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 .
DETAILED ACTION
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. 120 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. 62/988,453, 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. The limitation of claims 1 and 7 of the center of mass of the cleaning rod being at an unstressed local center of mass that is greater than half the radius of the handle is not supported in the Application No. 62/988,453. As such the claim have a priority date of Application No. 63/108,363 filed on 11/01/2020.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker at el. (US 2014/0045142 A1).
Regarding claim 13, Becker discloses a method of cleaning an endodontic canal with an endodontic brush (figs. 3a-3c showing the cleaning of a root canal with a brush) including a proximal handle attached to an eccentric portion (Figs. 3b/c element 12 proximal handle connected to eccentric portion 30) comprising: connecting the proximal handle to a dental handpiece (Fig. 3b element 12 connected to handpiece 11); rotating the proximal handle to produce spreading of the eccentric portion (Figs. 3b/3c showing rotation in figured 3b and 3c. showing the spreading the eccentric portion).
Regarding claim 14, Becker further discloses wherein said spreading includes producing a whipping motion of the eccentric portion (Fig. 3c the spreading of the handle when rotating inside the root canal shows the whipping motion of the eccentric portion that would hit into the sides of the root canal).
Regarding claim 15, Becker further discloses inserting said eccentric portion into an endodontic canal prior to said rotating (paragraph [0045] lines 10-11 “the brush file 40 is inserted without rotation”).
Regarding claim 16, Becker further discloses inserting said eccentric portion into the endodontic canal while rotating said proximal handle in a first direction and subsequent to said inserting, rotating said proximal handle in a second direction opposite said first direction (paragraph [0045] lines 10-11 “the brush file 40 is inserted…or at a very low speed i.e. about 100-200 rpm” and lines 24-28 disclosing the clockwise rotation when inserting and anti-clockwise after the clockwise).
Regarding claim 17, Becker further discloses wherein said rotating in said second direction spreads strands of a distal portion of said endodontic brush to form a brush (paragraph [00045] lines 14-18 disclosing the second direction opens the strands into a brush).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, 8, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Riitano et al. (US 5,775,904) in view of Sarfatti et al. (US 4,165,562).
Regarding claims 1, 7, Riitano discloses method for production of a kit for endodontic cleaning (title and abstract) comprising providing : an eccentric endodontic file (Fig. 3 element 1) including a proximal handle (Fig. 3 element 4) configured for attachment to a dental handpiece to rotate around an axis of rotation (Fig. 4 element 9) said handle having a mean center of mass (Figs. 3/4/6 showing the offsetting of the elongated file which by being a physical object would have a center of mass) and a flexible (column 1 lines 56-60 disclosing the file would be flexible) cleaning rod having a distal active section configured for rotating inside an endodontic canal for cleaning an inside of the canal (Fig. 4 showing active distal end of 1 inside of a canal or rotational cleaning of the canal);
the cleaning rod distal to said handle (Fig. 3 element 1 distal to element 4) wherein a distance between the axis of rotation and an unstressed local center of mass of the distal active section is greater than half a radius of the handle (column 3 lines 37-42 disclosing the file is made of a metal, Fig. 3 showing the majority of the distal end being offset from the center of rotation at Ү, which is outside of the radius of the handle and thus the center of mass being outside the radius of the handle and thus greater than a half radius of the handle).
Riitano discloses structure and method steps substantially identical to the instant application as discussed above but fails to explicitly disclose where the file is sterile and has a sterile packaging preserving the sterility of the sterile endodontic file as per claim 1, nor where the method includes sterilizing the file and packaging the file in a sterile state, as per claim 7.
However, Sarfatti disclose an endodontic file kit (title and abstract) that includes a sterilized endodontic file (Fig. 2 file 12) that is packed into a a sterile packaging to preserve sterility (Fig. 2 package 32, abstract disclosing “the cap acts to preserve sterility of the file prior to use” thus the file would have been sterilized in order to be able to be maintained in the sterile state).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the file being sterile and packaged in a package to preserve sterility as taught by Sarfatti into the file as taught by Riitano for the purpose of providing for keeping the file clean and protected at all time before use and to lower the incidence of infection to the patient as taught by Sarfatti (column 3 lines 35-44).
Regarding claims 2 and 8 Riitano/Sarfatti further disclose wherein said distance between the axis of rotation and said unstressed local center of mass of the distal active section is greater than a radius of the handle (Fig. 3 showing the majority of the distal end being offset from the center of rotation at Ү, which is outside of the radius of the handle).
Regarding claim 12, Riitano/Sarfatti discloses structure and processes substantially identical to the instant application as discussed above, including where the file includes an intermediate portion of a concentric endodontic file (fig. 3 showing intermediate form by the bend between 5a and 5b) but fails to explicitly disclose where the manner by which the eccentric file is produced is by bending the intermediate portion.
However, there are a number of choices available to a person of ordinary skill in the art for forming a bent eccentric file, such as either bending a straight file or 3d fabricating a file that would have the bent portion, therefore, it would have been obvious to have made the bend by bend the intermediate portion ( “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).).
Claims 3-6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Riitano et al. (US 5,775,904) in view of Sarfatti et al. (US 4,165,562) as applied to claims 1 or 7 above and further in view of Becker at el. (US 2014/0045142 A1).
Regarding claims 3-5 and 9-11, Riitano/Sarfatti discloses structure and method steps substantially identical to the instant application as discussed above, including where the file includes a core (fig. 3 element being a core tine) but fails to explicitly disclose where the flexible cleaning rod further includes the core with a spiral wire wrapped around the core as per claims 3 and 9, nor further having an outer spiral wrapping wrapped around the spiral wire as per claims 4 and 10, nor further having the outer spiral wrapping having a round surface as per claims 5 and 11.
However, Becker disclose providing an endodontic file kit (title and abstract) that includes an endodontic file (Fig. 4a all) that has an inner core wire (Fig. 4b element 17) that has a spiral wire wrapped around the core wire (fig. 4b elements 18/41 are the ends of spiral wires wrapped around core 17, paragraph [0037] lines 7-10) and a further having an outer spiral wrapping wrapped around the spiral wire (fig. 4b element 15), and where the outer spiral wrapping has a rough surface (paragraph [0040] lines 1-7).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the provided file rod to also have a core with a spiral wire wrapped around the core and having an outer spiral wrapping wrapped around the spiral wire and having the outer spiral wrapping having a round surface as taught by Becker into the cleaning rod as taught by Riitano/Sarfatti for the purpose of providing for a file with a core and wrappings and surface roughness that would cut through the root canal when entering the canal and would also sweep away debris and filings when being removed from the root as taught by Becker(paragraph [0021] lines 1-16).
Regarding claim 6, Riitano further discloses wherein said handle has a mean center of mass (Fig. 3a the center of mass of cylindrical handle 4 would be in the middle of the long axis within 4), the sterile eccentric endodontic file further including:
a transition section distal to said handle and proximal to said active section (Fig. 3 element 5b) wherein a distance between the axis of rotation and an unstressed local center of mass of the file increases distally (Fig. 3 the file having the eccentric shape without being stress and having the eccentricity results in the center of mass increasing distally when considered from the apical top of 4 traversing distally towards 5’, there is no requirement the center of mass increasing distally occurs over the entire distal length),
and wherein said active section extends from said transition section to a distal tip (Fig. 3 element 5’ to 5’’),
wherein an unstressed local center of mass of the active section is constantly on the same side of said axis of rotation (Fig. 3 the file is offset/eccentric such that it is always one same side when it would be viewed cross-sectionally) and a distance between the axis of rotation and an unstressed local center of mass of the active section is greater than said a distance between said mean center mass of the handle and the axis of rotation (Fig. 3, a distance between the mean center mass of the handle the axis of rotation would be zero as the handle is a cylinder with a center of rotation on its long axis, and the center of mass of the active section would have a greater than zero distance by being offset/eccentric form in relation to the long axis center of rotation at Ү).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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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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/M.P.S/Examiner, Art Unit 3772 06/18/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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