunter hereinabove, does not disclose wherein the biological signal comprises a skin conductance signal and the biological signal sensor is a skin conductance sensor, and optionally wherein the skin conductance sensor is a galvanic skin resistance measurement device.
However, Zuckerman-Stark directed to a medical device configured to determine a level of pain based on electrical conductance and physiological signals (para. [0003, 0042]) discloses wherein the biological signal comprises a skin conductance signal (“electrical signal from a GSR electrode array … conductance”; “GSR electrode array … skin conductance”, para. [0039, 0042, 0069]) and the biological signal sensor is a skin conductance sensor (GSR electrode array, para. [0039, 0042, 0069]), and optionally wherein the skin conductance sensor is a galvanic skin resistance measurement device (“galvanic skin resistance (GSR) electrode arrays”, para. [0007, 0069]). Zuckerman-Stark further discloses that a correlation between skin conductance and pain has also been demonstrated, in that skin conductance is elevated in response to nociception. Thus, measurement of changes in skin conductance is useful to provide an indication of pain levels (para. [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doidge, as modified by Hunter hereinabove, such that the biological signal comprises a skin conductance signal and the biological signal sensor is a skin conductance sensor, and optionally wherein the skin conductance sensor is a galvanic skin resistance measurement device, in view of the teachings of Zuckerman-Stark, as this would aid in indicating a level of pain by correlating pain levels with skin conductance measurements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Sarvazyan (US 20110066078 A1) directed to a pain monitor for a patient undergoing a medical procedure; Ramachandra SS, Mehta DS, Sandesh N, Baliga V, Amarnath J. Periodontal probing systems: a review of available equipment. Compend Contin Educ Dent. 2011 Mar;32(2):71-7. PMID: 21473303; Renatus A, Trentzsch L, Schönfelder A, Schwarzenberger F, Jentsch H. Evaluation of an Electronic Periodontal Probe Versus a Manual Probe. J Clin Diagn Res. 2016 Nov;10(11):ZH03-ZH07. doi: 10.7860/JCDR/2016/22603.8886. Epub 2016 Nov 1. PMID: 28050524; PMCID: PMC5198477.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791