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
Applicant's arguments filed 08/01/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 112 have been withdrawn.
Rejections under 35 USC 102 have been withdrawn. Newly-found reference of Lu has been introduced to teach that a needle can have an ultrasonic transmitter at its proximal end. Lu has been applied to claim 1, as well.
Claim Objections
Objections to the claims have been withdrawn in response to Applicant’s amendments filed 08/01/2026.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 08/01/2026.
Claim Rejections - 35 USC § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 08/01/2026.
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.
Claims 1-3, 16-17, & 27 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Okada (US 2006/0058677) and Lu (US 2018/0000446).
Regarding claim 1, Cummins teaches an imaging apparatus, comprising:
one or more energy sources (ultrasound transducer 128, [0049]) configured to generate energy waves ([0054]), the one or more energy sources comprising a first ultrasonic transmitter ([0049]);
a waveform generator (electrical subsystem 130, [0054]) configured to generate one or more signals (ultrasound pulse, [0054]), the waveform generator in electrical communication with the one or more energy sources ([0054]);
a needle (needle 112, [0047]) comprising a needle tip (distal end 120, [0049]) at a distal end, the needle acoustically coupled to the first ultrasonic transmitter ([0049]), the needle configured to emit at least a portion of the energy waves from the needle tip ([0049] & [0054]); and
an ultrasonic detector array (ultrasound imaging probe 108, [0045]) configured to detect ultrasonic signals based on at least the portion of the energy waves emitted by the needle ([0053]).
However, Cummins fails to disclose that the waveform generator is an arbitrary waveform generator and the one or more signals are chirp signals, wherein the one or more chirp signals are configured to modulate the energy waves from the one or more energy sources to generate modulated energy waves.
Okada teaches an arbitrary waveform generator (arbitrary waveform generator 9, [0027]) configured to generate one or more chirp signals (chirp waveform, [0051]), wherein the one or more chirp signals are configured to modulate the energy waves from the one or more energy sources to generate modulated energy waves.
By combining Okada with Cummins, the waveforms transmitted by the transducer of Cummins would be chirp waveforms. These comprise modulated energy waves.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins such that the waveform generator is an arbitrary waveform generator and the one or more signals are chirp signals, wherein the one or more chirp signals are configured to modulate the energy waves from the one or more energy sources to generate modulated energy waves, as taught by Okada. The use of arbitrary waveform generators is known to increase signal-to-noise ratio in a system, and the use of chirp signals provides an easily-identifiable signal for the detector array to attribute to the needle tip.
However, Cummins in view of Okada fail to disclose that the first ultrasonic transmitter is at a proximal end of the needle.
Lu teaches that the first ultrasonic transmitter (proximal ultrasound receiver 31p, [0021]; [0020]) is at a proximal end ([0021] & Figure 1) of the needle (biopsy needle 30, [0021]).
Although Lu teaches another ultrasonic transmitter at the distal end of the needle, in an arrangement in which only the proximal ultrasonic transmitter is present in the needle, the entirety of the needle, including the tip, would emit ultrasound waves from an ultrasonic transmitter to which the needle is acoustically coupled.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada such that the first ultrasonic transmitter is at a proximal end of the needle, as taught by Lu. In an arrangement in which the needle has only the first ultrasonic transmitter, disposing it proximal to the tip allows the insertion end of the needle to be smaller, reducing discomfort for the patient during a procedure.
Regarding claim 2, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches one or more data acquisition systems (FPGA 326, [0095]) configured to record and digitize the ultrasonic signals detected by the ultrasonic detector array ([0097]).
Regarding claim 3, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches:
the needle is a biopsy needle ([0049]); and
the ultrasonic detector array is configured to detect a first set of ultrasonic signals ([0053]).
Combined Cummins, Okada, and Lu teach that the biopsy needle emits at least the portion of the modulated energy waves from the needle tip (See rejection of claim 1).
Regarding claim 16, Cummins in view of Okada teach the imaging apparatus of claim 16, and Cummins further teaches a power amplifier (amplifier 150, [0055]) in electrical communication with the one or more energy sources ([0055]), the power amplifier configured to amplify the energy waves generated by the one or more energy sources ([0055]).
Regarding claim 17, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches that the one or more energy sources comprise an ultrasonic source (ultrasound transducer 128, [0049]).
Regarding claim 27, Cummins in view of Okada and Lu teach the imaging apparatus of claim 1, and Cummins further teaches that the needle tip is a retractable needle tip (“The needle then may be extracted from the introducer to collect the tissue sample.”, [0134], Figures 27-28).
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Okada and Lu, as applied to claim 3, above, in further view of Bates (US 2020/0405260).
Regarding claim 4, Cummins in view of Okada and Lu teach the imaging apparatus of claim 3.
However, Cummins in view of Okada and Lu fail to disclose: the one or more energy sources comprises a second ultrasonic transmitter; and the ultrasonic detector array is configured to detect a second set of ultrasonic signals while the second ultrasonic transmitter is rotated around a subject being imaged.
Bates teaches:
the one or more energy sources comprises a second ultrasonic transmitter (transducers 210 or 214, [0052], Figure 2); and
the ultrasonic detector array (transducers 210 or 214, [0053], Figure 2) is configured to detect a second set of ultrasonic signals (acoustic information, [0053]) while the second ultrasonic transmitter is rotated ([0060]) around a subject (patient, [0051]) being imaged.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins, Okada, and Lu such that: the one or more energy sources comprises a second ultrasonic transmitter; and the ultrasonic detector array is configured to detect a second set of ultrasonic signals while the second ultrasonic transmitter is rotated around a subject being imaged, as taught by Bates. When applied to Cummins, a second transmitter that rotates around the subject allows multiple angles of the needle to be detected, allowing for a 3D reconstruction of the location.
Regarding claim 5, Cummins in view of Okada, Lu, and Bates teach the imaging apparatus of claim 4, and Bates further teaches:
a motor (servo-mechanical system, [0060]); and
a gear coupled to the motor and to the second ultrasonic transmitter, wherein the motor is configured to move the second ultrasonic transmitter along an arc or a circle (scanning circle, [0060]).
In order for the transducers to undergo rotational movement, a gear or other equivalent part must be present in the system.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins, Okada, and Lu to include: a motor; and a gear coupled to the motor and to the second ultrasonic transmitter, wherein the motor is configured to move the second ultrasonic transmitter along an arc or a circle, as taught by Bates. This facilitates an automation of the transmitter rotation, allowing the second ultrasonic transmitter to be easily controlled during the imaging procedure.
Regarding claim 6, Cummins in view of Okada, Lu, and Bates teach the imaging apparatus of claim 5, and Bates further teaches a rotational shaft (posts 208 & 212, [0061], Figure 2) coupled to the motor and to the gear ([0061], Figure 2), wherein the motor is configured to rotate the second ultrasonic transmitter ([0061]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins, Okada, and Lu to include a rotational shaft coupled to the motor and to the gear, wherein the motor is configured to rotate the second ultrasonic transmitter, as taught by Bates. This connects the transmitter to the motor and allows it to rotate about the subject.
Regarding claim 7, Cummins in view of Okada, Lu, and Bates teach the imaging apparatus of claim 4, and Bates further teaches that the second ultrasonic transmitter is a single element ultrasonic transducer (single element focused transducer, [0023]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins, Okada, and Lu such that the second ultrasonic transmitter is a single element ultrasonic transducer, as taught by Bates. This simplifies the design and manufacturing of the transmitter and reduces its price.
Regarding claim 8, Cummins in view of Okada, Lu, and Bates teach the imaging apparatus of claim 4, and Cummins further teaches a computing device (computer 104, [0045]) configured to determine a location of the needle tip within the subject (patient 116, [0046]) based on the first set of ultrasonic signals detected by the ultrasonic detector array ([0050], Figure 3).
Combined Cummins, Okada, and Lu teach that the biopsy needle emits at least the portion of the modulated energy waves from the needle tip (See rejection of claim 1).
Bates further teaches generating one or more two-dimensional images ([0056]) of the subject based on the second set of ultrasonic signals detected by the ultrasonic detector array while the second ultrasonic transmitter is rotated around the subject being imaged ([0056] & [0060]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins, Okada, and Lu to include generating one or more two-dimensional images of the subject based on the second set of ultrasonic signals detected by the ultrasonic detector array while the second ultrasonic transmitter is rotated around the subject being imaged, as taught by Bates. Capturing the images while rotating the transmitter allows for the needle to be imaged from various angles, allowing for a precise triangulation of its position.
Regarding claim 9, Cummins in view of Okada, Lu, and Bates teach the imaging apparatus of claim 8, and Cummins further teaches that the computing device is further configured to superimpose an indicator (visual cue, [0085]) of the location of the needle tip ([0073]) onto at least one of the one or more two-dimensional images ([0073]).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Lu.
Regarding claim 18, Cummins teaches an imaging method, comprising:
causing a first ultrasonic transmitter (ultrasound transducer 128, [0049]) in electrical communication with a biopsy needle (needle 112, [0047]) ([0049]) to emit acoustic waves (ultrasound pulse, [0054]) at or near a needle tip (distal end 120, [0049]) inserted into a subject (patient 116, [0046]) being imaged, the needle tip at a distal end of the biopsy needle ([0049]); and
determining a location of the needle tip within the subject using a first set of ultrasonic signals detected by an ultrasonic detector array (ultrasound imaging probe 108, [0045]) while the biopsy needle emits the acoustic waves ([0050], Figure 3).
However, Cummins fails to disclose that the first ultrasonic transmitter is at a proximal end of the needle.
Lu teaches that the first ultrasonic transmitter (proximal ultrasound receiver 31p, [0021]; [0020]) is at a proximal end ([0021] & Figure 1) of the needle (biopsy needle 30, [0021]).
Although Lu teaches another ultrasonic transmitter at the distal end of the needle, in an arrangement in which only the proximal ultrasonic transmitter is present in the needle, the entirety of the needle, including the tip, would emit ultrasound waves from an ultrasonic transmitter to which the needle is acoustically coupled.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins such that the first ultrasonic transmitter is at a proximal end of the needle, as taught by Lu. In an arrangement in which the needle has only the first ultrasonic transmitter, disposing it proximal to the tip allows the insertion end of the needle to be smaller, reducing discomfort for the patient during a procedure.
Regarding claim 19, Cummins teaches the imaging method of claim 18, wherein the location of the needle tip is determined during an in vivo imaging procedure ([0050], Figure 3).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Lu, as applied to claim 18, above, in further view of Bates.
Claim 20 is rejected for similar reasons to claims 4 & 8-9.
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 ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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