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 .
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.
Claim(s) 1-2, 9-10 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (US 4734035 A) in view of Forrest (US 3911587 A), Chen (US 5154611 A), Zdarsky (US 3964170 A), and Siegel (US 3358826 A).
Re. Claim 1, Cheng teaches a spacer (Fig. 5-8; label 30) for an endodontic instrument (Abstract) comprising:
a base surface (Annotated Figure A of Fig. 5) having a diameter dG (Annotated Figure A of Fig. 5),
a top surface having a diameter dD (Annotated Figure A of Fig. 5),
an axis of rotation (see Fig. 5 where the endodontic tool 20 is fitted into),
a lateral surface (Annotated Figure A of Fig. 5),
a height h (Annotated Figure A of Fig. 5),
an opening (33) having a longitudinal axis (see Fig. Fig. 6A which shows it extends longitudinally) for receiving an endodontic instrument (Fig. 5),
a cylindrical recess (Fig. 5-8 shows element 32 is fitted in and shows the element is cylindrical and as such the recess would be cylindrical) for receiving a stopper (32) on the base surface (Fig. 5), and
wherein the opening extends from the base surface to the top surface (Fig. 6A),
wherein the longitudinal axis of the opening is coaxial with the axis of rotation of the spacer (Fig. 6A),
wherein the cylindrical recess is coaxial with the opening (Fig. 6A),
wherein the base surface is configured to abut a crown of a tooth (Abstract; Fig. 1-2 shows the prior art of applicant’s invention wherein the spacer of Cheng would also have the same function, Fig. 3, such that the file is inserted into the tooth),
wherein the spacer is made of a colored material, and wherein a color code of the colored material is indicative of the height of the frustoconical spacer;
However, Cheng is silent to the spacer being frustonical and the diameter dD is smaller than the diameter dG of the top surface. Further, Cheng is silent to the spacer is made of a colored material, and wherein a color code of the colored material is indicative of the height of the spacer. In addition, Cheng is silent to the spacer being part of a kit with a device, the device comprising a body which comprises at least one recess holding the frustoconical spacer at least partially in a form- fitting manner, wherein the at least partially form-fitting receptacle is configured in such a way that the frustoconical spacer sits in a clamping engagement in the at least one recess. Lastly Cheng is silent to at least one disk for a fine enlargement of the frustoconical spacer, wherein the at least one disk comprises a height of ≤ 0.5 mm.
Forrest teaches a spacer in the same field of endeavor of determining predetermined penetration depths and further discloses a spacer (Annotated Figure B of Fig. 6) with frustoconical shape wherein a base surface has a diameter dD is smaller than the diameter dG (Annotated Figure B of Fig. 6). The shape little to no additional restriction on position or manipulation of the instrument.
It would have been obvious to someone skilled in the art before the effective filing date to have the spacer of Cheng to be frustoconical and the diameter dD is smaller than the diameter dG of the top surface as taught by Forrest to allow the spacer little to no additional restriction on position or manipulation of the instrument.
Chen teaches a stopper in the same field of endeavor and further discloses the stopper (24b/24c) comprises different colors corresponding to different thickness and heights (Col. 4, lines 23-34; As it teaches that the stopper is provided with a color, it would need to be made of at least one material that is colored) to aid in identifying the sized spacers in a kit and during the operation. Chen further teaches in addition to the stopper, that a disc (24a can be applicable) may be present to provide fine enlargement (Fig. 2 shows that the addition to it provides precise and fine enlargement) to allow the user to have a clearer visual aid on when to stop and to adjust the depth penetration even further. In addition, it disclosed that the heights can be varying heights including 0.5 mm (Col. 4, lines 13-22).
It would have been obvious to someone skilled in the art before the effective filing date to have the spacer of Cheng and Forrest to comprise a marker indicating the height as taught by Chen to aid in identifying the sized spacers in a kit and during the operation.
It would have been obvious to someone skilled in the art before the effective filing date to have the system of Cheng, Forrest, and Chen to have a disk as taught by Chen to aid in providing a larger visual aid of when the user needs to stop. Further, it would have been obvious to someone skilled in the art before the effective filing date to have the disc of Cheng, Forrest, and Chen to comprise a height of 0.5 mm as taught by Chen as a design choice as it is dependent on the spacer and the user’s needs. It should be noted that the instant disclosure describes the disk height are merely preferable, and does not describe them as contributing any unexpected result to the device as the disk height is dependent on the spacer.
Zdarsky teaches a device (Fig. 1-4) providing the spacer (15) comprising a body (1) which comprises at least one recess (8) for holding the spacer (Fig. 3) at least partially in a form-fitting manner (Fig. 3; Col. 3, lines 21-34) wherein the at least partially form-fitting receptacle is configured in such a way that the spacer sits in a clamping engagement in the at least one recess (Col. 3, lines 21-34). The device as such aids in placing the stop in the proper place on the dental instrument.
It would have been obvious to someone skilled in the art before the effective filing date to have the spacer of Cheng, Forrest, and Chen to have a device to hold the spacer as taught by Zdarsky to act as a guide in placing the spacer and stopper into place.
Siegel teaches a kit including dental tools for root canal treatment (Title; Abstract) comprising a device (18/24) and a spacer (see Fig. 4a, label 40a where what is labeled as “red”, “yellow” and “blue” are the stops which is disclosed to be color coded in Col. 3, lines 34-35) and multiple compartments for receiving different endodontic instruments and tools (Col. 3, lines 54-65).
It would have been obvious to someone skilled in the art before the effective filing date to have the spacer and device of Cheng, Forrest, Chen and Zdarsky to be part of a kit as taught by Siegel to create an effective kit for canal treatment and provide easy access to all instruments needed for the procedure.
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Annotated Figure A
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Annotated Figure B
Re. Claim 2, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, wherein Cheng teaches the cylindrical recess for receiving a stopper comprises a volume which corresponds to the volume of a stopper (Fig. 5 shows the stopper is fully inserted into the recess).
Re. Claim 9, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, wherein Cheng teaches the spacer is made of a material which is selected from a group consisting of: plastic (Col. 2, lines 61-67 discloses that the hard member can be made of acrylic which is a type of plastic).
Re. Claim 10, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1 and Chen further teaches the spacer comprises a marker indicating the height (Col. 4, lines 23-34).
It would have been obvious to someone skilled in the art before the effective filing date to have the spacer of Cheng, Forrest, Chen, Zdarsky, and Siegel to comprise a marker indicating the height as taught by Chen to aid in identifying the sized spacers in a kit and during the operation.
Re. Claim 14, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, wherein Zdarsky further teaches in the area of the recess (Fig. 1), a slit-shaped (7) opening extending towards the edge of the body is configured in the bottom of the body for receiving an endodontic instrument (Col. 3, lines 26-35).
Re. Claim 15, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 14, but are silent to the slit-shaped opening comprises a diameter of ≤ 2.0 mm.
The instant disclosure describes the slit-shaped opening diameter ≤ 2.0 mm are merely preferable, and does not describe them as contributing any unexpected result to the device as the slit-shaped is dependent on the endodontic instrument being inserted. As such, these parameters are deemed matters of design choice (lacking in any criticality), and can be obtained through routine experimentation in determining optimum results well within someone skilled in the art.
Claim(s) 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (US 4734035 A) in view of Forrest (US 3911587 A), Chen (US 5154611 A), Zdarsky (US 3964170 A), Siegel (US 3358826 A) and Saffro (US 3781996 A).
Re. Claim 3, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the cylindrical recess for receiving a stopper comprises a diameter of 2.0 mm to 5.0 mm.
Saffro teaches a spacer (Fig. 2) comprising a cylindrical recess (Fig. 4 shows that where element 134 is fitted into is the cylindrical recess) for receiving a stopper (134) comprises a diameter of 2.0 mm to 5.0 mm (Col. 2, lines 56-59) to allow for a stopper to be present to aid in positioning the tool properly.
It would have been obvious to someone skilled in the art before the effective filing date to have the cylindrical recess of Cheng, Forrest, Chen, Zdarsky, and Siegel to have a diameter of 2.0 mm to 5.0 mm as taught by Saffro to allow for a stopper to be present to aid in positioning the tool properly.
Re. Claim 4, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the cylindrical recess for receiving a stopper comprises a height which is 0.5 mm to 2.0 mm.
Saffro teaches a spacer (Fig. 4) comprising a cylindrical recess (Fig. 4 shows that where element 134 is fitted into is the cylindrical recess) for receiving a stopper (134) comprises a height which is 0.5 to 2.0 mm (Col. 3, lines 54-58 discloses that the height of element 32 which is also the height of the recess in which holds the stopper is 1 mm. It is also disclosed that the entire recess of the spacer would be 2 mm as the total length of the spacer is 2 mm).
It would have been obvious to someone skilled in the art before the effective filing date to have the height of the cylindrical recess of Cheng, Forrest, Chen, Zdarsky, and Siegel to be between 0.5 to 2.0 mm as taught by Saffro to allow for a stopper to be present to aid in positioning the tool properly.
Re. Claim 5, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the diameter dG is 5.0 mm to 15.0 mm.
Saffro teaches a spacer (Fig. 2) in the same field of endeavor and further discloses a base surface (32) having a diameter dG being between 5.0 mm to 15.0 mm (Col. 4, lines 17-21 discloses that the diameter would be 5 mm) to accommodate the file without restricting its movement.
It would have been obvious to someone skilled in the art before the effective filing date to have the diameter dG of Cheng, Forrest, Chen, Zdarsky, and Siegel to be between 5.0 mm to 15.0 mm as taught by Saffro to accommodate the file without restricting its movement.
Re. Claim 6, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the height h is 0.75 mm to 15 mm.
Saffro teaches a spacer (Fig. 4) in the same field of endeavor and further discloses a height h being 0.75 mm to 15 mm (Col. 3, lines 54-58 discloses that the total length of the stop would be 2 mm) where the height of the stop is dependent upon the endodontic procedure based on the limit of penetration needed.
It would have been obvious to someone skilled in the art before the effective filing date to have the height of Cheng, Forrest, Chen, Zdarsky, and Siegel to have the height h is 0.75 mm to 15 mm as taught by Saffro as the height of the stop is dependent upon the endodontic procedure based on the limit of penetration needed.
Re. Claim 7, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the opening for receiving an endodontic instrument comprises a diameter ≤ 2.0 mm.
Saffro teaches a spacer (Fig. 2) in the same field of endeavor and further discloses the opening for receiving an endodontic instrument comprises a diameter ≤ 2.0 mm (Col. 2, lines 56-60) wherein the opening is sized to fit the files currently standardized (Col. 2, lines 56-60).
It would have been obvious to someone skilled in the art before the effective filing date to have the opening for receiving an endodontic instrument of Cheng, Forrest, Chen, Zdarsky, and Siegel to have a diameter ≤ 2.0 mm as taught by Saffro to fit the size of files currently standardized.
Re. Claim 8, Cheng, Forrest, Chen, Zdarsky, and Siegel teaches the kit of claim 1, but are silent to the diameter dD is from 2.5 mm to 10.0 mm.
Saffro teaches a spacer (Fig. 2) in the same field of endeavor and further discloses a top surface (30) having a diameter dD to be between 2.5 mm to 10 mm (Col. 4, lines 17-21 discloses that the diameter would be 3 mm) to accommodate the file without restricting its movement.
It would have been obvious to someone skilled in the art before the effective filing date to have the diameter dD of Cheng, Forrest, Chen, Zdarsky, and Siegel to be between 2.5 mm to 10 mm as taught by Saffro to accommodate the file without restricting its movement.
Response to Arguments
Argument #1: Applicant argues that Cheng does not disclose an element 8 but rather an element 32 and an element 31. Applicant noted that examiner intended to point out element 32 as the stopper when referencing element 8. Applicant argues that Cheng does not disclose the opening located at the base of the spacer but rather embedded within spacer 31 OR on top surface spacer as shown in Fig. 6A)
Response #1: It is noted that applicant is correct that element 8 should’ve been element 32 of Cheng. However, applicant’s argument that Cheng does not disclose the recess at the base of the spacer is not persuasive. Though Fig. 6A presents the stopper at the top surface and Fig. 7A shows the stopper at the central portion of the spacer, it should be noted that Fig. 5 presents the stopper at the base of the spacer on the side in which would abut the tooth. Fig. 5 presents the spacer to be found on the file presenting a configuration during use for filing (Col. 3, lines 5-13).
Argument #2: Applicant argues that there an error exchanged with the base and top surfaces. Applicant notes Forrest which shows a top surface with a diameter smaller than bottom diameter BUT does not disclose the functional role of such shape. Applicant argues that Forrest provides no indication that Forest’s geometry would be intended to contribute to the calibration system nor provide a sterile clamping workflow. Further, applicant argues that Forrest does not disclose the motivation used in the obvious statement that states the shape allowing no additional restriction on position or manipulation of the instrument.
Response #2: Applicant’s argument is found to not be persuasive. The argument regarding that the geometry is found to not be disclosed to contribute to the calibration system nor provide a sterile clamping workflow. This particular limitation is found to not be claimed in the claim limitation (specifically the topic of calibration and sterilization). It should be noted that though Forrest does not disclose the function of the shape as that of applicant, it still presents the same structure. Because it is capable of such it meets the structural limitation, it would function as claimed. Further, though Forrest does not assert the motivation explicitly, it is found that it is well known in the art that changing of the shape is a design choice where the functionality is found to be the same.
Argument #3: Applicant argues that Chen and Siegel disclose different usages of the color-coding system. Chen is disclosed to indicate various thicknesses through color coding whereas Siegel discloses maintaining patient-specific sets and avoid canal mix ups. Because they are found to function differently, one skilled in the art would not modify the two together.
Response #3: Applicant’s argument is found to not be persuasive. Applicant’s argument is found to not be persuasive. It should be noted that Siegel is not being relied upon for the color-coding limitation but is solely used for teaching a kit. It is pointed out in the office action that Siegel presents multiple spacers/stoppers within said kit with other elements. The mentioning of the spacers being color coded was not used to teach the limitation regarding color-coding but rather point out that different colored spacers/stoppers are present within the kit as well.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HOLLY T. TO/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 12/29/2025