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 .
Information Disclosure Statement
The information disclosure statement filed September 6, 2024 has been entered and the references cited therein have been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the pressure monitoring tube (para. 0035) as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 28 (see Fig. 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 disclosure is objected to because of the following informalities: In para. 0052, method 700 should be method 500.
Appropriate correction is required.
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 12 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 12 recites the limitation "the second microphone sensor" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslin et al. (PCT Publication No. WO 2023/225110) in view of Ramakrishna et al. (U.S. Patent Application No. 2017/0215837).
In regard to claims 1-19, Maslin et al. teach a catheter 10 with an occlusion balloon 16, a distal pressure sensor 22 positioned distal to the balloon 16 and a proximal pressure sensor 24 positioned proximal to the balloon 16 (see Fig. 1 and para. 0038). A control hub 18 is in fluid communication with the balloon 16 and in fluid communication with a fluid reservoir 32 that stores fluid for supply to the balloon 16 to facilitate inflation and deflation of the balloon 16 based on control signals from a controller 34 in control hub 18 (see Figs. 1 and 10 and para. 0041). The fluid may be a biocompatible gas, such as carbon dioxide (see para. 0041). The reservoir 32 is in fluid communication with the catheter 10 by medical tubing 62 that may further include a pump tubing section 62c configured for installation of a pump 42 in the control hub 18 (see paras. 0046-0047). The controller 34 may direct a motor controller 38 to operate a motor of the pump for driving or withdrawing fluid (see para. 0049). The controller 34 is designed and configured to collect data from the distal and proximal sensors 22, 24 to control titration of balloon volume and flow of blood past the balloon 16 (see para. 0051). The controller 34 may be able to allow the setting or target points to monitor and control partial occlusion, such as by setting a minimum blood pressure of blood pressure range monitored by the proximal pressure sensor 24 and/or a minimum blood pressure or blood pressure range monitored by the distal pressure sensor 22 (see para. 0051). Maslin et al. are silent as to the distal and proximal pressure sensors 22, 24 constituting microphone sensors. However, Ramakrishna et al. teach a medical device 10 that includes an acoustic sensor and/or microphone 22 that may be a piezoelectric microphone (see Fig. 1 and paras. 0057-0059). The acoustic sensor 22 is able to differentiate between the turbulence 46 of blood distal to a lesion from the laminar flow 44 proximal to a lesion where the turbulence 46 produces a bruit 42 (see para. 0064 and Fig. 3). Ramakrishna et al. contemplate that measuring the bruit 42 from within the vessel 24 may provide a greater signal to noise ratio than measuring the bruit 42 with a sensor on the skin thus creating better identification of a lesion (see para. 0065). Ramakrishna et al. thus demonstrate that it is well known in the art to provide a medical device with a microphone sensor 22 specifically used to measure a bruit 42 that is indicative of blood flow or turbulence for the purpose of creating better identification of structures and thus better operative outcomes. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to replace the pressure sensors 22, 24 of Maslin et al. with microphone sensors, in the manner disclosed by Ramakrishna et al., in order to measure a bruit that is indicative of blood flow or turbulence for the purpose of creating better identification of structures and thus better operative outcomes. As such, the controller 34 in the device of Maslin et al. in view of Ramakrisha et al. would control the pump 42 based on collected data from the microphone distal and proximal sensors 22, 24 to control titration of balloon volume and flow of blood past the balloon 16. With further respect to claims 3-5 and 11-15, see para. 0058 of Maslin et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794