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 Claims
Claims 1-29 as filed are subject to examination on merits.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, in claim 23, a support member includes a hole portion into which the imaging optical system is inserted and a side surface that surrounds the imaging unit, and a gap is formed between the side surface and the imaging unit must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive, see MPEP 606, Rule 1.72(a) “The title of the invention may not exceed 500 characters in length and must be as short and specific as possible”. A new title is required that is clearly indicative of the invention to which the claims are directed.
Likewise, the abstract of the disclosure is objected to because of reference to the title “The system”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 5 is objected to because of the following informalities: in line 6, “the transducer” lacks proper antecedence basis, it is suggested to amend to “a transducer” as it is clear that the intent is to refer to a transducer at a center of a transducer group that generates the ultrasound beam. Appropriate correction is required.
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.
Claims 1-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al., US 20100063392 A1 (“Nishina”) in view of Maslak et al., US 5235986 (“Maslak”)
Regarding claim 1, Nishina discloses a system (“1” [0089], Fig. 1, Fig. 17) comprising: an ultrasound endoscope (EUS”2”- [0089], Fig. 1) including a transducer array in which a plurality of transducers, each of which extends in a first direction intersecting an axial direction of an insertion part of the ultrasound endoscope, are arranged in a curved shape ([0095] - Fig. 2, [0158] “two dimensional array as an ultrasound transducer”, e.g., [0182] and Fig. 25 the two dimensional array scans S1 and S2 each define at least a first direction that intersect an axial direction of an insertion part of the ultrasound endoscope); and a processor configured to perform processing of generating an ultrasound image based on an output signal of the transducer array obtained by controlling the transducer array ([0163]), wherein an opening angle of the transducer array as viewed in the first direction is 90 degrees or more and less than 180 degrees (see illustration Fig. 2 transducer “30” defines an opening angle as defined in [0031] of specification as filed).
Nishina does not explicitly disclose wherein the processor is configured to perform first control of generating the ultrasound image with a first angle of view which is larger than the opening angle. Attention is directed to Maslak in the same field of endeavor of scanning method teaches a well-known prior art technique of variable vertex scanning by means of a control logic and a processor that involves steering acoustic lines beyond both ends of the array to extend a field of view for example where it may be important to include an entire organ or several organs in the body in the same image (see illustration Fig. 3, radius of curvature of the array “8” defines an opening angle, variable vertex “4a” defines an angle of view larger than opening angle as illustrated - see e.g. [abstract], [col. 2: 40-46], [col. 4: 12-24, 45-48] and [col. 6: 18-41). 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 modify the processor of Nishina to include a control logic that causes variable vertex scanning as taught by Maslak, for added advantage of an expanded field of view.
Regarding claim 2, see e.g., Fig. 2 of Nishina scanned surface “S” without expanded view defines an angle that is 140 degrees or more and 160 degrees or less.
Regarding claims 3-4, as modified by the teachings of Maslak, the variable vertex can define an angle of view that is greater than 15 degrees as the vertex adjusted towards the array and away from the curvature of the array and would include an angle of view that is 180 degrees or less, in purview of a user.
Regarding claims 5-14,[as to claim 5] the transducer array of Nishina is curved, hence arranged along an arc of a circle (see e.g.. Fig. 25 - [0182]), the scanned surface S1 and S2 include a first and second direction and includes a common transducer at the center where scanned surfaces S1 and S2 intersect;
[as to claims 6-8], see discussion in claim 5 above, as modified by the teachings of Maslak to include a variable vertex in scanned surface S1 and S2, the first driving control would include an expanded field of view beyond the opening angle, the second direction would include a direction towards a proximal side of the insertion part and towards a distal end side of the insertion part (see illustration Fig. 25 - “S1” -);
[as to claims 9-11], see discussion in claim 5 above, the processor in modified Nishina is configured to control the ultrasound beam to propagate in the third direction in a part of the transducer array (variable vertex as modified by Maslak may include all or part of the transducer array -see Maslak [col. 6: 18-41] shifting center of mass by one element implies part of the transducer array), that would include a center portion of the transducer array in a range of ±45 degrees that defines an angle of at least 90 degrees -see claim 1 above);
[as to claims 12-14], see discussion in claim 5 above, the processor of Nishina as modified by the teachings of Maslak is configured to generate an image with a second angle of view smaller than the first angle of view, owing to the variable vertex as discussed above, and the ultrasound beam for the second angle of view that is smaller than the first angle of view would propagate more towards a center of the transducer array for the smaller view angle e.g., as illustrated in Fig. 3 center of curvature 8 defines a smaller angle of view that would correspond to an end edge of the ultrasound image propagate more towards a center side of the transducer array when compared to extended field of view as a result of vertex 4a in Maslak; and Fig.3 of Maslak illustrates that intersection point for vertex “4a” for first control that generates the extended view is closer to the transducer group compared to center of curvature “8” of the second control.
Regarding claims 16-19, see Fig. 2 of Nishina regarding slope portion 34 (hence angled) comprising illumination lens cover 35, an observation lens cover 36 provided on a proximal side with respect to the transducer array, the transducer array are arranged along an arc of a circle as depicted, the observation window is inclined owing to slope portion 34, the structure depicted in Fig. 2 of Nishina is substantially identical, if not the same to Fig. 4 of instant disclosure and as recited in the claim in regards to transducer array arranged along an arc of a circle an observation window on an inclined surface and would therefore possess a similar first angle that is equal to or greater than a second angle as well as the properties recited in claims 16-19. Where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC § 102, on prima facie obviousness" under 35 USC § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products." In re Best, 562 F2d 1252, 1255, 195 USPQ 430,433-4 (CCPA 1977). (see MPEP 2112.01 (I)), the burden has been shifted to Applicant.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina in view of Maslak as applied to claim 5 above, and further in view of Kuniyasu US 20060241473 A1.
Regarding claim 15, Nishina in view of Maslak discloses the invention of claim 5 as discussed above, but does not explicitly disclose the number of channels of the transducer array is 96 or more and 128 or less. However, Kuniyasu discloses known prior art an ultrasonic probe with a convex ultrasonic scan mode with 94 to 128 transducers, suitable for medical diagnosis using ultrasound images ([0003-0004]). 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 specify a transducer array with 96 to 128 transducers/channels, as this is a known configuration for a compact and high density ultrasound scanning head in medical diagnostics as exemplified by Kuniyasu.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina in view of Maslak as applied to claim 1 above, and further in view of Yokoi JP 05344973 A (see attached machine language translation for references).
Regarding claims 20-22, Nishina in view of Maslak discloses the invention of claim 1 as discussed above, Nishina Fig. 2 discloses an observation window (observation lens cover 36 - [0097]) provided on a proximal end side with respect to the transducer array, while it is not clear whether one end edge of the transducer array is in an observation visual field of the observation window [claim 20], wherein a center of the transducer array is included between rays that constitute both ends of the observation visual field of the observation window [claim 21] and wherein a center of the observation visual field is located on a side opposite to the axis with respect to the one end edge [claim 22] as viewed in the first direction, Yokoi discloses a substantially similar configuration of an ultrasound endoscope (see e.g. [0014] “… The field of view 38 of the objective lens 34 shown in FIGS. 2 and 3 is directed so as to overlap the scanning cross-section 28 of the ultrasonic probe 26 while compensating for the dead angle of the scanning cross-section 28 (see FIG. 4)”), in view of overlapping filed of view 38 and objective lens 24, one end edge of the transducer array is in an observation visual field of the observation window, a center of the transducer array is included between rays that constitute both ends of the observation visual field of the observation window as the overlap includes more than half of the field of view 38, and a center of the observation visual field is located on a side opposite to the axis with respect to the one end edge when viewed in a first direction. In view of the teachings of Yokoi, it would have been obvious to one having ordinary skill in the art to have modified Nishina in view of Maslak to have a configuration with substantially overlapping field of view of the observation lens to enable better viewing during a surgical procedure while compensating for dead angle in the ultrasound image.
Claims 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina in view of Maslak and Yokoi as applied to claim 22 above, and further in view of Morimoto US 20110301413 A1.
Regarding claims 23-25, Nishina in view of Maslak and Yokoi discloses the invention of claim 22 as discussed above, the ultrasound scope of Nishina is disclosed as including an imaging module that includes an observation window, however, Nishina in view of Maslak and Yokoi doe does not disclose the structural features of the imaging module specified in claims 23-26.
Morimoto makes up for this deficiency by disclosing the structural features of a prior art imaging module an ultrasonic endoscope ([abstract], e.g., Figs. 4 and 5) that includes an imaging optical system including an observation window(13) and an imaging unit (solid state element 24 - [0029]) that performs imaging through the imaging optical system, and a support member (distal end body 4 - [0029]) that supports the imaging optical system and the imaging unit, the support member includes a hole portion (mounting hole 40 - [0035]) into which the imaging optical system is inserted and a side surface that surrounds the imaging unit (see e.g. Fig. 5), and a gap (space 42 - [0035]) is formed between the side surface and the imaging unit, wherein a first distance of the gap is larger than a second distance between an inner peripheral surface of the hole portion and an outer peripheral surface of the imaging optical system (space 42 is larger that a distance between inner peripheral surface of the hole portion that is in contact with prism holder 22, e.g., distance of gap in region next to “42” compared to region next to “43” in Fig. 5), as shown in Fig. 5, a position of the imaging optical system in a direction perpendicular to an optical axis is positioned at the hole portion.
In view of the teachings of Morimoto, it would have been obvious to one having ordinary skill in the art to have provided the imaging module with the ultrasonic endoscope of modified Nishina, as this was a known structure in the prior art for stably mounting an imaging module onto an endoscope.
Regarding claim 26, Nishina in view of Maslak, Yokoi and Morimoto discloses the invention of claim 25 as discussed above, although Nishina does not explicitly disclose wherein a distance in the axial direction between an end edge in the transducer array on the proximal end side of the insertion part and the observation window is 10 mm or less, however, this is a result effective variable as in reducing or minimizing the distance between an end edge in the transducer array on the proximal end side of the insertion part and the observation window would reduce the dead angle between the observation field of view and the ultrasound image. Since the particular parameter of the said distance affects a dead angle between a field of view of the observation window and the ultrasound image, it is the matter of optimization as being result effective variable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention to have specified a length of 10 mm or less in order to reduce the dead angle, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05 (II-B)).
Regarding claims 27-29, Nishina in view of Maslak, Yokoi and Morimoto discloses the invention of claim 26 as discussed above, Nishina Fig. 2 further discloses wherein the ultrasound endoscope has an illumination window (illumination cover 35 - [0097]) provided on the proximal end side with respect to the transducer array, and a center line of the illumination window is located on a side opposite to the axis with respect to the one end edge as viewed in the first direction (see illustration Fig. 2), as depicted in Fig. 2 of Nishina, the observation window and the illumination window are provided eccentric to a same direction as viewed in the axial direction and wherein the ultrasound endoscope has an outlet port of a treatment tool (opening 32- Fig. 2 - [0096]), and the transducer array, the observation window and the outlet port are provided in this order from a distal end side of the ultrasound endoscope as depicted in Fig. 2.
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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797