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
Response to Arguments
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive. Applicant has argued that the cited figure 9a does not provide for an opening at the tip of the needle with a forward facing axial opening, however this limitation is provided for by the needle of 9a which has a tip 120 with an axial forward facing opening at 64, as the claim does not exclude any other structure that the opening would face it does not exclude the impingement member 110 and the fluid is supplied inside the root canal by being exposed by elements 160 such as in figure 18, however for clarity and compact prosecution the embodiment of 4a has also been cited which discloses an end of the needle without any further structure at the tip except for the axial facing opening.
Applicant has further argued that Bergheim teaches away from generation of a backflow by arguing that the tip is not inside the root canal, however this is not persuasive as applicant has admitted and cited Berghiem’s recitation that the distal end of the guide tube is “inside the canal openings” in paragraph [0072]. Further the argument of backflow would depend upon the actual anatomy of some unknown patient and their particular root canal anatomy. As such it would appear the effect of a backflow would depend upon structure’s that are not part of the invention but of the particular person being treated, as such the only elements which are recited that would when use in the type of patient anatomy that would result in backflow, are those of the pump, handpiece, and needle parameters, all of which are provided by Bergheim.
Applicant has further argued that the width of the guide tube being 0.1mm to 5mm is outside of the range of 34G to 30G which is 0.159mm to 0.312mm however 0.1-5mm includes 0.159-0.312mm and thus provide for such a range. While Bergheim does disclose other diameters this does not in some way remove that recitation of the narrower range, as it would only appear that the difference would be implacability of reciting each number individually from Bergheim, which is what 0.1-5mm is disclosing.
Applicant has argued the selection of gauge is for the “generates a backflow in the root canal”, however this clearly is requiring the anatomy of the particular patient to enable the backflow and thus as Bergheim discloses the diameters recited, it would provide such generate of backflow when used in the root canal size of a patient whose anatomy would generate backflow when the other parameters of Bergheim existed.
Applicant has argued that Bergheim teaches that backflow is undesirable, however the portion cited (paragraph [0112]) does not discuss backflow. Paragraph [0053] of Bergheim discusses backflow out the tooth into the mouth in undesirable but this is distinct form backflow out of the root canal, as several embodiments of Bergheim have evacuation sources to capture the backflow that Bergheim anticipates to occur when spraying a fluid into a closed end space such as the inside of a tooth and root canal.
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 1-3,5,7-9, and 12-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergheim et al. (US 2011/0117517).
Regarding claim 1, Bergheim discloses an endodontic apparatus (title and abstract) comprising:
a supply for irrigant fluid (fig. 2 element 44) ;
a pump to deliver the irrigant fluid from the supply under pressure (Fig. 2 element 46);
a handpiece in fluid communication with the pump (Figs. 2/3 element 50) and comprising a needle extending from a rearward end proximal to the handpiece to a forward tip distal from the handpiece(Fig. 3 element 100), a lumen of the needle extending to an opening at the tip to deliver fluid received from the pump into a tooth cavity (Fig. 9a element 54), the opening at the tip of the needle being a forward-facing axial opening such that the fluid is expelled in a forward axial stream from the lumen (Fig. 4a element 100 showing an axial facing opening with no further structure beyond the opening, further Fig. 9a showing the axial stream from the tip of 120 which is open to the root canal space as the preamble does not exclude additional structure),
wherein the needle has a length, extending from its rearward end to its tip, of at least 3mm (paragraph [0072] lines 20-26 disclosing the length can be about 10mm), and an external diameter at the tip of no more than 520 micrometers (paragraph [0072] lines 1-20 disclosing the tip of the needle can be positioned within a tooth canal space and can have a diameter of 0.5mm which is 500 micrometers) and at least the distal end of the needle has a needle gauge size between 30G and 34G (paragraph [0072] lines 15-17 disclosing the diameter of the needle could be between 190microns to 300 microns and the range between 30G and 34G is approximately 178 microns to 305 microns) such that the needle tip is position-able within a portion of the root canal), and which would enable a backflow to pass between the root canal and the needle (the backflow ability would be present when placed in a root canal that would be larger than the needle, further as the needle is designed with a diameter sized to be able to be placed within a root canal it would thus enable the backflow, paragraph [0058] lines 1-16 disclosing needle having a nozzle that forms a cc jet and the use of a cc jet to clean root canals, abstract lines 7-9 disclosing the distal end can be position in the canal space itself, Fig. 1 element 30 cited in paragraph [0044] as the root canal space)
wherein the lumen has a diameter at the tip of at least 50 micrometer (Fig. 9a element 64 having diameter of the lumen at the tip of at least 50 micrometers, paragraph [0065] lines 1-14 disclosing that the nozzle orifice can be 50-65mircometers or more) and
the pump delivers irrigant at a delivery pressure in excess of a threshold cavitation pressure that gives an exit velocity of the irrigant at the needle tip is at least 20 m/s (paragraph [00560] lines 13-16 disclosing the velocity being about 100 m/s) such that the flow of irrigant through the needle generates a backflow in the root canal to facilitate forming of a cloud of inertial cavitation within the irrigant fluid in the root canal forward of the needle tip (paragraph [0042] all disclosing the pump of can deliver the fluid at a pressure in excess of a threshold cavitation pressure which would facilitate a cloud of cavitation forward of the needle in a canal).
Regarding claim 2, Bergheim further discloses wherein the delivery pressure is between 5 and 300 bar ( paragraph [0045] lines 18-27d disclosing the pump is adjustable to a pressure of 500psi or up to at least 4300psi which is a range of 34.5 bar to 300bar).
Regarding claim 3, Bergheim further discloses wherein the needle length is between 10 and 30mm (paragraph [0072] lines 20-26 disclosing the length can be about 10mm).
Regarding claim 5, Bergheim further discloses wherein a flow rate of irrigant through the needle is below 75 ml/min ( 75ml/min= 1.25ml/second. Paragraph [0050] discloses the column of liquid can have a velocity of 100m/s and the diameter of the jet can be 50microns as cited above and thus by the formula of a cylinder V=Hπr^3, the height of the cylinder of liquid in 1 second at 100m/s is 100m and with a diameter of 50 microns V=100m * π * (50microns)^3=0.2 mL per second * 60s=12mL/min.).
Regarding claim 7, Bergheim further discloses wherein the needle comprises a distal portion including the open forward tip and a proximal portion connected to the proximal end of the distal portion, and wherein the proximal portion has an increased diameter (Fig. 9d showing distal portion 57b at 64 being narrower than proximal portion of 57a near 58a).
Regarding claim 8, Bergheim further discloses wherein the irrigant fluid is a saline solution (paragraph [0046] lines 1-3).
Regarding claim 9, Bergheim further discloses wherein the irrigant fluid further comprises a disinfecting agent (paragraph [0046] lines 4-5).
Regarding claim 12, Bergheim further discloses wherein the apparatus comprises a regulator for controlling the delivery pressure (Fig. 2 elements 45/51 act together to regulate delivery pressure).
Regarding claim 13, Bergheim further discloses wherein the apparatus further comprises a heater to control the temperature of the irrigant fluid (paragraph [0046] lines 16-25 disclosing heating the fluid).
Regarding claim 14, Bergheim further discloses wherein the apparatus further comprises a pulse generator to pulse the supply of irrigant fluid (paragraph [0045] lines -9-10 disclosing the pump could include a piston pump with would by oscillating/pistoning deliver the fluid is pulses).
Regarding claim 15 Bergheim discloses an endodontic method (title and abstract) comprising:
positioning a needle, having a length of at least 5mm and an external tip diameter of no more than 520 micrometer (paragraph [0072] lines 20-26 disclosing the length can be about 10mm and paragraph [0072] lines 1-20 disclosing the tip of the needle can be positioned within a tooth canal space and can have a diameter of 0.5mm which is 500 micrometers), and at least the distal end of the needle has a needle gauge size between 30G and 34G (paragraph [0072] lines 15-17 disclosing the diameter of the needle could be between 190microns to 300 microns and the range between 30G and 34G is approximately 178 microns to 305 microns within a portion of the root canal (fig. 25, paragraph [0069] all disclosing the need in place in the canal space);
supplying an irrigant fluid to the needle under pressure such that the irrigant fluid is expelled from the needle tip in a forward axial stream into the root canal (Fig. 4a showing forward axial opening which when used would expel the fluid in a forward axial stream);
and selecting the delivery pressure of the irrigant fluid such that a pressure at the needle tip exceeds a threshold cavitation pressure that gives an exit velocity of the irrigant at the needle tip is at least 20 m/s (paragraph [00560] lines 13-16 disclosing the velocity being about 100 m/s) such that the flow of irrigant through the needle generates a backflow in the root canal to facilitate forming of a cloud of inertial cavitation to be formed within the irrigant fluid in the root canal forward of the needle tip (paragraph [0042] all disclosing the pump of would be used to deliver the fluid at a pressure in excess of a threshold cavitation pressure to cause a cloud of cavitation forward of the needle in a canal, as root canals are varied and non-standard anatomical shapes the result of the generate of backflow would occur in such root canals that would be anatomically capable of such result when the needle of Bergheim would be used).
Regarding claim 16, Bergheim further disclose wherein the delivery pressure is between 5 and 300 bar( paragraph [0045] lines 18-27d disclosing the pump is adjustable to a pressure of 500psi or up to at least 4300psi which is a range of 34.5 bar to 300bar).
Regarding claim 17, Bergheim further discloses heating the irrigant fluid (paragraph [0046] lines 16-25 disclosing heating the fluid).
Regarding claim 19, Bergheim further discloses pulsing the supply of irrigant fluid(paragraph [0045] lines -9-10 disclosing the pump could include a piston pump with would by oscillating/piston-ing deliver the fluid is pulses).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (US 2011/0117517) in view of Bergheim et al. (US 2013/0040267 A1).
Regarding claim 10, Bergheim ‘517 discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the fluid includes abrasive particles.
However, Bergheim ‘267, discloses an endodontic apparatus for cleaning root canals by a needle that injects fluid (title and abstract) and using a pump to cause cavitation (paragraph [0051] all) and the fluid includes abrasive particles (paragraph [0115] lines 1-3).
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 use of abrasive particles in the irrigant fluid as taught by Bergheim ‘267 into the irrigant fluid as taught by Bergheim ‘517 for the purpose of improving cleaning and the efficiency of conversion of pressure to cavitation as taught by Bergheim ‘267 (paragraph [0276] lines 17-20).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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 05/29/2026
/EDWARD MORAN/ Primary Examiner, Art Unit 3772
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