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 § 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.
Claims 1, 3, 5-6, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kert (US 6,010,335) in view of Johnson (US 5,286,423).
In reference to Claim 1, Kert discloses making a dental device to cover a root canal (a method of manufacturing an obturator for filling an endodontically prepared root canal, a dental device for applying material to a root canal with a filler material to reduce inflammation or infection and a thermoplastic filler material (1:45-63) (the obturator comprising an elongated carrier having a distal end, a proximal end, and a working portion with a combination of filler materials having multiple viscosities coated on the working portion); the materials include a thermoplastic filler and a filler material comprising an anti-microbiological substance for preventing irritation, inflammation, or infection (Abstract)) ((b) placing the at least two filler materials into each of the plurality of cavities of the mold);
Kert does not disclose said method comprising: (a) providing a mold having a plurality of cavities in the mold; (c) baking the mold at a temperature of between 98.9°C and 154.4°C for from about 4 h to about 24 h to form the mold having a heated filler material comprising the at least two filler materials, whereby the at least two filler materials have different viscosities upon heating; (d) inserting the working portion of the carrier into the mold having the heated filler material; (e) placing a lid on top of the mold to keep the carrier at a correct depth; (g) allowing the heated filler material to cool at about room temperature, solidify and thereby forming a coating comprising the combination filler material having multiple viscosities on the working portion of the carrier, thereby forming obturator; and (h) removing the obturator from the mold.
Johnson discloses a mold with cavities (1:62-63) (said method comprising: (a) providing a mold having a plurality of cavities in the mold); the material is baked from 210°F to 310°F for a time between 2-24 hours (2:49-53) ((c) baking the mold at a temperature of between 98.9°C and 154.4°C for from about 4 h to about 24 h to form the mold having a heated filler material comprising the at least two filler materials, whereby the at least two filler materials have different viscosities upon heating); inserting filler material tips into each cavity (4:51-59) ((d) inserting the working portion of the carrier into the mold having the heated filler material); the shaft potion of a filler carrier is then positioned in each cavity to partially displace the heated filler material therein and a handle portion that remains exterior of the mold (2:65-68) ((e) placing a lid on top of the mold to keep the carrier at a correct depth); after the mold is heated it is allowed to cool (3:26) ((g) allowing the heated filler material to cool at about room temperature, solidify and thereby forming a coating comprising the combination filler material having multiple viscosities on the working portion of the carrier, thereby forming obturator); and the product is removed (3:28) ((h) removing the obturator from the mold).
It would have been obvious to one of ordinary skill in the art to complete the molded product of Kert using the mold of Johnson because Johnson is molding maintaining the different materials in position. One of ordinary skill in the art would have been motivated to use the mold because one would want to position specific materials in specific positions. The reasonable expectation of success is based on positioning the material in specific points.
In reference to Claim 3, modified Kert discloses the method of Claim 1, as described above.
Kert discloses thermoplastic gutta percha (1:64-67) (the at least two filler materials are provided in a form of an injected gutta-percha point).
In reference to Claim 5, Kert discloses making a dental device to cover a root canal (a method of manufacturing an obturator for filling an endodontically prepared root canal), a dental device for applying material to a root canal with a filler material to reduce inflammation or infection and a thermoplastic filler material (1:45-63) (the obturator comprising an elongated carrier having a distal end, a proximal end, and a working portion with a combination filler material having multiple viscosities coated on the working portion); the materials include a thermoplastic filler and a filler material comprising an anti-microbiological substance for preventing irritation, inflammation, or infection (Abstract)) ((a) forming an initial coating of a first filler material over the working portion of the carrier; (b) filling a mold having a plurality of cavities in the mold with a second filler material);
Kert does not disclose (c) baking the mold to form the mold having a heated second filler material; (d) inserting the initial coated working portion carrier into each cavity of the mold having the heated second filler material; (e) placing a lid on top of the second mold to maintain the elongated carrier at a correct depth; (f) cooling the second filler material to form a subsequent coating of the second filler material on a portion of the initial coated working portion carrier, thereby forming the obturator and removing the obturator from the mold).
Johnson discloses a mold with cavities (1:62-63) (said method comprising: (a) providing a mold having a plurality of cavities in the mold); the material is baked from 210°F to 310°F for a time between 2-24 hours (2:49-53) ((c) baking the mold to form the mold having a heated second filler material); inserting filler material tips into each cavity (4:51-59) ((d) inserting the initial coated working portion carrier into each cavity of the mold having the heated second filler material); the shaft potion of a filler carrier is then positioned in each cavity to partially displace the heated filler material therein and a handle portion that remains exterior of the mold (2:65-68) ((e) placing a lid on top of the second mold to maintain the elongated carrier at a correct depth); after the mold is heated it is allowed to cool (3:26) ((f) cooling the second filler material to form a subsequent coating of the second filler material on a portion of the initial coated working portion carrier, thereby forming the obturator and removing the obturator from the mold).
It would have been obvious to one of ordinary skill in the art to complete the molded product of Kert using the mold of Johnson because Johnson is molding maintaining the different materials in position. One of ordinary skill in the art would have been motivated to use the mold because one would want to position specific materials in specific positions. The reasonable expectation of success is based on positioning the material in specific points.
In reference to Claim 6, modified Kert discloses the method of Claim 5, as described above.
Johnson discloses inserting filler material tips into each cavity (4:51-59) (step (a) comprises: (i) inserting the working portion of the carrier into a container having a heated first filler material); the shaft potion of a filler carrier is then positioned in each cavity to partially displace the heated filler material therein and a handle portion that remains exterior of the mold (2:65-68) ((ii) optionally placing a lid on top of the container to keep the carrier at a correct initial depth); after the mold is heated it is allowed to cool (3:26) ((iii) cooling the first filler material to form the initial coating of the first filler material over working portion of the carrier).
In reference to Claim 10, modified Kert discloses the method of Claim 5, as described above.
Kert discloses a taper (2:40-42 and Fig. 1) (the working portion has a taper, and the taper may be a constant taper or a variable taper along its length).
In reference to Claim 12, modified Kert discloses the method of Claim 5, as described above.
Kert discloses a material with a viscosity (4:51-59) (the heated first filler material is characterized by a first viscosity or a second viscosity).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kert (US 6,010,335) in view of Johnson (US 5,286,423) as applied to Claim 1 above, and further in view of Congy, et al. (US 2017/0311909).
In reference to Claim 2, modified Kert discloses the method of Claim 1, as described above.
Johnson discloses a mold with cavities (1:62-63) (the at least two filler materials are placed into each cavity of the mold) inserting filler material tips into each cavity (4:51-59) (a first segment of a first filler material is placed into each cavity of the mold; subsequently a second segment of a second filler material is placed over the first segment of the first filler material into the same cavity of the mold).
Modified Kert does not disclose finally then a third segment of a third filler material is placed over the second segment of the second filler material into the same cavity of the mold.
Congy discloses a third material can be added to the body ([0034]) (a third segment of a third filler material is placed over the second segment of the second filler material into the same cavity of the mold).
It would have been obvious to one of ordinary skill in the art to complete the molded product of modified Kert using the third material of Congy because Congy is adding the third material to improve mechanical properties ([0034]). One of ordinary skill in the art would have been motivated to use the third material because one would want to improve mechanical properties. The reasonable expectation of success is based on Congy’s want to improve the mechanical properties.
Allowable Subject Matter
Claims 4, 7-9, 11, and 13-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 4 would be allowable because the prior art of record does not disclose a gated-injection mold process for the injected gutta-percha point.
Claim 7 would be allowable because the prior art of record does not disclose the container is selected from a crucible or another mold having a plurality of cavities.
Claims 8 and 9 would be allowable because the prior art of record heats the materials all together.
Claim 11 would be allowable because the prior art of record does not disclose an initial depth of 16 mm.
Claim 13 would be allowable because the prior art of record does not disclose the heated first filler material is characterized by the first viscosity and is initially coated from a coronal end of the carrier to the distal end, the mold is filled with the second filler material up to between 5 mm and 10 mm from the distal end.
Claim 14 would be allowable because the prior art of record does not disclose a second viscosity having a target melt flow between 50 and 200g/10min.
Claim 15 would be allowable because the prior art of record does not disclose the mold is filled with second filler material to between 5 mm and 10 mm from the distal end, and is subsequently filled with a third filler material above the second filler material.
Claim 16 would be allowable because the prior art of record does not disclose the initial coating thickness is from 10 µm to 500 µm over a length of the working portion.
Claim 17 would be allowable because the prior art of record does not disclose the first viscosity having a target melt flow between 0 and 20g/10 min.
Claim 18 would be allowable because the prior art of record does not disclose the second viscosity having a target melt flow between 50 and 200g/10min.
Claim 19 would be allowable because the prior art of record does not disclose the third viscosity having a target melt flow between 0 and 20g/10 min.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY C GRACE whose telephone number is (571)270-1113. The examiner can normally be reached Monday-Thursday 7:00 AM - 5:00 PM EST, Friday 7:00 AM - 11:00 AM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at (571)272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELSEY C. GRACE
Examiner
Art Unit 1742
/CHRISTINA A JOHNSON/Supervisory Patent Examiner, Art Unit 1742