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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/25 has been entered.
Drawings
The drawings were received on 12/17/25. These drawings are acceptable.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/250,273, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claims 1, 3, and 7-13 receive priority of 09/30/21.
Claims 2, and 4-6 receive the application date of 09/19/22.
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.
Claims 1, 7-13, and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al. (US 20140272773, hereinafter Merritt) in view of Jacobs et al. (US 5562449, hereinafter Jacobs).
Regarding Claim 1, Merritt discloses a kit (10; figures 1-12; paragraph [0053] discloses a system with multiple components) for providing at least one fixture for use in an image guidance system for determining a registration coordinate mapping between a human jaw and a volumetric image of that jaw (abstract, paragraph [0053]), the kit comprising: one or more channeled trays (12; figure 1-4; paragraph [0053]) made of a rigid material (paragraph [0053]) that will not substantially deform when subjected to temperatures of about 70 degrees C (paragraph [0071]), a portion of the surface of the channel (Figure 4) in each channeled tray defining a coupling surface region (Figure 4); a moldable thermoplastic material (32; figure 4; paragraph [0059]) insertable into an individual channeled tray (figure 12 depicts one of the channel trays) of the one or more channel trays (12; figure 4), the moldable thermoplastic material being moldable into a molded shape within the individual channeled tray (paragraph [0059]), wherein the molded shape of the moldable thermoplastic material is configured to mate with a surface geometry of at least a portion of the human jaw (paragraph [0058]) and the coupling surface region of the individual channeled tray (Figure 12); the moldable thermoplastic material is hardenable into an impression part (paragraph [0014] and [0053]) such that when mated to the at least a portion of the human jaw and held within the channel of the channeled tray (paragraph [0014] and [0053]), the impression part resists displacement relative to the human jaw (paragraph [0014] and [0053]); the individual channeled tray is removable from the impression part (paragraphs [0014] discloses the material of the impression part is moldable and is flexible before being fully cured. The Examiner notes that the material before being fully cured is removable from the tray; further the Examiner notes that the impression material is capable of functioning as claimed); each channeled trays of the one or more channeled trays is individually repeatedly attachable to the impression part (paragraphs [0014] discloses the material of the impression part is moldable and is flexible before being fully cured, therefore can be placed on the tray and removed multiple times before fully curing. The Examiner notes that the material before being fully cured is removable from the tray; further the impression material is capable of functioning as claimed); when the individual channeled tray is removed from the impression when the impression part is mated to the at least a portion of the human jaw (intended use, see paragraphs [0014], [0053], [0057], and [0076]; paragraph [0014] discloses the material is flexible prior to fully cooling and removeable when partial cured and somewhat hardened through cooling but before full cooling/hardened as disclosed in paragraph [0074]; paragraph [0058] discloses the impression material is rigid in the cured state; the Examiner further notes that the impression material is functionally capable of being removed), the impression part is bendable away from the surface geometry of the at least a portion of the human jaw such that the impression part is removable from (paragraphs [0074] and [0076]; paragraph [0014] discloses the material is flexible prior to fully curing and partially cooled but before being fulling hardened by cooling is removable from the tray; the Examiner further notes that the impression material is functionally capable of being removed), and repeatedly attachable to, the portion of the human jaw (paragraphs [0074]-[0076]; paragraph [0014] discloses the material is flexible prior to curing and removeable when partial cured and somewhat hardened through cooling but before full cooling/hardened as disclosed in paragraph [0074]; paragraph [0058] discloses the impression material is rigid in the cured state; the Examiner further notes that the impression material is functionally capable of being removed); the at least one of the channeled trays comprises a fiducial region (at 34; paragraph [0061]) detectable in the volumetric CT image in a fixed spatial relation relative to the coupling surface region; and at least one channeled tray is pose-trackable by the image guidance system (paragraphs [0077] and [0079]).
Merritt does not disclose the individual channeled tray is shaped to retain the moldable thermoplastic material within the individual channeled tray during hardening of the moldable thermoplastic material into the impression part and to permit the individual channeled tray to be subsequently removable from the impression part once fully hardened; each channeled tray of the one or more channeled trays is individually repeatedly attachable to the impression part after the moldable thermoplastic material is fully hardened.
Jacobs discloses kit comprising: one or more channeled trays (14; figure 1-5) made of a rigid material (abstract) that will not substantially deform when subjected to temperatures of about 70 degrees C (column 3, lines 55-65), a portion of the surface of the channel (Figure 2) in each channeled tray defining a coupling surface region (Figure 2); a moldable thermoplastic material (12; figures 1-5; abstract) insertable into an individual channeled tray (figure 2) of the one or more channel trays (figure 2), the moldable thermoplastic material being moldable into a molded shape within the individual channeled tray (figure 2; column 5, lines 47-65) wherein the molded shape of the moldable thermoplastic material is configured to mate with a surface geometry of at least a portion of the human jaw (column 5, lines 47-65; column 7, lines 5-24) and the coupling surface region of the individual channeled tray (Figure 2); the individual channeled tray is shaped to retain the moldable thermoplastic material within the individual channeled tray (figure 2) during hardening of the moldable thermoplastic material into the impression part and to permit the individual channeled tray to be subsequently removable from the impression part once fully hardened (column 7, lines 55-column 8, line 20; claim 19); each channeled tray of the one or more channeled trays is individually repeatedly attachable to the impression part after the moldable thermoplastic material is fully hardened (claim 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the individual channeled tray of Merritt to so that the individual channeled tray is shaped to retain the moldable thermoplastic material within the individual channeled tray during hardening of the moldable thermoplastic material into the impression part and to permit the individual channeled tray to be subsequently removable from the impression part once fully hardened; each channeled tray of the one or more channeled trays is individually repeatedly attachable to the impression part after the moldable thermoplastic material is fully hardened as taught by Jacobs in order to allow for reuse of the tray a plurality of times to shape the inner trays by substituting the harden material and decrease the cost per use.
Regarding Claim 7, Merritt as modified by Jacobs discloses the fiducial region comprises a plurality of cylindrical fiducials (34; figure 4) of at least two different diameters (paragraph [0062] discloses the markers may be different sizes).
Regarding Claim 8, Merritt as modified by Jacobs discloses each channeled tray comprises a base (16; figure 4), a lingual wall (18; figure 4) and a facial wall (20; figure 4), the lingual wall and facial wall extending from the base and spaced from each other so as to be adapted to receive at least one tooth (figure 4), and wherein the fiducial region comprises a plurality of cylindrical fiducials (34; figure 4) embedded in the base of at least one of the channeled trays (Figure 4).
Regarding Claim 9, Merritt as modified by Jacobs discloses two optically pose-trackable channeled trays (Figure 12), each having trackable optical markings (paragraph [0085]), wherein the trackable optical markings on each of the two trays are in substantially different poses relative to the coupling surface region (Figure 12).
Regarding Claim 10, Merritt as modified by Jacobs discloses the coupling surface region shared by each channeled tray is shaped to constrain the motion for removing the tray from the impression part such that when attached to the impression part (Figure 4), the channeled tray remains in a fixed spatial relationship to the impression part when not pulled away from it by a human operator (paragraphs [0070]-[0076]).
Regarding Claim 11, Merritt as modified by Jacobs discloses a pose-trackable channeled tray carries trackable optical markings (figures 4 and 12), and the kit further comprises calibration data (paragraph [0020]) for defining a mapping between a coordinate frame of the trackable optical markings and a coordinate frame of the impression part when the channeled tray is in the fixed spatial relationship to the impression part (paragraph [0020]).
Regarding Claim 12, Merritt as modified by Jacobs discloses the coupling surface region is shaped (Figure 4) to prevent full insertion of the impression part into the channel in a channeled tray in an orientation or position other than a single unique one (Figures 4 and 12).
Regarding Claim 13, Merritt as modified by Jacobs discloses wherein the one or more channeled trays comprises two channeled trays, wherein one of the two trays is pose-trackable (Paragraph [0020]), and wherein a portion of the channel in the pose-trackable tray is narrower (figure 4 shows the tray is narrower on the bottom) than the corresponding portion of the channel in the other tray to provide it with increased retention when coupled to an impression part molded by the other tray (Figures 4 and 12).
Regarding Claim 24, Merritt discloses a kit (10; figures 1-12; paragraph [0053] discloses a system with multiple components) for providing at least one fixture for use in an image guidance system for determining a registration coordinate mapping between a human jaw and a volumetric image of that jaw (abstract, paragraph [0053]), the kit comprising: a plurality of channeled trays (12; figure 1-4; paragraph [0053]), each channeled tray made of a rigid material (paragraph [0053]) that will not substantially deform when subjected to temperatures of about 70 degrees C (paragraph [0071]), a portion of the surface of the channel (Figure 4) in each channeled tray defining a coupling surface region (Figure 4); And a moldable thermoplastic material (32; figure 4; paragraph [0059]) insertable into the channel of a first channeled tray (figure 4) of the plurality of channeled trays (figure 12), wherein the moldable thermoplastic material is moldable into an molded shape while contained within the channel of the first channeled tray (paragraph [0059]) and mated with at least a portion of the human jaw (paragraph [0058]), and the molded shape is defined to mate with a surface geometry of the at least a portion of the human jaw (figure 12) and the coupling surface region of each channeled tray wherein the moldable thermoplastic material (figure 4), once molded into the molded shape, is hardenable into an impression part having the molded shape such that the impression part is shaped to resist displacement when mated to the at least a portion of the human jaw (figure 1) and held within the channel of any of the channeled trays (paragraph [0058]); the first channeled tray is removable from the impression part once the moldable thermoplastic material is hardened (paragraph [0014] and [0053]; paragraph [0014] discloses the material is flexible prior to curing and removeable when partial cured and somewhat hardened through cooling but before full cooling/hardened as disclosed in paragraph [0074]; paragraph [0058] discloses the impression material is rigid in the cured state; the Examiner further notes that the impression material is functionally capable of being removed); each channeled tray is individually and repeatedly detachably attachable to the impression part (paragraphs [0014] and [0076] paragraph [0014] discloses the material is flexible prior curing and removeable when partial cured and somewhat hardened through cooling but before full cooling/hardened as disclosed in paragraph [0074]; paragraph [0058] discloses the impression material is rigid in the cured state; the Examiner further notes that the impression material is functionally capable of being removed); the impression part is removable from, and repeatedly attachable to, the portion of the human jaw (paragraphs [0014], [0053], [0057], and [0076] paragraph [0014] discloses the material is flexible prior to cooling and before hardened by cooling is removable from the tray as disclosed in paragraph [0074]; the Examiner further notes that the impression material is functionally capable of being removed); at least one pose-trackable channel tray of the plurality of channeled trays comprises a fiducial region detectable in the volumetric CT image in a fixed spatial relation relative to the coupling surface region (at 34; paragraph [0061]); and each pose-trackable channel tray is pose-trackable by the image guidance system (paragraphs [0077] and [0079]).
Merritt does not disclose the first channeled tray is shaped to retain the moldable thermoplastic material within the first channeled tray during hardening of the moldable thermoplastic material into the impression part and to permit the first channeled tray to be subsequently removable from the impression part once the moldable thermoplastic material is fully hardened; each channeled tray is individually and repeatedly detachably attachable to the impression part after the moldable thermoplastic material is fully hardened.
Jacobs discloses kit comprising: one or more channeled trays (14; figure 1-5) made of a rigid material (abstract) that will not substantially deform when subjected to temperatures of about 70 degrees C (column 3, lines 55-65), a portion of the surface of the channel (Figure 2) in each channeled tray defining a coupling surface region (Figure 2); a moldable thermoplastic material (12; figures 1-5; abstract) insertable into an individual channeled tray (figure 2) of the one or more channel trays (figure 2), the moldable thermoplastic material being moldable into a molded shape within the individual channeled tray (figure 2; column 5, lines 47-65) wherein the molded shape of the moldable thermoplastic material is configured to mate with a surface geometry of at least a portion of the human jaw (column 5, lines 47-65; column 7, lines 5-24) and the coupling surface region of the individual channeled tray (Figure 2); the individual channeled tray is shaped to retain the moldable thermoplastic material within the individual channeled tray (figure 2) during hardening of the moldable thermoplastic material into the impression part and to permit the individual channeled tray to be subsequently removable from the impression part once fully hardened (column 7, lines 55-column 8, line 20; claim 19); each channeled tray of the one or more channeled trays is individually repeatedly attachable to the impression part after the moldable thermoplastic material is fully hardened (claim 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the individual channeled tray of Merritt to so that the individual channeled tray is shaped to retain the moldable thermoplastic material within the individual channeled tray during hardening of the moldable thermoplastic material into the impression part and to permit the individual channeled tray to be subsequently removable from the impression part once fully hardened; each channeled tray of the one or more channeled trays is individually repeatedly attachable to the impression part after the moldable thermoplastic material is fully hardened as taught by Jacobs in order to allow for reuse of the tray a plurality of times to shape the inner trays by substituting the harden material and decrease the cost per use.
Regarding Claim 25, Merritt as modified by Jacobs discloses each channeled tray comprises a base (16; figure 4), a lingual wall (18; figure 4) and a facial wall (20; figure 4), the lingual wall and facial wall extending from the base and spaced from each other so as to be adapted to receive at least one tooth (figure 4), and wherein the fiducial region comprises a plurality of cylindrical fiducials (34; figure 4) embedded in the base of at least one of the channeled trays (Figure 4).
Regarding Claim 26, Merritt as modified by Jacobs discloses the at least one pose-trackable channel tray comprises a first pose-trackable channel tray (36; figure 1) and a second pose-trackable channel tray (36; figure 1), the first pose-trackable channel tray having first trackable optical markings (via 34; figure 1) in a first pose relative (figure 1 on the right side of the device) to the coupling surface region of the first pose-trackable channel tray (figure 1), the second pose-trackable channel tray having second trackable optical markings (via 34; figure 1) in a second pose (figure 1 on the left side of the device) relative to the coupling surface region of the second pose-trackable channel tray (figure 1), and the first pose is different from the second pose (figure 1 depicts 34 in two different locations).
Regarding Claim 27, Merritt as modified by Jacobs discloses the coupling surface region shared by each channeled tray is shaped to constrain the motion for removing the tray from the impression part such that when attached to the impression part (Figure 4), the channeled tray remains in a fixed spatial relationship to the impression part when not pulled away from it by a human operator (paragraphs [0070]-[0076]).
Regarding Claim 28, Merritt as modified by Jacobs discloses each pose-trackable channeled tray carries trackable optical markings (34; figure 1), and the kit further comprises calibration data for defining a mapping between a coordinate frame of the trackable optical markings and a coordinate frame (paragraph [0068]) of the impression part when the channeled tray is in the fixed spatial relationship to the impression part (paragraph [0068])
Regarding Claim 29, Merritt as modified by Jacobs discloses the coupling surface region is shaped (Figure 4) to prevent full insertion of the impression part into the channel in a channeled tray in an orientation or position other than a single unique one (Figures 4 and 12).
Regarding Claim 30, Merritt as modified by Jacobs discloses the plurality of channeled trays comprises a non-pose-trackable channeled tray (36 can be empty as 34 is removable; paragraph [0076]), wherein a portion of the channel in the pose-trackable tray is narrower ( it is narrower in 36 when 34 is inserted as it is filled; figure 1) than a corresponding portion of the channel in the non-pose-trackable channeled tray to provide the pose-trackable tray with increased retention when coupled to an impression part molded by the non-pose-trackable channeled tray (paragraph [0061]).
Claims 2 -6 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al. (US 20140272773, hereinafter Merritt) and Jacobs et al. (US 5562449, hereinafter Jacobs) in view of Burgio et al. (US 20030180679, hereinafter Burgio).
Regarding Claim 2, Merritt as modified by Jacobs discloses the kit of claim 1. Merritt does not disclose the moldable thermoplastic material is provided as a sheet less than 4 mm in thickness and 10g in weight.
Burgio discloses a tray (10) with a channel (11; Figure 10), a portion of the surface of the channel in each channeled tray defining a coupling surface region (Figure 10); a moldable thermoplastic material (22; figure 10; paragraph [0072]) for inserting into a channeled tray and for molding into a molded shape within the channeled tray (Figure 10; paragraph [0072]); the moldable thermoplastic material is provided as a sheet (paragraph [0074] discloses a sheet) less than 4 mm (paragraph [0085]) in thickness and 10g in weight (paragraph [0083]).
It would have been obvious to one of ordinary skill before the effective filing date in the art to have modified the moldable thermoplastic material of Merritt to be a sheet as disclosed by Burgio in order to easily fit within the patient’s mouth.
Regarding Claim 3, Merritt as modified by Jacobs discloses the kit of claim 1. Merritt does not disclose the moldable thermoplastic material is provided as a sheet less than 2 mm in thickness and 4g in weight.
Burgio discloses a tray (10) with a channel (11; Figure 10), a portion of the surface of the channel in each channeled tray defining a coupling surface region (Figure 10); a moldable thermoplastic material (22; figure 10; paragraph [0072]) for inserting into a channeled tray and for molding into a molded shape within the channeled tray (Figure 10; paragraph [0072]); the moldable thermoplastic material is provided as a sheet (paragraph [0074] discloses a sheet) less than 2 mm (paragraph [0085]) in thickness and 5 g in weight (paragraph [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Merritt to disclose the moldable thermoplastic material is provided as a sheet less than 2 mm in thickness and 4g in weight since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of Merritt would not operate differently with the claimed values and since something is disclosed similar would function appropriately with the claimed values.Further, Applicant places no criticality on the range claimed, indicating simply that the value “may” be within the claimed ranges (paragraph [0023]).
Regarding Claim 4, Merritt as modified by Jacobs and Burgio discloses the kit of claim 2. Merritt discloses the sheet becomes moldable when heated to a temperature in the range of 50-90 degrees C (paragraph [0058]).
Claims 2 -6 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al. (US 20140272773, hereinafter Merritt) and Jacobs et al. (US 5562449, hereinafter Jacobs) in view of Burgio et al. (US 20030180679, hereinafter Burgio) and Darnell (US 20080041400).
Regarding Claim 5, Merritt as modified by Jacobs and Burgio discloses the kit of claim 2. Merritt discloses the sheet becomes moldable when heated by water temperature of about 200 degrees C for about 1 minute (paragraph [0071] discloses heating the thermoplastic using hot water).
Merritt does not disclose heating the sheet using hot air.
Darnell discloses a tray (101; figure 2) with a channel (Figure 2), a portion of the surface of the channel in each channeled tray defining a coupling surface region (Figure 2); a moldable thermoformable material (paragraph [0026]); the tray becomes moldable when heated by hot air (using 206; figure 2; paragraph 0030]) at a temperature of about 200 degrees C (paragraph [0030] discloses heating the thermoplastic to 200 degrees F, which is about 200 degrees C).
It is well known and obvious within the art before the effective filing date to heat a moldable thermoplastic material for a dental mold as taught by Merritt using hot air as taught by Darnell as it is a known substitute for hot water and expedites the process of heating the mold.
Regarding Claim 6, Merritt as modified by Jacobs, Burgio and Darnell discloses the kit of claim 4. Merritt discloses comprises a hot air heater (Darnell, using 206; figure 2; paragraph 0030]) for heating the sheet (Burgio, paragraph [0074] discloses a sheet) to the temperature in the range of 50-90 degrees C (paragraph [0058]). As explained in the above rejection of claim 2, Burgio is used to modify the thermoplastic material of Merritt to be a sheet in order to easily fit within the patient’s mouth. Additionally, as explained in the above rejection of Claim 5, the use of the hot air heater as taught by Darnell instead of the hot water as taught in order to expedite the molding process.
Response to Arguments
Applicant's arguments filed 12/17/25 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that Merritt the amendments to claims 1 and 24, the Examiner agrees and such limitations are taught by Jacobs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney J Pulvidente whose telephone number is (571)272-8066. The examiner can normally be reached Monday - Thursday, 7:30 a.m. - 3:30 p.m..
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/SYDNEY J PULVIDENTE/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772