DETAILED ACTION
This office action is in response to the communication received on 05/18/2026 concerning application no. 18/022,902 filed on 02/23/2023.
Claims 1 and 6 are pending (Claim 6 is withdrawn from consideration).
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 with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, the “an electromagnetic rotation part for rotating a body of the ultrasound endoscope using an internal micromotor”, “wherein the electromagnetic rotation part is configured to rotate the body of the ultrasound endoscope 360 degrees in each of the clockwise and counterclockwise directions”, and “wherein the ultrasound endoscope is 3.3 mm or less in diameter, such that access to the stomach and an interior of a Pancreaticobiliary duct is possible” (Claim 1) 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.
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 1 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 1 is indefinite for the following reasons:
Recites “the clockwise and the counterclockwise directions”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the counterclockwise directions”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the stomach”. There is insufficient antecedent basis for this limitation in the claim.
Recites “such that access to the stomach and an interior of a pancreaticobiliary duct is possible”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if this element is establishing an intended use limitation or if the endoscope is actively claimed to be for insertion into the stomach or pancreaticobiliary duct.
Applicant is encouraged to provide consistent and clear language.
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 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Abraham (PGPUB No. US 2008/0183080) in view of Waters et al. (PGPUB No. US 2020/0178788) further in view of Assadsangabi et al. ("Catheter-Based Microrotary Motor Enabled by Ferrofluid for Microendoscope Applications", 2016) further in view of Zuo et al. ("A Balloon Endomicroscopy Scanning Device for Diagnosing Barrett's Oesophagus", 2017).
Regarding claim 1, Abraham teaches a ultrasound endoscope, comprising:
an ultrasound module for acquiring an ultrasound image (Abstract teaches the use of ultrasound transducers. Paragraph 0003 teaches ultrasound operates by creating an image from sound in three steps--producing a sound wave, receiving echoes, and interpreting those echoes to create an image);
a biopsy needle (Paragraph 0056 teaches the lumens accommodate biopsy needles. Paragraph 0020 teaches that the instruments in the lumens can be for biopsy); and
an electromagnetic rotation part for rotating the ultrasound endoscope using an internal micromotor (Paragraphs 0091-96 teaches the use of a motor to rotate the ultrasound imaging with respect to the endoscope. Paragraph 0093 teaches that the motor may be a micro motor),
wherein the ultrasound endoscope includes three channels at the central portion of a cross-section of the endoscope configured for the ultrasound module, the biopsy needle, and a guide wire (Paragraph 0056 teaches the lumen can have the biopsy needle and the guidewire. Any combination can be used and the instruments can be used simultaneously or individually. Paragraph 0065 teaches that the endoscope has an imaging channel for the imaging component. Paragraph 0021 teaches that the device is interventional and ultrasound imaging and integrates multiple lumen);
wherein the electromagnetic rotation part is configured to rotate in each of the clockwise and counterclockwise directions, wherein the ultrasound endoscope is 3.3 mm or less in diameter, such that access to the stomach and an interior of a pancreaticobiliary duct is possible (Paragraph 0093 teaches clockwise or counterclockwise rotation of the device. Paragraph 0054 teaches outer diameter ranging from about 1 F to 15 F. Paragraph 0026 teaches the insertion and operation on various organs and tissue such as myocardial, brain, muscle, lung, liver, kidney, uterine, ovarian, esophageal, stomach, intestinal, tumors, or other patient organs);
wherein the ultrasound module acquires the ultrasound image by generating ultrasound in a direction lateral to a longitudinal axis of the ultrasound endoscope (Paragraph 0062 teaches front-facing transducers can be provided in combination with side-facing transducers to provide a user with the capability to view structures in front of the device as well as to the sides of the device), and
wherein the ultrasound module generates ultrasound so that the biopsy needle is displayed on the ultrasound image (Paragraph 0088 teaches device can be used to provide ultrasound images as the device is advanced to the pericardial lining. Using the images provided by the device, the pericardial lining can be punctured using the needle, and the surgeon can confirm backflow in the device/syringe. The elongate body can be advanced, and the needle removed. See Fig. 3 and 5).
However, Abraham is silent regarding an endoscope,
an electromagnetic rotation part for rotating a body of the ultrasound endoscope using an internal micromotor, wherein the ultrasound module is configured by combining a pMUT chip and an ASIC chip,
wherein the electromagnetic rotation part includes permanent magnets positioned outside the three channels, and micro coils correspondingly arranged outside the permanent magnets,
wherein the electromagnetic rotation part is configured to rotate the body of the ultrasound endoscope 360 degrees,
a motor being a micromotor.
In an analogous imaging field of endeavor, regarding ultrasound guided biopsy endoscopes, Waters teaches an endoscope, an ultrasound module for acquiring an ultrasound image (Paragraph 0031 teaches a transducer array that utilizes PMUT for the transmission and reception of ultrasound with respect to the patient tissue. Paragraph 0032 teaches the imaging. Paragraph 0033 teaches control via the ASIC circuit for ultrasound imaging. See Figs. 7 and 10);
a biopsy needle (Paragraphs 0023-24 teaches the installation and use of a biopsy needle. Paragraph 0038 teaches that the images are obtained via the transducer assembly and can be used to detect and guide the biopsy needle. See Figs. 10-11. Paragraph 0019 teaches that the imaging of the lymph nodes can be performed and the needle aspiration can be guided. Paragraph 0022 teaches tissue visualization while inserting the biopsy needle); and
wherein the ultrasound module is configured by combining a pMUT chip and an ASIC chip (Paragraph 0031 teaches a transducer array that utilizes PMUT for the transmission and reception of ultrasound with respect to the patient tissue. Paragraph 0032 teaches the imaging. Paragraph 0033 teaches control via the ASIC circuit for ultrasound imaging. See Figs. 7 and 10).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Abraham with Waters’s teaching of the ultrasound module utilizing a PMUT and ASIC chip. This modified apparatus would allow the user to ensure high density wiring and have a partially flexible system that allows for the transducer array to be wrapped about a distal end (Paragraph 0035 of Waters). Furthermore, the modification provides for integrated electronics and relatively low cost (Paragraph 0031 of Waters).
However, Waters is silent regarding an endoscope,
an electromagnetic rotation part for rotating a body of the ultrasound endoscope using an internal micromotor,
wherein the electromagnetic rotation part includes permanent magnets positioned outside the three channels, and micro coils correspondingly arranged outside the permanent magnets,
wherein the electromagnetic rotation part is configured to rotate the body of the ultrasound endoscope 360 degrees,
a motor being a micromotor.
In an analogous imaging field of endeavor, regarding internal imaging devices, Assadsangabi teaches an endoscope, wherein the electromagnetic rotation part includes permanent magnets positioned outside the three channels, and micro coils correspondingly arranged outside the permanent magnets (Fig. 1 shows the coil and the magnet to the separate from the fiber channel. Additionally, the magnet is shown to be separate from the coils. Page 543 teaches use of a permanent magnet. Abstract teaches a micro rotary motor. See Fig. 1), and
a motor being a micromotor for rotation of an EM rotation part (Abstract teaches a micro rotary motor. See Fig. 1).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Abraham and Waters with Assadsangabi’s teaching of a micro rotary motor to control a part with permanent magnets and coils situated outside a channel system. This modified apparatus would allow the user to improve the effectiveness of the motor design (Abstract of Assadsangabi). Furthermore, the modification provides high potential for side-viewing microendoscopic applications (Abstract of Assadsangabi).
However, Assadsangabi is silent regarding an endoscope,
an electromagnetic rotation part for rotating a body of the ultrasound endoscope using an internal micromotor,
wherein the electromagnetic rotation part is configured to rotate the body of the ultrasound endoscope 360 degrees.
In an analogous imaging field of endeavor, regarding internal imaging devices, Zuo teaches an endoscope,
an electromagnetic rotation part for rotating a body of the endoscope using a motor (Fig. 2 shows rotation in both directions for the endoscopic device. Fig. 3 shows the operation unit that controls the device. Table 1 teaches a scanning device diameter of 2.8-3.2 mm. Fig. 1 shows insertion in the stomach),
wherein the electromagnetic rotation part is configured to rotate the body of the ultrasound endoscope 360 degrees in each of the clockwise and counterclockwise directions, wherein the ultrasound endoscope is 3.3 mm or less in diameter, such that access to the stomach and an interior of a pancreaticobiliary duct is possible (Fig. 2 shows rotation in both directions for the endoscopic device. Fig. 3 shows the operation unit that controls the device. Table 1 teaches a scanning device diameter of 2.8-3.2 mm. Fig. 1 shows insertion in the stomach).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Abraham, Waters, and Assadsangabi with Zuo’s teaching of the rotation of the endoscopic body. This modified apparatus would allow a user to high resolution manner of imaging with improved mobility (Abstract of Zuo). Furthermore, allows for real time evaluation of the tissue (Conclusion of Zuo).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zuo et al. ("Development of a Large Area Scanner for Intraoperative Breast Endomicroscopy", 2014): Teaches the control of an endoscopic body.
Seibel et al. (PGPUB No. US 2008/0243031): Teaches the control of an endoscopic body.
Kitahara (US Patent No. 11,684,340): Teaches the control of an endoscopic body.
Kim et al. (KR20170119094): Teaches the control of an endoscopic body.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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