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
Applicant's election with traverse of the election/restriction in the reply filed on August 12, 2026 is acknowledged. The traversal is on the ground(s) that “Groups I, II, and III are linked by a technical relationship involving the same or corresponding special technical features, and therefore form a single general inventive concept under PCT Rule 13.1”. This is found persuasive and the restriction requirement has been withdrawn.
Claims 1-17 are presently pending in this application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Examiner’s Note
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.
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, 11-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dannaher et al. (US 2018/0070976), herein referred to as Dannaher.
Regarding claim 1, Dannaher discloses a method (¶40 and figure 4) for determining a position of an ultrasonic osteotome (200) (¶29 and figure 3), comprising obtaining an acoustic impedance signal (e.g. step 410, see figure 4) of the ultrasonic osteotome (200) (¶29 and figure 3), and determining a current position of the ultrasonic osteotome (200) in bone tissue (¶48) to be cut based on the acoustic impedance signal (¶49).
Regarding claim 11, Dannaher discloses wherein the bone tissue to be cut comprises outer cortical bone (e.g. bone tissue, ¶48), the cancellous bone (e.g. bone tissue, ¶48), and inner cortical bone (e.g. bone tissue, ¶48) arranged sequentially from outside to inside (e.g. bone tissue, ¶48), and the method further comprises sending first prompt information (e.g. alerts, ¶49 and figure 7) in response to determining that the current position is an interface between the inner cortical bone (e.g. bone tissue, ¶48) and the soft tissue (e.g. soft tissue, ¶48).
Regarding claim 12, Dannaher discloses wherein the determining that the current position is an interface between the inner cortical bone and the soft tissue comprises determining that the current position is the interface between the inner cortical bone (e.g. bone tissue, ¶48) and the soft tissue (e.g. soft tissue, ¶48) in response to determining that the current position is at the interface between the cortical bone (e.g. bone tissue, ¶48) and the other tissue for the second time (¶49 and figure 7).
Regarding claim 13, Dannaher discloses wherein the bone tissue to be cut comprises the cortical bone (e.g. bone tissue, ¶48) and the cancellous bone (e.g. bone tissue, ¶48) arranged sequentially from outside to inside (e.g. bone tissue, ¶48), and the method further comprises sending second prompt information (e.g. alerts, ¶49 and figure 7) in response to determining that displacement of the ultrasonic osteotome (200) is within a preset size and the current position is the interface between the cancellous bone (e.g. bone tissue, ¶48) and the cortical bone (e.g. bone tissue, ¶48).
Regarding claim 14, Dannaher discloses wherein the bone tissue to be cut comprises the cortical bone (e.g. bone tissue, ¶48), and the method further comprises sending third prompt information (e.g. alerts, ¶49 and figure 7) in response to determining that the current position is the interface between the cortical bone (e.g. bone tissue, ¶48) and the soft tissue (e.g. soft tissue, ¶48).
Regarding claim 15, Dannaher discloses an ultrasonic surgical system (figure 3), comprising an ultrasonic osteotome (200) (¶29 and figure 3) configured to (i.e. capable of) cut bone tissue to be cut, a memory (¶18), and a computer processor (¶18) operatively coupled with the memory (¶18), the memory (¶18) embodying information indicative of instructions for causing the computer processor to perform operations (¶18) comprising obtaining an acoustic impedance signal (e.g. step 410, see figure 4) of the ultrasonic osteotome (200) (¶29 and figure 3), and determining a current position of the ultrasonic osteotome (200) in bone tissue (¶48) to be cut based on the acoustic impedance signal (¶49).
Regarding claim 17, Dannaher discloses a non-transitory computer-readable storage medium storing computer instructions (¶18), wherein the computer instructions are used to cause a computer processor (¶18) to perform obtaining an acoustic impedance signal (e.g. step 410, see figure 4) of an ultrasonic osteotome (200) (¶29 and figure 3), and determining a current position of the ultrasonic osteotome (200) in bone tissue (¶48) to be cut based on the acoustic impedance signal (¶49).
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) 2-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dannaher (US 2018/0070976) in view of Windolf et al. (US 10,736,644), herein referred to as Windolf.
Regarding claims 2, 3, 4, 5, 6, 7, 8, 9, 10, Dannaher’s method discloses all the features/elements as claimed but lacks a detailed description on wherein the determining a current position of the ultrasonic osteotome in bone tissue to be cut based on the acoustic impedance signal comprises determining that the current position is an interface between other tissue and cortical bone in response to determining that the acoustic impedance signal is on a first rising edge in a preset time and an average slope of the first rising edge is within a first slope range, wherein the determining that the current position is an interface between other tissue and cortical bone comprises determining that the current position is an interface between air and the cortical bone in response to determining that an acoustic impedance amplitude at a start point of the first rising edge is within a first preset range, wherein the determining that the current position is an interface between other tissue and cortical bone comprise determining that the current position is an interface between soft tissue and the cortical bone in response to determining that an acoustic impedance amplitude at a start point of the first rising edge is within a second preset range, wherein the determining that the current position is an interface between other tissue and cortical bone comprises determining that the current position is an interface between cancellous bone and the cortical bone in response to determining that an acoustic impedance amplitude at a start point of the first rising edge is within a third preset range, wherein the determining a current position of the ultrasonic osteotome in bone tissue to be cut based on the acoustic impedance signal comprises determining that the current position is an interface between cortical bone and other tissue in response to determining that the acoustic impedance signal is on a first falling edge in a preset time and an average slope of the first falling edge is within a second slope range, wherein the determining that the current position is an interface between cortical bone and other tissue comprises determining that the current position is an interface between the cortical bone and cancellous bone in response to determining that an acoustic impedance amplitude at an end point of the first falling edge is within a third preset range, wherein the determining that the current position is an interface between cortical bone and other tissue comprises determining that the current position is an interface between the cortical bone and soft tissue in response to determining that an acoustic impedance amplitude at an end point of the first falling edge is within a second preset range, wherein the determining a current position of the ultrasonic osteotome in bone tissue to be cut based on the acoustic impedance signal comprises determining that the current position is in cortical bone in response to determining that the acoustic impedance signal is within a fourth preset range throughout a preset time wherein the determining a current position of the ultrasonic osteotome in bone tissue to be cut based on the acoustic impedance signal comprises determining that the current position is in cancellous bone in response to determining that the acoustic impedance signal is consistently within a third preset range throughout a preset time.
However, Windolf teaches a processing unit (14) comprises one or more differentiators to determine at least the first and second derivatives of the position x with respect to time and a peak detector (col. 9, ll. 32-50). Windolf teaches in figure 5 a first rising edge (e.g. element B) in a preset time (figure 5), an average slope of the first rising edge (figure 5), a first falling edge (e.g. between elements “B” and “C”) in a preset time (figure 5) and an average slope of the first falling edge is within a second slope range (figure 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dannaher’s method having a control module with the functionality of the processing unit of Windolf, such that the rising edges, falling edges, slopes, preset ranges is identifiable by a surgeon in order for the surgeon to clearly identify distinct increases and subsequent revisions to know when the ultrasonic osteotome has gone through the bone layers and help prevent cutting/damaging any soft tissue on the other side of the bone (col. 9, ll. 32-50).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dannaher (US 2018/0070976) in view of Cao et al. (US 10,588,645), herein referred to as Cao.
Regarding claim 16, Dannaher’s method discloses all the features/elements as claimed including wherein the system further comprises a surgical robot (¶59) connected to the ultrasonic osteotome (200), and the processor (¶18) is further configured to (i.e. capable of) operate the ultrasonic osteotome (200) by controlling the surgical robot (¶59) but lacks a detailed description on a display device configured to display an acoustic impedance signal of the ultrasonic osteotome.
However, Cao teaches a display device (23) (figure 1) configured to (i.e. capable of) display a signal of an ultrasonic osteotome (11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Dannaher’s method with a display device configured to display a signal of an ultrasonic osteotome as taught by Cao, so that the doctors and/or operators can monitor the surgery procedure in real time (col. 6, ll. 4-12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Voic (US 2014/0276849) is cited to show bone tissue comprises outer cortical bone, cancellous bone, inner cortical bone.
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/SI MING KU/Primary Examiner, Art Unit 3775
