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 amendment
The claim amendments obviate the previous claim objection and 112(f) interpretations.
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) 1, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. [US 2019/0269381 A1, hereinafter “Masuda”] in view of Gorenberg et al. [US 2004/0044288, hereinafter “Gorenberg,” newly cited].
Re. claim 1, Masuda discloses an imaging apparatus [10] comprising:
a base portion [12] having a space in which a part of a human body is placed [the space where arm 29 is placed; Fig. 4; Par. 0036], the space having a tubular shape [Figs. 1 and 4];
a probe [14] having a probe body [the body of 14] attached to the base portion and facing the space [Fig. 4] and through which a cross-sectional image of the part of the human body when the part of the human body is acquired when the part of the human body is placed in the space [Par. 0040];
a first inflatable [Par. 0046] pressing portion [42] attached to the base portion and by which the part of the human body can be pressed against the probe body when the first inflatable portion is inflated [Fig. 4; Par. 0046]; and
a controller [22] configured to control a pressure applied to the part of the human body by the first pressing portion [Par. 0046].
Re. the second inflatable pressing portion, Masuda is silent. However, Gorenberg teaches, in a cuff having a first inflatable pressing portion [104, Fig. 5], a second inflatable pressing portion [106, Figs. 5, 9] attached to the base portion [Fig. 5], surrounding the space of the base portion [Fig. 9] and by which the part of the human body can be pressed when the second inflatable pressing portion is inflated [Fig. 9]. Masuda also teaches the pressure applied to the second inflatable pressing portion being controlled by a controller [Par. 0149]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by adding a second inflatable pressing portion as taught by Gorenberg in order to allow the pressure to be further customized/controls [two bladders can be inflated to different degrees, separately; see Gorenberg Par. 0149].
Re. claim 21, Masuda-Gorenberg discloses the second inflatable pressing portion is located on a proximal side of the first inflatable pressing portion [Gorenberg Fig. 5]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by adding a second inflatable pressing portion proximal to the first as taught by Gorenberg in order to allow the pressure to be further customized/controls [two bladders can be inflated to different degrees, separately; see Gorenberg Par. 0149].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of Bruder et al. [US 2016/0000409 A1, hereinafter “Bruder”].
Re. claim 2, Masuda discloses the imaging apparatus according to claim 1, wherein the controller controls the pressure [“the inflatable bag 42 is inflated to increase the tension of the compression band 40, by controlling an air pump 58, a pressure control valve 60, etc. by the compression pressure control portion 88 included in the electronic control device 22,” Par. 0046] but fails to teach controlling pressure based on image quality.
Bruder teaches, in an ultrasound imaging apparatus, a controller determines the position of the transducer based on a quality of the cross-sectional image acquired by the imaging unit [see Fig. 1, steps 14-18]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by configuring the imaging apparatus controller to determine the ideal position based on image quality as taught by Bruder in order to allow the ultrasound transducer to be placed at an optimal position [Bruder Par. 0042].
Because the pressure in Masuda’s invention affects the location of the body part relative to the transducer, therefore, one of ordinary skill, upon reviewing the teaching of Masuda in view of Bruder, would reasonably be apprised of the benefits of having the controller control pressure based on a quality of the cross-sectional image acquired through the probe as claimed.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of in view of Cohen et al. [US 2014/0012120 A1, hereinafter “Cohen”].
Re. claim 5, Masuda discloses the base portion includes first [16] and second [40] base members connected along a longitudinal direction of the space [left-right in Fig. 4], but fails to teach the base members being movable to open/close the space. However, Cohen teaches a sensor for an arm with two components which are movable to open and close the space [Fig. 11a/Par. 0264]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by configuring the base members to move to open/close the space as taught by Cohen in order to allow a body part to be easily inserted/removed.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of in view of Cohen in view of Shimizu et al. [US 20120075266 A1, hereinafter “Shimizu”]
Re. claim 6, the modified Masuda discloses the imaging apparatus according to claim 5. Masuda fails to teach detecting a closed state. However, Shimizu teaches, in a medical apparatus that can be opened and closed, a sensor [112-4] by which a closed state of a space can be detected [“The lid member 112-1 is provided with a closed state sensor 112-4 at a closed position, which detects the closed state of the lid member 112-1,” Par. 0040]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Masuda by adding a sensor which detects a closed state as taught by Shimizu and configuring the controller to detect the open/closed state in order to allow the system to operate as intended and save energy. Regarding the controller increasing pressure, since this is how Masuda’s device begins operation, configuring the controller to increase the pressure a certain period of time after the closed state is detected by the sensor would have been obvious to achieve the above benefits, and one of ordinary skill would thus reasonably be apprised of the benefits of the claimed operation.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of in view of Wang et al. [US 2014/0121520 A1, hereinafter “Wang”].
Re. claim 7, Masuda discloses the imaging apparatus according to claim 1, but fails to teach the base portion having a slit with which the probe body can engage. However, Wang teaches, in an imaging apparatus [Fig. 11], a base portion includes a slit [1120] formed along a circumferential direction of the space and with which the probe body [1104] can engage such that an orientation of the imaging unit can be changed [Fig. 11, Par. 0055]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by addin ga slit with which the probe body engages as taught by Want in order to allow the probe to scan an area while allowing another part such as a needle to be attached to and move with the probe to be restricted to the scan plane [Wang Par. 0055].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of in view of Yamamoto [US 2015/0045667 A1].
Re. claim 8, Masuda discloses the apparatus set forth above, including increasing the pressure [Par. 0046], but fails to teach the controller determining a sharpness.
However, Yamamoto teaches, in an ultrasound imaging apparatus, a controller is configured to: determine a sharpness of the cross-sectional image [“The image quality determination unit 52 determines the image quality of the ultrasound image based on the…sharpness… of the ultrasound image produced by the image producer 18,” Par. 0098] , and when the determined sharpness is lower than a threshold [Step S40, Fig 7],have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by determining if a sharpness meets a threshold and controlling the imaging unit to acquire another image if not, as taught by Yamamoto, in order to ensure that the resulting image meets predetermined quality standards.
Furthermore, given the above teachings, (the pressure in Masuda’s invention affects the location of the body part relative to the transducer, which is known to affect clarity—see Bruder, cited above), therefore, one of ordinary skill, upon reviewing the teaching of Masuda in view of Yamamoto, would reasonably be apprised of the benefits of having the controller increase or decrease pressure based on a quality of the cross-sectional image acquired by the probe, and thus in turn having the controller increase the pressure (for once the above is obvious selecting increasing vs. decreasing is selecting one from a list of two options for repositioning the transducer of Masuda), as claimed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Gorenberg as applied to claim 1 and further in view of in view of Soto [US 8888714 B1].
Re. claim 22, Masuda discloses the imaging apparatus as set forth with respect to claim 1 above, but teaches a puncture operation being performed manually [Par. 0020] and fails to teach the robot. However, Soto teaches, in an automatic blood draw system using an ultrasonic probe and a needle,
a robot arm [Col. 7 line 27] to which a needle is attached and configured to perform a puncture operation on the human body based on the cross-sectional image [Col. 6 lines 38-68]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Masuda by adding a robot arm and configuring the needle to be attached to the robot arm and configured as set forth above, as taught by Soto, because this amounts to automating a manual activity to accomplish the same result [see MPEP 2144.04.III].
Allowable Subject Matter
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 23-24 are allowed.
The cited prior art does not teach determining whether a blood vessel is deformed/a position is changed, and inflating or deflating the inflatable portion/increasing or decreasing pressure, as claimed. While detecting deformation/change in position of a blood vessel is known, applying it in the context of repositioning an ultrasound detector is not found.
Response to arguments
The examiner agrees that Masuda fails to teach all of the amended limitations (namely the second pressing portion being inflatable). However, a new reference has been introduced above which teaches these features.
ConclusionApplicant'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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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, JACKIE HO can be reached at (571) 272-4696. 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.
/ERIN MCGRATH/Primary Examiner, Art Unit 3771