DETAILED ACTION
This is a Non-Final Rejection for Application 19/094,914 filed March 20, 2025. This application is a continuation of Application 17/438,430 filed September 12, 2021 which is a 371 of PCT/EP2020/056740 filed March 12, 2020 which further claims foreign priority to foreign applications EP19162285.1 filed March 12, 2019 and EP19169667.3 filed April 16, 2019. Claims 1-17 are currently pending.
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 .
Drawings
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: 82 depicted 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
Claim 2 is objected to because of the following informalities: “according to claims 1” in line 1 should be corrected to “according to claim 1”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “an modification” in line 2 should be corrected to “a modification”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “a heart rate senor” in line 2 should be corrected to “a heart rate sensor”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3, 5-7, 9-10, 12 and 14-17 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 claim 3, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as limiting the external sensoring device to be a clothing comprising an intelligent textile, a breathing belt, a wearable computer, an ear piece, or a hearable.
Regarding claim 5, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as requiring either wherein in particular the modulation device comprises a micromotor or wherein the distractor is manually adjustable.
Claim 9 recites the limitation "the at least one property" in. There is insufficient antecedent basis for this limitation in the claim. At least one property is not previously recited so it is unclear how the recitation is being further limited.
Regarding claim 10, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as requiring at least wherein the system is configured to transmit the template dataset to a 3D printer, but not specifically a digital light processing printer.
Regarding claim 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as requiring that the system is configured to measure the at least one measurable quantity continuously over time or at a plurality of predefined time points, but not specifically a plurality of successive equally spaced time points.
Regarding claim 14, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as requiring wherein the alert device is configured to give an alert to the person.
Regarding claim 15, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as requiring that the system is configured to determine a sleep disorder, but not specifically that the sleep disorder is snoring, sleep hypopnoea, or sleep apnoea.
Claims 6-7 and 16-17 are rejected for depending from and not curing the deficiencies of a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 11-17 are rejected under 35 USC 102(a)(1) as being anticipated by US 2016/0199215 (Kopelman).
Regarding claim 1, Kopelman discloses an adaptation system ([0066] – “FIG. 5 illustrates an exemplary system 500, comprising a set of one or more sensors 502 (e.g., n sensors, where n is one, two, three, four, five, or more), a processor 504, and an intraoral appliance 506 comprising an actuator 508.” The system 500 is interpreted as an adaptation system.), comprising
- a mouthpiece, configured to be positioned in a mouth of a person ([0069] – “In some embodiments, when the intraoral appliance 506 is positioned in the patient's mouth, processor 504 can send a control signal to intraoral appliance 506 and/or actuator 508 to cause the intraoral appliance to, when in place in the patient's mouth, retract the lower jaw to a habitual or starting jaw position when symptoms of obstructive sleep apnea and/or snoring are observed to be lessening, and/or when termination of a sleep apnea event is detected, based on or in response to sensor data received by processor 504 from sensors 502.” See the figures showing an exemplary intraoral appliance which is interpreted as a mouthpiece.),
- an external sensoring device, configured to be positioned at the person, wherein the external sensoring device comprises at least one sensor configured to sense at least one measurable quantity when the mouthpiece is positioned in the person’s mouth and the external sensoring device is positioned at the person ([0070] – “Systems of the present disclosure provide for collecting data on the patient's apnea patterns over time and using such collected data to improve treatment of sleep apnea and/or snoring. In some embodiments, processor 504 can be configured to collect sensor data from sensors 502 comprising patient data related to the patient's sleep apnea patterns over time.” [0075] – “Sensors described herein can be adapted to be positioned outside of a patient's body (externally positioned), inside of a patient's body (internally positioned), or on a patient's body surface.” Sensors 502 and processor 504 form an external sensoring device.),
characterised in that the adaptation system comprises an analysis device configured to determine a compliance of the adaptation system and/or to determine an orientation of an upper jaw and a lower jaw to each other derived from the at least one sensed measurable quantity (The processor 504 is interpreted as an analysis device as the processor 504 is configured to determine the termination of a sleep apnea event, which indicates compliance of the system, derived from sensor data received from the sensors 502 ([0069]). The processor 504 determines compliance using a machine learning algorithm that detects sleep apnea events from data received from the sensors 502 ([0021]). The data from the sensors includes one or more of breathing sounds, snoring sounds, breathing rate, respiratory air flow, chest expansion, oxygen level, cardiac data, or sleeping position, or combinations thereof ([0024]). Compliance is being interpreted as whether the system is functioning as intended.).
Regarding claim 2, Kopelman discloses the system according to claims 1, characterised in that the external sensoring device comprises the analysis device (Sensors 502 and processor 504 form an external sensoring device ([0075]).).
Regarding claim 3, Kopelman discloses the system according to claim 1, characterised in that the external sensoring device is at least one of: a clothing comprising an intelligent textile, a breathing belt, a wearable computer, and in particular an ear piece, in particular a hearable (The external sensoring device comprises the sensors 502 which are capable of being positioned on a patient’s body surface and comprise a computer such as an EKG, making the sensors 502 a wearable computer ([0075]).).
Regarding claim 4, Kopelman discloses the system according to claim 1, characterised in that the mouthpiece is adaptable to modify the orientation of the upper jaw and the lower jaw to each other based on the at least one sensed measurable quantity (The lower jaw 102 is advanced by the intraoral appliance based on information received from the sensors ([0040]-[0041],[0068]).).
Regarding claim 5, Kopelman discloses the system according to claim 1, characterised in that the mouthpiece comprises a distractor, wherein the distractor is configured to modulate at least one property of the mouthpiece to modify the orientation of the upper jaw and the lower jaw to each other, wherein in particular the system comprises a modulation device through which the distractor is accessible to modify the orientation of the upper jaw and the lower jaw to each other, wherein in particular the modulation device comprises a micromotor or, wherein the distractor is manually adjustable (An upper advancement structure 26 is interpreted as a distractor and is configured to modulate the displacement of the lower shell 24 and the upper shell 22 which causes displacement of the lower jaw and upper jaw of the patient ([0054]). The upper advancement structure 26 is coupled to an actuator which is interpreted as a modulation device ([0056]). The actuator is a motor ([0050]). A micromotor is interpreted as a motor that is sized to fit within the device, which requires small components.).
Regarding claim 6, Kopelman discloses the system according to claim 5, characterised in that the system comprises a feedback device configured to determine an modification of the orientation of the upper jaw and the lower jaw to each other from the modulation of at least one property of the mouthpiece by the distractor (Data from the patient is collected and used by a control algorithm to allow feedback to control the mandibular advancement motor ([0061]). The control algorithm is interpreted as a feedback device.).
Regarding claim 7, Kopelman discloses the system according to claim 5, characterised in that the at least one property of the mouthpiece is one of: a width of the mouthpiece, a length of the mouthpiece, and a height of at least a section of the mouthpiece (The device displaces one jaw by adjusting the distance or a position in an anterior-posterior direction, a vertical direction, a lateral direction or a combination thereof and hence modifying a length or a height of the appliance ([0068]).).
Regarding claim 8, Kopelman discloses the system according to claim 1, characterised in that the mouthpiece comprises an upper oral splint related to the upper jaw of the person and/or a lower oral splint related to the lower jaw of the person (An upper shell 12,22,32 is interpreted as an upper oral splint and a lower shell 14,24,34 is interpreted as a lower oral splint (Figs. 2A-4B).).
Regarding claim 9, Kopelman discloses the system according to claim 8, characterised in that the at least one property of the mouthpiece is an angle between the upper oral splint and the lower oral splint, and/or an offset between the upper oral splint and the lower oral splint (The system advances the mandible of a user in response to real-time sleep apnea status ([0048]). Mandibular advancement offsets the upper shell and lower shell.).
Regarding claim 11, Kopelman discloses the system according to claim 1, characterised in that the at least one sensor is one of: a sound sensor, a temperature sensor, an inclination sensor, a heart rate senor, a blood pressure sensor, a blood oxygen sensor, a muscle tension sensor (The sensor 502 monitors breathings sounds, making it a sound sensor ([0073]).).
Regarding claim 12, Kopelman discloses the system according to claim 1, characterised in that the system is configured to measure the at least one measurable quantity continuously over time, or in that the system is configured to measure the at least one measurable quantity at a plurality of predefined time points, in particular at a plurality of successive equally spaced time points (The device continuously collects data to build a patient specific profile ([0060]).).
Regarding claim 13, Kopelman discloses the system according to claim 1, characterised in that the system is configured to analyse the at least one measurable quantity in real-time (The sensors monitor physiological data from a patient in real-time ([0072]).).
Regarding claim 14, Kopelman discloses the system according to claim 1, characterised in that the system comprises an alert device configured to compare at least one measurable quantity with a predefined reference value of the respective at least one measurable quantity, wherein in particular the alert device is configured to give an alert to the person, when the at least one measurable quantity deviates from the predefined reference value of the respective at least one measurable quantity by a predefined deviation factor (The collected data may also be used to generate patient alarms and reports on patient treatment and status ([0062]). The data is automatically assessed by the processor which is capable of sensing an alert for help if worsening breathing patterns are detected.).
Regarding claim 15, Kopelman discloses the system according to claim 1, characterised in that the system is configured to determine a sleep disorder, wherein the sleep disorder is in particular snoring, sleep hypopnoea, or sleep apnoea (The device is drawn to monitoring and treating sleep apnea (Abstract).).
Regarding claim 16, Kopelman discloses the system according to claim 5, characterised in that the mouthpiece comprises an upper oral splint related to the upper jaw of the person and/or a lower oral splint related to the lower jaw of the person (An upper shell 12,22,32 is interpreted as an upper oral splint and a lower shell 14,24,34 is interpreted as a lower oral splint (Figs. 2A-4B).).
Regarding claim 17, Kopelman discloses the system (500) according to claim 16, characterised in that the at least one property of the mouthpiece is an angle between the upper oral splint and the lower oral splint, and/or an offset between the upper oral splint and the lower oral splint (The system advances the mandible of a user in response to real-time sleep apnea status ([0048]). Mandibular advancement offsets the upper shell and lower shell.).
Allowable Subject Matter
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Claim 10 contains allowable subject matter as the closest prior art of record is US 2016/0199215 (Kopelman) in view of US 2011/0232652 (Levendowski et al). Kopelman does not disclose that the system comprises a prediction device which is configured to evaluate a template dataset based on the at least one measurable quantity sensed by the at least one sensor, wherein the template dataset characterises a template of an optimised mouthpiece with modified orientation of the upper jaw and the lower jaw to each other, wherein in particular the system is configured to transmit the template dataset to a 3D printer, in particular to a digital light processing printer. However, Levendowski teaches using a removable oral appliance and sleep studies to determine and optimize the efficacy of the treatment of the oral appliance by using a predictive model to generate a prediction for initial appliance settings, adjusting the appliance settings based on the efficacy assessment to create modified appliance settings, and fabricating a custom appliance for the patient based on the modified appliance settings of the temporary appliance ([0016]). Though, neither reference teaches a prediction device capable of performing the claimed function.
Therefore, claim 10 is indicated as containing allowable subject matter as the prior art dopes not disclose a prediction device capable of the claimed limitations.
The Examiner notes that Applicant should not use the same language as U.S. Patent 12,263,059 if claim 10 is rewritten into claim 1 as this will result in a statutory double patenting rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 6-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,263,059. Although the claims at issue are not identical, they are not patentably distinct from each other because they largely claim the same invention except that the limitations of claim 10 are rewritten into claim 1 of U.S. Patent No. 12,263,059.
Regarding claim 1, all of the limitations of the present application are claimed in claim 1 of U.S. Patent No. 12,263,059.
Regarding claim 2, all of the limitations of the present application are claimed in claim 2 of U.S. Patent No. 12,263,059.
Regarding claim 3, all of the limitations of the present application are claimed in claim 3 of U.S. Patent No. 12,263,059.
Regarding claim 4, all of the limitations of the present application are claimed in claim 5 of U.S. Patent No. 12,263,059.
Regarding claim 6, all of the limitations of the present application are claimed in claim 7 of U.S. Patent No. 12,263,059.
Regarding claim 7, all of the limitations of the present application are claimed in claim 8 of U.S. Patent No. 12,263,059.
Regarding claim 8, all of the limitations of the present application are claimed in claim 9 of U.S. Patent No. 12,263,059.
Regarding claim 9, all of the limitations of the present application are claimed in claim 10 of U.S. Patent No. 12,263,059.
Regarding claim 10, all of the limitations of the present application are claimed in claim 1 of U.S. Patent No. 12,263,059.
Regarding claim 11, all of the limitations of the present application are claimed in claim 12 of U.S. Patent No. 12,263,059.
Regarding claim 12, all of the limitations of the present application are claimed in claim 13 of U.S. Patent No. 12,263,059.
Regarding claim 13, all of the limitations of the present application are claimed in claim 14 of U.S. Patent No. 12,263,059.
Regarding claim 14, all of the limitations of the present application are claimed in claim 16 of U.S. Patent No. 12,263,059.
Regarding claim 15, all of the limitations of the present application are claimed in claim 20 of U.S. Patent No. 12,263,059.
Regarding claim 16, all of the limitations of the present application are claimed in claim 9 of U.S. Patent No. 12,263,059.
Regarding claim 17, all of the limitations of the present application are claimed in claim 10 of U.S. Patent No. 12,263,059.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,263,059 in view of US 2016/0199215 (Kopelman).
Regarding claim 5, all of the limitations of the present application are claimed in claims 6 and 18 of U.S. Patent No. 12,263,059, except for wherein in particular the modulation device comprises a micromotor or, wherein the distractor is manually adjustable. However, Kopelman discloses an upper advancement structure 26 that is interpreted as a distractor and is configured to modulate the displacement of the lower shell 24 and the upper shell 22 which causes displacement of the lower jaw and upper jaw of the patient ([0054]). The upper advancement structure 26 is coupled to an actuator which is interpreted as a modulation device ([0056]). The actuator is a motor ([0050]). It would be obvious to modify U.S. Patent No. 12,263,059 to include a micromotor as a modulation device as taught by Kopelman such that the device may be automatically controlled.
Conclusion
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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