DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 19, 2013, is being examined under the first inventor to file provisions of the AIA .
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 17-18 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 17, the use of the term "coronal segment" in line 6, is indefinite. It is not understood if said "coronal segment" refers to one of the "at least one coronal segment" described in line 5, or if it is another structural limitation. For examination purposes, the term will be interpreted as if said "coronal segment" refers to one of the "at least one coronal segment" of line 5.
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.
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 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kfir (WO 2010010558 A1) in view of Cattadori et al. (IT 202300002361 A1).
[AltContent: arrow][AltContent: textbox (Tapered portion)][AltContent: textbox (Counterpart of the coronal groove)][AltContent: ][AltContent: ][AltContent: textbox (Internal threading)][AltContent: textbox (Apical end shoulder with groove)][AltContent: ][AltContent: ][AltContent: textbox (Coronal end)][AltContent: ][AltContent: textbox (Coronal external threading)][AltContent: textbox (Apical shoulder seat)][AltContent: ][AltContent: ][AltContent: textbox (Coronal end shoulder)][AltContent: arrow][AltContent: textbox (Abutment)][AltContent: ][AltContent: textbox (Apical skirt)][AltContent: textbox (Connector)][AltContent: ][AltContent: ][AltContent: textbox (Connection aperture/
Connection fixture aperture)][AltContent: ][AltContent: arrow][AltContent: textbox (At least one coronal segment)][AltContent: arrow][AltContent: textbox (Apical external threading)][AltContent: arrow][AltContent: textbox (Apical end)][AltContent: arrow][AltContent: textbox (Apical segment)]
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Regarding claim 1, Kfir discloses a multi-segment dental implant (sese Fig. 1 & 7 above) including:
an apical segment (400) including an apical end and apical external threading (460) at least partially surrounding the apical segment (400) (see annotated Fig. 1 &7, and [0042]), wherein the apical segment (400) defines a connection aperture including internal threading (420) and an apical shoulder seat (see annotated Fig. 1 above, [0036] and [0042]); and
at least one coronal segment (300) including coronal external threading (360) at least partially surrounding the at least one coronal segment and terminating in an apical skirt (352) (see annotated Fig. 1 above and [0036] and [0039]), the coronal segment further including a coronal end (see annotated Fig. 1 above), a coronal end shoulder, and an apical end shoulder and connector constructed and arranged to connect to the connection aperture (see annotated Fig. 1 and 7 above and [0036]); and
where the apical shoulder seat and the apical end shoulder may include a groove and its counterpart in shape, or different joining means may be implemented such as different types of slices, rebates, dados, etc. (see [0038]).
However, Kfir does not disclose that the apical shoulder seat and the apical end shoulder may both be generally conical in shape (for claim 1); that the apical shoulder seat and the apical end shoulder includes complimentary profiles relative to one another to facilitate substantially uniform contact when the apical segment is attached to the at least one coronal segment (for claim 3).
[AltContent: arrow][AltContent: textbox (Conical apical and coronal shoulder seat, and the apical end shoulder)]
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[AltContent: textbox (Apical end shoulder)][AltContent: ][AltContent: ][AltContent: textbox (Conical apical shoulder seat)][AltContent: textbox (Fig. 14 zoomed portion)]
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Cattadori et al. teaches a similar modular dental implant system including a plurality of sections, where the sections include a conical apical shoulder seat, apical end shoulder (see annotated Fig. 14 and 14 zoomed portion above). Each of the end shoulders on each portion includes an annular channel (285) has a complementary shape of the connecting shoulder seat of the adjacent module (see Fig. 14 zoomed portion above). Said annular channel has tapered surfaces on both sides of the channel, in this way forming a general conical shape. The shape of the seat and the shoulder provides a uniform contact throughout the seat and should surfaces, for improving stability of the modules stacked one on top of the other, and for creating a sort of labyrinth that counteracts any possible infiltration of bacteria, in this way avoiding bacterial proliferation (see Fig. 14 above, page 3, lines 1-2, and page 4, line 33 through page 5, line 2).
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 shape of the shoulder seat, and for the end shoulder on each of the apical and coronal modules of Kfir, with the truncated conical apical shoulder seat, apical end shoulder, coronal shoulder seat, a coronal shoulder of Cattadori, in order to form in the contact area a labyrinth that counteracts the possibility of bacteria infiltration and proliferation between modules.
Regarding claim 4, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Kfir discloses that the apical shoulder seat (354) and the apical end shoulder include complimentary profiles relative to one another such that an apical end seat and apical end shoulder abut one another when the apical segment is attached to the at least one coronal segment (see Fig. 1 and 7 above).
Regarding claim 5, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Kfir discloses that the coronal external threading (360) of a coronal segment (300) does not terminate at a knife-edge segment (see Fig. 7 above).
Regarding claim 6, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Kfir discloses that the apical skirt (352) is constructed and arranged to facilitate removal of a coronal segment after osseointegration (the system is configured to be installed in segments, therefore it is understood that each coronal segment can be removed using the same procedure).
Regarding claim 7, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Kfir discloses that the coronal end includes a tissue-level prosthetic connection (see Fig. 1 – where the coronal end of the coronal segment 300 includes a connection for an implant neck 200 that is for a prosthetic connection at the level of the gum tissue).
Regarding claim 8, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Kfir discloses that the connector is a screw (310) (see annotated Fig. 1 and 7 and [0031] – where the “helical threads are applied to some components of modular dental implant 10” and that each “implant body segment 300 includes an external fastening surface 310 and an internal fastening surface 320, conveniently having a substantially cylindrical shape, so that a first implant body segment 300 could be fastened into a second adjacent implant body segment 300”).
Regarding claim 17, Kfir discloses a screw-less multi-segment dental implant including:
an apical segment (400) including an apical end and apical external threading (460) at least partially surrounding the apical segment (400) (see Fig. 1 in the previous page), wherein the apical segment (400) defines a connection fixture aperture including a coronal shoulder (see annotated Fig. 1 in the previous page);
at least one coronal segment (300) including coronal external threading (360) at least partially surrounding the coronal segment and terminating in an apical skirt (352), the coronal segment further including a coronal end (see Fig. 1 in the previous page), a coronal shoulder (see Fig. 1 in the previous page); and
a connector; the connector being constructed and arranged to connect to the connection fixture aperture of the apical segment and the at least one coronal segment (see Fig. 1), wherein the connector and the connection aperture includes complimentary profiles relative to one another to facilitate substantially uniform contact between the coronal shoulder seat and the coronal shoulder (see Fig. 1 in the previous page).
However, Kfir does not disclose that the coronal shoulder is approximately a truncated cone in shape.
Cattadori et al. teaches a similar modular dental implant system including a plurality of sections, where the sections include a conical apical shoulder seat, apical end shoulder (see annotated Fig. 14 and 14 zoomed portion above). Each of the end shoulders on each portion includes an annular channel (285) has a complementary shape of the connecting shoulder seat of the adjacent module (see Fig. 14 zoomed portion above). Said annular channel has tapered surfaces on both sides of the channel, in this way forming a general conical shape. The shape of the seat and the shoulder provides a uniform contact throughout the seat and should surfaces, for improving stability of the modules stacked one on top of the other, and for creating a sort of labyrinth that counteracts any possible infiltration of bacteria, in this way avoiding bacterial proliferation (see Fig. 14 above, page 3, lines 1-2, and page 4, line 33 through page 5, line 2).
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 shape of the shoulder seat, and for the end shoulder on each of the apical and coronal modules of Kfir, with the truncated conical apical shoulder seat, apical end shoulder, coronal shoulder seat, a coronal shoulder of Cattadori, in order to form in the contact area a labyrinth that counteracts the possibility of bacteria infiltration and proliferation between modules.
Regarding claim 18, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 17, and where Kfir discloses that the connector threadingly attaches to the coronal segment approximately near the apical skirt (see Fig. 1 – where the connector is already attached to the coronal segment near the apical skit).
Regarding claim 20, Kfir/Cattadori discloses the claimed invention substantially as claimed, as set forth above for claim 17, and where Kfir discloses that the apical segment is tapered (see annotated Fig. 1).
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kfir (WO 2010010558 A1) in view of Cattadori et al. (IT 202300002361 A1) in further view Mushayev (WO 2013186765 A1).
Regarding claims 9-11, Kfir discloses a multi-segment dental implant including:
an apical segment (400) including an apical end and apical external threading (460) at least partially surrounding the apical segment (400) (see annotated Fig. 1 &7, and [0042]), wherein the apical segment (400) defines a connection fixture aperture including a coronal shoulder (see annotated Fig. 1 above);
at least one coronal segment (300) including coronal external threading (360) at least partially surrounding the at least one coronal segment (300) and terminating in an apical skirt (352) (see annotated Fig. 1 above and [0036] and [0039]), the at least one coronal segment (300) further including a coronal end, a coronal shoulder; and a connector affixed to the at least one coronal segment, the connector being constructed and arranged to connect to the connection fixture aperture (see annotated Fig. 1 above) (for claim 9); and that the at least one coronal segment is a plurality of coronal segments (see annotated Fig. 7 above) (for claim 10).
However, Kfir does not disclose that the connector and the connection fixture aperture include complimentary profiles relative to one another to facilitate substantially uniform contact between a coronal shoulder seat and the coronal shoulder; wherein the connector is star-shaped (for claim 9); and that the coronal shoulder seat and the coronal shoulder may both be generally truncated conical in shape (for claim 11).
Cattadori et al. teaches a modular dental implant system including a plurality of sections, where the sections include a conical apical shoulder seat, apical end shoulder (see annotated Fig. 14 and 14 zoomed portion above). Each of the end shoulders on each portion includes an annular channel (285) has a complementary shape of the connecting shoulder seat of the adjacent module (see Fig. 14 zoomed portion above). Said annular channel has tapered surfaces on both sides of the channel, in this way forming a continuous conical shape. The shape of the seat and the shoulder provides a uniform contact throughout the seat and should surfaces, for improving stability of the modules stacked one on top of the other, and for creating a sort of labyrinth that counteracts any possible infiltration of bacteria, in this way avoiding bacterial proliferation (see Fig. 14 above, page 3, lines 1-2, and page 4, line 33 through page 5, line 2).
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 shape of the shoulder seat, and for the end shoulder on each of the apical and coronal modules of Kfir, with the uniform contact conical apical shoulder seat, apical end shoulder of Cattadori, in order to form a uniform engagement between the contact area, in this way forming a labyrinth that counteracts the possibility of bacteria infiltration and proliferation between modules.
However, Kfir/Cattadori does not disclose the connector is star-shaped.
[AltContent: arrow][AltContent: textbox (Connector)][AltContent: arrow][AltContent: textbox (Coronal segment)][AltContent: arrow][AltContent: textbox (Apical segment)]
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[AltContent: textbox (Connector)]
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Mushayev teaches a modular dental implant system including an apical segment (120) and a coronal segment (130) interconnected to each other through a connector (131) having a polygonal shape. Said connector fits tightly into a corresponding socket (121) in the coronal end of the apical segment (120). Furthermore, it is taught that even when the connector may be of a hexagonal shape, it can have other shapes other than hexagonal. Said connector is a snap lock mechanism to connect the coronal segment (130) with the apical segment (120), and the polygonal shape connector is an anti-rotational feature (see annotated Fig. 1b-1C and 2A above, and page 7, last paragraph though page 8, 2nd paragraph).
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 connector and the connector aperture of Kfir/Cattadori, with the polygonal shape connector and the connector aperture of Mushayev, in order to quickly engage the coronal segment with the apical segment by the snap connection, but in addition the same connector provides an anti-rotational feature, so that the coronal segment does not rotate the dental prosthesis in its axis during normal use.
Furthermore, even when Mushayev does not teach the star-shaped connector, he teaches that other shapes can be used instead. Therefore, having the connector in a star-shape is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed connector shape is significant.
Regarding claim 12, Kfir/Cattadori/Mushayev discloses the claimed invention substantially as claimed, as set forth above for claim 10, and where Kfir discloses that the coronal shoulder seat and the coronal shoulder includes complimentary profiles relative to one another such that a coronal shoulder seat and coronal shoulder abut one another when the apical segment is attached to the at least one coronal segment (see annotated Fig. 1 just above, and 7 above).
Regarding claim 13, Kfir/Cattadori/Mushayev discloses the claimed invention substantially as claimed, as set forth above for claim 10, and where Kfir discloses that the apical external threading (460) does not terminate at an approximate knife-edge (see Fig. 1 just above).
Regarding claim 14, Kfir/Cattadori/Mushayev discloses the claimed invention substantially as claimed, as set forth above for claim 10, and where Kfir, Cattadori and Mushayev disclose that the apical skirt (352) is constructed and arranged to facilitate removal of a coronal segment after osseointegration (the system is configured that each coronal segment is installed after the previous segment is installed in the bone; therefore, each removal only depends on the separation of the apical skirt from engaging the adjacent coronal seat, therefore it is understood that each coronal segment can be removed using the same procedure of un).
Regarding claim 15, Kfir/Cattadori/Mushayev discloses the claimed invention substantially as claimed, as set forth above for claim 10, and where Kfir discloses that the coronal end includes a prosthetic connection (see Fig. 1 – where the coronal end of the coronal segment 300 includes a connection for an implant neck 200 that is for a prosthetic connection through the abutment 100).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-15, 17-18 and 20 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.
Regarding claims 1 and 17, applicant argues that the claimed dental implant includes an apical shoulder seat and an apical end shoulder with a generally conical shape (language of claim 2, previously rejected under Kfir in view of Cattadori, now canceled), in which the combination of the prior arts is not proper.
The Office disagrees, the connecting portion between the at least one coronal portion and the apical portion through the apical shoulder seat and the apical end shoulder in Kfir includes a circumferential tongue (342 and 352), that is shaped so as to fit into a groove (344 or 354, respectively) in an adjacent implant body segment (see [0038]). Furthermore, it is described that “different joining means may be implemented such as different types of slices, rebates, dados, etc.” can be used instead of the tongue and groove shown. It is understood that other shapes can be use too, such as a conical shape taught by Cattadori. Furthermore, by using the conical shape of Cattadori, it improves the sealing capabilities between segments, in this way minimizing the proliferation of microorganisms in the connection.
Therefore, using the conical shape of the apical portion and the apical shoulder seat, do not destroy the intended use of the invention of Kfir, but creates a labyrinth that avoid the bacterial proliferation in that area.
For that reason, it is understood that the combination of Kfir and Cattadori is proper and will be maintained.
Regarding claim 9, the amendment includes the allowable subject matter indicated in the last Office action of 22 April 2025. However, after a further search was found in the prior art of Mushayev, teaching other shapes for a connector between segments of an implant. Therefore, it is understood that the claim is not ready for allowance.
Regarding claims 3-8, 10-15, 18 and 20, for the reasons given above, it is understood that the claims.
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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/MIRAYDA A APONTE/Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772