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 .
Response to Arguments
The amendments to the claims have overcome the previously presented claim objections and 35 USC 112b rejections. In view of the amendments, a new 35 USC 112b rejection of claim 10 appears below. Applicant's arguments filed 7/15/2026 with respect to the prior art of Gordon have been fully considered but they are not persuasive. Applicant asserts that Gordon fails to disclose a widening, and the notch 180 of Gordon is not a widening as “no part of the inner cutting head extends beyond the radius of the cutting head to form a widening”, and includes an annotated fig. 10B with a reference line A. With respect to the prior art of Gordon, the examiner considers the claimed “widening” to be the area of the sidewall extending from the trough (i.e., radially innermost point) of the concave portion formed by side surface 180 toward, and including part of, the side surface 182. See the examiner-annotated figures below. Figure 10 is not annotated, but has been included to provide context for annotated figure 10B. Since the radius of the inner cutting head increases along this portion of the bone engaging sidewall portion (i.e., increasing from the radius at the trough of 180 to the radius at 182), it is considered a “widening”. This appears consistent with applicant’s interpretation of “widening” on page 8 of the remarks filed 7/15/2026, wherein a widening increases the diameter (and therefore radius) of the cutting head. Applicant notes that the radius of the widening identified by the examiner is not greater than R1. However, the claims require that radius R1 is the maximum radius of the inner cutting head. The radius along the widening increases from the radius of the inner cutting head at the trough (i.e., radially innermost point) of the concave portion (formed by side surface 180) of Gordon to the radius R1 taken at a location along the side surface 182. Therefore, the prior art rejections are maintained.
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Claim Objections
Claims 3, 6, and 19 are objected to because of the following informalities:
Claim 3: in line 4, “the axis A” should read “a rotational axis A” for consistency (it is clear that the axis A in line 4 and in line 5 are one and the same).
Claim 6: in line 5, “the engaging side wall portion” should read “the bone engaging side wall portion” for consistency.
Claim 19: “the rotational axis A” in line 3 should read “a rotational axis A” as this is its first recitation. 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 10 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 10, line 5, has been amended to read “a further side wall portion”. However, this amendment makes the reference to “the further side wall portion” in line 6 of claim 10 unclear since claim 1 (line 9), from which claim 10 ultimately depends, already recites “a further side wall portion”. In other words, it is unclear which previously recited “further side wall portion” is being referenced in line 6 of claim 10. As best understood, the further side wall portion of claim 1 and the further side wall portion in lines 5 and 6 of claim 10 are one and the same. Claim 10, line 5, is being treated as though it reads “[[a]] the further side wall portion” purposes of claim interpretation. Correction or clarification is required.
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.
Claim(s) 1, 3-14, and 16-20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Gordon (US 2009/0024129). Gordon discloses a perforator for drilling bone tissue, comprising: a drive shaft (42; fig. 2, 3) with a rotational axis A; an inner cutting head (44; fig. 1, 2, 8) with the same rotational axis A, configured to cut a substantially cylindrical hole; and a coupling mechanism (54,56,58; fig. 2) for coupling the drive shaft and the inner cutting head, wherein the inner cutting head comprises a bone engaging side wall portion (182; figs. 10, 10B) having a radius r1, the radius r1 being a maximum radius of the inner cutting head so that radius r1 defines a radius of a hole the inner cutting head is configured to cut, and a further side wall portion (formed by surface 180 at its trough, i.e., most radially inward point; fig. 10, 10B) having a radius (at trough of 180) which is smaller than radius r1. The inner cutting head further comprises a widening (area between radius at trough of concave portion 180 that widens towards 182; fig. 10, 10b) forming at least a portion of the bone engaging side wall portion. See the examiner-annotated reproduction of fig. 10B below.
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Regarding claim 3, the widening can be considered a tapered widening, as it includes a gradual widening. Note that the three options following “wherein the widening:” are connected by “and/or” and thus the prior art need only meet one of the three options in order to meet the limitations of the claim.
Regarding claim 4, wherein the bone engaging side wall portion (182) is arranged distally of the further side wall portion (180; fig. 10, 10b).
Regarding claim 5, the inner cutting head, at a distal end, further comprises a plurality of cutting protrusions (146, 148, 150, 152). The remaining limitations following the word “optionally” in line 2 of the claim are optional, and thus not required in order to meet the claim.
Regarding claim 6, the inner cutting head further comprises: a helical groove (see groove formed in part by ramp 134, which is a helix as per [0051]; see fig. 8) extending helically around the inner cutting head along the rotational axis A (at least along its helical ramp edge 134); and a margin (124) forming at least a portion of the bone engaging side wall portion (see fig. 8, 10, 10b). The limitations following “optionally” are not required.
Regarding claim 7, at least a portion of the inner cutting head (44) is substantially frustoconical (consider tapered area joining 142 to 140 in fig. 8; [0053]).
Regarding claim 8, the inner cutting head is displaceable with respect to the drive shaft along the rotational axis A between a distal position ([0037]), in which the inner cutting head is not driveable by the drive shaft ([0076]), and a proximal position ([0077]; bias of spring overcome such that drive cap end plate 94 engages inner cutting head), in which the coupling mechanism couples the drive shaft and the inner cutting head to transmit rotational motion from the drive shaft to the inner cutting head (see [0077]-[0078]).
Regarding claim 9, the perforator further comprises an outer cutting head (46) arranged coaxially around the inner cutting head (see fig. 1 and 10), in which a cutting head coupling mechanism (190, 194; fig. 12-16; [0066], [0071]) is provided, the cutting head coupling mechanism being configured to couple the inner cutting head and the outer cutting head when the inner cutting head is in the proximal position (fig. 16) so that rotational motion is transmitted from the inner cutting head to the outer cutting head ([0083]). The limitation following “optionally” is not required by the claim.
Regarding claim 10, the perforator is configured so that when the inner cutting head is in the proximal position, a distal end portion of the inner cutting head projects distally beyond a distal end of the outer cutting head (see fig. 10; [0083]), and wherein the distal end portion comprises at least a portion of each of the bone engaging side wall portion and the further side wall portion (fig. 10). The limitations following the word “optionally” in lines 6-12 of the claim are not required by the claim.
Regarding claim 11, the perforator is configured so that when the inner cutting head is in the proximal position, the bone engaging side wall portion and the further side wall portion of the inner cutting head extend distally beyond a distal end of the outer cutting head (fig. 10-12; [0081]).
Regarding claim 12, the outer cutting head (46) comprises an outer cutting head bone engaging side wall portion (radially outermost surface of a flute 209; fig. 10) having a radius r3, the radius r3 being a maximum radius of the outer cutting head so that the radius r3 defines a radius of a hole the outer cutting head is configured to cut, and an outer cutting head further side wall portion (consider side wall portion forming innermost surface of cutting face 210 of flute 209) having a radius which is smaller than the radius r3.
Regarding claim 13, Gordon discloses an inner cutting head (44) configured to cut a substantially cylindrical hole into bone tissue, for a perforator for cutting bone tissue comprising: a bone engaging side wall portion (182) having a radius r1, the radius r1 being a maximum radius of the cutting head so that the radius r1 defines a radius of a hole the cutting head is configured to cut; and a further side wall portion (portion of concavity 180 near its trough) having a radius (at most radially inward part of concavity 180) which is smaller than the radius r1. The inner cutting head comprises a widening (area between radius at trough of concave portion 180 that widens towards 182; fig. 10, 10B) forming at least a portion of the bone engaging side wall portion. See the examiner-annotated figure above.
Regarding claim 14, the inner cutting head further comprises: a coupling mechanism portion (54, 56, 58) configured to engage a corresponding coupling mechanism portion of a drive shaft (42) of a perforator when the cutting head is in a proximal position along a rotational axis of the drive shaft, to transmit rotational motion from the drive shaft to the inner cutting head.
Regarding claim 16, the widening comprises a tapered widening (noting widening includes a gradual widening). The three options following “wherein the widening:” are joined by “and/or” and thus the prior art need only meet one of the three options in order to satisfy the limitations of the claim.
Regarding claim 17, the widening is arranged at a distal end portion of the inner cutting head (figs. 10, 10b), so that the bone engaging side wall portion (182) is arranged distally of the further side wall portion (180).
Regarding claim 18, the inner cutting head, at a distal end, comprises a plurality of cutting protrusions (flutes 146, 148, 150, 152 and their respective cutting faces 162/166). The limitations following “optionally” are not required by the claim.
Regarding claim 19, the inner cutting head further comprises: a helical groove (see groove formed in part by ramp 134, which is a helix as per [0051]; see fig. 8) extending along the rotational axis A; and a margin (124) forming at least a portion of the bone engaging side wall portion (fig. 8, 10, and 10b). The limitations following “optionally” are not required by the claim.
Regarding claim 20, Gordon discloses a perforator for drilling bone tissue, comprising: a drive shaft (42) with a rotational axis A; an inner cutting head (44) with the same rotational axis A (see figs. 1, 2), configured to cut a substantially cylindrical, or cylindrical, hole; and a coupling mechanism (54,56,58; fig. 2) for coupling the drive shaft and the inner cutting head, wherein the inner cutting head comprises reducing means (widening that occurs from concavity 180 to surface 182, note that corresponding structure of “reducing means”, which invokes 35 USC 112f, is a widening) configured to reduce a contact area between a side wall of the inner cutting head and bone tissue defining a boundary of a hole the inner cutting head is configured to cut. In particular, the widening results in an area of the inner cutting head with a reduced radius (area at trough of 180) as compared to the widest part, which reduces contact area between a side wall of the inner cutting head and bone tissue at the reduced radius area. Limitations following “optionally” are not required by the claim.
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, 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) 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. Gordon discloses the invention substantially as stated above including that radius r1 is greater than the radius of the further side wall portion, but does not expressly disclose that the radius r1 is greater than the radius of the further side wall portion by about 0.005 mm to about 5 mm, or about 0.01 mm to about 1 mm, or about 0.015 mm to about 0.5 mm, or about 0.02 mm to about 0.1 mm, or about 0.025 mm to about 0.05 mm. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Gordon to have sized the engaging side wall portion and further side wall portion such that the radius r1 is greater than the radius of the further side wall portion by the claimed amount 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 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, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, a device having the claimed dimensions would not perform differently than the prior art of Gordon since the claimed dimensions merely result in a reduced dimension that minimizes contact between the sidewall and tissue, which minimize the likelihood that tissue will be damaged, as already disclosed by Gordon ([0093]).
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 9/9/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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