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 .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 September 2026 has been entered.
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).
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[AltContent: textbox (Shaft portion of the Bar portion)][AltContent: ][AltContent: textbox (Stop portion)][AltContent: ][AltContent: textbox (Guide hole)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Body portion)][AltContent: arrow][AltContent: textbox (Osteotome)]
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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), the body portion including a guide hole terminating in a stopper portion (43) (see annotated Fig. 4 above and page 4, lines 30-33, where the stopper portion is understood be the internal surface 43, that sized that the drill or the drill shank 23 with the holding piece 40 mounted thereon can only be pushed into the sleeve 10 until the sleeve end abuts the stop surface 43; and where said internal surface 43 can be at the apical end of the guide hole section);
a bar portion (23), wherein the bar portion is slidable within the guide hole and is detachable from the body portion (see Fig. 4 above – where the bar portion is attached to the body portion via a screw 41, and when the screw 41 is removed, the bar portion is detached and slidable from the guide hole); via removal of the bar portion via a distal end of the guide hole (see annotated Fig. 4 above – due to the bar portion is attached and removed from the body portion via a screw 41; the bar portion is capable of been removed from the body portion through the distal end of the guide hole); 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).
As indicated previously, 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”).
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Regarding claim 27, Mainil discloses that the osteotome further includes a second bar portion (see Fig. 2 above – where it shows a second embodiment of a drill attached to a second bar) configured to be attached and detached from the body portion (40) in the position of the bar portion (23) , upon detachment of the bar portion (23) from the body portion (40); and wherein an end portion (21) of the bar portion (23) and an end portion (26) of the second bar portion have different diameters (see annotated Fig. 1 and 2 above – where the second end portion of the second bar portion in Fig. 2 has a mandrel 26 having a smaller diameter than the end portion 21 shown in Fig. 1 and having a tip angled approximately 50 degrees that is smaller than the diameter of the flat end portion of the bar portion shown in Fig. 1).
Claim 25 is 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 the 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”.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Mainil et al. (WO 9848707 A1) in view of Isidori (US 20100129768 A1).
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), the body portion including a guide hole terminating in a stopper portion (43) (see annotated Fig. 4 above and page 4, lines 30-33, where the stopper portion is understood be the internal surface 43, that sized that the drill or the drill shank 23 with the holding piece 40 mounted thereon can only be pushed into the sleeve 10 until the sleeve end abuts the stop surface 43; and where said internal surface 43 can be at the apical end of the guide hole section);
a bar portion (23), wherein the bar portion is slidable within the guide hole and is detachable from the body portion (see Fig. 4 above – where the bar portion is attached to the body portion via a screw 41, and when the screw 41 is removed, the bar portion is detached and slidable from the guide hole); via removal of the bar portion via a distal end of the guide hole (see annotated Fig. 4 above – due to the bar portion is attached and removed from the body portion via a screw 41; the bar portion is capable of been removed from the body portion through the distal end of the guide hole); 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”.
Response to Arguments
Applicant's arguments filed 4 September 2026 have been fully considered but they are not persuasive.
Regarding claim 22 rejection, applicant argues that the prior art of Mainil-Varlet does not disclose the claimed subject matter. Specifically, the argument is directed that the bar portion is detachable from the body portion in the present application and not in the prior art.
The Office disagrees; the language and construction of the claim fail to disclose the extension of in which it is understood the present instrument includes but it is not claimed.
For example, claim 22 basically describes that the osteotome includes a body portion including a main body portion, a guide hole terminating in a stopper. A bar portion slidable and detachable form the body portion via a distal end of the guide hole, and that the diameter of the end portion is larger than that of the shaft portion of the bar portion.
The Office has identified that the prior art of Mainil-Varlet includes in the embodiment of Fig. 4 a body portion that can be considered a main body portion including guide hole terminating in a stopper portion (43) (see page 4, lines 30-33, where the stopper portion is the internal surface 43, that is “sized that the drill or the drill shank 23 with the holding piece 40 mounted thereon can only be pushed into the sleeve 10 until the sleeve end abuts the stop surface 43”).
Furthermore, it includes a bar portion (23) that slides through the guide hole/through bore (42) of the body portion. The bar portion can be attached and detached from the body portion by the adjustment of the screw (41) located on the lateral side of the body portion. And lastly, the diameter of the distal end of the bar portion can include a drill (20) (as shown in Fig. 1), tip of said drill has a diameter larger than the shaft portion of the bar portion.
For that reason, it is understood that the claimed subject matter is found in the prior art of Mainil-Varlet.
On the other hand, if the intention is to claim the instrument shown in Fig. 30A-32 and described in par. [0195], [0200]-[0213] of the present application, the Office observes that the instrument has an elongated body that includes a handle on one end of the body for easily handle by the dentist, and a guide portion (64) on the opposing end of the elongated body. The guide portion (64) extends along an axis from a distal end and a proximal end, where it includes a through hole/hollow portion (61A) from said distal end to said proximal end. On the external surface of the guide portion (64) includes a stopper portion (65) formed into a stepped shape having a diameter larger than that of the distal end of the guided portion (64).
The handle is axially displaced from the axis of the guide portion (64), while both axes are in general parallel alignment (shown in Fig. 30A).
Furthermore, the instrument includes a bar portion (62) including a shaft portion that extends from a proximal end to a distal end. The shaft portion is slidable within the hollow portion (61A) of the guide portion (64) and configured to be detachable from said guide portion (64) through the screw (67). The distal end of the bar portion (62) includes an end portion (63) having a larger diameter than the rest of the shaft portion and configured for soft tissue displacement in the upper jaw. The bar portion (62) also includes an information presentation unit (62b) extending from the proximal end to the distal end of the shaft portion. Said information presentation unit (62b) indicates the extension in which the end portion 63 is protruded from the guide portion (64).
The above description of the present osteotome instrument further defines the present subject matter than in the claim.
Even when the claimed subject matter is interpreted in light of the specification. The claims describe the subject matter in such a way that any prior art that includes a body portion with a guide hole and terminating in a stopper, a bar portion that is slidable withing the guide hole, where the bar portion can be removed through the distal end of the guide hole complies with the claimed language. Even if this is the inventive feature in the present application, the claim should include the full or a bigger scope of the invention, in order to exclude any other subject matter publicly known.
It is understood that not all the limitations mentioned above for Fig. 30A-32 are found in the claim, and the ones described in the claim are not described where they are located with respect to the other, how they interact with each other and intended use within the instrument.
The Office understands that the construction and language used in the claim fails to indicate the full scope of the present instrument.
Therefore, due to the claim broadly describes an instrument for osteotome including a list of structures, it is understood that said instrument is found in the prior art of Mainil-Varlet, making the rejection proper and will be maintained.
Regarding claim 27 rejection, the applicant has the same argument of detachment of the bar portion as in the bar portion of claim 22. Fig. 2 shows another embodiment shown in Mainil-Varlet having another end portion, providing the difference of diameters within the bar portion as claimed. Like in the previous embodiment of the bar portion, this one shown in Fig. 2 can be used with the same instrument. Therefore, it can be releasably attached to the body portion of Fig. 1 or Fig. 4 as explained above for bar portion in claim 22.
Therefore, the subject matter claimed of claim 27 is not novel based on interpretation given to the language of the claim.
Regarding claim 28 rejection, the applicant argues that the prior arts of Mainil-Varlet and Isidori do not disclose claimed guide detachment element. The Office understands that for the same reasons given above for claim 22, the subject matter claimed is found in Mainil-Varlet, because the same deficiencies found in claim 22, are present for claim 28.
Therefore, for all the reasons given above, it is understood that the present set of claims is not ready for allowance.
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.
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, 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
