usNotice 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 05/21/2026 have been fully considered but they are not persuasive. Applicant has argued that Jundt fails to provide for the new limitation of the aperture diameter being smaller than a needle hub, however this is not persuasive as the portion cited as the aperture is shown as smaller than a needle hub as clarified in the following action.
Further the new limitation of the hub being only on one lateral side is addressed in combination and by the new prior art of Lu et al. (CN 105662552 A).
Applicant has argued that Neeman fails to provide for a needle that would be smaller than an aperture however Neeman is only relied upon for the teaching of the benefits of a bushing for a 3d printed guide for some type of oral treatment.
The new claims of 21-23 are also addressed in relation to the cited art.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-11, and 21-23 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the new limitation of “wherein the diameter is smaller than a needle hub of the needle such that the needle hub is prevented from passing through the aperture when the needle is inserted through the aperture” which is new matter. The original disclosure is completely silent to any relational sizing of the aperture and some needle hub. The original disclosure does not recite for discuss any “needle hub” and thus does not provide any basis of support for such a relational limitation between a needle hub, whose diameter is not defined or recited in the original disclosure, and the aperture diameter. As such claim 1 and all claims depending from claim 1 contain and recite the new matter.
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 1-3, 5-11, and 21-23 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.
Claim 1 recites the new limitation of “wherein the diameter is smaller than a needle hub of the needle such that the needle hub is prevented from passing through the aperture when the needle is inserted through the aperture” however the needle and any hub it may have are not part of the guide but are only separate non-inventive objects meant to be used with the instant dental guide. As such any dimensions a some needle and hub may are undefined and have no basis for clearly limiting the aperture of the dental guide.
All claims depending upon claim 1 also recite the same indefinite language and are themselves indefinite for the same reasons as claim 1.
For purposes of examination any prior art that has a diameter to a needle support that can receive some needle with be deemed to provide for the claim limitation.
Regarding claim 5, the claim is indefinite as it depends on itself; accordingly its dependency is unclear.
Regarding claim 21, the new limitation of “a tolerance between an inner diameter of the bushing and an outer diameter of the needle is between ±0.0001 in. and ±0.005in.” is rendered unclear and indefinite as it is dependent on the diameter of some needle which is not part of the dental guide and as such has no definite diameter. As such a tolerance between the bushing and some undefined needle is indefinite. For purposes of examination any prior art that recites a bushing with an inner diameter that could have a tolerance with any possible need in the range claimed will be deemed to provide for the claim limitation.
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.
Claims 1-3, 5-11, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (CN 105662552 A) in view of Neeman et al. (US 2015/0182298 A1).
Regarding claims 1 and 5, and Lu discloses a 3d printed dental guide (title and abstract) for guiding a needle to the maxillary nerve (translation page 2 lines 12-13) that includes an elongate member defining a first end and a second end (Fig. 8 element 3) and a needle support proximate the first end (Fig. 8 element 4), the needle support defining an aperture structured to receive a needle (Fig. 8 element 5) where the aperture is oriented to direct the needle along a path toward a target area comprising a nerve access point of a patient (page 2 lines 12-13 disclosing the guide is directed to the maxillary nerve), wherein the aperture has a diameter sufficient to slidably receive the needle (Fig. 8 element 5 is sized to allow the needle to enter by sliding, page 5 line 39), and wherein the diameter is smaller than a needle hub of the needle such that the needle hub is prevented from passing though the aperture when the needle is inserted thought the aperture (Fig. 8 element 5 would be smaller in diameter than some needle hub);
and a fixed hub proximate the second end, the fixed hub structured to attach to only at least one tooth of a single arch of teeth of a patient (Fig. 8 elements 2, page 5 lines 38-39 disclosing that the hub is cover molar teeth 4-6 which are only on one lateral side of the arch),
wherein the target area comprising the nerve access point of the patient is spaced apart from the at least one tooth (Fig. 8 the target area from the exit of element 5 is spaced apart from the at least one tooth portion 2).
Regarding claims 1 and 5, Lu discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the guide includes a bushing for the needle guide nor where the bushing is a metal.
However, Neeman discloses a 3d printed dental guide (title and abstract) include a guide hole that receives a bushing made of metal (Fig. 3c bushing element 304a/b/c and guide holes 202a/b/c that receive the bushings, paragraph [0080] lines 14-16 disclosing metal bushings/sleeves).
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 guide to have metal bushings as taught by Neeman into the aperture hole as taught by Lu for the purpose of ensuring a 3d printed guide opening will accurately guide a tool through a guide hole as taught by Neeman (paragraph [0007] all).
Regarding claim 2 Lu further discloses wherein the fixed hub comprises a contoured portion structured to receive a portion of at least one tooth (Fig. 8 element 2 showing a contour portion on the bottom of the fixed hub to receive at least one tooth, page 5 line 39 disclosing the hub is contour for the upper molar teeth 4-6)..
Regarding claim 3, Lu further discloses wherein the fixed hub comprises a first material and the contoured portion comprises a second material (Fig. 8 showing the fixed hub thus being a material and showing the contoured area thus being a second material, there is no requirement for the first or second materials to be different or any particular material).
Regarding claim 6, Lu further discloses wherein at least one of the elongate member, the needle support, and the fixed hub, comprises an additive manufacturing material (abstract disclosing the device is made by 3D printing which is a type of additive manufacturing).
Regarding claims 7 and 8, Lu/Neeman as combined above, discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the 3d printed guide is made of polymer/metal.
However, Neeman further discloses a 3d printed dental guide (title and abstract) that is made by 3d printing use an additive process of printing a polymer (paragraph [0008] lines 1-8) or additively forming a with a metal (paragraph [0008] lines 1-10 disclosing metal printing by electron beam melting).
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 3D printed guide to be made of either polymer or metal as taught by Neeman into material of the 3D printed guide as taught by Lu/Neeman for the purpose of providing a guide made of a tough material as taught by Neeman (paragraph [0008] lines 6-8), and as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, Lu further discloses wherein the needle support defines a lingual surface for receiving a proximal end of the needle (Fig. 8 left side of element 4).
Regarding claim 21, Lu/Neeman disclose a needle and bushing that would receive a needle but fails to explicitly disclose where the tolerance would be between an inner diameter of the bushing and an outer diameter of the needle is between ±0.0001 in. and ±0.005in,however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected an appropriate needle which would have resulted in a clearance of between ±0.0001 in. and ±0.005in to provide for the needle to be able to slide through the aperture towards the target location of the guide, 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 involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 23, Lu further discloses where the fixed hub covers both buccal and lingual surfaces of the at least one tooth to surround the at least one tooth (page 5 disclosing “tooth socket sleeve upper molars, can cover the upper teeth 4-6” which to cover the upper teeth would cover their buccal and lingual sides)).
Claims 1-3, 5-11, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Jundt et al. (“Computed tomography-guided 3D printed patient-specific regional anesthesia”, J Dent Anesth Pain Med 2020;20(5):325-329) in view of Neeman et al. (US 2015/0182298 A1) and further in view of Lu et al. (CN 105662552 A).
Regarding claims 1 and 5, Jundt discloses a dental guide (title and abstract disclosing a 3d printed guide for a needle) comprising:
an elongate member defining a first end and a second end (See annotated Fig. 2 below) ;
a needle support proximate the first end defining an aperture structured to receive a needle (See annotated figure 2 below) where the aperture is oriented to direct the needle along a path toward a target area comprising a nerve access point of a patient (Fig. 1 showing the target area of the nerve access point at T2), wherein the aperture has a diameter sufficient to slidably receive the needle (see image below where needle is slide into the cited aperture of the need support), and wherein the diameter is smaller than a needle hub of the needle such that the needle hub is prevented from passing though the aperture when the needle is inserted thought the aperture (See image below where the hub is larger than the cited aperture);
and a fixed hub proximate the second end, the fixed hub structured to attach to only at least one tooth of a single arch of teeth of a patient (See annotated figure 2 below the hub is only attached to teeth of one arch),
wherein the target area comprising the nerve access point of the patient is spaced apart from the at least one tooth (See annotated figure 2 below).
PNG
media_image1.png
688
971
media_image1.png
Greyscale
Regarding claims 1 and 5, Jundt discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the guide includes a bushing for the needle guide nor where the bushing is a metal.
However, Neeman discloses a 3d printed dental guide (title and abstract) include a guide hole that receives a bushing made of metal (Fig. 3c bushing element 304a/b/c and guide holes 202a/b/c that receive the bushings, paragraph [0080] lines 14-16 disclosing metal bushings/sleeves).
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 guide to have metal bushings as taught by Neeman into the aperture hole as taught by Jundt for the purpose of ensuring a 3d printed guide opening will accurately guide a tool through a guide hole as taught by Neeman (paragraph [0007] all).
Further regarding claim 1, Jundt/Neeman discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the fixed hub is structured to attach to only at least one tooth of only one lateral side of a single arch.
However, Lu discloses a 3d printed dental guide (title and abstract) for guiding a needle to the maxillary nerve (translation page 2 lines 12-13) that includes an elongate member defining a first end and a second end (Fig. 8 element 3) and a needle support proximate the first end (Fig. 8 element 4), the needle support defining an aperture structured to receive a needle (Fig. 8 element 5) where the aperture is oriented to direct the needle along a path toward a target area comprising a nerve access point of a patient (page 2 lines 12-13 disclosing the guide is directed to the maxillary nerve), wherein the aperture has a diameter sufficient to slidably receive the needle (Fig. 8 element 5 is sized to allow the needle to enter by sliding, page 5 line 39), and wherein the diameter is smaller than a needle hub of the needle such that the needle hub is prevented from passing though the aperture when the needle is inserted thought the aperture (Fig. 8 element 5 would be smaller in diameter than some needle hub);
and a fixed hub proximate the second end, the fixed hub structured to attach to only at least one tooth of a single arch of teeth of a patient (Fig. 8 elements 2, page 5 lines 38-39 disclosing that the hub is cover molar teeth 4-6 which are only on one lateral side of the arch),
wherein the target area comprising the nerve access point of the patient is spaced apart from the at least one tooth (Fig. 8 the target area from the exit of element 5 is spaced apart from the at least one tooth portion 2).
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 fixed hub is structured to attach to only at least one tooth of only one lateral side of a single arch as taught by Lu into the fixed hub as taught by Jundt/Neeman for the purpose of providing a needle guide that would be convenient in fuse as taught by Lu (page 6 lines 5-6).
Regarding claim 2 Jundt further discloses wherein the fixed hub comprises a contoured portion structured to receive a portion of at least one tooth (See second image of figure 2 showing a contour portion on the bottom of the fixed hub to receive at least one tooth).
Regarding claim 3, Jundt further discloses wherein the fixed hub comprises a first material and the contoured portion comprises a second material (Fig. 2 showing the fixed hub thus being a material and showing the contoured area thus being a second material, there is no requirement for the first or second materials to be different or any particular material).
Regarding claim 6, Jundt further discloses wherein at least one of the elongate member, the needle support, and the fixed hub, comprises an additive manufacturing material (abstract disclosing the device is made by 3D printing which is a type of additive manufacturing).
Regarding claims 7 and 8, Jundt/Neeman as combined above, discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the 3d printed guide is made of polymer/metal.
However, Neeman further discloses a 3d printed dental guide (title and abstract) that is made by 3d printing use an additive process of printing a polymer (paragraph [0008] lines 1-8) or additively forming a with a metal (paragraph [0008] lines 1-10 disclosing metal printing by electron beam melting).
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 3D printed guide to be made of either polymer or metal as taught by Neeman into material of the 3D printed guide as taught by Jundt/Neeman for the purpose of providing a guide made of a tough material as taught by Neeman (paragraph [0008] lines 6-8), and as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Jundt further discloses wherein the elongate member defines a longitudinal axis, and wherein the needle support extends from the elongate member in a direction substantially orthogonal to the longitudinal axis of the elongate member (See second image in figure 2 showing the elongated member axis being orthogonal to the needle support).
Regarding claim 10, Jundt further discloses wherein the needle support defines a lingual surface for receiving a proximal end of the needle (See annotated image above).
Regarding claim 11, Jundt/Neeman as combined above, discloses the claimed invention as discussed above, including where the device can be install on a patient and is patient customized for positioning the needle support to target the CT scanned location of their mandibular foramen (page 2 “technique description” disclosing the patient’s jaw is CT scanned, Fig. 1 showing the scanned lower jaw with the location of the mandibular foramen at T2) and where guide is printed to direct a needle to the foramen (Figs 3 and 4 showing the lingual surface of the needle support being within the mouth near the mandibular foramen based off the CT scan), but fails to explicitly disclose for the lingual surface to be between approximately 6mm and approximately 50mm from the mandibular foramen.
However it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the lingual surface for be withing approximately 6-50 mm from the mandibular foramen when performing a surgical planning, 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 involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 21, Jundt/Neeman disclose a needle and bushing that would receive a needle but fails to explicitly disclose where the tolerance would be between an inner diameter of the bushing and an outer diameter of the needle is between ±0.0001 in. and ±0.005in,however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected an appropriate needle which would have resulted in a clearance of between ±0.0001 in. and ±0.005in to provide for the needle to be able to slide through the aperture towards the target location of the guide, 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 involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 23, Jundt further discloses where the fixed hub covers both buccal and lingual surfaces of the at least one tooth to surround the at least one tooth (Fig. 2 showing the hub material covering both buccal and lingual sides of the at least one tooth).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Jundt et al. (“Computed tomography-guided 3D printed patient-specific regional anesthesia”, J Dent Anesth Pain Med 2020;20(5):325-329) in view of Neeman et al. (US 2015/0182298 A1) in view of Lu et al. (CN 105662552 A) and further in view of Haber et al. (US 2014/0026419 A1).
Regarding claim 22, Jundt/Neeman/Lu discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where contoured portion comprises a pliable material that is different from a material of the remainder of the fixed hub.
However, Haber discloses a 3d printed dental guide (title and abstract) that is made by 3d printing use an additive process of printing a first material for a fixed hub of a guide to receive teeth (Fig. 11 element 1104) and further has a contoured portion that comprises a pliable material that is different from a material of the remainder of the fixed hub (Fig. 11 element 1102, paragraph [0098] lines 1-12 disclosing the inner layer is more pliable for securing to the dentition better).
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 contoured portion comprising a pliable material that is different from a material of the remainder of the fixed hu as taught by Haber into the material of the contour portion of the fixed hub as taught by Jundt/Neeman/Lu for the purpose of providing for a printed guide that would have a dentition gripping hub that was better to securely and precisely retain the printed tooth mounting guide on teeth as taught by Haber (paragraph [0098] lines 1-10).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (CN 105662552 A) in view of Neeman et al. (US 2015/0182298 A1) and further in view of Haber et al. (US 2014/0026419 A1).
Regarding claim 22, Lu/Neeman discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where contoured portion comprises a pliable material that is different from a material of the remainder of the fixed hub.
However, Haber discloses a 3d printed dental guide (title and abstract) that is made by 3d printing use an additive process of printing a first material for a fixed hub of a guide to receive teeth (Fig. 11 element 1104) and further has a contoured portion that comprises a pliable material that is different from a material of the remainder of the fixed hub (Fig. 11 element 1102, paragraph [0098] lines 1-12 disclosing the inner layer is more pliable for securing to the dentition better).
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 contoured portion comprising a pliable material that is different from a material of the remainder of the fixed hu as taught by Haber into the material of the contour portion of the fixed hub as taught by Lu/Neeman for the purpose of providing for a printed guide that would have a dentition gripping hub that was better to securely and precisely retain the printed tooth mounting guide on teeth as taught by Haber (paragraph [0098] lines 1-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.P.S/Examiner, Art Unit 3772 05/30/2026
/EDWARD MORAN/Primary Examiner, Art Unit 3772
