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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, the specification is silent as to the newly added claim limitation “wherein said body portion has a predetermined cross-sectional configuration.” The specification discloses in [0003] that “the osteotomy has attained a predetermined size or diametrical extent” but that is not the same as a predetermined cross-sectional configuration of the body portion. The newly added claim limitation requiring that the plurality of concave pocket sections that are defined upon the plurality of left-handed flute sections “are disposed immediately ahead of said plurality of right-handed cutting edges” is not supported by the specification. Additionally, the newly added limitation that “said plurality of left-handed flute sections and said plurality of concave pocket sections continuously alternate with each other” is not supported by the specification.
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, 3-13 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, it is unclear how “said plurality of left-handed flute sections and said plurality of concave pocket sections continuously alternate with each other.” Since the “plurality of concave pocket sections which are respectively defined upon said plurality of left-handed flute sections” are disclosed early in the claim as such, it is unclear how the plurality of left handed flute sections can both define the concave pocket sections (as is seen in Figure 4) and alternate with the concave pocket sections. Additionally, it is unclear what is meant by the added limitation “disposed immediately ahead of said plurality of right-handed cutting edges” as the term “ahead” implies a directional component that has not been claimed. For the purpose of examination, concave pockets that are adjacent the cutting edges will be considered to meet the claim limitation.
All claims not specifically addressed above are rejected based on their dependency on Claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, and 3-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huwais (US 2019/0029695 A1).
Regarding Claim 1, Huwais discloses a compression tool (Figure 6, 36) for performing a finishing procedure within a bore hole formed within a human jawbone so as to serve as an implantation site for a dental implant by compression and densification processes when rotated in a particular rotational direction (abstract). The compression tool comprises a body portion (Figure 6, 42) defined around a longitudinal axis (Figure 6, A), wherein a lower distal end section (Figure 6) of the body portion is tapered such that the smallest diameter of the lower distal end section of the body portion is disposed at a distal end of the body portion (as seen in Figure 6) and the body portion has a predetermined cross-sectional configuration (as the body portion has a cross-section and is selected from a kit of osteotomes for a specific size as seen in Figure 5, it would have a predetermined cross-sectional configuration).
Huwais further discloses a plurality of left-handed cutting edge portions (Figure 14, 72) disposed within a circumferential array upon the lower distal end section (Fig. 14) of the body portion for continuously cutting bone material from bone mass surrounding and defining the bore hole formed within the human jawbone ([0086]), and a plurality of right-handed flute sections (see annotated Figure 15 below, where interpretation of the right-handed flute sections is the same as the disclosure of the present application) angularly spaced from but operatively associated with the plurality of left-handed cutting edges. Additionally, Huwais discloses a plurality of concave pocket sections (annotated Fig. 15) which are respectively defined upon the plurality of right-handed flute sections, which are disposed immediately ahead of the plurality of left-handed cutting edges (see annotated Figure 15, where the concave pocket sections are adjacent the cutting edges) and which extend continuously between consecutive ones of the plurality of left-handed cutting edges such that throughout the cross-sectional configuration of the body portion, the plurality of left-handed flute sections and the plurality of concave pocket sections continuously alternate with each other (as seen in annotated Figure 15, inasmuch as the present disclosure shows this claimed element, Huwais also discloses this claimed arrangement with the concave pocket sections as defined by the flute sections alternating with cutting edges) and immediately ahead of the plurality of left handed cutting edges, as considered in a particular rotational direction (as seen in Figure 7, in a rotational direction, the pocket sections would be ahead of the cutting edges) for accumulating bone material cut from the bone mass surrounding and defining the bore hole formed within the human jawbone (as described in [0015]).
Huwais further discloses that when the compression tool is rotated only in a clockwise direction and simultaneously axially inserted into the bore hole, the plurality of left-handed cutting edges, for continuously cutting bone material from bone mass surrounding and defining the bore hole formed within the human jawbone, will continuously cut bone material from the bone mass surrounding and defining the bore hole within the human jawbone, the bone material, continuously cut from the bone mass surrounding and defining the bore hole formed within the human jawbone, will be accumulated within the pocket sections so as not to be evacuated from the implantation site, and will be immediately compressed radially outwardly back into the bone mass surrounding and defining the bore hole formed within the human jawbone so as to compress, compact, and enhance the density of the bone mass surrounding and defining the bore hole formed within the human jawbone (densifying as described in [0009]). Additionally, please note: as Huwais discloses the structure of the claimed device, it is understood that it can carry out of the function as claimed.
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Huwais discloses a generic helical configuration of the device (Figure 15) but illustrates right-handed flutes and therefore left-handed cutting edge portions as seen in Fig. 6. However, as described in [0085], an opposite (right-handed cutting edge/left -handed flutes) configuration is disclosed. Please note: the structure of Huwais is the same directionally as that of the present application, regardless of the terminology for handedness applied: therefore, for the purpose of examination, the flutes and edges of Huwais are considered to be opposite handed directionally.
Regarding Claim 3, Huwais discloses that the right-handed cutting edges (as modified above, annotated Fig. 15) comprise a leading crest or cutting edge portion (annotated Figure 15) for cutting radially innermost bone matter from the bone mass surrounding and defining the bore hole formed within the human jawbone, and a plurality of tangentially oriented trailing margin portions (annotated Figure 15) that are respectively connected to and immediately trail a respective one of the plurality of leading crest or cutting edge portions for compressing the cut bone matter back into the bone mass surrounding and defining the bore hole formed within the human jawbone so as to enhance the density of the bone mass surrounding and defining the bore hole formed within the human jawbone.
Regarding Claim 4, Huwais as modified discloses the compression tool as set forth in Claim 3, and the plurality of leading crest or cutting edge portions for cutting radially innermost bone matter from the bone mass surrounding and defining the bore hole formed within the human jawbone are disposed within tangential planes as considered in connection with the inner circumferential wall of the bone mass surrounding and defining the bore hole formed within the human jawbone and located upon a single circular locus (as seen in Figure 15, the tangential planes to the leading crest portions form the outer circumference of the tool which would connect with the wall of the bone mass) and the plurality of trailing margin portions are effectively disposed within the same tangential plane and upon the same circular locus as that of the plurality of leading crest or cutting edge portions (as seen in Figure 15).
Regarding Claim 5, Huwais as modified discloses the compression tool as set forth in Claim 3, wherein each one of the plurality of flute sections further comprises a plurality of trailing relieved land portions (annotated Figure 15) respectively integrally connected to the plurality of trailing margin portions (47A annotated Fig. 6) where the plurality of trailing relieved land portions are angled away from the tangentially oriented trailing margin portions by means of a predetermined relief angle (annotated Fig. 15) so as to effectively reduce the surface area disposed in contact with the inner circumferential wall of the bone material defining the bore hole which thereby, in turn, reduces the amount of heat generated during the compression or densification process of the procedure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable in view of Huwais as applied to claim 1 above, in view of Desrosiers (US 2005/0272004 A1).
Regarding Claim 6, Huwais as modified discloses the compression tool as set forth in Claim 1, but is silent wherein adjacent ones of the plurality of flute sections are spaced unequally from other adjacent ones of the plurality of flute sections, as considered within the circumferential array of flute sections, so as to effectively prevent vibration or chattering of the compression tool as the compression tool is rotated during the finishing procedure.
Desrosiers teaches a file, reamer, and condenser with reduced surface area contact [abstract] for drilling and shaping [0026 lines 1-6] where adjacent ones of the plurality of flute sections (363, 365, 367 Fig. 10A) are spaced unequally from other adjacent ones of the plurality of flute sections [0068 lines 1-8], as considered within the circumferential array of flute sections, so as to effectively prevent vibration or chattering of the compression tool as the compression tool is rotated during the finishing procedure (though not stated by Desrosiers, as the flutes are unequally spaced they would prevent vibration as claimed due to the similar structures).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the plurality of flute sections of Huwais to be spaced unequally as taught by Desrosiers for the purpose of creating a device that efficiently bores a hole [Desrosiers 0037].
Claims 7-8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Huwais as applied to claim 1 above, in view of Strong et al. (US 6,863,529 B2, hereinafter “Strong”).
Regarding claims 7 and 8, Huwais as modified discloses the compression tool as set forth in Claim 1, where the compression tool comprises an indicia in the area of the fluted section (Figure 14 where the banded areas are indicia). However, Huwais is silent where the compression tool comprises first indicia noted upon a first surface portion of an upper non-fluted section of the body portion for readily visually indicating the diametrical extents, from smallest to largest, of the tapered lower distal end portion of said compression tool (claim 7), and a second indicia noted on a second surface portion of the upper non-fluted section of the body portion for readily visually indicating the length dimension of the lower fluted section of the body portion (claim 8).
Strong discloses a compression tool (20) with a first indicia (30, Fig. 3) noted upon a first surface portion of an upper non-fluted section of the body portion for readily visually indicating the diametrical extents, from smallest to largest, of the tapered lower distal end portion of the compression tool ([col. 6 lines 50-55] disclose that the indicia 30 illustrates the diametrical extents of the device), and a second indicia (30, Fig. 3. Note that the first and second indicia are interchangeable) noted on a second surface portion of the upper non-fluted section of said body portion for readily visually indicating the length dimension of the lower fluted section of the body portion (the indicia 30 illustrates the length direction as disclosed in [col. 6 lines 45-49]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Huwais to include an indicia in the non-fluted section of the tool body for the purpose of illustrating the dimensions of the tool (as taught by Strong ) which allows for accurately drilling a bore hole of predetermined dimensions.
Regarding Claims 12 and 13, Huwais as modified discloses the compression tool as set forth in Claim 1, but is silent wherein an end face of the compression tool is flat whereby the compression tool cannot pierce membranes or enter sinus cavities (claim 12), where the end face is flat so as to enable bone mass to be added to a bottom end portion of the bore hole in order to build or uplift existing bone in order to compensate for bone loss (claim 13).
Strong discloses an end face (28, Fig. 3) of a compression tool (20, Fig. 3) which is flat [col. 6 lines 10-11] whereby the compression tool cannot pierce membranes or enter sinus cavities [col. 6 lines 29-39] and further where the flat end face (28, Fig. 3) has the claimed structure and is able to enable bone mass to be added to a bottom end portion of the bore hole in order to build or uplift existing bone in order to compensate for bone loss (the shape of the drill as seen in Fig. 3 compacts bone and enables bone mass at the bottom of the bore hole to be added to the surface of the bore hole which would compensate for bone loss).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Huwais as modified to have a flat end as taught by Strong for the purpose of increasing the bone density of the bore hole which affects the mechanical anchorage of implants.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Huwais as applied to claim 1 above, in view of Mansueto (US 2017/0049531 A1).
Regarding Claim 9, Huwais as modified discloses the compression tool as set forth in Claim 1, wherein a section of the body portion can cooperate with a safety device to prevent the progressions of the tool beyond a predetermined amount (stopper section as disclosed in [0013]).
Huwais is silent regarding a circumferentially extending flanged portion defined upon an axially central portion of the body portion for serving as a stopper for preventing axial progression of the compression tool beyond a predetermined amount so as to prevent the compression tool from piercing any membranes or entering any sinus cavities.
Mansueto discloses a surgical drill with a circumferentially extending flanged portion (20P, Figs. 4 and 5) defined upon an axially central portion of a body portion (28, Fig. 4 A.) for serving as a stopper for preventing axial progression of the compression tool beyond a predetermined amount [abstract lines 7-9, 0047] so as to prevent the compression tool from piercing any membranes or entering any sinus cavities (The stopper of Mansueto is capable of stopping the device once it reaches a predetermined depth. One of ordinary skill would recognize to select a size based on the anatomy of the patient [0012 lines 1-14]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Huwais to include a circumferentially extending flanged portion for serving as a stopper as taught in Mansueto for the purpose of streamlining and adding a safe guard to drilling procedures [Mansueto 0012 lines 6-14].
Regarding Claim 10, Huwais as modified by Mansueto discloses compression tool as set forth in Claim 9, and Mansueto further discloses that the circumferentially extending flanged stopper (Mansueto 20P, Fig. 4) comprises two circumferentially extending colored bands (Mansueto Fig. 4) integrally formed thereon [Mansueto [0049] lines 4-7, 0008]. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the tool of Huwais with colored bands formed on the stopper as taught by Mansueto for additional orientation with regard to drilling depth.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Huwais and Mansueto as applied to claims 9 and 10, and further in view of Suter et al. (2011/0177469 A1, hereinafter “Suter”).
Regarding Claim 11, Huwais as modified by Mansueto discloses compression tool as set forth in Claim 10, and Mansueto further discloses that a first one of the two colored bands provides a visual indication of the maximum and minimum diametrical extents of the tapered lower fluted section of the body portion [Mansueto 0008 describes that the colors indicate the diameter of the drill bit, therefore indicating the diametrical extents].
Mansueto is silent regarding wherein a second one of the two colored bands provides an indication that the tool is tapered.
Suter discloses a surgical tool with a colored band (50a, 50b, and/or 50c Fig. 4)[0058 line 1, 0039] that provides an indication that the tool is tapered (taper is included in the diameter and function as listed in [0069 lines 5-6].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the colored bands of Mansueto to include a colored band which indicates the shape of the tool as taught by Suter for the purpose of easing the stress of a dentist as taught by Mansueto [Mansueto 0006 lines 1-4] through color coding of the tools [Mansueto 0008 final 5 lines].
Response to Arguments
Applicant’s arguments with respect to claims 1, and 3-13 have been considered but are moot because the new ground of rejection of Huwais (US 2019/0029695 A1) meets the newly added limitations as claimed as described above.
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.
/CHRISTINE L NELSON/Examiner, Art Unit 3772 /EDWARD MORAN/Primary Examiner, Art Unit 3772
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