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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/04/2026 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CH00645/20, filed on 05/29/2020.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
For examination purposes, the priority date for claims 1-17 is the date of the associated PCT, 05/26/2021.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 15 recites the limitation, “wherein the proximal angle is greater than the distal angle”. While Paragraph [0020] discloses a distal angle (16) and proximal angle (17), and Paragraph [0032] discloses the distal angle (16) as substantially zero, the specification does not disclose the proximal angle (17) being greater than the distal angle (16).
Claims 16-17 disclose “a perimeter of the angular cutting segment”. This terminology is not used in the specification. For examination purposes, Examiner is interpreting this limitation as “the circumscribed circle diameter”, consistent with Paragraphs [0023] and [0032] of the specification.
Claim Objections
Claims 1, 2, 8, 9, 10 and 11 are objected to because of the following informalities:
Claim 1:
Paragraph 4, line 1, “the guide head”, should be, “the rounded guide head”.
Paragraph 7, line 1, and paragraph 8, line 1, “the cross-sectional geometry in transverse planes”, does not clearly state what the planes are transverse to. Examiner is interpreting the planes as transverse to the longitudinal axis as shown in Fig. 1b and described in Paragraph [0014].
Claim 2, line 2, claim 4, line 2, claim 5, lines 2-3, “the guide head”, should be, “the rounded guide head”.
Claims 8-9, line 2, “the circumscribed circle”, should be “a circumscribed circle”.
Claims 10-11, line 2, recite the limitation “the distal section. There is insufficient antecedent basis for this limitation in the claim. Examiner understands this limitation as referring to the cross-sectional geometry of the distal zone, consistent with the language of claim 1.
Appropriate correction is required.
Applicant is advised that should claim 3 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 1-14, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Desrosiers (US 20050272004 A1), in view of Mordeniz (US 20120208146 A1), and further in view of Sato et al. (JP H09117460 A; refer to the updated translation), herein referred to as Sato.
Regarding claim 1, Desrosiers discloses an endodontic instrument (334) notably for reaming a root canal of a tooth of a patient (refer to Paragraph [0026]; the instruments disclosed are shown as reamers or files for cleaning and shaping root canals), the instrument (334) extending along a longitudinal axis (17) and comprising a working length (340+342+344) having a working section (refer to Paragraph [0008]; Examiner understands a working section as a cross section of the working length, perpendicular to the longitudinal axis, as demonstrated in Fig. 6b and Paragraph [0026] of the specification; at any axial location along the working length, a cross-section may be taken perpendicular to the longitudinal axis) the working length (340+342+344) being terminated by a distal portion having a cutting function (refer to Paragraph [0069], annotated Fig. 11 below; a plurality of flutes are arranged);
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the distal portion comprising a distal head (14) and an angular cutting segment (338) between the head (14) and the working length (340+342+344);
wherein the angular cutting segment (338) comprises a distal zone adjacent to the distal head (14) and a proximal zone between the distal zone and the working length (340+342+344) (refer to annotated Fig. 11 below);
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the angular cutting segment (338) further comprising cutting edges (346) that extend over the entire length of the proximal zone and the distal zone (refer to Paragraph [0069]; tapered section (338) incorporates a plurality of flutes arranged about the circumference of the working length (336) of which only a single flute (346) is visible);
Although Desrosiers teaches a cross section may be taken perpendicular to the longitudinal axis (17) at any axial location (refer to Paragraph [0008]), Desrosiers does not explicitly teach:
wherein, in the distal zone, the cross-sectional geometry in transverse planes remains constant along the longitudinal axis (of note, Examiner understands the transverse planes as planes transverse to the longitudinal axis); and
wherein, in the proximal zone, the cross-sectional geometry in transverse planes varies along the longitudinal axis between the distal section and the working section (of note, Examiner understands the transverse planes as planes transverse to the longitudinal axis).
Desrosiers can be modified to meet these limitations by Mordeniz, which discloses a fluted reamer in the same field of endeavor (refer to Paragraphs [0007]-[0008]), as follows:
Modifying the shape of the distal zone to be a constant cross-sectional geometry in the transverse planes, as demonstrated by the distal zone (P1) of the reamer of Mordeniz, where the geometric characteristics are the same throughout this zone (refer to Paragraphs [0034], [0037], annotated Fig. 1 below, and Fig. 2).
A person of ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to make the above modification because:
The identical geometric characteristics of the distal zone (P1) are chosen to obtain the best distribution of mechanical stress, while providing a centering function (refer to Paragraph [0042]).
Modifying the shape of the proximal zone, such that the cross-sectional geometry in the transverse planes varies along the longitudinal axis as shown in the proximal zone (P2) of the reamer of Mordeniz (refer to Paragraph [0047], Figs. 3A-3D; a progressive evolution of the cross-sectional geometry of the blade is shown from a three-sided blade towards the distal zone to a two-sided S-shaped blade towards the working portion).
A person of ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to make the above modification
because:
The variation of geometric characteristics of the proximal zone (P2) are chosen to optimize cutting for that section of the reamer blade between the distal portion (P1) and working portion (P3), while also accounting for the mechanical stress of this blade section (refer to Paragraph [0048]).
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Desrosiers is further silent to the distal portion comprising a rounded guide head, such that the distal portion provides a guiding function.
Sato discloses a dental instrument for cutting a root canal wall in the same field of endeavor where the distal end is formed as a rounded guide head (2b) (refer to Paragraph [0036]). Sato further teaches that this rounded tip is known in the art for guiding the working portion (refer to Paragraph [0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal head as taught by Desrosiers and Mordeniz with the rounded guide head as taught by Sato in order to appropriately guide the working portion (refer to Paragraph [0007]).
Regarding claim 2, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers discloses the overall working length (refer to Paragraph [0028]); however, Desrosiers does not explicitly teach the length of the distal zone or guide head.
Mordeniz further discloses the length of the distal zone (P1) as in the range of 2- 6mm (refer to Paragraph [0042]), where the length is based on obtaining the best distribution of mechanical stresses and centering (refer to Paragraph [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have assigned a value in the range of 2-6mm to the length of the distal zone as taught by Desrosier, Mordeniz and Sato, as Mordeniz teaches this range for optimal distribution of mechanical stress and centering for the distal zone (P1) of a reamer (refer to Paragraph [0042]).
Although Mordeniz discloses the length of the distal zone (P1), Mordeniz does not explicitly teach the length of the guide head.
Sato further discloses that the rounded guide head is of a length of 1mm-2mm (refer to Paragraph [0030]), demonstrating that this length is a known dimension in the art for engaging the root of a patient (refer to Paragraphs [0024], [0026]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have assigned a value in the range of 1-2 mm to the rounded guide head as taught by Desrosier, Mordeniz, as Sato teaches this length is a known dimension in the art for engaging the root of a patient (refer to Paragraphs [0024], [0026]).
In modifying the length of the distal zone to be 2mm-6mm, and the length of the rounded guide head to be 1-2mm, the ratio of the length of the distal zone to the length of the rounded guide head is in the range of 1-6, an overlapping range with the claimed range of greater than 1 or greater than 2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the distal zone of Desrosier, Mordeniz and Sato such that the ratio of the length of the distal zone to the rounded guide head is greater than 1 or 2, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Regarding claim 3, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers further discloses wherein at least one portion of the distal zone and the proximal zone is tapered, respectively forming a distal angle and a proximal angle with the longitudinal axis of the instrument (17) (refer to Paragraph [0069], annotated Fig. 11 above; the tapered section (338) that defines the distal and proximal zones has a positive taper of 0.1mm/mm).
Regarding claims 4-5, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers and Mordeniz are silent to wherein the diameter of the guide head is greater than the diameter of the circumscribed circle of the distal zone over at least a part of the length of the distal zone, at the junction of the guide head and the distal zone.
Sato further discloses that the junction of the guide head (2b) and the distal zone (2a) forms an obtuse angle (refer to Paragraph [0034]), such that the diameter of the guide head is greater than the diameter of the circumscribed circle at the junction (refer to annotated Fig. 3 below). This obtuse angle formed at this junction allows the edge of the guide head (2b) to remove foreign matter or cutting waste without biting into the root canal wall (refer to Paragraph [0035]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the junction of the guide head and the distal zone of Desrosiers and Mordeniz with the obtuse angle configuration as taught by Sato in order to remove foreign matter or cutting waste without biting into the root canal wall (refer to Paragraph [0035]).
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Regarding claims 6-7, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers discloses the overall working length (refer to Paragraph [0028]); however, Desrosiers does not explicitly teach the length of the distal zone or proximal zone, such that the ratio of the length of the proximal zone to the length of the distal zone is between 0.2 and 4.5 or between 0.6 and 1.8.
Mordeniz further discloses the length of the distal zone (P1) as in the range of 2- 6mm (refer to Paragraph [0042]), and the length of the proximal zone (P2) as in the range of 3-7mm (refer to Paragraph [0048]). This gives a range of the ratio of the length of the proximal zone to the length of the distal zone as between 0.5-3.5. Both lengths of the distal zone (P1) and the proximal zone (P2) are based on obtaining the best distribution of mechanical stresses and centering (refer to Paragraphs [0042], [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have assigned a value in the range of 2-6mm to the length of the distal zone and 3-7mm to the length of the proximal zone as taught by Desrosier, Mordeniz and Sato, as Mordeniz teaches these ranges for optimal distribution of mechanical stress and centering (refer to Paragraph [0042]). Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Regarding claims 8-9, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers does not disclose wherein the diameter of the circumscribed circle of the distal zone and the proximal zone is constant over the entire length of the distal zone and the proximal zone respectively, in the original embodiment (334).
Although these features are not explicitly disclosed as part of the original embodiment, Desrosier discloses that the angular cutting segment (338), which includes the distal zone and the proximal zone may have any of the geometric arrangements previously described, suggesting modification (refer to Paragraph [0069]; Examiner understands the “geometric arrangements” as the shape of the segment, which includes the flutes, facets and taper of the segment as these all affect the shape of device). One such geometric arrangement disclosed is the working length (16) having a uniform cross-sectional diameter, or zero taper (refer to Paragraph [0028]). The working length (16) of this alternative embodiment (10) is analogous to the working length (336) that encompasses the angular cutting segment (338) of the original embodiment (334). In the case of a zero taper, the angular cutting segment (338) and thus, the distal zone and the proximal zone have a constant diameter of a circumscribed circle over their entire lengths. A zero taper segment provides an alternative, cylindrical surface of revolution for when a non-tapered shape in the root canal is desired (refer to Paragraph [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the angular cutting segment (338) of the original embodiment (334) of Desrosiers with a zero-taper as taught by the alternative embodiment (10), in order to provide an alternative, cylindrical surface of revolution for when a non-tapered shape in the root canal is desired (refer to Paragraph [0031]).
Regarding claims 10-11, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers does not explicitly disclose wherein the distal section has the form of a substantially regular hexagon, an "S" with two cutting edges, a triangular form with three cutting edges, or a quadrilateral form with four cutting edges in the original embodiment (334).
Although these features are not explicitly disclosed as part of the original embodiment (334), Desrosier discloses that the angular cutting segment (338), which includes the distal zone, and thus the distal cross-section may have any of the geometric arrangements previously described, suggesting modification (refer to Paragraph [0069]; Examiner understands the “geometric arrangements” as the shape of the segment, which includes the flutes, facets and taper of the segment as these all affect the shape of device). Previously described arrangements include a hexagonal cross-sectional profile (refer to Paragraph [0050], Fig. 5D). This cross-sectional profile provides a plurality of edges for contact with the canal wall (refer to Paragraph [0009]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the angular cutting segment (338) of the original embodiment (334) of Desrosiers with a hexagonal cross-sectional profile as taught by the alternative embodiment (10) in order to provide a plurality of edges for contact with the canal wall (refer to Paragraph [0009]).
Desrosier further discloses alternative embodiments where the cross-section has a triangular form (refer to Paragraph [0047], Fig. 5A) or quadrilateral form (refer to Paragraph [0048], Fig. 5B), but does not explicitly teach the triangular form having three cutting edges and/or the quadrilateral form having four cutting edges. However, the number of cutting edges is a results effective variable, in that the number may be modified among the various embodiments as shown in Figs. 5A-5G in order to change the number of contact points of the instrument (10) (refer to Paragraph [0054]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the triangular form and/or the quadrilateral form to have three cutting edges or four cutting edges, respectively, as it involves only adjusting the quantity of a component disclosed to require adjustment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the distal cross-section of Desrosiers by making the triangular form have three cutting edges and/or the quadrilateral form have four cutting edges as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 12-13, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers does not explicitly disclose
wherein the working section (340+342+344) is triangular or has the form of an "S" with two cutting edges, has a triangular form with three cutting edges, or a quadrilateral form with four cutting edges in the original embodiment (334).
Although these features are not explicitly disclosed as part of the original embodiment (334), Desrosiers discloses an alternative embodiment (10) where the working length (16) has a triangular cross-sectional profile (refer to Paragraph [0047], Fig. 5A). As demonstrated in Figs. 5A-5E, a triangular cross-sectional profile provides more void area between the edges, which can be beneficial when increased material removal is desired.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the working section (340+342+344) of the original embodiment (334) of Desrosiers with a triangular cross-sectional profile as taught by the alternative embodiment (10) in order to provide a working length (16) with more void area between the edges for increased material removal.
Desrosier further discloses alternative embodiments where the cross-section of the working length (16) has a triangular form (refer to Paragraph [0047], Fig. 5A) or quadrilateral form (refer to Paragraph [0048], Fig. 5B), but does not explicitly teach the triangular form having three cutting edges and/or the quadrilateral form having four cutting edges. However, the number of cutting edges is a results effective variable, in that the number may be modified among the various embodiments as shown in Figs. 5A-5G in order to change the number of contact points of the instrument (10) (refer to Paragraph [0054]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the triangular form and/or the quadrilateral form to have three cutting edges or four cutting edges, respectively, as it involves only adjusting the quantity of a component disclosed to require adjustment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the distal cross-section of Desrosiers by making the triangular form have three cutting edges and/or the quadrilateral form have four cutting edges as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers further discloses wherein at least a portion of the distal zone and the proximal zone is tapered (refer to Paragraph [0069], annotated Fig. 11 above; the tapered section (338) that defines the distal and proximal zones has a positive taper of 0.1mm/mm); and
wherein the tapered portions of the distal zone and the proximal zone define, respectively, a distal angle and a proximal angle, the distal and proximal angles being measured with respect to the longitudinal axis of the instrument (17) (refer to Paragraph [0069], annotated Fig. 11 above).
Regarding claims 16-17, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 1; Desrosiers further discloses wherein in the proximal zone, a perimeter of the angular cutting segment (338) increases progressively over at least a proximal length between the distal zone toward the working length (340+342+344) and wherein in the distal zone, the perimeter of the angular cutting segment (338) increases progressively over at least a part of a distal length between the distal head (14) and the proximal zone (refer to Paragraph [0069], annotated Fig. 11 above; Examiner understands perimeter as the circumscribed diameter of the tool, consistent with Paragraphs [0023], [0032], as the term “perimeter” is not defined; the tapered section (338) that defines the distal and proximal zones has a positive taper of 0.1mm/mm; a positive taper means the diameter of a circumscribed circle of the tapered section (338) increases between the head (14) and working length (340+342+344) ).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Desrosiers (US 20050272004 A1), in view of Mordeniz (US 20120208146 A1), and further in view of Sato et al. (JP H09117460 A; refer to the updated translation), herein referred to as Sato as applied to claim 14 above, and further in view of Maillefer et al. (US 5658145 A), herein referred to as Maillefer.
Regarding claim 15, Desrosiers, Mordeniz and Sato disclose the endodontic instrument as claimed in claim 14; these references are silent to wherein the proximal angle is greater than the distal angle.
Maillefer discloses an instrument for boring dental radicular canals in the same field of endeavor (refer to col. 1, lines 10-15). The instrument (Fig. 1) comprises a guide head region (tip-D3), a distal zone (D3 -D9), and proximal zone (D9 -D13) (refer to col. 2, lines 60-64, annotated Fig. 2 below), the conicity varies at the distal zone (D9), and proximal zone (D13), thus forming a trumpet shape where the angle of the proximal zone is greater than the angle of the distal zone (refer to col. 4, lines 8-25; the conicity of the front part of the instrument forward of D9 is 2%, with the rear portion, corresponding to D9 -D13, the proximal zone, being variable from 4.5%-6%). This configuration creates a bell-mouthed canal which is more optimal, with the additional benefit of a continuous surface (refer to col.3 lines 58-61, col. 4, lines 3-8).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of angular cutting segment of Desrosiers, Mordeniz and Sato with the trumpet shape of increasing conicity as taught by Maillefer in order to produce a bell-shaped canal (refer to col.3 lines 58-61, col. 4, lines 3-8).
Response to Arguments
The outstanding specification objection of the incorporation by reference is withdrawn in view of the newly submitted specification amendment.
The outstanding drawing objections of Figs. 1-4 are withdrawn in view of the newly submitted drawing amendment.
Applicant’s arguments with respect to claim(s) 1-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 10:00-7:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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