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 .
Election/Restrictions
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/29/2026.
Applicant’s election without traverse of Group I, claims 1-19, in the reply filed on 1/29/2026 is acknowledged.
Claim Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites “the cutting window” in line 2 which should read “the cutting window opening” for consistency purposes. 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 10-11 and 17 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 10-11 and 17 recite “to generate first signals” in lines 2, respectively. Claims 10-11 depend from claim 1 which recites “to generate first signals” in lines 6-7 and claim 17 depends from claim 16 which recites “to generate first signals” in lines 13-14. It is unclear if the first signals of claims 10-11 and 17 are intended to be the same as those recited in claims 1 and 16 or in addition thereto. For the purposes of examination, the first signals of claims 10-11 and 17 are interpreted as the same as those recited in claims 1 and 16.
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) 1-19 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); 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 relative to the body about a rotational axis ([0036]); 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 (Fig. 3), 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 4, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the body (2, 10) comprises an outer shaft (outer tube 10) extending along the rotational axis and defining a lumen (Fig. 2), the rotary member (9) being rotatably disposed within the lumen (Fig. 2; [0036]).
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 14, Matusaitis modified discloses the invention as disclosed above, and Matusaitis further discloses wherein the magnet (50) comprises a plurality of north and south pole magnets (50A, 50B) in a circumferentially-alternating arrangement (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, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jezierski et al. (US 2021/0353321 A1) and Germain et al. (US 2021/0093371 A1) are noted for teaching orientation sensors (Fig. 4B), (Fig. 2A-2B).
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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771