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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10, 13-14, 17, 25-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergheim et al. (US 2012/0237893 A1).
Regarding claim 1, Bergheim teaches a method of performing a treatment on a tooth (abstract), comprising:
accessing an interior of the tooth through at least one opening in the tooth (65) (see Figures),
the interior of the tooth containing bacteria ([0098]; bacteria is removed from the infected tooth);
delivering a fluid into the bacteria-containing interior of the tooth through the opening in the tooth ([0072], [0098]),
dispersing the bacteria in the fluid (the fluid enters the tooth opening and mixes with the bacteria as the bacteria is contained in the tooth canal);
inserting an ultrasonic instrument (64 and see [0048]) through the opening in the tooth (see Figures); and
transmitting ultrasonic energy to the fluid by the ultrasonic instrument at a predetermined an amplitude and at a predetermined frequency, causing adapted to cause inertial cavitation of gas vesicles ([0054], [0259-0260]) located in the bacteria present in the fluid to (a) rupture cellular walls of the bacteria, killing the bacteria and disinfecting the interior of the tooth of the bacteria by the inertial cavitation of the gas vesicles, and (b) ablate pulp, tissue, and/or debris contained within the interior of the tooth by the inertial cavitation of the gas vesicles ([0113], [0213], [0059-0060]; the acoustic cavitation is used to remove the smear layer, which includes a layer of dentin, organic and inorganic debris, and bacteria and causes cellular rupture of bacteria and cell dissociation).
Regarding claim 2, Bergheim teaches the method according to claim 1 (see rejection above), further comprising creating the opening in the tooth ([0044], see Figures; the opening is in the tooth).
Regarding claim 3, Bergheim teaches the method according to claim 1 (see rejection above), comprising filling the interior of the tooth with a filling material after the transmitting ([0005], [0252]; it is well known that after cleaning and delivering a drug to a root canal, it must be finished off by filling it using a material such as gutta percha).
Regarding claim 5, Bergheim teaches the method according to claim 1 (see rejection above), further comprising closing the opening in the tooth ([0005] and [0252]; the tooth crown is restored).
Regarding claim 6, Bergheim teaches the method according to claim 1 (see rejection above), wherein the opening includes a cavity in the tooth ([0044], see Figures; 65 is an opening/cavity in a tooth).
Regarding claim 7, Bergheim teaches the method according to claim 1 (see rejection above), wherein the interior of the tooth includes a pulp chamber (28) and at least one root (30) of the tooth ([0044], and see Figures).
Regarding claim 8, Bergheim teaches the method according to claim 7 (see rejection above), further comprising removing a portion of the pulp, tissue, and/or debris from the pulp chamber and/or root of the tooth before delivering the fluid into the interior of the tooth ([0259], [0260], see Figures; fig. 16c, the pulp of the tooth is removed from the pulp chamber and tissue is removed from the root canals prior to performing the treatment).
Regarding claim 10, Bergheim teaches the method according to claim 1 (see rejection above), further comprising removing the fluid from the interior of the tooth after the transmitting of ultrasonic energy to the fluid ([0072], [0142]).
Regarding claim 13, Bergheim teaches the method according to claim 1 (see rejection above), wherein the frequency is approximately 670 kHz ([0055], [0260], [0290]; the frequency may be about 500 or greater than about 500 kHz and therefore is approximately as claimed).
Regarding claim 14, Bergheim teaches the method according to claim 1 (see rejection above), wherein the treatment includes a root canal procedure (see Figures, Fig. 16C, and abstract).
Regarding claim 17, Bergheim teaches the method according to claim 1 (see rejection above), wherein the ultrasonic instrument includes a piezoelectric and/or capacitive transducer ([0202]).
Regarding claim 25, Bergheim teaches the method according to claim 1 (see rejection above), further comprising at least partially submerging a tip of the ultrasonic instrument into the fluid after the inserting, wherein the ultrasonic energy is transmitted to the fluid by the at least partially submerged tip of the ultrasonic instrument ([0213], ,fig. 5C, such that pressure waves 67 are within the fluid, see Figures; the probe is inserted into the root canal after the solution is injected into the root canal and then ultrasonic energy is transmitted through the probe as to cause cavitation in the solution).
Regarding claim 26, Bergheim teaches method according to claim 1 (see rejection above), wherein the fluid is delivered into the interior of the tooth in a turbulent flow to disperse the bacteria in the fluid ([0078], [0165], [0263]).
Regarding claim 27, Bergheim teaches method according to claim 1 (see rejection above), wherein the fluid is removed from the interior of the tooth by a suction port (72) located at a distal end of the ultrasonic instrument (50) ([0159] and see Figure 12b; the suction line extends towards the distal end of the handpiece which is the ultrasonic instrument).
Regarding claim 28, Bergheim teaches method according to claim 1 (see rejection above), wherein the pulp, tissue, and/or debris is ablated by propagation of shock waves through the fluid caused by the inertial cavitation of the gas vesicles dislodging and/or disintegrating the pulp, tissue, and/or debris ([0113], [0213], [0059-0060]; the acoustic cavitation is used to remove the smear layer, which includes a layer of dentin, organic and inorganic debris, and bacteria and causes cellular rupture of bacteria and cell dissociation).
Regarding claim 29, Bergheim teaches a method of performing a treatment on a tooth (abstract), comprising:
accessing an interior of the tooth through at least one opening in the tooth (65) (see Figures),
the interior of the tooth containing bacteria ([0098]; bacteria is removed from the infected tooth);
delivering a fluid into the bacteria-containing interior of the tooth through the opening in the tooth ([0072], [0098]),
dispersing the bacteria in the fluid (the fluid enters the tooth opening and mixes with the bacteria);
inserting an ultrasonic instrument (64 and see [0048]) through the opening in the tooth (see Figures); and
transmitting ultrasonic energy to the fluid by the ultrasonic instrument at a predetermined an amplitude and at a predetermined frequency, causing adapted to cause inertial cavitation of gas vesicles ([0054], [0259-0260]) located in the bacteria present in the fluid to ablate pulp, tissue, and/or debris contained within the interior of the tooth by the inertial cavitation of the gas vesicles ([0113], [0213], [0059-0060]; the acoustic cavitation is used to remove the smear layer, which includes a layer of dentin, organic and inorganic debris, and bacteria and causes cellular rupture of bacteria and cell dissociation).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (US 2012/0237893 A1).
Regarding claim 4, Bergheim teaches the method according to claim 3 (see rejection above). Bergheim teaches filling the root canal and mentions that in conventional root canal procedures, the root canal is filled with solid matter such as gutta percha or a flowable obturation material ([0005], [252]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include using gutta percha as a filling material for filling the root canal as it is a well-known material for filling and restoring a root canal.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (US 2012/0237893 A1), in view of Lee et al. (NPL, 2017. Bacteria in the apical root canals of teeth with apical periodontitis).
Regarding claim 9, Bergheim teaches a method of performing a treatment on a tooth (abstract), comprising:
accessing an interior of the tooth through at least one opening in the tooth (65) (see Figures),
the interior of the tooth containing bacteria ([0098]; bacteria is removed from the infected tooth);
delivering a fluid into the bacteria-containing interior of the tooth through the opening in the tooth ([0072], [0098]),
dispersing the bacteria in the fluid (the fluid enters the tooth opening and mixes with the bacteria);
inserting an ultrasonic instrument (64 and see [0048]) through the opening in the tooth (see Figures); and
transmitting ultrasonic energy to the fluid by the ultrasonic instrument at a predetermined an amplitude and at a predetermined frequency, causing adapted to cause inertial cavitation of gas vesicles ([0054], [0259-0260]) located in the bacteria present in the fluid to (a) rupture cellular walls of the bacteria, killing the bacteria and disinfecting the interior of the tooth of the bacteria by the inertial cavitation of the gas vesicles, and (b) ablate pulp, tissue, and/or debris contained within the interior of the tooth by the inertial cavitation of the gas vesicles ([0113], [0213], [0059-0060]; the acoustic cavitation is used to remove the smear layer, which includes a layer of dentin, organic and inorganic debris, and bacteria and causes cellular rupture of bacteria and cell dissociation).
Bergheim is silent to wherein the bacteria include at least one of Fusobacterium nucleatum, Prevotella intermedia, Peptostreptococcus micros, Peptostreptococcus anaerobius, Eubacterium alactolyticum, Eubacterium lentum, Wolinella recta, and combinations thereof.
Lee teaches bacteria in the root canal which may cause apical periodontitis and shows identified bacterial species in root canals (abstract), including Fusobacterium nucleatum, Prevotella intermedia, and Peptostreptococcus (see table 1).
It would have been obvious for one having ordinary skill in the art before the effective filing date that the bacteria of Bergheim would include Fusobacterium, Eubacterium, Peptosteptociccus, or Prevotella, as taught by Lee, because they are species of bacteria commonly found in periodontal and endodontic sites.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (US 2012/0237893 A1), in view of Mourad et al. (US 2011/0159461 A1).
Regarding claim 11, Bergheim teaches the method according to claim 1 (see rejection above), but is silent to wherein the ultrasonic energy is transmitted to the fluid at a mechanical index value less than 1.9 MPa MHz -1/2.
Mourad et al. teaches a device in the same field of endeavor or devices for delivering fluid to a dental site (abstract). Mourad teaches the device is energized ultrasonically to induce cavitation in the fluid for removal of loosening and removing dental plaque from a dental site ([0029]). Mourad teaches the ultrasonic energy has a mechanical index value within the range of 0.01 to 5 and more specifically from 0.01 to 1.9 ([0081]).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method of Bergheim to have the mechanical index value of the fluid be within the range of 0.01-1.9, as taught by Mourad, to provide an ultrasonic energy sufficient to loosen up and remove particles from the dental site.
Regarding claim 12, Bergheim teaches the method according to claim 1 (see rejection above), but is silent to wherein the ultrasonic energy is transmitted to the fluid at a mechanical index value of approximately 0.49 MPa MHz -1/2.
Mourad et al. teaches a device in the same field of endeavor or devices for delivering fluid to a dental site (abstract). Mourad teaches the device is energized ultrasonically to induce cavitation in the fluid for removal of loosening and removing dental plaque from a dental site ([0029]). Mourad teaches the ultrasonic energy has a mechanical index value within the range of 0.01 to 5 and more specifically from 0.01 to 1.9 ([0081]).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method of Bergheim to have the mechanical index value of the fluid be within the range of 0.01 to 1.9 MPA, as taught by Mourad, to provide an ultrasonic energy sufficient to loosen up and remove particles from the dental site.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (US 2012/0237893 A1), in view of Zhenping et al. (NPL, 2020), and further in view of Pitt et al. (NPL, 2004).
Regarding claim 15, Bergheim teaches the method according to claim 1 (see rejection above), but is silent to introducing further bacteria into the interior of the tooth through the opening, the further bacteria carrying a medicament, inertial cavitation of the gas vesicles located in the further bacteria causing rupture of cellular walls of the further bacteria to deliver the medicament to the fluid and to the interior of the tooth to treat a condition of the tooth.
Zhenping et al. teaches a method in the same field of endeavor of using bacteria as a drug delivery instrument (abstract). Zhenping teaches that bacteria and bacteria-derived membrane vesicles are promising in controllable drug delivery (abstract). Zhenping teaches that bacteria can be simply genetically modified and can be cultured in large amounts in addition to being able to colonize specific body sites of mammalian hosts for example, disease sites. They also have inherent properties of interacting with live matters such as the adhesion ability to epithelial cells of the host and decorating with synthetic materials such as nanoparticles of therapeutic drugs for cargo delivery. They can also generate outer membrane vesicles positively or passively, showing significant potential to be safe and efficient drug carriers (p. 397 Col. 1).
Pitt et al. teaches a method in the same field of endeavor of ultrasonic drug delivery (abstract). Pitt teaches a medium containing carrier vesicles to deliver drugs is used. Pitt teaches ultrasonic energy is applied to induce cavitation in the medium, which disrupts the structure of the carrier vesicle and releases the drugs, in addition to making cell membranes and capillaries more permeable to drugs (abstract). Pitt teaches ultrasonication and cavitation lead to an increased rate of transport since the carrier end up rupturing and spilling its contents (p. 3, 1.3.2.2).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method of Bergheim to use a bacteria as a cargo element, as taught by Zhenping, and to include said cargo bacteria in the fluid/medium such that when cavitation occurs by the ultrasonic energy, it causes rupture of the membrane of the carrier bacteria to deliver the drug/medicament, as taught by Pitt, since such modification would improve therapeutic efficacy, enhance targeted delivery and reduce systemic side effects.
Regarding claim 16, Bergheim in view of Zhenping and Pitt teaches the method according to claim 15 (see rejection above). Bergheim teaches wherein the medicament includes a medication ([0099]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17, 25-29 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 attached to this Office Action.
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 extension fee 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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/LINA FARAJ/Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 8/27/2025