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 .
Specification
The amendment filed 08/20/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/IB2021/054580 and of the foreign patent application CH00645/20 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 05/26/2021, see MPEP 1893.03(b). Therefore the specification amendment of 11/29/2022 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the nominal diameters, D1 and D2, as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Figures 1-3 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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.
Claim(s) 1-3, 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buchanan (US 20050214711 A1).
Regarding claim 1, Buchanan discloses an endodontic instrument (refer to Fig. 2) notably for reaming a root canal of a tooth of a patient (refer to Paragraph [0013]; the invention is drawn to files designed to enter and shape root canals), the instrument comprising a working length having a working section (refer to annotated Fig. 11 below and Paragraph [0013]; the working length is the β region, with the working section defined by the cross-section formed by the diameter at 4mm from the tip (D4)), the working length being terminated by a distal portion (refer to figure below) having a dual guiding and cutting function (refer to Paragraph [0049] and Fig. 3; the pilot tip (20a) develops a guide path for the file; refer to Paragraph [0013]; the α region behind the pilot tip geometry has parabolic cutting flutes)
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the distal portion comprising a rounded guide head (20a) and an angular cutting segment (α) between the guide head (20a) and the working length (β) (refer to annotated Fig. 11 above);
wherein the angular cutting segment (α) comprises a distal zone adjacent to the guide head and a proximal zone between the distal zone and the working length (β) (refer to annotated Figs. 3 and 11 below; the distal zone and proximal zone are separated by the dashed line bisecting the α region);
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the angular cutting segment further comprising cutting edges that extend over the entire length of the proximal zone and the distal zone (refer to Paragraph [0048] and annotated Fig. 2 below; cutting flutes 22a, 22b, 22c extend over the length of the proximal zone and distal zone);
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the distal zone comprising a distal section (refer to annotated Fig. 11 below; the distal cross-section is formed at the dashed line of D1) having a constant cross-section geometry (the geometry is constant at D1) and the proximal zone comprising a proximal section (refer to annotated Fig. 11 below; the proximal cross-section is formed at the dashed line dividing the distal and proximal zones), having a cross-section geometry which varies between the distal section and the working section (refer to annotated Fig. 11 below; geometry is defined as a shape or form of a surface or solid (dictionary.com); the distal cross section and working cross section have different tapers, and therefore different forms of the cross-sectional surface, meeting the definition of different geometries).
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Regarding claim 2, Buchanan discloses the endodontic instrument as claimed in claim 1, wherein the ratio of the length of the distal zone (refer to annotated Fig. 2 above, the distal half of the α region) to the length of the guide head (20a) is greater than 1 or is greater than 2 (refer to Paragraph [0016] and annotated Fig. 3 above; the length of the distal zone is 1.5mm and the length of the guide head is 1mm, giving a ratio of 1.5, which is greater than 1).
Regarding claim 3, Buchanan discloses the endodontic instrument as claimed in claim 1, wherein at least one portion of the distal zone and the proximal zone is tapered (refer to annotated Fig. 11 below and Paragraph [0016]; the α taper section has a 0.10mm/mm slope, with the distal and proximal zones defined in the α taper section and therefore both having tapered portions), respectively forming a distal angle (refer to figure below) and a proximal angle (refer to figure below) with the longitudinal axis of the instrument (C/L).
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Regarding claim 6, Buchanan discloses the endodontic instrument as claimed in claim 1, wherein the ratio of the length of the proximal zone to the length of the distal zone is between 0.1 and 10 (refer to annotated Fig. 11 below and Paragraph [0016]; the dashed line bisects the α region to create two equal length zones of 1.5mm, giving a ratio of 1).
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Regarding claim 7, Buchanan discloses the endodontic instrument as claimed in claim 6, wherein 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 (refer to annotated Fig. 11 above and Paragraph [0016]; the dashed line bisects the α region to create two equal length zones of 1.5mm, giving a ratio of 1).
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, 4-5, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Randin (US 5236357 A) in view of McSpadden (US 4299571 A).
Regarding claim 1, Randin discloses an endodontic instrument (refer to Fig. 1) notably for reaming a root canal of a tooth of a patient (refer to Paragraph col.1, lines 7-10), the instrument comprising a working length having a working section (refer to annotated Fig. 1 below; the working length is the region below the dashed line, with the working section defined by the cross-section formed at the dashed line; applicant does not disclose a specified length for the distal region and only defines the distal portion as comprising a tapered segment, the area defined in the figure meets this definition), the working length being terminated by a distal portion (refer to annotated Fig. 1 below) having a cutting function (refer to col. 1, lines 66-68; the helicoidal cutting edges are for cutting);
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the distal portion comprising an angular cutting segment between the guide head and the working length (refer to annotated Fig. 2 below);
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wherein the angular cutting segment comprises a distal zone adjacent to the guide head and a proximal zone between the distal zone and the working length (refer to annotated Fig. 2 below; the distal zone and proximal zone are separated by the dashed line through the median of the angular cutting region);
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the angular cutting segment further comprising cutting edges (3) that extend over the entire length of the proximal zone and the distal zone (refer to col. 1, lines 66-68 and figure above; the helicoidal cutting edges form four cutting edges);
the distal zone comprising a distal section (refer to annotated Fig. 2 below; the distal cross-section is formed at the dashed line between the guide head and distal zone) of constant geometry and the proximal zone comprising a proximal section (refer to annotated Fig. 2 below; the proximal cross-section is formed at the dashed line dividing the distal and proximal zones), the geometry of which varies between the distal section and the working section (refer to col. 2, lines 1-5 and annotated Fig. 2 below; the distal cross section varies in taper and cutting flute geometry from the distal to working section).
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Randin is silent to the guide head being rounded and the associated functionality.
McSpadden discloses an endodontic instrument (10) in the same field of endeavor, for the purpose of cleaning and enlarging tooth canals (refer to col. 1, lines 5-7). The endodontic instrument comprises a working length (14) being terminated by a distal portion comprising a rounded guide head (15) for guiding the file (refer to col. 1, lines 5-11 and annotated Fig. 1 below). The round guide head (15) is advantageous for preventing uncontrolled cutting or abrasion of the root canal (refer to col.1, lines 5-11).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal region of Randin, with the round guide head, as taught by McSpadden, for dual function of both reaming and guiding the root canal, with the rounded tip preventing uncontrolled cutting or abrasion of the root canal.
Regarding claim 4, the combination of Randin and McSpadden discloses the endodontic instrument as claimed in claim 1, with Randin further disclosing 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 (refer to annotated Fig. 2 below; the diameter of the guide head is shown as the parallel lines adjacent to the guide head edges, with the dotted lines exceeding the width of the distal zone).
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Regarding claim 5, the combination of Randin and McSpadden discloses the endodontic instrument as claimed in claim 4, with Randin further disclosing wherein the diameter of the guide head is greater than the diameter of the circumscribed circle of the distal zone at the junction (4) of the guide head and of the distal zone (refer to annotated Fig. 2 above; the diameter of the guide head is shown as the parallel lines adjacent to the guide head edges, with the dotted lines exceeding the width of the distal zone).
Regarding claims 8-9, the combination of Randin and McSpadden discloses the endodontic instrument as claimed in claim 1, but Randin is silent to the diameter of the circumscribed circles of the distal and proximal zones being constant.
As stated in claim 1, McSpadden discloses an endodontic instrument (10) in the same field of endeavor, for the purpose of cleaning and enlarging tooth canals (refer to col. 1, lines 5-7). The endodontic instrument comprises a working length (14) being terminated by a distal portion comprising a rounded guide head (15) for guiding the file (refer to col. 1, lines 5-11 and figure below), similar to applicant's disclosure. Also similar to applicant's disclosure, McSpadden's device is designed to both cut and guide (refer to col. 1, lines 57-62). McSpadden further discloses, the entire distal portion (15) of the instrument as being straight (refer to col. 2, lines 13-15). The benefit of the straight distal portion is a smoother (non-tapered or zero-tapered) end for piloting through the canal. Also of note, applicant does not disclose any advantages associated with the zero-taper angle of the distal zone.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal region of Randin, which includes the distal and proximal zone, to be straight, as taught by McSpadden for easier piloting through the canal. Furthermore, regarding the shape of the zero-taper distal zone as disclosed by applicant, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), [t]he court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchanan (US 20050214711 A1) in view of Buchanan (US 5752825 A).
Buchanan (US 20050214711 A1) is referred to as Buchanan (1), and Buchanan (US 5752825 A) is referred to as Buchanan (2).
Regarding claim 10, Buchanan (1) discloses the endodontic instrument as claimed in claim 1, wherein the distal section (refer to annotated Figs. 3 and 11 below; the distal cross-section is formed at D1) has a shape formed by the cutting flutes of the distal portion (α) to funnel files and filling materials through the canal, but is silent to what shape is cut by the flutes (refer to Paragraph [0023]).
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Buchanan (2) discloses an endodontic instrument in the same field of endeavor for the purpose of reaming a tooth canal of a tooth a patient (refer to Abstract). The endodontic instrument comprising a working length (57; refer to annotated Fig. 4G below) having a working section (67; the cross-section defined by angle α), the working length (57; refer to annotated Fig. 4G below) being terminated by a distal portion (refer to annotated Fig. 4G below), having a distal section (67; the cross-section defined by angle α); the distal zone comprises a rounded guide head (64) and an angular cutting segment (refer to annotated Fig. 4G below) between the guide head (64) and the working length (57) (refer to col. 14, lines 58-62; the radiused, non-cutting tip (64) is following by fully-sharp flutes (60)), wherein the geometry varies between the distal section (67; the cross-section defined by angle α) and working section (62; the cross-section defined by angle β). Similar to Buchanan (1), Buchanan (2) discloses the geometry of the flutes as being varied for cutting efficiency (refer to col. 10, lines 34-39), with the geometry of the distal section having the form of a substantially regular hexagon, decreasing the chance of a cutting flute near the tip catching a canal wall and breaking (refer to Fig. 4D-1 and 4D-2 and col. 14, lines 46-56).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal section of Buchanan (1) with the hexagon cross-section, as taught by Buchanan (2), to reduce the chance of the cutting flutes in the distal zone catching the canal wall and breaking.
Regarding claim 11, Buchanan (1) discloses the endodontic instrument as claimed in claim 1, wherein the distal section (refer to annotated Figs. 2 and 11 below; the distal cross-section is formed at D1) has a plurality of cutting edges formed by the cutting flutes (refer to Fig. 2 and Paragraph [0048]; cutting flutes 22a-22c form the distal region (α)) but is silent to the shape the edges of the flutes form.
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Buchanan (2) discloses an endodontic instrument in the same field of endeavor for the purpose of reaming a tooth canal of a tooth a patient (refer to Abstract). The endodontic instrument comprising a working length (57; refer to annotated Fig. 4G below) having a working section (67; the cross-section defined by angle α), the working length (57; refer to annotated Fig. 4G below) being terminated by a distal portion (refer to annotated Fig. 4G below), having a distal section (67; the cross-section defined by angle α); the distal zone comprises a rounded guide head (64) and an angular cutting segment (refer to annotated Fig. 4F below) between the guide head (64) and the working length (57) (refer to col. 14, lines 58-62; the radiused, non-cutting tip (64) is following by fully-sharp flutes (60)), wherein the geometry varies between the distal section (67; the cross-section defined by angle α) and working section (62; the cross-section defined by angle β). Similar to Buchanan (1), Buchanan (2) discloses the geometry of the flutes as being varied for cutting efficiency (refer to col. 10, lines 34-39), with the geometry of the distal section having the form of a triangle, decreasing the chance of a cutting flute near the tip catching a canal wall and breaking (refer to Figs. 4E-1 and 4E-2 and col. 14, lines 46-56).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal section of Buchanan (1) with the triangular cross-section, as taught by Buchanan (2), to reduce the chance of the cutting flutes in the distal zone catching the canal wall and breaking.
Regarding claim 12, Buchanan (1) discloses the endodontic instrument as claimed in claim 1, wherein the working section (refer to annotated Fig. 2 below and Paragraph [0013]; the working length is the β region, with the working section defined by the cross-section formed by the diameter at 4mm from the tip (D4)) has a plurality of cutting edges formed by the cutting flutes (refer to Fig. 2 and Paragraph [0048]; cutting flutes 22a-22d form the working length (β)) but is silent to the shape the edges of the flutes form.
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Buchanan (2) discloses an endodontic instrument in the same field of endeavor for the purpose of reaming a tooth canal of a tooth a patient (refer to Abstract). The endodontic instrument comprising a working length (57; refer to annotated Fig. 4G below) having a working section (67; the cross-section defined by angle α), the working length (57; refer to figure below) being terminated by a distal portion (refer to annotated Fig. 4G below), having a distal section (67; the cross-section defined by angle α); the distal zone comprises a rounded guide head (64) and an angular cutting segment (refer to annotated Fig. 4F below) between the guide head (64) and the working length (57) (refer to col. 14, lines 58-62; the radiused, non-cutting tip (64) is following by fully-sharp flutes (60)), wherein the geometry varies between the distal section (67; the cross-section defined by angle α) and working section (62; the cross-section defined by angle β). Similar to Buchanan (1), Buchanan (2) discloses the geometry of the flutes as being varied for cutting efficiency (refer to col. 10, lines 34-39), with the geometry of the working section having the form of a triangle, increasing cutting efficacy near the working end flutes where more dentin removal is needed (refer to Figs. 4D-1 and 4D-2 and col. 14, lines 46-56).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the working section of Buchanan (1) with the triangular cross-section, as taught by Buchanan (2), to improve cutting efficacy where greater dentin removal is needed.
Regarding claim 13, Buchanan (1) discloses the endodontic instrument as claimed in claim 1, wherein the working section (refer to figure annotated Fig. 2 below and Paragraph [0013]; the working length is the β region, with the working section defined by the cross-section formed by the diameter at 4mm from the tip (D4)) has three cutting edges formed by the three cutting flutes (refer to Fig. 2 and Paragraph [0048]; cutting flutes 22a-22d form the working length (β)) but is silent to the shape the edges of the flutes form.
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Buchanan (2) discloses an endodontic instrument in the same field of endeavor for the purpose of reaming a tooth canal of a tooth a patient (refer to Abstract). The endodontic instrument comprising a working length (57; refer to annotated Fig. 4G below) having a working section (67; the cross-section defined by angle α), the working length (57; refer to figure below) being terminated by a distal portion (refer to annotated Fig. 4G below), having a distal section (67; the cross-section defined by angle α); the distal zone comprises a rounded guide head (64) and an angular cutting segment (refer to annotated Fig. 4F below) between the guide head (64) and the working length (57) (refer to col. 14, lines 58-62; the radiused, non-cutting tip (64) is following by fully-sharp flutes (60)), wherein the geometry varies between the distal section (67; the cross-section defined by angle α) and working section (62; the cross-section defined by angle β). Similar to Buchanan (1), Buchanan (2) discloses the geometry of the flutes as being varied for cutting efficiency between the tip and shank (refer to col. 10, lines 34-39), with the geometry of the working section having the form of a triangle, increasing cutting efficacy near the working end flutes where more dentin removal is needed (refer to Figs. 4D-1 and 4D-2 and col. 14, lines 46-56).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the working section of Buchanan (1), with the triangular cross-section, as taught by Buchanan (2), to improve cutting efficacy where greater dentin removal is needed.
Response to Arguments
The outstanding objection to the specification amendment stands. The incorporation by reference of the international patent application PCT/IB2021/054580 and of the foreign patent application CH00645/20 to the specification in the amendment filed 08/20/2025 is new matter. The priority to the foreign applications is retained; however, no new statements to the priority can be added, these statements must be removed.
The outstanding objections to the claimed subject matter of claims 8-9, 11 and 13 not being shown is withdrawn in view of the amended Figures 6c, 7a, and 7b.
The outstanding objection for the failure to show the nominal diameters, D1 and D2, stands. Applicant’s remarks state a modified Figure 4 is provided in the replacement drawings; however, the replacement drawings only display Figs. 6c, 7a, and 7b.
The outstanding objection for the failure to designate Figs. 1-3 with a legend, such as --Prior Art-- stands. The replacement drawings do not show Figs. 1-3, only Figs. 6c, 7a, and 7b.
The outstanding objections to claims 1 and 5 are withdrawn in view of the amended claims.
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments for claim 1, in which the geometry is defined in terms of the cutting edges, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. The specification does not delineate between the “geometry of the tapered guiding segment 13” (refer to Paragraph [0009] of the specification) and the “hexagonal geometry forming six cutting edges” (refer to Paragraph [0017] such that the term “geometry” is redefined. Per MPEP 2111.01 (IV), to act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess.
Further, the alternative definition provided by Applicant that geometry is “an arrangement of objects or parts that suggests geometric figures” does not change the claim rejection, as Buchanan (US 20050214711 A1) discloses an arrangement of parts (pilot tip + cutting flutes) which suggest geometric figures (refer to Figs. 2, 3, 11). Randin (US 5236357 A) also discloses an arrangement of parts (tip + helicoidal ramps + annular grooves) which suggest geometric figures (refer to Figs. 1-2).
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.
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 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. 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
/THOMAS C BARRETT/SPE, Art Unit 3799
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