DETAILED ACTION
This office action is in response to the communication received on 01/30/2026 concerning application no. 18/022,902 filed on 02/23/2023.
Claims 1 and 3-6 are pending (Claim 6 is withdrawn from consideration).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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
Claims 1 and 3-6 are pending (Claim 6 is withdrawn from consideration).
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Regarding the 103 rejection, Applicant argues that Abraham does not teach the three channels as claimed because it broadly describes the multiple lumens but does not talk about configuration for the ultrasound module, needle, and the guidewire. Applicant further argues that Waters and Assadsangabi do not teach the element. Applicant further argues that Abraham and Waters do not teach the electromagnetic rotation part. With Assadsangabi, Applicant argues that it rotates a prism mirror, and is situated on the outer wall of the endoscope and that it uses a ferro-fluid. Applicant further argues that the claimed invention rotates 360 degrees.
Examiner disagrees. With the lumens, Applicant is reminded that Abraham is the relied upon reference and not Waters and Assadsangabi. Similarly, with the electromagnetic rotation part, the Assadsangabi reference is relied on and not Waters and Abraham. With the lumen argument, Applicants remarks are conclusory and without support. MPEP establishes “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Additionally, they are counter to the very teachings of Abraham. Abraham clearly shows at least three lumens in the Fig. 2. Paragraph 0056 clearly teaches that the lumens can facilitate the biopsy needle and the guidewire. It even states that the tools can be used in any combination and can be used simultaneously.1 This concurrent use of the instruments means that both the needle and the guidewire may be used at the same time and one with ordinary skill in the art would understand such a matter. Applicant’s allegations that there is no teaching is without support. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” With the ultrasound imaging, paragraph 0065 teaches that the imaging component has its own channel. With the electromagnetic rotation argument, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the rotation of 360 degrees) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., preclusion of rotation of a prism mirror, and is situated on the outer wall of the endoscope and that it uses a ferro-fluid) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). One with ordinary skill in the art would be able to utilize the rotating mechanics of Assadsangabi and facilitate the rotation of the components of Abraham. Assuming, arguendo, the 360 degrees was present in the claim, such an element is not novel and is already addressed by Assadsangabi. The reference teaches that the very purpose of the rotation mechanics is to facilitate 360 degree rotation. Assuming, arguendo, that Abraham was silent regarding the three channels for imaging, the needle, and the guidewire, such an element is not novel. At least Tolkowsky (PGPUB No. US 2010/0041949), Hossack et al. (PGPUB No. US 2013/0331706), Nakazato et al. (PGPUB No. US 2009/0227866), Kutikov et al. (PGPUB No. US 2011/0105841), Fitzsimons et al. (PGPUB No. US 2008/0004528), Saadat (PGPUB No. US 2007/0287886), Hastings et al. (PGPUB No. US 2012/0059241), Fonger et al. (PGPUB No. US 2017/0319233), and Steward et al. (US Patent No. 6,554,801) disclose the use of three channels for an ultrasound imaging, guidewire, and needle instrument and are pertinent art.
Examiner maintains the rejection.
Drawings
The drawings are objected to because:
The drawings (Figs. 3 and 6-7) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
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 § 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.
Claims 1 and 3-5 are 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).
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 motor (Paragraphs 0091-96 teaches the use of a motor to rotate the ultrasound imaging with respect to the endoscope),
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).
However, Abraham is silent regarding an endoscope,
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,
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 wile 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, wherein the electromagnetic rotation part includes permanent magnets positioned outside the three channels, and micro coils correspondingly arranged outside the permanent magnets, and
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).
Regarding claim 3, modified Abraham teaches the ultrasound endoscope in claim 1, as discussed above.
Abraham further teaches an endoscope, wherein the ultrasound endoscope is 3.3 mm or less in diameter (Paragraph 0054 teaches outer diameter ranging from about 1 F to 15 F).
Regarding claim 4, modified Abraham teaches the ultrasound endoscope in claim 1, as discussed above.
Abraham further teaches an endoscope, wherein the ultrasound module acquires the ultrasound image by generating 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).
Regarding claim 5, modified Abraham teaches the ultrasound endoscope in claim 4, as discussed above.
Abraham further teaches an endoscope, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tolkowsky (PGPUB No. US 2010/0041949): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Hossack et al. (PGPUB No. US 2013/0331706): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Nakazato et al. (PGPUB No. US 2009/0227866): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Kutikov et al. (PGPUB No. US 2011/0105841): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Fitzsimons et al. (PGPUB No. US 2008/0004528): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Saadat (PGPUB No. US 2007/0287886): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Hastings et al. (PGPUB No. US 2012/0059241): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Fonger et al. (PGPUB No. US 2017/0319233): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
Havel et al. (PGPUB No. US 2015/0094595): Teaches the use of a microcoil and permanent magnet for rotation.
Steward et al. (US Patent No. 6,554,801): Teaches the use of three channels for an ultrasound imaging, guidewire, and needle instrument.
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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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Simultaneously: in a simultaneous manner : at the same time : concurrently (Link: https://www.merriam-webster.com/dictionary/simultaneously)