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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 1, 8, 12, 13 and 16 are objected to because of the following informalities:
Claim 1: in line 8, “that radius r1” should read “that the radius r1” since it has been previously recited.
Claim 1: in line 10, “than radius r1” should read “than the radius r1” since it has been previously recited.
Claim 8: in line 2, “the rotational axis” should read “the rotational axis A” for consistency.
Claim 12: in line 3, ““that radius r3” should read “that the radius r3” since it has been previously recited.
Claim 12: in line 5, “than radius r3” should read “than the radius r3” since it has been previously recited.
Claim 13: in line 4, “that radius r1” should read “that the radius r1” since it has been previously recited.
Claim 13: in line 6, “than radius r1” should read “than the radius r1” since it has been previously recited.
Claim 16: “the axis A” in line 3 should read “[[the]] a rotational axis A” and “a rotational axis A” in line 4 should read “[[a]] the rotational axis A”; it is understood that these are one and the same axis in view of the “A” following each axis. 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.
Claims 5, 10, and 13-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 18 each recites “a widening portion forming a part of the, or a, widening”. Since no widening is previously recited (which appears to be distinct from the widening portion since the claim recites that the widening portion forms a part of the…widening”), the widening lacks antecedent basis, and it is unclear if, or how, “the widening” or “a widening” (of “the, or a, widening”) refer to different widenings. For purposes of claim interpretation, “a widening portion forming a part of the, or a, widening, preferably of the, or a, widening having a rotational symmetry…” in each of claims 5 and 18 is being treated as though it reads “a widening portion forming a part of
Claim 10 recites “the projecting side wall” in the last line of the claim, which lacks antecedent basis. For purposes of claim interpretation, “the projecting side wall” is being considered to read “a projecting side wall”.
Claim 13 appears to be drawn only to an inner cutting head, noting “configured to cut” and “for a perforator for cutting bone tissue according to claim 1” in the preamble are functional. However, it is unclear what is meant by “for a perforator for cutting bone tissue according to claim 1” because the perforator of claim 1 already includes an inner cutting head with an engaging side wall portion, further side wall portion, and radius r1. It is suggested that “for a perforator for cutting bone tissue according to claim 1 be amended to read “for a perforator for cutting bone tissue
Regarding claim 18, the phrase "preferably" in lines 2 and 5 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase “preferably” are part of the claimed invention. See MPEP § 2173.05(d). For purposes of claim interpretation, the limitations after “preferably” are not considered part of the claimed invention.
Regarding claim 19, the phrase "preferably" in line 5 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase “preferably” are part of the claimed invention. See MPEP § 2173.05(d). For purposes of claim interpretation, the limitations after “preferably” are not considered part of the claimed invention.
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 an 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 which is smaller than radius r1.
Regarding claim 3, wherein the inner cutting head further comprises a widening (area between r1 at trough of concave portion 180 that widens towards 182; fig. 10, 10B) forming at least a portion of the engaging side wall portion. It is noted that the remainder of the claim limitations follow the word “optionally” and are thus not required as understood by the ordinary and plain meaning of “optionally”.
Regarding claim 4, wherein the 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 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 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 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 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 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 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 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 (see 35 USC 112b rejection above), comprising: an engaging side wall portion (182) having a radius r1, the radius r1 being a maximum radius of the cutting head so that 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 radius r1.
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, wherein the inner cutting head further comprises a widening (area extending between r1 and trough of concave portion 180 that widens towards 182; fig. 10, 10B) forming at least a portion of the engaging side wall portion. It is noted that the remainder of the claim limitations follow the word “optionally” and are thus not required as understood by the ordinary and plain meaning of “optionally”.
Regarding claim 17, the widening is arranged at a distal end portion of the inner cutting head (figs. 10, 10b), so that the 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). As noted above in the 35 USC 112b rejections, the limitations after “preferably” are being interpreted as optional, and not required.
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 engaging side wall portion (fig. 8, 10, and 10b). See the 35 USC 112b rejections above, noting that the limitations following “preferably” are not required.
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
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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KSH 4/10/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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