DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Rejections - 35 USC § 112
2. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
3. Claims 1- 13, 15, and 20-21, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites “a handpiece adjacent an end of the first fluid line in contact with the HVE fitting” (line 4); it is unclear whether it is the handpiece or the first fluid line that is in contact with the HVE fitting.
Claim 1 recites “a manifold arranged at an end of the second fluid line in contact with the HVE fitting” (line 7); it is unclear whether it is the manifold or the second fluid line that is in contact with the HVE fitting.
Claim 2 then recites “a high-volume evacuator configured to be coupled between the HVE fitting and the dental office vacuum line”, which contradicts the base claim 1’s recitation “an HVE fitting configured to attach to a dental office vacuum line” (claim 1 lines 2-3). Claim 2 is indefinite because it is unclear how the high volume evacuator is between the HVE fitting and the dental office vacuum line when the HVE fitting attaches to a dental office vacuum line.
Claim 3 recites “the high-volume evacuator” which lacks antecedent basis in the claims. Note that claim 3 depends on claim 1, which does not define a high-volume evacuator.
Claims 4-6 each recites antecedent bases “a first endodontic tip, a second endodontic tip”, which is indefinite because it is unclear whether these are the same or different from “a first endodontic tip” and “a second endodontic tip” previously defined in claim 1.
Claim 7 recites “a hardness between about shore 30 and about shore 80” which is indefinite because it does not indicate the specific durometer type used (e.g. shore A, shore B, shore C, shore D, shore DO, etc.).
Claim 15 recites “a dental dam clamp”; it is unclear whether such element is the same or different from the antecedent basis “a dental dam clamp” previously recited in the base claim 14.
Claim 20 recites "the rubber dam clamp" (line 6) which lacks antecedent basis.
Claim 21 recites “a dental dam clamp”; it is unclear whether such element is the same as or different from “the rubber dam clamp” previously recited in the base claim 20.
The dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 14-17 and 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Buchanan et al. (US 2023/0135573).
Regarding claim 14, Buchanan et al. discloses an endodontic treatment kit (Fig. 9) comprising:
a tubing assembly 85 (Fig. 9; [0124] “vacuum tubing 85”);
an HVE fitting configured to attach a dental office vacuum line to the tubing assembly 85 (Fig. 9; [0124] “vacuum tubing 85 that fits … HVE suction”;
an evacuation cannula 46/49 in fluid connection with the tubing assembly 85 (see Fig. 11); and
a first clip (first outrigger peg 48) configured to attach to a dental dam clamp (staging assembly 10’s socket 39) and to hold the evacuation cannula 46 in a fixed position relative to a tooth so that the evacuation cannula 46 can be positioned in a working space of the tooth (Figs. 1A; ¶0116] “The top plate 45 include a port 49. The outrigger pegs 48 of the top plate reside within the sockets 39. The port 49 serves as a suction port”; ¶0117] “top plate 45 may include an installed vacuum line 46”).
As to claim 15, the dam clamp/assembly 10 itself or its skirt 11 is a dental dam clamp because the dam clam 10 is attached to the tooth via the skirt 11 which is attached and sealed to the tooth (see Figs. 1A-1B; [0111]-[0112] “staging assembly 10… include a staging skirt 11 and a staging ring 13… The staging skirl material may be a rubber material… attached and sealed to the tooth…”).
As to claim 16, the tubing assembly 85 comprises a handpiece that is in fluid contact with the HVE fitting, the handpiece comprising a luer taper fitting configured to mate with an endodontic evacuation tip (Fig. 11 shows vacuum/tubing assembly 46/85 has a black bulbous handle equivalent to the claimed handpiece).
As to claim 17, the kit further comprise a second clip (second outrigger peg 48) configured to hold an evacuation hood 45 in a fixed position relative to the tooth, the evacuation hood configured to attach to the dental dam clamp 10 while the evacuation hood 45 is in fluid contact with the HVE fitting (Fig. 1A; ¶[0116] The top plate 45 include a port 49. The outrigger pegs 48 of the top plate reside within the sockets 39. The port 49 serves as a suction port”).
Regarding claim 20, Buchanan et al. discloses an endodontic treatment kit comprising:
a tubing assembly 46/85 (Fig. 2D; ¶[0117] “vacuum line 46”; Fig. 9 ¶[0124] “vacuum tubing 85”);
an HVE fitting configured to attach dental office vacuum line to the tubing assembly 85 (Fig. 9; [0124] “vacuum tubing 85 that fits … HVE suction”); and
an evacuation hood (top plate 45) configured to be placed on top of a tooth in a fixed position through attachment to the rubber dam clamp/assembly 10 (see Figs. 1A-1B; [0111]-[0112] “staging assembly 10… include a staging skirt 11 and a staging ring 13… The staging skirl material may be a rubber material… attached and sealed to the tooth…”).
The evacuation hood (top plate 45) in fluid contact with the tubing assembly 46/85 (Figs. 2D, 9, 11; ¶0116] “top plate 45 include a port 49… [that] serves as a suction port…”; ¶0117] “top plate 45 may include an installed vacuum line 46”).
As to claim 21, the dam clamp/assembly 10 itself or its skirt 11 is a dental dam clamp because the dam clam 10 is attached to the tooth via the skirt 11 which is attached and sealed to the tooth (see Figs. 1A-1B; [0111]-[0112] “staging assembly 10… include a staging skirt 11 and a staging ring 13… The staging skirl material may be a rubber material… attached and sealed to the tooth…”).
Claim Rejections - 35 USC § 103
6. 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.
7. Claim 19 is rejected under 35 U.S.C. 103 as being unpatenable over Buchanan et al. (US 2023/0135573).
Buchanan et al. discloses a portion of the first clip 48 that is in contact with the dental dam clamp 10 at socket 39 (Fig. 1A; ¶[0116] “The outrigger pegs 48 of the top plate reside within the sockets 39”). However, Buchanan et al. is silent to the dimensions of length and height of said portion of the first clip 48 that is in contact with the dam clamp 10. Nonetheless, note that Buchanan et al. discloses: ¶[0150] “Place each catheter to length into each canal, with the proximal end placed into a respective catheter slot of the staging ring and the distal end in a range of 2 mm to 5 mm from the terminus end of the canal”. Such slot in the staging ring would correspond to the portion of clip 48 received in recess 39. Therefore, such claimed ranges of between about 2 mm and about 6 mm in length and between about 0.5 mm and about 2 mm in height for said portion of the clip 48 that is in contact with the dam clamp would have been obvious to one having ordinary skill in since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
7. Claims 1-7 and 12 are rejected under 35 U.S.C. 103 as being obvious over Ukrainian Reference UA 141033 (also refer to the provided machine-generated English Translation) in view of McLean (2016/0030729) and Pond (2007/0244425).
Regarding claim 1, the UA141033 reference discloses an endodontic treatment kit (Figs. 1-2) comprising:
a tubing assembly 7 that bifurcates into a first fluid line (toward 8) and a second fluid line (toward 3);
an HVE fitting 4 configured to attach to a dental office vacuum line and connected to the tubing assembly 7;
a handpiece (mandrel 8) adjacent an end of the first fluid line (8) in contact with the HVE fitting 4; and
a manifold 2/3 arranged at an end of the second fluid line (3) in contact with the HVE fitting 4 (see UA Reference Figs. 1-2; English translation “standard hose from the system 7 which is attached to the macroaspiration mandrel 8… needle 3”).
Regarding the handpiece 8 at the first fluid line 8, the UA Reference discloses the handpiece 8 mating with a first endodontic tip (Figs. 1-2; English translation “macroaspiration mandrel has 8 for connection through a hose with a large endodontic needle..”). However, the UA Reference but is silent to the handpiece connection joint comprising a luer taper fitting.
McLean discloses an HVE handpiece 10/20 having a luer taper fitting 22 for mating with a first endodontic tip 30 (see McLean Figs. 2-4; ¶[0035] “extractor or ejector can be a High Volume Evacuator (HVE) … luer connector 18… a suction tip 30 is also shown that can be used in endodontics”; ¶[0039] “FIG. 4 provides… the suction tip via a male luer connector 22 for engaging with a female portion 36 of a female luer connector 38”).
Note that Fig. 4 shows the luer fitting 24 being taper.
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 UA reference by utilizing the luer taper fitting on the handpiece connection joint to mate with the endodontic needle as taught by McLean as a suitable alternative connection mechanism for such joint between handpiece and needle yielding the same and/or predictable results.
Regarding the manifold 2/3 at the second fluid line 3, the UA reference discloses the manifold 2/3 having a second endodontic tip 3 attached to a syringe 1, but fails to disclose an internal chamber receiving the second endodontic tip that protrudes therefrom the manifold.
Pond discloses a manifold 210 (Figs. 9-10) arranged at an end of fluid line 254 in contact with HVE fitting 256, wherein the manifold 210 comprises an internal chamber 250 sized to receive an endodontic tip 230 configured to attach to a syringe 200 and protrude from a proximal end of the manifold 210 (see Pond Figs. 9-10; ¶[0033]-[0035] “FIGS. 9-10 show a needle assembly 210 attached to a syringe 200… the assembly 210 generally comprises a needle 230 and a housing 250… The tubing 254 will be connected to an adaptor 256, which will allow the tubing to be connected to a suction device or evacuation source”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the UA reference’s manifold 2/3 with Pond’s manifold that is connected to HVE and receiving a needle protruding from the manifold and attached to syringe in order to obtain an effective and efficient joint suction and irrigation manifold system.
As to claim 2, the UAreference discloses a high-volume evacuator configured to be coupled between the HVE fitting 4 and the dental office vacuum line (English translation “standard retainer 4 on a saliva ejector… Patient… went to the dentist … Root canal irrigation was performed using device RB-18… suction force at the end of needle…”).
As to claims 3-6, the UA reference discloses a surgical suction adapter 5 mated to an evacuation orifice of the high-volume evacuator, and a third endodontic tip 6 that differs from both the first endodontic tip 8 and the second endodontic tip 3; wherein the first endodontic tip 8 is configured to evacuate fluid away from a root canal of a tooth, and the second endodontic tip 3 is configured to deliver irrigants to the root canal of the tooth (see UA reference Fig. 1; English translation “syringe 1 filled with irrigation solution… endodontic needle 3 for injection the solution”).
However, the UA reference fails to disclose the surgical suction adaptor mandrel 5 being frictionally mated to the evacuation orifice (as recited in claim 3); and that the third endodontic tip is configured to couple to the luer taper fitting (as recited in claim 6).
McLean discloses various needles 30 (Figs. 2-4), needles 50, 60 (Fig. 1) having quick-release adaptor for mating with evacuator orifice 20, wherein the quick-release adaptor provides a luer taper fitting (Fig. 3) and/or frictional fitting (Figs. 5-12). 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 UA reference by utilizing the quick-release adaptor of luer taper fitting and/or frictional fitting as taught by McLean as suitable alternative connection mechanisms for such joint between handpiece and needle yielding the same and/or predictable results.
As to claim 7, it is noted that the Application discloses the manifold is made from elastomeric which is inherently flexible. Pond discloses the incorporated manifold/housing being formed of flexible material (see Pond ¶0031] “Because of the preferred flexible material of the housing 150, the exit and the needle will form a fluid tight connection”); such flexible material is deemed to have a hardness similar to Applicant’s elastomeric material or at least overlaps with the claimed range. Therefore, such claimed range of about shore 30 to about shore 80 would have been obvious to one having ordinary skill in art before the filing of the invention since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
As to claim 12, the UA Reference shows the HVE fitting 4 comprises a single outer port 4 and a bifurcated port 7 (Figs. 1-2).
8. Claims 8-11 and 13 are rejected under 35 U.S.C. 103 as being unpatenable over the UA 141033 Reference in view of McLean and Pond, and further in view of Buchanan et al.
UA Reference/McLean/Pond discloses the invention substantially as applied to claim 1 as detailed above. However, UA Reference/McLean/Pond fails to disclose the various dimensions of the elements as recited in claims 8-11 and 13.
Note that Buchanan et al. discloses the catheter/needle may be in 40 mm in length (¶[0096]), 0.32 mm in diameter (¶[0020]), and the handpiece 54/56 has a longer length than the needle (Figs. 6A-6B), effectively indicate that all the claimed ranges of the elements’ diameters and lengths are of optimizable variables. Therefore, all the claimed ranges of diameters or lengths of the various elements would have been obvious to one having ordinary skill in since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner HAO D. MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (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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/HAO D MAI/
Examiner, Art Unit 3772
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