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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on July 1, 2026 is acknowledged.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 1, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 13, 130a, and 130b. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 112
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.
Claims 5, 7 and 9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation of the external diameter of the tip being less than 50% of the diameter of the proximal end, and the claim also recites the external diameter of the tip being between 10-30% of the diameter of the proximal end which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation the tip deflection by more than the tip deflection more than 8mm with a load of 0.05N, and the claim also recites the tip deflection more than 2mm with a load of 0.01N (in the alternative of “additionally”) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With respect to claim 9, the applicant further claims “at least one side vent”, however, it is noted that the applicant has previously claimed “at least one opening that is an axially directed outlet”. It is unclear if the side vent is in addition to the opening or is trying to reference the claimed opening. It is noted that for examination purposes, the claimed vent of claim 9 is in addition to the claimed opening, however, the applicant should amend the claim to clarify what is being claimed.
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, 3-4, 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (2009/0004621) in view of Riitano (6,079,979) as evidenced by United States Plastic Corp. and Birmingham gauge.
Quan teaches a needle assembly for endodontic procedure apparatus, the needle assembly configured for removably coupling the needle assembly to a handpiece (see par. 103, such that the needles are provided with a single handle, therefore, it is obviously configured for removably connection to a handpiece, i.e. handle); and a needle 31 extending axially from a proximal end to a distal tip 31b, the tip having at least one opening that is an axially directed outlet (pars. 62-63, such that the side wall 31d includes holes along its length including holes at the distal end 31b), the needle having a lumen extending through the needle to define a fluid passageway from the proximal end to the at least one opening (see figs. 1, 6, such that the needle is a cannula) wherein the tip has an external diameter of 360 µm and a wall thickness of less than 50 µm (see pars. 83-84, such that the outer diameter is 360 µm and the inner diameter is 318 µm, which makes the wall thickness 42 µm which is less than 50 µm) , and wherein the needle is formed from a material having a tensile modulus of at least 1GPa,and wherein the needle is formed from a material having an ultimate tensile strength of between 40 and 150MPa (par. 82, such that the needle is made of Lexan, see cited material properties of Lexan which teaches the tensile modulus is 345,000 psi which is 2.38 GPa and the ultimate tensile strength is 9,500 psi which is 65.5 MPa, both of which are within the claimed range). Quan teaches the invention as substantially claimed and discussed above including the needle connected to a handpiece and having a small diameter, however, does not specifically teach the needle assembly comprises a connector for removably coupling the needle assembly to a handpiece, a body portion extending from the connector and providing a fluid conduit, a fluid passageway from the fluid conduit of the body to at least the one opening and wherein the tip has an external diameter of no more than 300 µm.
Riitano teaches a needle assembly for endodontic procedure apparatus, the needle assembly comprising a connector 24 for removably coupling the needle assembly to a handpiece (col. 5, ll. 16-23, such that portion 24 includes end 26); a body portion 40 extending from the connector and providing a fluid conduit 52 (see fig. 3); and a needle 60 extending axially from a proximal end 62 at the body portion to a distal tip 76, the tip having at least one opening that is an axially directed outlet (see fig. 6b showing axially directed outlet), the needle having a lumen 72 extending through the needle to define a fluid passageway from the fluid conduit of the body to the at least one opening (see figs. 3, 6b) ,wherein the tip has an external diameter of no more than 300 µm and a wall thickness of less than 50 µm (see col. 5, ll. 56-65, such that the cannula is a 33 gauge needle, see evidence needle size chart, such that the outer diameter is about 200 µm and the wall thickness can be 44 µm which is less than 50 µm, such that .0508mm-.0064mm is .444 mm which is 44 µm). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the needle assembly taught by Quan to includes a connector and body as taught by Riitano in order to allow for easy connection to a handpiece. Further it would have been obvious to one having ordinary skill in the art to modify the diameter of the needle taught by Quan to be less than 300 µm as taught by Riitano since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (see MPEP 2144.07). It is noted that the diameter taught by Quan is very close to the claimed range and further that Riitano teaches the claimed range and both Quan and Riitano teaches using the needle as claimed by the applicant for use in an endodontic space. It is noted that the applicant has not disclosed the claimed range provides unexpected results or a particular advantage.
With respect to claim 2, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan further teaches the needle has a tapered profile with the external diameter of the needle portion converting towards the distal tip (see par. 63, specifically “The cannula 31 having a substantially cylindrical shape with a slight taper from its proximal end 31a towards its distal end 31b”).
With respect to claim 3, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan further teaches wherein the needle has a frustoconical profile (see par. 63, specifically “The cannula 31 having a substantially cylindrical shape with a slight taper from its proximal end 31a towards its distal end 31b”, such that the slight taper from the proximal end to the distal end provides a frustoconical profile).
With respect to claim 6, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan further teaches the needle comprises a conical form (see par. 63, specifically “The cannula 31 having a substantially cylindrical shape with a slight taper from its proximal end 31a towards its distal end 31b”). The claimed phrase “comprises a cylindrical needle which is processed into a conical form” is being treated as a product by process limitation; that is, that the conical needle is formed by shaping a cylindrical needle to form the conical needle. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Quan is silent as to how the conical needle is formed, it appears that the product in Quan would be the same or similar.
With respect to claim 7, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan teaching the needle being made of a material having the same tensile modulus and ultimate tensile strength and similar dimensions as the applicant and Riitano further teaches the same dimensions, such that the modification of Quan/Riitano teaches the needle having the claimed material properties and dimensions, therefore it would be obvious that the needle taught by Quan/Riitano would have a flexibility such that the needle tip deflects laterally by more than 2mm with a tip load of 0.01 N and, additionally or alternatively, by more than 8mm with a tip load of 0.05N. Such that it is noted that the dimensions and material of the needle would determine how it would deform under different forces and since the prior art teaches the needle being of a material having the same claimed material properties and having the same dimensions, it would function as claimed.
With respect to claim 8, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan teaching the needle is formed from polycarbonate (par. 82, such that it is formed from Lexan, which includes polycarbonate and therefore it is formed from polycarbonate).
With respect to claim 9, Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan teaching at least one side vent in the wall of the needle between the proximal end at the body and the distal tip (see pars. 62-63, such that the side wall 31d includes holes along its length).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (2009/0004621) in view of Riitano (6,079,979) as evidenced by United States Plastic Corp. and Birmingham gauge as applied to claim 3 above, and further in view of Ruddle et al. (2006/0234182).
Quan/Riitano teaches the invention as substantially claimed and discussed above including Quan teaching the needle is tapered, however, does not specifically teach the external diameter of the tip is less than 50% of the diameter of the proximal end of the needle, and wherein the external diameter of the tip is between 10 to 30% of the diameter of the proximal end of the needle.
Ruddle teaches a needle assembly for endodontic procedure apparatus, the needle assembly comprising a connector 14 for removably coupling the needle assembly to a handpiece (par. 23) and a needle 16 extending axially from the connector to a distal tip, the tip having at least one opening that is an axially directed outlet (see figs. 3-5), the needle having a lumen 30 extending through the needle to define a fluid passageway from the connector to the at least one opening (see figs. 3-4,par. 33), wherein the tip has an external diameter of no more than 300 µm (par. 27, such that the diameter of D0 is 100-200 µm).
Further with respect to claim 5, Ruddle further teaches the external diameter of the tip is less than 50% of the diameter of the proximal end of the needle (par. 25, such that the diameter at the tip can be 0.1-1.5mm and the diameter at the proximal end can be 2mm, such that if the diameter at the tip is 1.5mm and the diameter is 2mm at the proximal end, the diameter at the tip is as claimed), and wherein the external diameter of the tip is between 10 to 30% of the diameter of the proximal end of the needle (such that when the diameter is 1.5 at the tip, the diameter as the proximal end would be 1.65-1.95mm which is within the claimed 10-30%). It would have been obvious to one having ordinary skill in the art to modify the diameter of the needle at the proximal end relative to the tip as taught by Quan/Riitano to have the related dimensions as taught by Ruddle since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (see MPEP 2144.07). Such that that applicant does not claim the taper of the needle (i.e. the relationship between the proximal end and distal end) provides any advantage or unexpected result. It is noted that Ruddle teaches the rate of taper being the same as that disclosed by the applicant (see par. 25 of Ruddle and par. 17 of the applicant’s specification), such that it would be obvious to provide the needle with a taper to match that of the root canal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Malmin teaching different openings for an endodontic needle.
The prior art of Yared teaching different openings for an endodontic needle.
The prior art of Spironelli Ramos teaching a needle made of polycarbonate.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772
7/23/2026
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