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
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that the 35 USC 112b rejections of claims 7 and 18 have been maintained as the issue raised in item 9 of the previous office action dated 10/6/2025 (with respect only to claims 7 and 18) was not addressed.
Claim Objections
Claims 2, 6, and 15 are objected to because of the following informalities:
Claims 2, 6, and 15: “at least one inner tube opening” should read “at least one inner .
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 7 and 18 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.
Claim 7 (line 2) and claim 18 (line 3) each recite “the outer tube opening”. Because “at least one outer tube opening” has been previously recited in each of the claims (noting claims depend from claim 1 or 14), it is unclear which particular one of the previously recited at least one outer tube opening is being referenced by “the outer tube opening”. For purposes of claim interpretation, “the outer tube opening” is being treated as though it reads “the at least one outer tube opening” each time it appears in claims 7 and 18.
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) 1-3, 5, 7-9, 11-12, 14-15, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jezierski et al. (US 2021/0353321) in view of Malackowski (US 2003/0093103).
Regarding claim 1, Jezierski discloses a method for controlling a rotatable shaver driven by a powered handpiece having a drive means (MDU 110; includes motor 314, which corresponds to 35 USC 112f invoked structure of “drive means”) and a sensor (420; fig. 4b), the method comprising the steps of: providing a shaver assembly comprising: an outer tube (208; fig. 4b) having a proximal end, a distal end, at least one outer tube opening (200) at the distal end and an outer hub (204) at the proximal end, the outer hub being configured for attachment of the outer tube to the handpiece; an inner tube (400; fig. 4b) rotatably positioned in the outer tube ([0032]), the inner tube having a proximal end, a distal end, at least one inner opening (404) at the distal end, a cutting edge (“cutting window 404” is understood to have a cutting edge) at the inner opening for cooperating with the outer tube opening to cut tissue and an inner hub (406) at the proximal end, the inner hub being configured for attachment of the inner tube to the drive means; exactly one outer magnet (418) coupled to the outer tube or the outer hub, and exactly one inner magnet (416) coupled to the inner tube or the inner hub; inserting the shaver assembly into the handpiece, and determining the orientation of the outer tube and the inner tube from at least one of the outer magnet and the inner magnet ([0044]).
Regarding claims 14 and 20, Malkevich discloses a surgical shaver system comprising: a powered handpiece further comprising: a motor (314); a controller (116; fig. 1) for controlling the motor; and a magnet sensor (420) coupled to the controller; a shaver assembly comprising: an outer tube (208) further comprising a proximal end, a distal end, at least one outer tube opening (200) at the distal end and an outer hub (204) at the proximal end, the outer hub being configured for attachment of the outer tube to the handpiece; an inner tube (400) rotatably positioned in the outer tube, the inner tube having a proximal end, a distal end, at least one inner opening (404) at the distal end, a cutting edge (“cutting window 404” understood to have a cutting edge) at the inner opening for cooperating with the outer tube opening to cut tissue and an inner hub (406) at the proximal end, the inner hub being configured for attachment of the inner tube to the drive means ([0032]; fig. 4a); exactly one outer magnet (418) coupled to the outer tube or outer hub and exactly one inner magnet (416; fig. 4b, 5a, 5b) coupled to the inner tube or the inner hub; and wherein the controller is configured to operate the motor to rotate the inner tube relative to the outer tube while using the magnet sensor to determine the orientation of the outer tube and the inner tube from at least one of the outer magnet and the inner magnet ([0037], [0038]).
Regarding claims 1, 14 and 20, Jezierski does not disclose an RFID tag affixed to the outer tube or the outer hub, the RFID tag storing information about the type of shaver assembly, an RFID sensor coupled to the controller and configured to detect the presence of the RFID tag and read information from the RFID tag, and the step of sensing shaver information from the RFID tag.
Malackowski discloses another rotatable cutter having an outer tube (162) and an inner tube (166) rotatably positioned in the outer tube, the outer tube having an outer hub (160). Malackowski discloses an RFID tag (170) affixed to the outer tube or the outer hub ([0096]; fig. 11A), the RFID tag storing information about the type of shaver assembly including the maximum torque the motor is allowed to develop for that particular cutting accessory ([0068]). Malackowski discloses detecting the RFID tag and sensing cutter information from the RFID tag via a RFID sensor (coil 66/174 and associated circuit; [0096]-[0099]; fig. 3) in the hand piece. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Jezierski to include an RFID tag affixed to the outer hub as taught by Malackowski, and an RFID sensor coupled to the controller of the handpiece in order to provide additional information about the shaver assembly to the powered hand piece including data indicating the maximum speed at which the motor should run and, for given speeds, the maximum torque the motor is allowed to develop for that particular cutting accessory ([0068]).
Regarding claims 2 and 15, the method further comprises the step of positioning the inner tube opening at a predetermined position relative to the outer tube opening (via the controller; [0038] of Jezierski).
Regarding claim 3, detection of the RFID tag indicates insertion of the shaver assembly into the handpiece ([0072]-[0076]), [0127], [0143]-[0144]; note also fig. 25 – step 388 of Malackowski).
Regarding claims 5 and 17, the RFID contains information about a maximum torque usable with the shaver assembly ([0068] of Malackowski).
Regarding claim 7, the step of determining the orientation of the outer tube and the inner tube further comprises determining the orientation of the outer tube opening by sensing the position of the outer magnet ([0049]-[0050] of Jezierski).
Regarding claim 8, the step of determining the orientation of the outer tube and the inner tube further comprises determining the orientation of the at least one inner opening by sensing the position of the inner magnet ([0049]-[0050] of Jezierski).
Regarding claim 9, the step of determining the orientation of the outer tube and the inner tube further comprises determining the orientation of the at least one inner opening by rotating the inner tube relative to the outer tube and sensing changes in the position of the inner magnet (figs. 5a, 5b; [0048]-[0050], noting speed of rotation also sensed by changes in magnetic field strength).
Regarding claim 11, the inner tube is rotated relative to the outer tube until the inner magnet has passed either closest to or farthest from the sensor to determine orientation ([0039] of Jezierski – since rotation can be stopped when windows are aligned, which corresponds to inner magnet being closest to sensor, or when outer window is blocked by inner tube, which corresponds to inner magnet being farthest from sensor).
Regarding claim 12, Malackowski teaches automatically initiating new settings once detection of the RFID tag indicates insertion of the shaver assembly into the handpiece (see fig. 26). Jezierski includes a “predetermined orientation; see 706 in fig. 7, considered a setting, wherein the inner tube is oriented in a particular position relative to the outer tube. It would have been obvious to one of ordinary skill in the art to have further modified Jezierski to automatically initiate determination of the orientation of the inner and outer tubes once the RFID tag is detected in order to facilitate automatic placement of the shaver assembly in this pre-selected rotational position (i.e., the new setting) upon insertion of the shaver assembly into the handpiece.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jezierski in view of Malackowski as applied to claim 9 above, and further in view of Malkevich et al. (US 2019/0374278). Jezierski in view of Malackowski discloses the invention substantially as stated above determining the orientation of the inner and outer tube openings by rotating the inner tube relative to the outer tube and sensing changes in the position of the inner magnet ([0056]-[0057], [0059]), but does not expressly disclose rotating by about 360 degrees.
Malkevich discloses another method for controlling a rotatable shaver driver driven by a powered handpiece that includes determining an orientation of the outer tube (140) and inner tube (142) by rotating the tubes and sensing changes in the position of magnets (250a,255a; fig. 2a) associated with each tube. Malkevich discloses that the inner tube is rotated relative to the outer tube by about 360 degrees to determine orientation (see [0057] of Malkevich: “at least 360°”) in order to quantify the field strength of every relative rotational position of the inner and outer tubes.
It would have been obvious to one of ordinary skill in the art to have modified the method of Jezierski to include rotating the inner tube relative to the outer tube by about 360 degrees to determine the orientation of the outer tube and inner tube in view of Malkevich’s teaching that the claimed amount of rotation is known and satisfactory for determining orientation of two coaxial tubes via sensing of their associated magnets and such full, 360 degree rotation advantageously ensures that the magnetic field strength for every rotational position is sensed, thereby allowing the true peak to be sensed and the degrees of rotation away from the true peak to be determined.
Claim(s) 4, 13, 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jezierski in view of Malackowski as applied to claims 1 and 14 above, and further in view of Berberich (US 8,529,593). Jezierski in view of Malackowski discloses the invention substantially as stated above except for the inner tube further comprising two inner windows, or the RFID containing information about how many inner openings are present in the shaver assembly.
Berberich discloses another surgical cutting device comprising an inner tube (28/22) rotatably disposed within an outer tube (12), the outer tube comprising an outer tube opening (18) and the inner tube comprising an inner opening (44; fig. 2, fig. 6). In addition to the inner opening (44), the inner tube comprises two inner windows (46, 48; figs. 2, 6). According to Berberich, the multiple cutting windows of the inner tube advantageously allow different sizes of tissue fragments to be sucked into the cutting windows to efficiently cut different sizes of tissue fragments and further prevents clogging of the cutting element. It would have been obvious to one of ordinary skill in the art to have modified the inner tube to have at least two inner windows, in addition to the inner tube opening of Jezierski, as taught by Berberich in order to improve cutting and reduce clogging of the cutting element.
Regarding claims 4 and 16, Malackowski discloses that the RFID contains information about the physical characteristics of the cutting accessory and the type of cutting accessory (see abstract; [0181], [0182]). Thus, it would have been obvious to provide the RFID tag with information about how many inner openings are present in the shaver assembly as this is a physical characteristic (i.e., three openings on inner tube) that differentiates the cutting accessory from other cutting accessories attachable to the handle.
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jezierski in view of Malackowski as applied to claims 1 and 14 above, and further in view of Houser et al. (US 2012/0116381) and Casey et al. (US 2012/0109130). Jezierski in view of Malackowski discloses the invention substantially as stated above, including that the controller can stop the inner tube in a pre-selected rotational position, but does not expressly disclose that the predetermined position of the inner tube opening relative to the outer tube opening is user specific and information about a user's preferred predetermined position is accessible to a controller for controlling the powered handpiece.
Houser teaches providing a memory unit loaded with user preference information such that when the memory unit is coupled to the instrument, the controller is operable to configure the instrument according the user preference data ([0043]). Casey further teaches that orientation of the cutting window of a surgical cutting tool is a known user preference ([0005]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Jezierski to include a memory unit loaded with user preference information that is accessible to a controller for controlling the powered handpiece, the user preference information relating to the position of the inner opening relative to the outer tube opening in view of the teachings of Houser and Casey in order to allow the controller to automatically position the inner and outer openings of the inner and outer tubes in accordance with the user’s preferences.
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.
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KSH 4/8/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771