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 .
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 § 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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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”).
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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).
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.
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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”.
Response to Arguments
Applicant's arguments filed 8 May 2026 have been fully considered but they are not persuasive.
Regarding claim 22 rejection, applicant argues that the prior art of Mainil does not disclose a bar portion detachable from the body portion as claimed.
The Office disagrees, it is understood that the language and construction of the claim provides an ample interpretation of what the osteotome can looks like and how the different structures listed in the claim works with each other.
To further explain the position of the Office, in Fig. 30A-31 shows one of the osteotome embodiments (60). It is observed based on the drawings and in combination with the present specification, that said osteotome includes;
A body portion 61 and a bar portion 62.
The body portion 61 includes a guide portion 64 that includes along its entire longitudinal length a hollow portion 61a.
The bar portion 62 includes an elongated shape configured to slidable moves inside the entire longitudinal length of the hollow portion 61a of the guide portion 64, for freely change the extension into which an end portion 63 of the bar portion 62 extends outside the hollow portion 61a. The guide portion 64 includes a screw 67 configured to hold in place the bar portion 62 inside the hollow portion 61a.
When comparing to the description found in at least claim 22 where the osteotome includes a body portion, a bar portion detachable form the body portion, and an end portion on the distal end of the bar portion, and a diameter of the end portion that is larger than a shaft portion of the bar portion. It is understood that it is generically describing the present osteotome, but not enough to distinctively describing it from the prior art of Mainil.
Furthermore, the limitation body portion has not been described that includes the guide portion, that at the same time is the structure that detachably hold the bar portion. Therefore, the body portion has been interpreted that the device includes a portion of the body where the bar portion can be detached from.
For that reason, it is understood that the prior art of Mainil includes the argued subject matter because the device of Mainil shows in Fig. 4 and it is described in page 4, line 28-36, that the bar portion is mounted in the body portion/holding piece 40 and with the use of a through bore 42 on that body portion/holding piece 40 for fixing screw 41 is configured to hold the bar portion relative to the body /holding piece 40, and both pieces can be detachable from each other, in this way complying with the claim language.
With respect to the removal of the mucosa, the prior art discloses that the cutting edge 11 of the heath 10 punches the cartilaginous tissue, but the end portion of the drill 20 is the one that removes the punched material away during drilling (see abstract). Therefore, the end portion of the bar portion/drill is the one that displaces the mucosa as claimed.
On the other hand, if the applicant refers to the sinus mucosa that lies inside the nasal passage and needs to be lifted during certain dental procedures after and osteotomy, the claim is not clearly defining that.
The term mucosa in the claim has been interpreted as soft tissue, such as the mucosa gingival/ gum.
Furthermore, the term behind used in the preamble, is considered that after an osteotome, the punched gum tissue is combined with the bone material during drilling that ends up behind the treatment area or in other words outside of the drilling area, in which it is considered behind the treatment area
The all the reasons given above; it is understood that the language used in the claim is broad enough that the description found in the claim 22 is found in the prior art of Mainil.
Regarding the amended claim 27, applicant argues that the prior art of Mainil does not includes the claimed subject matter. The Office understands that the described subject matter is found in the prior art of Mainil’s as described in the rejection above.
Regarding the claims 25 and 28 rejections under 35 USC 103, it is understood that the limitations described in the claims are found the prior art of Mainil for all the reasons given above.
The Office position with respect to claims 22-28 is that the set of claims are not ready 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 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
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