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 .
Response to Arguments
The previous objection of claim 9 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/07/2026.
The previous rejection of claim(s) 10-11 and 17 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 10-11 and 17 on 7/07/2026.
Applicant's arguments filed 7/07/2026 have been fully considered but they are not persuasive. Applicant argues Palushi et al. (US 2020/0107885 A1) makes no reference to a Hall effect sensor, to a magnet fixedly secured to a rotary member, or to detecting an angular position of the rotary member using the Hall effect sensor and magnet. Therefore, Palushi neither discloses nor suggests the claimed Hall effect sensor secured against movement relative to the outer shaft as presently claimed. However, as discussed below and in the Non-Final Rejection mailed 4/08/2026, Palushi is relied upon to teach a navigation sensor, not the Hall effect sensor as claimed.
Applicant argues Matusaitis et al. (US 2013/0085498 A1) teaches away from the claimed feature of the Hall effect sensor secured against movement relative to the outer shaft as Matusaitis expressly discloses that the sensor 70 is provided on the handpiece 2, while at the same time permitting adjustment of the rotational orientation of the outer tube cutting window relative to the handpiece. Thus, Matusaitis intentionally designed its sensor to be movable relative to the outer tube in direct contract to the claimed feature.
However, in applicant’s own invention, “the shaft assembly alignment system 101 includes a Hall effect sensor 160 in operative communication with the processor 52 and fixedly secured to a portion of the handle assembly 102” ([0031]), similar to the sensor 70 of Matusaitis being secured to handpiece 2. Applicant recites “the magnetic base 162 is configured to rotate together with the cutting member 118 relative to the outer shaft 116, while the Hall effect sensor 160 may be configured to remain stationary relative to the outer shaft 116 during such rotation of the cutting member 118 relative to the outer shaft 116 (e.g., while the rotation control knob 114 is stationary). Thus, the angular position of the cutting window opening 122 is fixed relative to the magnetic base 162, while the angular position of the shaft window opening 121 may be fixed relative to the Hall effect sensor 160.” ([0031]). The device of Matusaitis works in the same manner. For example, the sensor 70 in the handpiece 2 is configured to remain stationary relative to the outer cutting blade 10 during rotation of the cutting blade 9 while the first part 90a on the handpiece is stationary (as the coupling 90 is provided between the outer cutting blade 10 and the handpiece 2 such that the rotational orientation of the outer cutting blade relative to the handpiece 2 can be varied; [0045]). Thus, the angular position of the cutting window 40 may be fixed relative to the handpiece 2 and the sensor 70 therein ([0045]).
While applicant has support for other versions in which the Hall effect sensor 160 may be fixedly secured directly to the outer shaft 116 ([0031]), such language is not found within the present claims.
Accordingly, applicant’s arguments over Matusaitis are not found persuasive.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 is dependent on canceled claim 4. For the purposes of examination, claim 5 is interpreted as being dependent on claim 1. Appropriate correction is required.
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.
Claim(s) 1-3, 5-13 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matusaitis et al. (US 2013/0085498 A1) in view of Palushi et al. (US 2020/0107885 A1).
Regarding claim 1, Matusaitis discloses a medical instrument (surgical instrument system 1; Fig. 1) comprising: a body (handpiece 2 and outer tube 10) comprising an outer shaft (10) extending along a rotational axis (axis of 10) and defining a lumen (Figs. 4-5; 8A-8C); a rotary member (inner tube 9 rotatable relative to the outer tube 10 and the handpiece 2; [0036]) sized and configured to fit in an anatomical passageway of a patient (ear, nose and throat, head, neck, spine, etc.; [0033]), the rotary member (9) being configured to rotate within the lumen of the outer shaft relative to the body about the rotational axis ([0036]; Figs. 4-5); and an alignment system comprising: a magnet (magnet member 50) fixedly secured to the rotary member (50 is provided on the inner cutting blade 9 on hub 13; [0040]; Fig. 3), the magnet being configured to generate a magnetic field (via magnetically permeable member 60 and magnets inherently generate a magnetic field; Fig. 6B), and a Hall effect sensor (including sensor 70, it is noted that sensor 70 senses the magnetic flux of the magnetically permeable member 60 base on magnet 50; thus, is a hall effect sensor because it detects magnetic fields and produces an electrical signal based on such detection; [0040]) fixedly secured to the body (at least on handpiece 2; Fig. 3) and secured against movement relative to the outer shaft (it is noted applicant’s own invention includes Hall effect sensor 160 fixedly secured to a portion of the handle assembly 102 such that that Hall effect sensor 160 may be configured to remain stationary relative to the outer shaft 116 during rotation of the cutting member 118 relative to the outer shaft 116 while the rotation control knob 114 is stationary; [0031]; and the instrument of Matusaitis works in the same manner as the sensor 70 in the handpiece 2 is configured to remain stationary relative to the outer cutting blade 10 during rotation of the cutting blade 9 while the first part 90a on the handpiece is stationary (as the coupling 90 is provided between the outer cutting blade 10 and the handpiece 2 such that the rotational orientation of the outer cutting blade relative to the handpiece 2 can be varied); [0045]), the Hall effect sensor (70) being configured to detect a magnitude of the magnetic field and to generate second signals indicative of an angular position of the rotary member relative to the body about the rotational axis (as 70 outputs a signal that fluctuates as the inner cutting blade 9 rotates to detect the position of the inner cutting blade 9 relative to the outer cutting blade 10 even if the rotational orientation of the outer cutting blade 10 relative to the handpiece 2 is changed; [0042]; [0044]).
Matusaitis fails to disclose a navigation sensor coupled to the body, the navigation sensor being configured to generate first signals indicative of a position of the body in three-dimensional space.
However, Palushi teaches a medical instrument (surgical cutting instrument 10; Fig. 2) comprising a body (handle assembly 12 and/or outer shaft 28); a rotary member (inner cutting member 30) sized and configured to fit in an anatomical passageway of a patient ([0026]); and a navigation sensor (navigation system 100; Fig. 1) coupled to the body (as the navigation system 100 determines the location of the surgical cutting instrument via one or more position sensors within 10; [0026]), the navigation sensor being configured to generate first signals indicative of a position of the body in three-dimensional space (as 100 provides information regarding the position of the instrument within the head of a patient in real time via display screen 114; [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical instrument of Matusaitis to include the navigation system/sensor as taught by Palushi in order to desirably have information regarding the position of the instrument within the head of a patient in real time.
Regarding claim 2, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the rotary member comprises a cutting member (inner cutting blade 9).
Regarding claim 3, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the body (2, 10) comprises a handle body (handpiece 2; Fig. 1).
Regarding claim 5, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the outer shaft (10) comprises a shaft opening (cutting window 40) in fluid communication with an environment (Fig. 3).
Regarding claim 6, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the rotary member (9) comprises a cutting window opening (cutting window 30) configured to be (a) at least partially angularly aligned with the shaft opening to define an open state (Fig. 3) and (b) fully angularly misaligned from the shaft opening to define a closed state (Fig. 5).
Regarding claim 7, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the rotary member (9) comprises a suction lumen (lumen within 9) extending along the rotational axis, the cutting window opening (30) being in fluid communication with the suction lumen (via suction source 28; Fig. 1).
Regarding claim 8, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses a processor (microprocessor; [0040]) in operative communication with the Hall effect sensor (70) to receive the second signals therefrom ([0040]), the processor being configured to determine whether the cutting window opening (30) is in the open state or the closed state based on the second signals ([0040]; [0044]).
Regarding claim 9, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the processor is configured to transition the cutting window toward the closed state ([0053]).
Regarding claim 10, Matusaitis modified discloses wherein the navigation sensor (100 of Palushi) is configured to generate first signals indicative of a position of the shaft opening in three-dimensional space (as the position and orientation of the shaft window opening 50 may be provided in real time via display screen 114; [0032] of Palushi).
Regarding claim 11, Matusaitis modified discloses wherein the navigation sensor (100 of Palushi) is configured to generate first signals indicative of a position of a distal portion of the body (outer shaft) in three-dimensional space (as the position and orientation of the distal end of the surgical cutting instrument 10 i.e., shaft may be provided in real time via display screen 114; [0032] of Palushi).
Regarding claim 12, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the magnet (50) is fixedly secured to a proximal end of the rotary member (9 via 13; [0040]; Fig. 3).
Regarding claim 13, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses a magnetic base (base of 50A, 50B) centered on the rotational axis (Fig. 6A), the magnetic base including the magnet (Fig. 6A).
Regarding claim 15, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the Hall effect sensor (70) is offset from the rotational axis (Fig. 3).
Regarding claim 16, Matusaitis discloses a medical instrument (surgical instrument system 1; Fig. 1) comprising: a shaft (outer tube 10) extending along a longitudinal axis (Fig. 3), the shaft comprising: a lumen (lumen of 10; Fig. 3), and a shaft opening (cutting window 40) in fluid communication with an environment (Fig. 3); a cutting member (inner cutting blade 9) disposed within the lumen of the shaft (Fig. 3) and configured to rotate relative to the shaft about the longitudinal axis between an open state and a closed state (inner tube 9 rotatable relative to the outer tube 10 and the handpiece 2; [0036]), the cutting member (9) comprising: a suction lumen (lumen through 9 that may include suction view suction source 28) extending along the longitudinal axis (Figs. 1, 3), and a cutting window opening (cutting window 30) in fluid communication with the suction lumen (Fig. 3), the cutting window opening being configured to be at least partially aligned with the shaft opening to define the open state (Fig. 3), and configured to be fully misaligned from the shaft opening to define the closed state (Fig. 5); and an alignment system comprising: a magnet (magnet member 50) fixedly secured to the cutting member (50 is provided on the inner cutting blade 9 on hub 13; [0040]; Fig. 3), the magnet (50) being configured to generate a magnetic field (via magnetically permeable member 60 and magnets inherently generate a magnetic field; Fig. 6B), and a Hall effect sensor secured against movement relative to the shaft (it is noted applicant’s own invention includes Hall effect sensor 160 fixedly secured to a portion of the handle assembly 102 such that that Hall effect sensor 160 may be configured to remain stationary relative to the outer shaft 116 during rotation of the cutting member 118 relative to the outer shaft 116 while the rotation control knob 114 is stationary; [0031]; and the instrument of Matusaitis works in the same manner as the sensor 70 in the handpiece 2 is configured to remain stationary relative to the outer cutting blade 10 during rotation of the cutting blade 9 while the first part 90a on the handpiece is stationary (as the coupling 90 is provided between the outer cutting blade 10 and the handpiece 2 such that the rotational orientation of the outer cutting blade relative to the handpiece 2 can be varied); [0045]), the Hall effect sensor (sensor 70, it is noted that sensor 70 senses the magnetic flux of the magnetically permeable member 60 base on magnet 50; thus, is a hall effect sensor because it detects magnetic fields and produces an electrical signal based on such detection; [0040]) being configured to detect a magnitude of the magnetic field and to generate second signals indicative of an angular position of the cutting member relative to the shaft about the longitudinal axis (as 70 outputs a signal that fluctuates as the inner cutting blade 9 rotates to detect the position of the inner cutting blade 9 relative to the outer cutting blade 10 even if the rotational orientation of the outer cutting blade 10 relative to the handpiece 2 is changed; [0042]; [0044]).
Matusaitis fails to disclose a navigation sensor coupled to the shaft, the navigation sensor being configured to generate first signals indicative of a position of the shaft in three-dimensional space.
However, Palushi teaches a medical instrument (surgical cutting instrument 10; Fig. 2) comprising a body (handle assembly 12 and/or outer shaft 28); a rotary member (inner cutting member 30) sized and configured to fit in an anatomical passageway of a patient ([0026]); and a navigation sensor (navigation system 100; Fig. 1) coupled to the shaft (as the navigation system 100 includes one or more sensors on shaft assembly 16 and determines the location of the surgical cutting instrument via one or more position sensors within 10; [0026]; [0032]), the navigation sensor being configured to generate first signals indicative of a position of the body in three-dimensional space (as 100 provides information regarding the position of the instrument within the head of a patient in real time via display screen 114; [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical instrument of Matusaitis to include the navigation system/sensor on the shaft as taught by Palushi in order to desirably have information regarding the position of the instrument within the head of a patient in real time.
Regarding claim 17, Matusaitis modified discloses wherein the navigation sensor (100 of Palushi) is configured to generate first signals indicative of a position of the shaft opening in three-dimensional space (as the position and orientation of the shaft window opening 50 may be provided in real time via display screen 114; [0032] of Palushi).
Regarding claim 18, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses a magnetic base (base of 50A, 50B) fixedly secured to a proximal end of the cutting member (via 13; [0040]; Fig. 3), the magnetic base comprising the magnet (Fig. 6A).
Regarding claim 19, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the magnetic base (base of 50A, 50B) is centered on the longitudinal axis (Fig. 6A), the Hall effect sensor (70) being offset from the longitudinal axis (Fig. 3).
Allowable Subject Matter
Claims 14 and 21-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Matusaitis, does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, wherein the magnet (50A, 50B of Matusaitis) comprises a plurality of north pole magnets and a plurality of south pole magnets in a contiguous, alternating arrangement, in an annular form comprising a central opening, with at least 8 north pole magnets and 8 south pole magnets. Instead, two oppositely polarized magnets 50A and 50B are disposed at diametrically opposite positions relative to the longitudinal axis of the inner cutting blade 9 (Figs. 6A, 6B), such that a polarity of an outwardly-facing pole of one magnet is opposite the other ([0041]). The magnets do not touch nor are there a plurality of each to make a contiguous, annular form. It would not have been obvious to one of ordinary skill in the art to modify the magnet/magnetic base of Matusaitis as claimed, as doing so would interfere with the magnetic flux induced in the ferromagnetic pieces 60a and 60b as the polarity of the magnets 50A, 50B would alternate without gaps.
Because none of the prior art documents teach * as claimed, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the technical solutions of claim * according to the prior art documents or a combination thereof. Therefore, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SARAH A LONG/Primary Examiner, Art Unit 3771
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