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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: the character 2 of Fig. 1, characters 110 and 118 of Fig. 2, character 294 of Fig. 8 and in character 294 of Fig. 9.
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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a drill bit including an interface profile, where the interface profile is configured to form a first interface surface on the surgical template as per claim 1 must be shown or the features canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 1-8 and 15-20 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.
Regarding claim 1, the preamble indicates that the claims are directed to a kit for irrigating a dental implant surgical template, but the kit described are not understood if it is for providing the irrigation on a surgical site, or for forming an irrigation system on a surgical template. For examination purposes, the claims will be interpreted as providing the irrigation on a surgical site.
Regarding claims 2, 3 and 5, the description of the “second interface surface fitting within the first interface surface to secure the irrigation guide to the first interface surface”, turns the claim indefinite, because in claim 1 describes that the drill bit includes an interface profile that is configured to form a first interface surface on the surgical template. It is not understood how the drill bit will be fitting with the second interface surface for securing the irrigation guide to the first interface surface, if it is within said first interface surface is part of the drill bit.
Regarding claims 15-20, the preamble indicates that the claims are directed to a method of irrigating an osteotomy site, in which it is understood that the claims are related to the method of using an irrigation structure for irrigating on an osteotomy site. However, the steps described are directed to a method of making/assembling said irrigation structure for irrigating an osteotomy site. It is not understood if the intention of the applicant to claim the method of using or a method of making. Furthermore, the claim does not include a step of irrigating the osteotomy site as the preamble dictates. Therefore, for all the reasons given above the claims are indefinite. For examination purposes, due to the body of the claims are directed to the method of making/assembling the irrigation structure, the claims will be interpreted as the method of making/assembling an irrigation structure for irrigating an osteotomy site.
Claim Rejections - 35 USC § 102
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.
Claims 9-12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macri et al. (US 20210022830 A1).
[AltContent: textbox (Irrigation guide)][AltContent: textbox (Second interface surface)][AltContent: ][AltContent: arrow][AltContent: oval][AltContent: arrow][AltContent: textbox (Guide portion)][AltContent: ][AltContent: textbox (Anchoring feature)][AltContent: arrow][AltContent: textbox (Guide sleeve)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Irrigation channel)][AltContent: textbox (Coupling end)]
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[AltContent: arrow][AltContent: textbox (Irrigation passage)][AltContent: arrow][AltContent: textbox (Output end)][AltContent: textbox (Guide chamber)][AltContent: arrow][AltContent: ][AltContent: textbox (Anchoring feature)][AltContent: arrow][AltContent: textbox (Guide sleeve)][AltContent: ][AltContent: arrow][AltContent: textbox (Irrigation passage)][AltContent: textbox (Guide portion)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Interface profile)][AltContent: arrow][AltContent: textbox (Cutting tip)][AltContent: textbox (Second interface surface)][AltContent: arrow][AltContent: textbox (Shank)][AltContent: ][AltContent: textbox (First interface surface)]
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Regarding claim 9, Macri et al. discloses an implant osteotomy kit for dental implant placement in the mouth of a patient, the kit including:
a surgical template (100) including an anchoring feature adapted for engagement with the patient's anatomy (see annotated Fig. 1 above and 5 above), a guide portion coupled to the anchoring feature and defining a guide chamber (see annotated Fig. 1 above), an irrigation passage fluidly communicating with the guide chamber (see annotated Fig. 5 above - see the open space on the surgical site), and a first interface surface surrounding the irrigation passage (see annotated Fig. 5 above – where first interface surface is located in the surgical template, as the inner surface of a through opening on one side of the template for engaging an irrigation tubing); and
an irrigation guide including a second interface surface, a coupling end (114), and an irrigation channel (106) extending between the second interface surface and the coupling end (114) (see annotated Fig. 1 and 5 above – where the second interface surface is the external surface of the irrigation housing 124, the coupling end is an attachment end 114 and the irrigation channel is the guide sleeve 106), wherein the second interface surface is engageable with the first interface surface to secure the irrigation guide to the first interface surface and to place the irrigation channel into fluid communication with the guide chamber (see annotated Fig. 1 and 5 above), and wherein the coupling end (114) is coupleable to a source of irrigation fluid for providing irrigation fluid to the guide chamber by way of the irrigation channel (see annotated Fig. 1 above and [0034], [0036]).
Regarding claim 10, Macri et al. discloses that the first interface surface defines a cylinder surrounding the irrigation passage and the second interface surface is tapered such that the second interface surface fits snugly within the cylinder when the second interface surface is inserted into the cylinder (see annotated Fig. 5 above).
Regarding claim 11, Macri et al. discloses that the irrigation channel (106) defines an input axis and an output axis, and wherein the input axis is angled at least about 20 degrees relative to the output axis (see annotated Fig. 1 zoomed portion above – where input axis is at coupling end 114, and is angled less than 90 degrees relative to the output axis located inside the osteotomy site at one side of the surgical template).
Regarding claim 12, Macri et al. discloses that when the second interface surface is engaged with the first interface surface the irrigation guide is rotatable relative to the surgical template about the output axis (see Fig. 5 – due to the second interface surface is from a separated structure from the first interface surface, it is understood that before the two surfaces are completely glued two each other, the second interface surface is capable of rotate in its own axis relative to the surgical template).
Regarding claim 14, Macri et al. discloses that the coupling end (114) includes a length of rigid tubing extending therefrom, and wherein the rigid tubing further extends through the irrigation guide from the coupling end (114) to the second interface surface and at least partially defines the irrigation channel (106) (see annotated Fig. 1 and 5 above, and [0043] – due to the structure is formed using a 3D printer, it is understood that the tubing of the coupling end is rigid as the surgical template).
Regarding claim 15, Macri et al. discloses a method of making/assembling an irrigation for an osteotomy site, the method including:
providing a surgical template (100) including an anchoring feature adapted for engagement with the patient's anatomy (see annotated Fig. 5 above – where the lower portion of the surgical template includes a surface contour for engaging the osteotomy site), and a guide portion coupled to the anchoring feature and defining a guide chamber (see annotated Fig. 5 above – it is understood that the guide portion is formed by the material of the surgical template that surrounds the guide sleeve and that the same time forms the guide chamber below);
forming an irrigation passage fluidly communicating with the guide chamber, and a first interface surface surrounding the irrigation passage (106) (see annotated Fig. 5 above – where the irrigation passage is between the element 112 and 126, that is configured to allow the irrigation flow to be guided into the guide chamber);
providing an irrigation guide including a second interface surface, a coupling end (114), and an irrigation channel extending between the second interface surface and the coupling end (see annotated Fig. 1 and 5 above - where the second interface surface is the external surface of the irrigation housing 124, the coupling end is an attachment end 114 and the irrigation channel is the guide sleeve 106);
engaging the second interface surface with the first interface surface to secure the irrigation guide to the first interface surface and to place the irrigation channel into fluid communication with the guide chamber (see annotated Fig. 1 and 5 above – where the second interface surface is the external surface of the housing 124, that is engaged with the first interface surface, and where the housing 124 is part of the hydraulically activated valves 122 that at the same time includes the irrigation passage 106); and coupling the coupling end (114) to a source of irrigation fluid to deliver irrigation fluid to the guide chamber via the irrigation channel ([0043]).
Regarding claim 16, Macri et al. discloses further including rotating the irrigation guide relative to the surgical template to locate the coupling end relative to the surgical template (see Fig. 1 – due to the irrigation guide is already coupled and the coupling end is at the correct rotational alignment with the surgical template, the action of rotating has been done).
Regarding claim 17, Macri et al. discloses further including securing the irrigation guide to the surgical template with adhesive (see [0013] and [0034]).
Regarding claim 18, Macri et al. discloses a drill bit (500) including a cutting tip, a shank, and an interface profile between the tip and the shank (see annotated Fig. 5 above).
Regarding claim 19, Macri et al. discloses further including using the drill bit to form the irrigation passage and the first interface surface (see annotated Fig. 5 above –the irrigation fluid exit the distal end of the first interface surface and reaches the drill bit; as soon as the irrigation fluid reaches the drill bit it turns around the interface profile of the drill bit in its way to the cutting tip of the drill bit, in this way the drill bit is part of the irrigation passage).
Regarding claim 20, Macri et al. discloses that after engaging the second interface surface with the first interface surface an output end of the irrigation guide extends through the surgical guide and into the guide chamber (see annotated Fig. 5 above – where the housing 124 is placed inside the opening of the surgical template, the second interface surface of the housing engages the first interface surface of the surgical template),
the method further including grinding away a portion of the output end that is located within the guide chamber until an end of the output end is substantially flush with a wall of the guide chamber (see annotated Fig. 5 above – where the opening facing the guide chamber has been grinded away forming the output end).
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.
[AltContent: ][AltContent: ][AltContent: textbox (Shank)]Claims 1, 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kaspo (US 20210236237 A1) in view of Macri et al. (US 20210022830 A1).
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[AltContent: textbox (Guide chamber)][AltContent: ][AltContent: textbox (Guide portion)][AltContent: textbox (Guide sleeve)][AltContent: arrow][AltContent: textbox (Anchoring feature)][AltContent: ][AltContent: arrow][AltContent: textbox (Dental implant surgical template)][AltContent: arrow][AltContent: textbox (Surgical drill)]
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Regarding claim 1, Kaspo discloses a kit for irrigating a dental implant surgical template (200), the surgical template including a guide chamber (204) adapted to receive a surgical drill (100) (see annotated Fig. 4 above), the kit including:
a drill bit (100) including a cutting tip (110), a shank, and an interface profile between the tip and the shank (see annotated fig. 1 above), the tip configured to form an irrigation passage (134) in the surgical template (200) that communicates with the guide chamber (204) (see annotated Fig. 1 and 4 – where the tip turns around the irrigation flow, in this way forming part of the irrigation passage, and the guide chamber is the space between the template and the surgical site), and the interface profile configured to form a first interface surface on the surgical template (see [0049-0050] – “the stop 142 is formed integrally with the guide body 112 and extends radially outward from the proximal end 128 thereof so as to define a flange 144” and “the dental implement 100 is advanced until the stop 142 (e.g., the flange 144) is brought into abutment with the surgical guide 200, thereby preventing the continued removal of material and over-advancement of the dental implement 100”).
However, Kaspo does not disclose an irrigation guide including a second interface surface, a coupling end, and an irrigation channel extending between the second interface surface and the coupling end, wherein the second interface surface is engageable with the first interface surface to secure the irrigation guide to the first interface surface and to place the irrigation channel into fluid communication with the guide chamber, and wherein the coupling end is coupleable to a source of irrigation fluid for providing irrigation fluid to the irrigation channel and the guide chamber.
[AltContent: textbox (Guide sleeve)][AltContent: ][AltContent: textbox (Guide portion)][AltContent: ][AltContent: textbox (Anchoring feature)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Angle)][AltContent: arrow][AltContent: textbox (Input axis projected on the Output axis)][AltContent: arrow][AltContent: ][AltContent: arrow][AltContent: arrow][AltContent: textbox (Irrigation channel)][AltContent: textbox (Coupling end)][AltContent: textbox (Second interface surface)][AltContent: ][AltContent: textbox (Second interface surface)]
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Macri et al. teaches an irrigation guide on a surgical template (100) including a second interface surface (126), a coupling end (114), and an irrigation channel (106) extending between the second interface surface and the coupling end (114) (see annotated Fig. 1 above), wherein the second interface surface is capable of been engageable with the first interface surface of the drill to secure the irrigation guide to the first interface surface and to place the irrigation channel into fluid communication with the guide chamber (see annotated Fig. 5 above – where engagement is when the drill is inserted into the guide chamber, the sides of the drill pushes the second interface surface (126) allowing the irrigation fluid to enter the surgical site through the drill), and wherein the coupling end (114) is coupleable to a source of irrigation fluid for providing irrigation fluid to the irrigation channel and the guide chamber (see annotated Fig. 1 above and [0034], [0036]).
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 irrigation guide of the surgical template of the kit of Kaspo, with the irrigation guide of the surgical template of the kit Macri, in order to avoid the necessity for an assistance to hold the irrigation tube during surgery, in this way it allows said assistance to aid in other areas of the procedure (see [0012]).
Regarding claim 4, Kaspo/Macri discloses the claimed invention substantially as claimed, as set forth above for claim 1.
Kaspo does not disclose that the irrigation channel defines an input axis and an output axis, and wherein the input axis is angled at least 20 degrees relative to the output axis.
Macri teaches that the irrigation channel defines an input axis and an output axis, and wherein the input axis is angled less than 90 degrees relative to the output axis.
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 angle of Kaspo/Macri, with the angle of less than 90 degrees of Macri, in order to direct the irrigation channel to the outside of the mouth of the patient.
Regarding claims 6 and 7, Kaspo/Macri discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Kaspo does not disclose that the coupling end includes a length of rigid tubing in communication with the irrigation channel and having a distal end, and wherein the distal end includes a retention feature (for claim 6); and that the rigid tubing extends through the irrigation guide from the coupling end to the second interface surface and at least partially defines the irrigation channel (for claim 7).
Macri teaches that the dental template including the irrigation guide is formed using a 3D printer, and that the coupling end (114) is an attachment for an irrigation line (see [0043]). Therefore, if the irrigation guide is formed from a 3D printer, it is understood that the tubing of the coupling end is rigid, and that if the coupling end is configured for the attachment for an irrigation line, it is understood that it includes a retention feature.
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 coupling end of Kaspo/Macri, with the rigid tubing of the coupling end and the configuration for attachment for an irrigation line of Macri, in order to avoid the tubing from collapsing during a dental procedure and for holding in place the irrigation line.
Regarding claim 8, Kaspo/Macri discloses the claimed invention substantially as claimed, as set forth above for claim 1, where Kaspo and Macri disclose that the surgical template includes at least one anchoring feature for engagement with the patient and a guide portion coupled to the anchoring feature and including a guide sleeve at least partially defining the guide chamber (see annotated Fig. 4 of Kaspo and annotated Fig. 1 of Macri – where at least the inner portion of the guide sleeve partially defines the guide chamber).
Allowable Subject Matter
Claim 13 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 13, the prior art of Kaspo and Macri do not describe an interface profile between the tip and the shank of the drill bit configured to form the first interface surface on the surgical template.
Claims 2, 3 and 5 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the prior art of Kaspo and Macri do not describe that the second interface surface fits within the first interface surface to secure the irrigation guide to the first interface surface.
Regarding claim 5, the prior art of Kaspo and Macri do not describe that the second interface surface is engaged with the first interface surface the irrigation guide is rotatable relative to the surgical template about the output axis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAYDA ARLENE APONTE whose telephone number is (571)270-1933. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 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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/MIRAYDA A APONTE/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799