Detailed Action
This is the first office action on the merits for US application number 18/430,154.
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 .
Election/Restrictions
Applicant’s election without traverse of the product of invention I, i.e. of claims 1-13, in the reply filed on October 27, 2025 is acknowledged, which indicated that claims 1-13 read on the elected invention.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a handle configured to be gripped by a user;” of claim 1 line 2, the handle coupled to the cutting body of claim 1 line 3, the shank is releasably coupled with the cutting body of claim 3 line 1, “the annular disk …correspond to a maximum depth of the tapered region within the bore when the annular disk interfaces with an outer surface of the bone” in claim 5 lines 1-3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 line 3 should read “a cutting body coupled to the handle and comprising:”.
Appropriate correction is required.
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(s) 5 and 13 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 5 is/are unclear with regards to “the annular disk is spaced apart from the tapered region so as to correspond to a maximum depth of the tapered region within the bore when the annular disk interfaces with an outer surface of the bone” in lines 1-3 as such appears to claim that the annular disk interfaces with an outer surface of the bone and thereby claim the human body. Further, the annular disc 506 as shown in Fig. 3A has a smaller diameter than the cutting body 504 and would therefore never be able to contact/interface with the bone as the hole created in the bone by the cutting body would be larger than the annular disc. Examiner is interpreting this as referring to, and suggests amending as, “the annular disk is spaced apart from the tapered region so as to correspond to a maximum depth of the tapered region within the bore
Claim(s) 13 is/are unclear with regards to “a circumference axis of the threaded region” in line 2 and is such is intended to refer to a circumference or an axis or the intend scope of “a circumference axis”. Examiner is interpreting this broadly and suggests amending to clarify.
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 of this title, 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.
Claim(s) 1, 2, 6-10, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicken et al. (US 2004/0064143, hereinafter “Hicken”).
As to claims 1, 2, and 6-10, Hicken, in an initial embodiment, discloses a tool (5, Fig. 3) capable of use in performing an orthopedic surgery on a subject (¶26 discloses use in bone), the tool comprising: a handle (400, left portion of 300) capable of being gripped by a user (Fig. 3, ¶35); and a body (200, 100) coupled to the handle (Fig. 3, ¶37) and comprising: i) a threaded region (215, Fig. 3) capable of compacting bone particles within a bone bore (Fig. 3, ¶s 12, 14, 39, 40, and 42), and ii) a tapered region (100, Fig. 3) is capable of opening the bone to define/create a bone tunnel in bone (¶s 14 and 31). As to claim 2, Hicken, in an initial embodiment, discloses a shank (central portion of 300 as shown in Fig. 3, Fig. 3) capable of coupling the handle to the body (Fig. 3, ¶37). As to claim 6, Hicken, in an initial embodiment, discloses a neck region (320, 325, Fig. 3, ¶34) extending between the shank and the cutting body (Fig. 3, ¶34), the neck region tapering radially inwards from a wide end interfacing with the cutting body to a narrow end interfacing with the shank (Fig. 3, ¶34). As to claim 7, Hicken, in an initial embodiment, discloses that the tapered region further comprises a first protrusion (140, Fig. 3) extending from an external surface of the tapered region (Fig. 3, ¶31). As to claim 10, Hicken, in an initial embodiment, discloses an opening (500) extending through a longitudinal axis of the cutting body (Fig. 3, ¶36).
Hicken, in an initial embodiment, is silent to the tool being a reamer, the body being a cutting body, and the tapered region configured to cut the bore into the bone. As to claim 8, Hicken, in an initial embodiment, is silent to a second protrusion extending from the external surface of the tapered region. As to claim 9, Hicken, in an initial embodiment, is silent to the tapered region further comprises a first cutting channel.
Hicken, in another embodiment, teaches a similar tool that is a reamer (Figs. 6-9, ¶s 45, 46, and 48) capable of use in performing an orthopedic surgery on a subject (¶45 discloses use in bone), the reamer comprising: a cutting body (Figs. 6-9, ¶s 45, 46, and 48) comprising: i) a threaded region (left portion as shown in Figs. 6 and 9, Figs. 6, 8, and 9) capable of compacting bone particles within a bone bore (Figs. 6, 8, and 9), and ii) a tapered region (right left portion as shown in Figs. 6 and 9, Figs. 6, 7, and 9) capable of cutting a bore into bone (Figs. 6, 7, and 9, ¶s 45, 46, and 48) and comprising a cutting channel (805, 815, Figs. 6 and 7, ¶46). As to claim 8, Hicken, in an initial embodiment, discloses a second protrusion (Figs. 6 and 7) extending from the external surface of the tapered region (Figs. 6 and 7). As to claim 9, Hicken, in an initial embodiment, discloses that the tapered region further comprises a first cutting channel (805, 815, Figs. 6 and 7, ¶46).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tapered region for opening the bone to define/create a bone tunnel in bone as disclosed by Hicken, in an initial embodiment, by adding the cutting channel as taught by Hicken, in another embodiment, in order to aid in opening the bone while forming a bone tunnel by cutting away the inner-most soft cancellous bone encountered to facilitates passage of the tool into the bone (Hicken ¶46).
As to claim 13, the combination of Hicken discloses the invention claim 1 and that the threaded region comprises one or more threads (220, Fig. 3, ¶32) appears to show that the one or more threads are angled 5°, 10°, 15°, 20°, 25°, or 30° relative to a circumference axis of the threaded region (Fig. 3) and that the taper 105 is about 5-30° relative to the longitudinal axis (100, ¶28).
The combination of Hicken is silent to the angular value of the one or more threads being 0°, 5°, 10°, 15°, 20°, 25°, or 30° relative to a circumference axis of the threaded region.
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 one or more threads of the combination of Hicken to be angled 5°, 10°, 15°, 20°, 25°, or 30° relative to a circumference axis of the threaded region since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the one or more threads of the combination of Hicken would not operate differently with the claimed angles of 5°, 10°, 15°, 20°, 25°, or 30° relative to a circumference axis of the threaded region as such appears to be shown in Fig. 3 given that the taper 105 is disclosed to be about 5-30° relative to the longitudinal axis and therefore the threads would function appropriately with the claimed values to define a compacted bone tunnel/hole (Hicken ¶s 12, 32, and 33). Further, Applicant places no criticality on the angles claimed, indicating simply that the threads are angled of 5°, 10°, 15°, 20°, 25°, or 30° relative to a circumference axis of the threaded region (¶s 11, 12, and 38).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicken in view of Steiner et al. (US 5,499,984, hereinafter “Steiner”).
As to claim 3, the combination of Hicken discloses the invention of claim 2.
The combination of Hicken is silent to the shank is releasably coupled with the cutting body.
Steiner teaches a similar reamer (10, Figs. 1-9) capable of use in performing an orthopedic surgery on a subject (abstract), the reamer comprising: a handle (33, Fig. 1); and a cutting body (20) coupled to the handle (Fig. 1) and comprising: ii) a tapered region (upper portion of 20 as shown in Fig. 1, Fig. 1) capable of cutting a bore into bone (Fig. 1, abstract), wherein the shank is releasably coupled with the cutting body (Figs. 1-3, and 6-8, col. 2 lines 13-17 and col. 5 lines 40-42). Steiner teaches that the reamer of Figs. 1-9 is a known alternate of that of Fig. 10, which comprises a fixed cutting body (Fig. 10, col. 3 lines 25-26, and col. 5 lines 40-47).
Hicken discloses the claimed invention except that Hicken is silent as to how the shank is coupled/mounted to the body. Steiner teaches shows that the shank is releasably coupled with the cutting body is an equivalent structure known in the art to a fixed cutting body. Therefore, because these two couplings were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute/specify that the shank is releasably coupled with the cutting body for a fixed or unspecified connection between the shank and the cutting body. That is, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the connection of the shank to the body as disclosed by the combination of Hicken to specify a releasable coupling and adding a plurality of cutting bodies as taught by Steiner in order to provide differently sized cutting bodies for use with the shank (Steiner col. 4 lines 33-35) so that the cutting body can be changed when desired (Steiner col. 5 lines 16-20), e.g. to predictably create a larger diameter hole in bone.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicken in view of Strong et al. (US 2002/0172923, hereinafter “Strong”).
As to claims 4 and 5, the combination of Hicken discloses the invention of claim 2.
The combination of Hicken is silent to an annular disk extending radially from the shank. As to claim 5, the combination of Hicken is silent to the annular disk is spaced apart from the tapered region so as to correspond to a maximum depth of the tapered region within the bore.
Strong teaches a similar reamer (35, Figs. 4-7) capable of use in performing surgery on a subject (Figs. 4-7, ¶s 1 and 43), the reamer comprising: a handle (39); and a cutting body (43) coupled to the handle (Fig. 4) and comprising: ii) a tapered region (48) capable of cutting a bore into bone (¶s 1 and 48); further comprising a shank (36) capable of coupling the handle to the cutting body (Fig. 4); further comprising an annular disk (47s) extending radially from the shank (Figs. 4-7, ¶s 45, 58, and 62). As to claim 5, Strong teaches that the annular disk is spaced apart from the tapered region so as to correspond to a maximum depth of the tapered region within the bore (Figs. 4-7, ¶s 45, 58, and 62).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the shank as disclosed by the combination of Hicken by adding the annular disks as taught by Strong in order to indicate predetermined distances measured from the reamer tip (Strong ¶45) so that the surgeon can sight along a selected annular disk to a desired depth (Strong ¶58) by observing the penetration of the reamer into the bone and tissues of the patient until the desired annular disk is reached (Strong ¶62).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicken in view of Kim (US 2023/0301696, hereinafter “Kim”).
As to claims 11 and 12, the combination of Hicken discloses the invention of claim 1.
The combination of Hicken is silent to the threaded region further comprises a first notch extending longitudinally between a proximal and distal end of the cutting body and at least partially recessed into the threaded region. As to claim 12, the combination of Hicken is silent to the threaded region further comprises a second notch extending longitudinally between the proximal and distal end of the cutting body and at least partially recessed into the threaded region.
Kim teaches a similar reamer (100) capable of use in performing surgery on a subject (Fig. 2), the reamer comprising: a handle (121, 210, Figs. 2 and 3); and a cutting body (110) coupled to the handle (Figs. 2 and 3) and comprising: i) a threaded region (111) capable of compacting bone particles within a bone bore (¶s 19-22, 48, 54, 56, 58, 61, 85, and 86), and ii) a tapered region (lower-left portion of 110 as shown in Fig. 4, Fig. 4) capable of cutting a bore into bone (¶s 19, 21, 57-61, and 84), wherein the threaded region further comprises a first notch (left 115 as shown in Fig. 4, Fig. 4, ¶67) extending longitudinally between a proximal and distal end of the cutting body (Fig. 4) and at least partially recessed into the threaded region (Fig. 4). As to claim 12, the combination of Kim teaches that the threaded region further comprises a second notch (right 115 as shown in Fig. 4, Fig. 4, ¶67) extending longitudinally between the proximal and distal end of the cutting body (Fig. 4) and at least partially recessed into the threaded region (Fig. 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the threaded region and the tapered region as disclosed by the combination of Hicken by adding notches as taught by Kim in order to provide a channel/guide for bone powder (Kim ¶s 70 and 85) created by cutting (Kim ¶s 84 and 85) to move and become compressed (Kim ¶s 71 and 85) to perform osseodensification (Kim ¶s 54, 71, and 74) as well as reduce a patient’s pain (Kim ¶72).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775