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 .
Status of the Claims
This Office Action is responsive to the amendment filed November 14, 2025. As directed by the amendment: Claims 15, 16, 18, 19 and 22-27 have been amended. Claims 11, 17, 20, 21, and 28-87 have been cancelled. Claims 1-10 and 12-14 were withdrawn. Claims 1-10, 12-16, 18, 19, and 22-27 are presently pending in this application.
Claim Rejections - 35 USC § 112(b)
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 15 and 16 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 15 recites the limitations "the ultrasonic sender" in ll. 4, “the ultrasonic receiver” in ll. 4-5. There is insufficient antecedent basis for these limitations in this claim.
Claim 16 is rejected on being dependent to a rejected base claim.
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 § 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) 15, 16, 18, 19, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (US 2001/0044578), herein referred to as Ben-Haim, in view of Moctezuma de la Barrera et al. (US 2005/0020909), herein referred to as Moctezuma de la Barrera, and further in view of Badano et al. (US 6,167,292), herein referred to as Badano.
Regarding claim 15, Ben-Haim discloses a surgical guidance system (figure 2) comprising a surgical tool (36) (¶135) including senders (¶26, ¶27, ¶138, ¶139), a reference frame (20) (figures 1A, 1B) including receivers (¶26, ¶27, ¶132), a CPU (46) having hardware (¶140) including machine readable code (¶140) to determine time of flight (TOF) of a signal (¶144) generated by the ultrasonic sender (¶26, ¶27, ¶138, ¶139) as received by the ultrasonic receiver (¶26, ¶27, ¶132), and a visual display (152) or feed-back system (48) to inform a surgeon as to how to create a pathway through the reference frame (20) configured to (i.e. capable of) contain the subject patient body part (32) (figure 2).
Yet, Ben-Haim lacks wherein the surgical tool is a handheld surgical drill.
However, Moctezuma de la Barrera teaches a tracking unit and display is particularly useful for power surgical tools such as drills and non-power hand tools such as needles (¶57). Furthermore, Moctezuma de la Barrera teaches a handheld surgical drill (100) (figure 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Ben-Haim’s surgical tool (e.g. needle) with a handheld surgical drill as taught by Moctezuma de la Barrera, since such a modification is a mere substitution of one known surgical tool for another to yield predictable results.
The modified Ben-Haim’s surgical targeting system further lacks wherein the senders are piezoelectric ultrasound senders and wherein the receivers are wideband microphone receivers.
However, Badano teaches wherein the senders are piezoelectric ultrasound senders (col. 5, ll. 14-21) and wherein the receivers are wideband microphone receivers (col. 5, ll. 14-21).
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 the modified Ben-Haim’s surgical targeting system with wherein the senders are piezoelectric ultrasound senders and wherein the receivers are wideband microphone receivers as taught by Badano, since such a modification is a specific type of emitter element and receiver element well known to the person skill in the art (col. 5, ll. 14-21).
Regarding claim 16, the modified Ben-Haim’s surgical system has wherein reference points for a pathway created by the surgical drill (¶57 of Moctezuma de la Barrera) are obtained through digital images (60 of Ben-Haim) (¶144 of Ben-Haim).
Regarding claim 18, Ben-Haim discloses a surgical targeting system (figure 2) guided by ultrasonic sender/receiver pairs (¶26, ¶27, ¶132, ¶138, ¶139), a surgical tool (36) (¶135), the sender/receiver pairs being in proximity to x-ray opaque fiducials (¶149) positioned relative to a subject surgical area (figure 2) located within a defined three-dimensional reference frame (20) (figures 1A, 1B), and a CPU hardware (46) and software (via element 48) to determine the proximity in space of the associated ultrasonic sender/receivers (¶26, ¶27, ¶132, ¶138, ¶139) as they change course over time (¶36).
Yet, Ben-Haim lacks wherein the sender receiver pairs are mounted on a hand-held surgical drill.
However, Moctezuma de la Barrera teaches a tracking unit and display is particularly useful for power surgical tools such as drills and non-power hand tools such as needles (¶57). Furthermore, Moctezuma de la Barrera teaches sender receiver pairs (¶36) are mounted on a handheld surgical drill (100) (figure 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Ben-Haim’s surgical tool (e.g. needle) with the sender receiver pairs are mounted on a hand-held surgical drill as taught by Moctezuma de la Barrera, since such a modification is a mere substitution of one known surgical tool for another to yield predictable results.
The modified Ben-Haim’s surgical targeting system further lacks wherein each the pair including a wideband microphone receiver and a piezoelectric ultrasound sender.
However, Badano teaches wherein the senders are piezoelectric ultrasound senders (col. 5, ll. 14-21) and wherein the receivers are wideband microphone receivers (col. 5, ll. 14-21).
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 the modified Ben-Haim’s surgical targeting system with wherein the senders are piezoelectric ultrasound senders and wherein the receivers are wideband microphone receivers as taught by Badano, since such a modification is a specific type of emitter element and receiver element well known to the person skill in the art (col. 5, ll. 14-21).
Regarding claim 19, the modified Ben-Haim’s surgical targeting system has wherein a surgical pathway (¶115 of Ben-Haim) is determined by a user (e.g. surgeon) and includes a drill entry point (e.g. start point) and an end point (e.g. target) and where the drill entry point (e.g. start point) and the end point (e.g. target) are selected by the user (¶140 of Ben-Haim) and entered into a computer (48 of Ben-Haim).
Regarding claims 22, 23, the modified Ben-Haim’s surgical targeting system discloses all the features/elements as claimed but lacks a detailed description on wherein the sender is used in a pattern that is from 3 to 6 0° pulses followed by the same number of 180° pulses, wherein the sender is used in a pattern that is from four 0° pulses followed by four 180° pulses.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
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 the modified Ben-Haim’s surgical targeting system with wherein the sender is used in a pattern that is from 3 to 6 0° pulses followed by the same number of 180° pulses, wherein the sender is used in a pattern that is from four 0° pulses followed by four 180° pulses, since the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Claim(s) 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim and Moctezuma de la Barrera as applied to claims above, and further in view of Roth, II et al. (US 2020/0149980), herein referred to as Roth, II.
Regarding claims 24, 25, 26, 27, the modified Ben-Haim’s surgical targeting system discloses all the features/elements as claimed but lacks a detailed description on wherein algorithmic means are used to locate a phase inflection point, wherein code is used along with analog data taken to produce a final measurement output, wherein an offset is used to account for detection of wave inversion, the offset is based on one or more of a wave number, a microphone displacement, and a transmitter or receiver foci.
However, Roth, II teaches wherein algorithmic means (¶86, ¶87) are used to locate a phase inflection point (¶149), wherein code (¶86, ¶87) is used along with analog data (¶86) taken to produce a final measurement output (¶86, ¶87), wherein an offset is used to account for detection of wave inversion (¶91), the offset is based on one or more of a wave number (¶91), a microphone displacement, and a transmitter or receiver foci.
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 the modified Ben-Haim’s surgical targeting system with wherein algorithmic means are used to locate a phase inflection point, wherein code is used along with analog data taken to produce a final measurement output, wherein an offset is used to account for detection of wave inversion, the offset is based on a wave number as taught by Roth, II, since ultrasonic signals may be propagated and sensed to measure environmental conditions such as temperature to which the sensors are subjected (¶5).
Response to Arguments
Applicant's arguments filed November 14, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 8-11, under 35 U.S.C. 103, of the Remarks are directed to the amended claims and the combination of references (Ben-Haim, Moctezuma de la Barrera, Badano). Applicant argues that “claims 15 and 18 are directed to a "handheld surgical drill[s]," while Badano relates to a robotic surgical drill” and “Thus, a person of skill in the art would NOT have been motivated to combine the teachings of Badano with the teachings of either Ben Haim or Moctezuma, since Badano expressly teaches away from the use of such senders/receivers (e.g., piezoelectric ultrasound senders and wideband microphone receivers) on handheld surgical devices such as drills”. However, the Examiner respectfully disagrees because the reference Badano was specifically used to teach an energy emitting element and a receiving element, wherein the emitter element is an ultrasonic emitter element (e.g. piezoelectric type) and wherein the ultrasound receiver element comprises at least one microphone (col. 5, ll. 14-21). The reference Badano was not used to teach a drill. The Examiner notes that the handheld drill was specifically taught by the reference Moctezuma de la Barrera.
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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/SI MING KU/Primary Examiner, Art Unit 3775