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 Statements
The information disclosure statements (IDSs) filed May 6, 2024 and August 1, 2025 have been entered and the references cited therein have been considered by the examiner.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-8, 10-12 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergida et al. (U.S. Patent Application Publication No. 2013/0060103) in view of Tran et al. (U.S. Patent Application Publication No 2011/0008746).
In regard to claims 1, 4, 10, 15 and 16, Bergida et al. teach a monitoring system 100 for monitoring a biological parameter of one or more biological tissue according to an electromagnetic (EM) signal that is propagated between an implantable body element 101 and an extrabody probe 102 (see Fig. 1 and para. 0070). The probes 101, 102 are placed so that more of the energy of an EM signal passes via a region of interest, such as the lungs (see Fig. 1 and para. 0072). Bergida et al. teach than one of the probes 101, 102 includes a transmitter while the other includes a receiver (such as intrabody element 101 having the receiver and extrabody probe 102 having the transmitter) (see para. 0073). Optionally, both probes 101, 102 can includes transceivers so that they can both send and receive signals in both directions (see para. 0073). At least one of the probes 101, 102 includes or communicates with a processing unit that analyzes the propagated EM signals to detect a change in one or more biological parameters of the one or more tissues that are placed between the probes 101, 102 (see para. 0079). The analysis of the propagated EM signals can be based on dielectric related properties and/or dielectric related property changes of the tissue where a biological parameter means any one or more values of biological indicators which reflect a property of one or more organs and/or tissue, for example fluid level in a tissue (see para. 0080). Bergida et al. do not specifically state that the analysis performed by the processing unit includes analyzing the attenuation of the EM signal. However, Tran et al. teach a similar system 100 for monitoring excess fluid accumulation in the thoracic region of a subject 108 comprised of an implanted acoustic transducer 114 and a second external device (see Fig. 1 and paras. 0023-0024). Tran et al. teach that a parameter than can be monitored is an attenuation of the received acoustic energy (see para. 0027). Tran et al. also demonstrate that it is well known that as the fluid level increases, an acoustic signal traveling through a wet lung region experiences less attenuation (see para. 0019). Accordingly, since Bergida et al. teach measuring fluid levels in tissues, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to equip the processing unit of Bergida et al. with the ability to analyze the EM signal by measuring the attenuation of the signal received from the implanted probe 101. With further respect to claim 10 and in regard to claims 2, 3, 11 and 12, Bergida et al. teach that the extrabody probe 102 may transmit EM energy in two frequencies (see para. 0121), intrabody element 101 may be energized by a low frequency magnetic field such as 13.4 MHz (see para. 0122) and that EM radiation can be from a few 100 MHz up to a few GHz (see para. 0140). Bergida et al. also disclose that the EM energy may be in several recognized frequency bands (see para. 0142). In regard to claims 5, 13 and 14, see para. 0042 of Tran et al. In regard to claim 8, Bergida et al. teach that once the intrabody probe 101 has been implanted, it does not have to be repositioned (see para. 0076). In regard to claim 17, Bergida et al. teach that the extrabody probe 102 may be positioned in proximity to the body of a patient, such as in or on a mattress or bed frame (see para. 0087). In regard to claims 6 and 7, Bergida et al. teach that the intrabody probe 101 may be equipped with biological sensors, such as gyroscopes or activity sensors, where the combination enhances the system’s ability to measure the biological parameters and/or perform a clinical assessment based on the biological parameters and specifically mentions posture identification (see para. 0135)
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergida et al. (U.S. Patent Application Publication No. 2013/0060103) in view of Tran et al. (U.S. Patent Application Publication No 2011/0008746) and further in view of Goldshtein et al. (U.S. Patent No. 11,642,084).
In regard to claims 9 and 18, Bergida et al. teach that the intrabody probe 101 may be integrated as part of an implantable medical device (IMD) such as a pacemaker (see para. 0094) or a ventricular assist device (VAD) (see para. 0098) (see also para. 0090). Goldshtein et al. teach an implant 24 that is an intraarterial shunt where implant 34 has an antenna coil 36 and an external unit 32 has an antenna coil 33 and the intensity of the magnetic field that reaches implant 24 is affected by fluid between the two coils 33, 36 (see col. 6, lines 21-31 and Fig 2). Goldshtein et al. thus demonstrate that placing the intrabody portion of a device for measuring the fluid in a thorax or lung region is well known in the art. Since Bergida et al. teach placing the intrabody probe 101 on an IMD, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to place the intrabody probe 101 of Bergida et al. on an intraarterial shunt, in the manner disclosed by Goldshtein 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