DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim 27 is 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 27 recites the limitation "bar portions" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 27, the description of “a plurality of the bar portions having the end portions with different diameters” is indefinite. It is not understood if the bar portion described in claim 22 further includes a plurality of portions, where each of those portions has a different diameter, or that the osteotome further includes a plurality of bar portions with different diameters in addition to the bar portion described in claim 22. For examination purposes, the term will be interpreted as the bar portion described in claim 22 further includes a plurality of portions, where each of those portions has a different diameter.
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 22-24 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mainil et al. (WO 9848707 A1).
[AltContent: textbox (Bar portion)][AltContent: ][AltContent: textbox (End portion of this bar portion)][AltContent: arrow][AltContent: textbox (Bar portion)][AltContent: textbox (End portion of this bar portion)][AltContent: ][AltContent: arrow][AltContent: textbox (End portion)][AltContent: ]
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Regarding claim 22, Mainil et al. an osteotome used as an instrument which is embedded from a surface layer of a treatment area in a jaw region of a patient into a deep portion to apply an impact in expanding or compressing a bone so as to displace a position of a tissue behind the treatment area, the osteotome including:
a body portion (40) corresponding to a main body portion of the osteotome (see annotated Fig. 4 above);
a bar portion (23) detachable from the body portion (see annotated Fig. 4 above); and
an end portion (21) formed at a distal end of the bar portion (23) to displace the position of soft tissue (see abstract – where the end portion 21 removes the cut soft tissue made by the cutting edge 11 shown in Fig. 1 and 7 above),
wherein a diameter of the end portion (21) is larger than that of a shaft portion of the bar portion (23) (see annotated Fig. 1, 4 and 7 above – where the end portion 21 has a cross-sectional dimension larger than the drill 20 from where the end portion 21 is attached to).
Furthermore, the osteotome of Mainil et al. includes all the claimed structures and it is configured for “pressing the cutting edge into the tissue, advantageously only into the cartilage tissue, a tissue column is punched out, which is then cut and removed by screwing in the flat drill” (see page 3, lines 2-3). And, the “drill shaft 23 has an area 25 with a smaller diameter, the axial extent of this area 25 being at least so large that the machined material of a drilled-out column of tissue between the sleeve 10 and the thinner area 25 of the Drill shaft 23 finds ample space” (see page 3, lines 26-29). In this way, the soft tissue is displaced behind the treatment area. Therefore, the osteotome of Mainil et al. is capable of been used in the jaw region of a patient and into a deep portion to apply an impact in expanding or compressing of a bone so as to displace a position of a mucosa behind the treatment area.
Regarding claim 23, Mainil et al. disclose that the diameter of the end portion is larger than a diameter of an end portion of an implant-dedicated osteotome (see page 4, lines 17-18 - it is disclosed that the diameter of the end portion (21) can be of 5 mm or larger; therefore, due to the diameter of the implant is not disclosed, it is understood that the diameter of the end portion is capable of been larger than the end portion of the implant-dedicated osteotome).
Regarding claim 24, Mainil discloses that that the diameter of the end portion is 5 mm or more (see page 4, lines 17-18).
Regarding claim 26, Mainil discloses an amount of protrusion from the body portion to the end portion of the bar portion (23) is changeable (see page 4, lines 34-36 – “drilling depth can thus be adjusted relative to the cutting edge”).
Regarding claim 27, Mainil discloses further including: a plurality of the bar portions having the end portions with different diameters (see annotated Fig. 1 above – where each portion of the drill having a shaft portion includes different diameter at the end portion).
Claims 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Mainil et al. (WO 9848707 A1) as applied to claim 24 above, and further in view of Isidori (US 20100129768 A1).
With respect to claims 25 and 28:
Regarding claim 25, Mainil discloses the claimed invention substantially as claimed, as set forth above for claim 24, and where Mainil discloses that the osteotome provides markings (24) in the proximal part of the bar portion (23) to indicate the depth in which the end portion (21) of the drill (20) will extend in the tissue (see annotated Fig. 4 above).
However, Mainil does not disclose a guided portion which is guided along a guide hole formed in a surgical guide is formed in a portion of the body portion, the surgical guide being provided according to a surface shape of the treatment area of the patient to offset, by a predetermined amount, a reference position serving as a guide for a depth during a treatment.
[AltContent: arrow][AltContent: textbox (Guide portion)][AltContent: textbox (Guide hole)][AltContent: ][AltContent: ][AltContent: textbox (Lower surface)][AltContent: arrow][AltContent: textbox (Offset)][AltContent: arrow][AltContent: textbox (Surgical guide)][AltContent: arrow][AltContent: textbox (Osteotome)]
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Isidori teaches an osteotome including a guided portion (10) that is used in a guide hole of a surgical guide (14). Where the surgical guide (14) includes a lower surface configured to provide a complementary shape according to the shape of a surgical site of a patient’s jaw. The osteotome uses the guide portion (10) to centrally guide the end portion of the drill through the guide hole of the surgical guide (14). The guide portion (10) is vertically offset by a predetermined amount from the top surface of the surgical site, by having stops on the external surface of the guide portion that engages a metal band (13) in the guide hole, in this way maintaining the distal end surface of the guide portion at a predetermined distance form the crest of the treatment area (see annotated Fig. 3A above, and [0034]-[0036], [0047] and [0050]).
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 osteotome of Mainil, with the surgical guide and offset from the stops of the guide portion from the surgical guide of Isidori, in order to “to reduce the angular dispersion, to respect the operated tissues and to adjust the penetration of the implant(s)” with respect to the depth of the drill will be displaced”.
Regarding claim 28, Mainil et al. an osteotome used as an instrument which is embedded from a surface layer of a treatment area in a jaw region of a patient into a deep portion to apply an impact in expanding or compressing a bone so as to displace a position of a tissue behind the treatment area, the osteotome including:
a body portion (40) corresponding to a main body portion of the osteotome (see annotated Fig. 4 above);
a bar portion (23) detachable from the body portion (see annotated Fig. 4 above);
an end portion (21) formed at a distal end of the bar portion (23) to displace the position of soft tissue (see abstract – where the end portion 21 removes the cut soft tissue made by the cutting edge 11); and
the osteotome provides markings (24) in the proximal part of the bar portion (23) to indicate the depth in which the end portion (21) of the drill (20) will extend in the tissue (see annotated Fig. 4 above).
Furthermore, the osteotome of Mainil et al. includes all the claimed structures and it is configured for “pressing the cutting edge into the tissue, advantageously only into the cartilage tissue, a tissue column is punched out, which is then cut and removed by screwing in the flat drill” (see page 3, lines 2-3). And, the “drill shaft 23 has an area 25 with a smaller diameter, the axial extent of this area 25 being at least so large that the machined material of a drilled-out column of tissue between the sleeve 10 and the thinner area 25 of the Drill shaft 23 finds ample space” (see page 3, lines 26-29). In this way, the soft tissue is displaced behind the treatment area. Therefore, the osteotome of Mainil et al. is capable of been used in the jaw region of a patient and into a deep portion to apply an impact in expanding or compressing of a bone so as to displace a position of a mucosa behind the treatment area
However, Mainil does not disclose a guided portion which is guided along a guide hole formed in a surgical guide formed in a portion of the body portion, the surgical guide being provided according to a surface shape of the treatment area of the patient to offset, by a predetermined amount, a reference position serving as a guide for a depth during a treatment.
Isidori teaches an osteotome including a guided portion (10) that is used in a guide hole of a surgical guide (14). Where the surgical guide (14) includes a lower surface configured to provide a complementary shape according to the shape of a surgical site of a patient’s jaw. The osteotome uses the guide portion (10) to centrally guide the end portion of the drill through the guide hole of the surgical guide (14). The guide portion (10) is vertically offset by a predetermined amount from the top surface of the surgical site, by having stops on the external surface of the guide portion that engages a metal band (13) in the guide hole, in this way maintaining the distal end surface of the guide portion at a predetermined distance from the crest of the treatment area (see annotated Fig. 3A above, and [0034]-[0036], [0047] and [0050]).
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 osteotome of Mainil, with the surgical guide and offset from the stops of the guide portion from the surgical guide of Isidori, in order to “reduce the angular dispersion, to respect the operated tissues and to adjust the penetration of the implant(s)” with respect to the depth of the drill will be displaced”.
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 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772