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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 27, 2026 is noted. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “at least an implant driver” is believed to be in error for -an implant driver. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “at least a surgical template” is believed to be in error for -a surgical template-. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the one or more first markers comprises a thread” is believed to be in error for -wherein at least one of the first one or more markers comprises a thread-. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “the kit including one or more spring-biased pins that are the one or more second markers” is believed to be in error for -wherein at least one of the one or more second markers is a spring-biased pin. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: On line 15 of the claim “the thread which is in or one the outer surface of the implant driver” is believed to be in error for -the thread which is on the outer surface of the implant driver-. Appropriate correction is required.
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 1-7 and 12 are 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 has been amended to include the thread follower being “one or more spring-based pins”, however, support for the pins being “spring-based” is not provided in the originally filed specification. It is noted that support for the pins being removable or retractable is provided.
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 1-7, 12 and 14 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.
Further with respect to claim 1, the applicant further claims “the thread when present”. It is noted that the limitation is unclear as to what the applicant is claiming since they applicant has claimed the thread, therefore, it is present if claimed. The applicant should amend the claim to clarify what is being claimed, however, for examination purposes, the limitation is being interested as functional, such as when the two elements are connected and the pin is engaged with the thread.
Further with respect to claim 1, the applicant claims “one or more second markers” and that the one or more second markers “comprises a thread follower” and further that the thread follower is “one or more spring-based pins”. It is unclear from the limitation if the “one or more second markers” together are a single thread follower and that single thread follower is one or more spring-based pins or if one of the claimed markers is a thread follower, such that the one or more second markers would have two thread followers and then each thread follower is one or more spring-based pins. It is noted that for examination purposes, the limitation is being interested as one of the claimed one or more markers is a singular thread follower, such that the single follower is a single spring-based pin, however, the applicant should amend the claim to clarify.
With respect to claim 3, the limitations with respect to the digital planned implant and implant position being stored on a single storage device are unclear. It is noted that the applicant is claiming an implant driver and NOT the method of designing it or the virtual implant. It is unclear how the limitations are related to the claimed driver. The applicant should amend to include limitations directed towards the claimed driver.
With respect to claim 12, it is unclear what elements are contained in the kit. It is noted that a kit would be required to have physical elements within it, therefore, the limitation of the kit having “a digital virtually planned implant and implant positioned stored on a single storge device” is unclear. It is unclear if that applicant is trying to claim the kit including a computer device or that the kit includes an implant, such that the implant was selected based on a digital plan. It is noted that for examination purposes, the limitations are being interpreted as the claimed kit includes an implant that was selected based on digital planning, however, the applicant should amend the claim to clarify.
With respect to claim 14, the applicant claims that the first marker “includes a thread and a number of distributed markers”. It is unclear what the applicant is claiming with respect to the thread. It is unclear if the thread is the claimed helical thread of claim 13 or a different thread. It is noted for examination purposes, it is being interpreted as the claimed helical thread, however, the applicant should amend the claim to clarify.
Further with respect to claim 14, it is unclear how the claimed helical thread, that is the first maker is also “a number of distributed markers. It is unclear if the applicant is trying to claim the helical thread is distributed, such that each rotation is a marker or if the helical thread includes additional markers. It is noted that for examination purposes, the limitation is being interpreted as the claimed helical thread is the claimed first marker and the claimed distributed markers are in addition to the claimed first marker.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The applicant claims the that implant driver is adapted to pass through the smooth bored bushing, however, in the independent claim, the applicant has claimed the smooth bored bushing as the guiding element and the pins are retractable from the guiding element and that the pins engage with the groove of the implant driver, such that implant driver is inherently passed through the bushing. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-7, 12 and 14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13 and 15-16 are allowed. It is noted that claim 13 is objected to.
The following is an examiner’s statement of reasons for allowance: With respect to claim 1, the prior art fails to teach the claimed implant driver assembly comprising an implant driver and a surgical template, the implant driver including one or more first markers, the surgical template having a guiding element and having one or more second markers, wherein the guiding element is a bushing with a smooth bore, wherein the one or more first markers comprises a thread in or on an outer surface of the implant driver, wherein the one or more second markers comprises a thread follower for following the thread which is in or one the outer surface of the implant driver, wherein the thread follower comprises one or more spring biased pins that are retractable from the guiding element of the surgical template, the one or more spring-biased pins engage with and glide in a helical groove of the thread allowing the implant driver to be rotated and disengage with the thread ends in combination with the other claimed limitations.
With respect to claim 12, the prior art fails to teach a kit of parts comprising an implant driver, the implant driver including one or more first markers, an implant, and a guiding element of a surgical template including one or more second markers, wherein the one or more first markers comprises a thread on an outer surface of the implant driver, wherein the one or more second markers comprises a thread follower for following the thread, wherein the one or more second markers are one or more spring-biased pins, the one or more spring-biased pins are retractable form the guiding element of the surgical template, the one or more spring biased pins engage with and glide in a helical groove of the thread when non-retracted allowing the implant driver to be rotated and disengage when the thread ends in combination with the other claimed limitations.
With respect to claim 13, the prior art fails to teach an implant driver assembly comprising an implant driver, a surgical template including a guiding element, wherein the implant driver includes a first marker to align with the surgical template, wherein the first marker is a helical thread having a pitch and length selected according to the digital virtually planned implant and implant position, wherein the guiding element includes a bore to accept the implant driver, wherein the bore includes a second marker, wherein the second marker includes a pin that is retractable from the guiding element of the surgical template, wherein the pin glides in a helical groove of the helical thread when non-retracted allowing the implant driver to be rotated and follow the helical thread when engaged with the helical thread in combination with the other claimed limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The prior art of Kim teaches an implant driver 20, a surgical template 40, wherein the implant driver having a surface configured to removably engage and drive an implant 20 during placement, the implant driver including a first marker 32 and being adapted and aligned with the surgical template, the surgical template having a guiding element 10 and having a second marker 31 so that when the implant driver is connected to the implant, alignment of the first marker on the implant driver and the second marker on the surgical template defines a spiral motion of the implant when it is being inserted in a jaw bone according to parameter derived from the digital virtually planned implant and implant position, wherein the guiding element is a bushing with a smooth bore (see fig. 3, such that it is smooth and the marker is element 31), wherein the first maker comprises a thread on the outer surface of the implant driver (see fig. 2), wherein the second marker is a thread follower for following the thread (see figs 2-3, such that spiral 31 follows the thread 32), wherein the first marker and the second marker together provide feedback during implant placement operations to control implant depth and rotation according to the digital virtually planned implant and implant position (see figs. 1-3, translation). However, Kim does not teach the second marker comprises one or more spring-biased pins or retractable pins engaged with and gliding in a helical groove of the thread allowing the implant driver to be rotated and disengage when the thread ends.
The prior art of Pieri teaches an implant driver 1, a surgical template 5, wherein the implant driver having a surface configured to removably engage and drive an implant 3 during placement, the implant driver including a first marker (the threads) and being adapted and aligned with the surgical template, the surgical template having a guiding element 2 and having a second marker (internal threads) so that when the implant driver is connected to the implant, alignment of the first marker on the implant driver and the second marker on the surgical template defines a spiral motion of the implant when it is being inserted in a jaw bone according to parameter derived from the digital virtually planned implant and implant position, wherein the guiding element is a bushing with a smooth bore (see fig. 1, such that it is smooth and the marker is element is the threads), wherein the first maker comprises a thread on the outer surface of the implant driver (see fig. 1), wherein the second marker is a thread follower for following the thread (see figs, 1, 4, such that the groove follows the thread), wherein the first marker and the second marker together provide feedback during implant placement operations to control implant depth and rotation according to the digital virtually planned implant and implant position (see figs. 1, 4-5, abstract, description). However, Pieri does not teach the second marker comprises one or more spring-biased pins or retractable pins engaged with and gliding in a helical groove of the thread allowing the implant driver to be rotated and disengage when the thread ends.
The prior art of Calhau teaches an implant driver 1, a surgical template 8, wherein the implant driver having a surface configured to removably engage and drive an implant 2 during placement, the implant driver including a first marker (the threads) and being adapted and aligned with the surgical template, the surgical template having a guiding element 3 and having a second marker (internal threads) so that when the implant driver is connected to the implant, alignment of the first marker on the implant driver and the second marker on the surgical template defines a spiral motion of the implant when it is being inserted in a jaw bone according to parameter derived from the digital virtually planned implant and implant position, wherein the guiding element is a bushing with a smooth bore (see fig. 1, such that it is smooth and the marker is element is the threads), wherein the first maker comprises a thread on the outer surface of the implant driver (see fig. 1), wherein the second marker is a thread follower for following the thread (see figs. 1-5, such that the groove follows the thread), wherein the first marker and the second marker together provide feedback during implant placement operations to control implant depth and rotation according to the digital virtually planned implant and implant position (see figs. 1-5, abstract, description). However, Calhau does not teach the second marker comprises one or more spring-biased pins or retractable pins engaged with and gliding in a helical groove of the thread allowing the implant driver to be rotated and disengage when the thread ends.
The prior art of Telara have been cited to teach a driver assembly for limiting the insertion depth of an implant.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
See above comments regarding allowability. It is noted that no art rejections have been applied, as the applicants’ amendments have overcome the rejections.
The applicant is invited to schedule an interview with the examiner with proposed amendments to place the application in condition for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
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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.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 8/14/2026
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