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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35, 43, and 53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claims 35 and 53, there does not appear to be support for the axis orthogonal to the current imaging plane wherein the movement is translational or along a longitudinal axis. While the specification does refer to movement along this axis, Examiner is unable to find that this is translationa/longitudinal movement. It appears this may be referring translational movement along 8b in Figure 2, the claimed “imaging plane” orientation is not known and, therefore, it cannot be determined whether or not translational movement along 8b is orthogonal to the imaging plane.
In claim 43, there do not appear to be support for oscillatory movement “around the axis”, as the specification only refers to oscillation along axes.
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 34-53 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.
In claim 34, line 6, ‘the imaging device’ lacks antecedence.
In claims 35, 36, 45, 46, it is unclear which ‘the movement’ refers to as there are multiple movements introduced in claim 34.
In claims 36 and 52, it is unclear how the movement is rotational when the movement is previously defined as movement away from a target site or away from a referenced position, as a rotation would not move the probe ‘away’.
In claim 36, line 2, ‘the focal spot’ lacks antecedence.
In claim 41, ‘the first movement’ lacks antecedence.
In claim 42, ‘the user’ lacks antecedence.
In claim 47, ‘the collected images’ lacks antecedence.
In claim 49, ‘the display’, ‘the acquired images’, and ‘the zone’ lack antecedence.
In claim 51, line 4, it appears ‘a vein’ should be ‘the vein’.
In claim 52, line 8, ‘the focal point’ lacks antecedence.
In claim 53, line 2, ‘the acquisition’ lacks antecedence. In line 6, ‘the target’ lacks antecedence. In line 11, it appears ‘a set’ should be ‘the set’.
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.
Claims 34-50 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Ishibashi et al (US Pub 2004/0122493 -cited by applicant) in view of Darlington et al (US Pub 2010/0241005 -cited by applicant).
Re claims 34-40, 53: Ishibashi discloses a device for treatment of a patient by HIFU, the device comprising:
a treatment head for emission of HIFU pulses [0044; see applicator 11 and HIFU unit 21];
an imaging probe [0044; see probe 22]; and
a control unit for controlling the movement of the probe [0043; see mechanism control unit 18 that controls rotational probe movement].
Ishibashi discloses a method of preparing for a treatment of a patient with HIFU comprising the acquisition of 2D images prior to or during treatment including steps of positioning the treatment head on the patient, defining a direction for movement, and performing the movement to acquire images [0043, 0044; see the rotational movement about axis z and obtaining images from probe 22].
Ishibashi further discloses that the control unit is adapted to allow a user-controlled movement or to carry out an imaging movement of the probe which approximately follows one of the following axes: axis orthogonal to the current imaging plane, axis parallel to the main axis of the target, projection of the main target axis in a plane orthogonal to the main ultrasound propagation axis, and protection of the main target axis in a plane parallel to the skin surface [0063; see the rotation control signal to rotate the imaging probe 22 around a Z axis]. Ishibashi does not disclose the control unit is adapted to carry out a translational movement or longitudinal direction of the probe away from a target site during operation of the imaging device, wherein the control unit is adapted to store at least one current reference position in a memory, and wherein the control unit is further adapted to trigger a movement of the probe to the reference position. Ishibashi also does not disclose that the control does not allow HIFU to be delivered during a user-controlled movement or that a HIFU pulse is emitted if the treatment head is in the reference position. However, Darlington teaches of an imaging/HIFU device wherein a control unit translates a probe of an imager at a first speed and a second movement to return to an initial position [0092, 0095; see that the HIFU transducer and imaging transducer are located on the same treatment head and see that the steerer 205 adjusts the x-y position (i.e. when the translation of movement is along the x axis)]. Further, translational imaging movement being away from an initial/reference position where HIFU is to be delivered, and back to the initial position or to a reference position saved in memory where HIFU is to be delivered [0054, 0063, 0092, 0095; see the arrangement where the imaging and HIFU transducers are located on the same transducer head and wherein locating a target is known to involve moving the head across a region to find an optimal position to deliver HIFU including at away from an initial position and then back to the initial position]. Darlington also teaches that the control does not allow HIFU to be delivered during the translational movement while allowing HIFU when in a reference position [0094, 0096; see that HIFU is selectively delivered (i.e. only delivered when the user determines the transducer is at a desired location and then activates the footswitch) and see the imaging controller 204 that permits imaging during movement (i.e. the imaging transducer is capable of acquiring images during movement)]. Darlington teaches that the device includes a trigger that, when activated, triggers translational movement of the probe away from the initial position and to a stored position [0013, 0088, 0095, Fig 7; see the “computer-controlled mechanism to automatically move”, the motors that activate movement, the steerer 205, or graphical interface adjustment for translational movement, such that when activated each triggers the automatic translational movement]. It would have been obvious to the skilled artisan to modify Ishibashi, to either modify the imaging probe to be translated instead of only rotated or to replace the HIFU/imaging unit with the integrated HIFU/imaging unit for automatic translational movement of Darlington, in order to make imaging and treatment of a desired target more accurate.
Re claims 41, 42: Ishibashi discloses the device comprises a user interface, the user interface having a button to trigger the first movement of the probe away from a current position, wherein the control unit is adapted to trigger a second movement of the probe back to its initial position when the user releases or presses the button [0059; see the interface as a keyboard or mouse that has physical buttons to enter the information to control the probe movement].
Re claims 43, 44: Ishibashi discloses the control unit is adapted to carry out an oscillatory movement of the probe around the axis or roughly along one of the axes [0066, Figs 11A, 11B; see the oscillatory movement in lines or in circles of a predefined number/pattern].
Re claims 45, 47: Ishibashi discloses the control unit is adapted to carry out the movement by a control representing the coordinates of the probe, wherein the device is adapted to associate the collected images to a coordinate along a trajectory [0066; see the operation unit 17 for input of the control signal for probe movement with corresponding coordinates of the imaging probe].
Re claim 46: Ishibashi discloses the control unit is adapted to limit the movement of the probe and/or provides a spring-like effect when the treatment head is released after a manual displacement (Figs 1B, 11A, 11B; see the outer region of the probe pattern that indicates a range limit defined by mechanical limits of a current probe location, providing a spring effect).
Re claim 48: Ishibashi discloses the device comprises a display adapted to display an image corresponding to a given coordinate [0066; see the trajectory of the circular movement pattern of the imaging probe 22 wherein the situation of the heating is displayed].
Re claim 49: Ishibashi discloses the display comprises a first dedicated area for display of the acquired images and a second dedicated area for display of an image of the zone where a sonication has to be delivered [0066, Figs 11A, 11B; see the images taken during the movement of the probe 22b which show where the cancer has been irradiated in real time]..
Re claim 50: Ishibashi discloses the display comprises a shared area, for displaying acquired images and for displaying of an image of a zone where a sonication has to be delivered, whereby a. when a virtual position of the probe is set at an actual position of the probe, a live image of the zone where a sonication has to be delivered is displayed, and b. when the virtual position of the probe is set at another position, a corresponding image from the set of the acquired images is displayed [0066, Figs 11A, 11B; see the images taken during the movement of the probe 22b which show where the cancer has been irradiated in real time].
Claims 51 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Ishibashi et al (US Pub 2004/0122493 -cited by applicant) in view of either Partanen et al (US Pub 2017/0000376 -cited by applicant) or alternatively Grisey et al (WO 2019/110133 -cited by applicant).
Re claims 51, 52: Ishibashi discloses a method of preparing a treatment of a vein with HIFU, comprising the steps:
moving a treatment head away from a reference position representing a target site of a portion of a vein, including a rotational movement around an axis through a focal point [0043, 0072; see the movement about axis z of the treatment head relative a target];
acquiring at least one image away from the referenced position [0073; see the imaging probe];
defining the position of a target in the vicinity of the target site based on the at least one acquired image, thereby defining a corrected reference position [0073; see the cancer 2 target defined in the image]; and
moving the treatment head to the corrected reference position [0072, 0073; see the movement of the treatment head to irradiate the cancer 2].
Ishibashi discloses all features including that the target is a fibroid that contains veins [see Darlington 0048; see the fibroid target that is formed by blood vessels 22, which are known to include veins], but do not disclose that the target is formed by a portion of a collapsed vein. However, Partanen teaches of a method for HIFU treatment wherein the target is a blood clot (which is considered a collapsed vein) of a fibroid [0163; see the HIFU of a clot of a fibroid]. Alternatively, Grisey teaches of HIFU treatment of a collapsed vein (page 16, lines 27-32), wherein the translational movement moves the probe away from a collapsed where the vein is not visible to a second site where the vein is visible (page 20 line 19 -page 22 line 20; see the displacement of the probe head by the “means for moving” which indicates automatic movement contrasting to the manual movement and see the movement of the probe head “away” from the collapsed vein so that it becomes visible, whereby the visibility is determined by imaging). It would have been obvious to the skilled artisan to modify Ishibashi to specifically treat a collapsed vein, as taught by Partanen or Grisey, as such are well known targets for HIFU and such would facilitate treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
Prosecution Insights