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 .
Preliminary Note
Claims 1-6 as filed on March 07, 2023 are presently pending.
Claim Objections
Claims 1, 5 and 6 are each objected to because of the following informalities:
In claim 1, stanza “a”, the phrase “configured to an actuated mounting shaft” appears to omit the phrase “couple to”, see corresponding recitation in claim 5 in stanza “a”.
In each of claim 1, 5 and 6, in stanza “a(i)”, the phrase “an adapter platform defining” should be deleted as the phrase is repetitive.
In claim 1 in stanza “c” should be amended to “at least one transducer housing” consistent with corresponding recitation in claim 5 in stanza “c” and for proper antecedence basis.
In each of claim 1 and 5 in stanza “c (iii)/(3)” and in claim 6, in stanza “a(iii)3” , the phrase “a coupling cone” should be amended to “the coupling cone” for proper antecedence basis.
In claim 4, in line 3, the phrase “the position and orientation” should be amended to “a position and orientation” for proper antecedence basis.
In claim 5, stanza “b”, the focused ultrasound transducer” should be amended to “a focused ultrasound transducer” for proper antecedence basis.
In claim 6, the abbreviation “FUS-BBB” should be accompanied by the full expression, as this is the first instance in the claims.
In claim 6, stanza “a” the word comprising should include colon “:”.
In claim 6, stanza “b” the phrase “an actuated shaft” and “a mounting bore” should be amended to “the actuated shaft” and “the mounting bore” respectively, for proper antecedence basis.
In claims 1-2 and 4-6, additional periods are present in the claims and should be removed. Proper claim format dictates that claims begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims, i.e. within multilevel outlining lists (e.g. a. or iii.). See MPEP § 608.01(m).
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.
Claim 6 is 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 6 recites the limitation "the FUS device" in stanza "b". There is insufficient antecedent basis for this limitation in the claim as the claim does not previously set forth a FUS device. For examination purposes only, it will be presumed that FUS device refers to FUS system specified in stanza “a”.
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Phipps et al. "Considerations for ultrasound exposure during transcranial MR acoustic radiation force imaging" ("Phipps"), in view of Jack et al. WO 2021202374 A1 ("Jack"), in view of Vasan et al. WO 2022251554 A1 ("Vasan") and in view of Martin et al. US 20030060736 A1 ("Martin").
Regarding claim 1, Phipps discloses a focused ultrasound (FUS) device for delivering FUS to a targeted tissue ([0014], [0043] - Figs. 3A-3C) comprising:
an adapter configured to couple to an actuated mounting shaft of a stereotaxic system, the adapter comprising an adapter platform that connects the mounting shaft and the transducer (see illustration Fig 3A reproduced below with added annotations and text associated with figure 3 in page 3 “… As shown, the phantom mold was rigidly attached to the transducer housing. The transducer-phantom apparatus was mounted on a three-axis stereotactic frame …”), a focused ultrasound (FUS ) transducer (see reproduced illustration fig. 3A below with added annotations for clarity purposes); and at least one transducer housing.
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Phipps does not explicitly disclose the adapter platform defining a mounting bore at one end configured to receive the actuated mounting shaft. However, it was known in the prior art to provide an adapter housing with a bore configured to facilitate attachment of a transducer housing to a robotic arm, for instance, Jack in Fig. 3 and 14 and [0096] discloses a transducer housing assembly mounted on a robotic arm via an attachment bore 261. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the adapter of Phipps with a mounting bore at one end, so as to facilitate connection of the adapter to the actuated shaft as exemplified by Jack, since this was a known technique of connecting an adapter platform to a robotic arm (MPEP 2144.03 (A-E)).
Phipps does not explicitly disclose a transducer housing bore configured to receive a transducer housing, however, Vasan discloses a known adapter platform (see Figs. 2A-3, bracket 210 and mounting plate 202 define an adapter platform) comprising a transducer housing bore configured to receive a transducer housing as illustrated, as an art recognized way of mounting a transducer to an adapter platform. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to provide the adapter platform of Phipps with transducer housing bore configured to receive a transducer housing to facilitate connection of the transducer housing to the adapter as exemplified by Vasan, since it was a known technique of mounting a transducer onto an adapter platform (MPEP 2144.03 (A-E)).
Phipps in view of Jack and Vasan does not explicitly disclose the transducer housing comprising a transducer bore connecting a receptacle configured to receive and house the FUS transducer and a coupling cone positioned on opposite face of the housing, the coupling cone projecting downward from the transducer bore and configured to insert through the transducer bore housing. However, Martin discloses details of a prior art structure of a headpiece of an ultrasonic applicator (see Figs. 1A and 1B) with a coupling applicator to guide acoustic rays in a focused manner, comprising a transducer housing (“104”) comprising a transducer bore (“107” defines a transducer bore) connecting a receptacle configured to receive and house a transducer (“103”) and a coupling cone (“101”) positioned on opposite face of the housing, the coupling cone projecting downward from the transducer bore (see illustration Fig. 1, 1A and 1B, [0042], [0045]). In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to provide the transducer housing of Phipps with a transducer bore connecting a receptacle configured to receive and house the FUS transducer and a coupling cone positioned on opposite face of the housing, the coupling cone projecting downward from the transducer bore, since this was a known configuration of a transducer housing used to guide acoustic rays in a focused manner as exemplified by Martin (MPEP 2144.03 (A-E)). In modified Phipps, the coupling cone would be configured to insert through the transducer bore housing, so as to couple the transducer housing to the adapter e.g. as illustrated in Fig. 3 of Vasan.
Regarding claim 2, modified Phipps as discussed in claim 1 above does not explicitly disclose the use of magnets on the adapter and transducer housing to lock the transducer housing to the adapter when the coupling cone is inserted through the transducer bore. However, Vasan discloses the use of magnets (“212”) bonded to a mounting plate (“202”) and bracket (“210”), to facilitate mounting of simulation apparatus (“120”) comprising the backet (“210”) onto the mounting plate (“202” - [0082-0083]), i.e., it was known to use pair of magnets fixated onto two components that needs to be attached, to facilitate locking in place the two components. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to further modify the adapter and transducer housing of Phipps with corresponding pair of magnets, to facilitate locking of the transducer housing to the adapter when the coupling cone is inserted through the transducer housing bore, since this was a known prior art technique of locking in place two components of an ultrasound device as exemplified by Vasan (MPEP 2144.03 (A-E)).
Regarding claim 3, modified Phipps as discussed in claim 1 above discloses the claimed invention, as modified by Martin, the coupling cone is made of an impedance matched coupling material that is configured to provide low-impedance acoustic path for delivery of FUS to targeted tissue ([0046]).
Regarding claim 6, see claim 1 above for overlapping subject matter, the citations and discussion in claim 1 are equally applicable here and will not be repeated for brevity sake. The device of modified Phipps can be described as a stereotaxic-guided FUS-BBB system as the system comprise a stereotaxic system and the FUS can be used in blood brain barrier applications (see Phipps page 1, paragraph after the abstract, “… researchers are using FUS to … transiently open the blood brain barrier” and text associated with Fig. 3 in page 3, “three-axis stereotactic frame” comprise an actuated mounting shaft). As modified by the teachings of Jack in claim 1 above, the actuated mounting will be inserted into the mounting bore to couple the FUS system to the stereotaxic system.
Claims 4 and 5 is rejected under 35 U.S.C. 103 as being unpatentable over Phipps in view of Jack, Vasan and Martin as applied to claim 1 above, and further in view of Chevillet et al. US 20170071515 A1 (“Chevillet”).
Regarding claim 4, modified Phipps as discussed in claim 1 above does not explicitly disclose a pointer insert configured to provide a visual indication of a position and orientation of the FUS produced by the device, however, the use of a pointer for the same purpose was known in the prior art as exemplified by Chevillet teachings in [0075], “For positioning the HIFU focus at a depth of 12 mm within the sample, a removable “pointer” was attached to the transducer before each exposure. The pointer was also used to position the ultrasound imaging probe so that the HIFU axis was aligned with the B-mode imaging plane”. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to further modify the device of Phipps with pointer, to provide an indication of focus to be produced by the FUS, since this was a known prior art technique of simulating a focus point as exemplified by Chevillet (MPEP 2144.03 (A-E)). In modified Phipps, in order for the pointer to mimic the position of a focus, it would have a shaft extending to the pointed tip that concedes with position of focus of the FUS. Moreover, it would have been prima facie obvious to provide the pointer insert with a flanged insert configured to insert into the transducer mounting bore, so as to facilitate coupling the pointer to the transducer housing.
Regarding claim 5, all limitations are to be found in claim 1 above, except for limitations in stanza “d”. Phipps further discloses a FUS waveform generator (see page 8, last line), Phipps does not explicitly disclose an amplifier, however, Chevillet discloses a known prior art configuration (see Fig. 1 function generator “100” and amplifier “200”) wherein the amplifier is used to amplify ultrasound energy waveforms ([0054]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the ultrasound system of Phipps to include an amplifier, so as to amplify the ultrasound waveforms from the waveform generator having different peaks to increase versatility in different applications. See claim 1 above for overlapping limitations, the discussion and citations in claim 1 are equally applicable here and will not be repeated for brevity sake.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797