DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on January 13, 2026 were received and fully considered. Claims 1, 12, 18, and 30 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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.
Claims 1, 3, 12, 13, 16-18, 20, 21, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Tai et al. (US PG Pub. No. 2017/0100054 A1) (hereinafter “Tai”), Beeckler et al. (US PG Pub. No. 2017/0312022 A1) (hereinafter “Beecker”), and Ben-Haim et al. (US PG Pub. No. 2020/0305970 A1) (hereinafter “Ben-Haim”).
With respect to claims 1 and 18, Tai teaches an apparatus for being inserted into a living body and acquiring biological information (EIS-based diagnostic system 100 in Figs. 1-2), the apparatus comprising: a balloon configured to be inserted into the living body to expand or contract (inflatable balloon 122/212 in Figs. 1-2); and electrodes disposed on a surface of the balloon and each having an inner surface attached to the surface of the balloon and an outer surface opposite to the inner surface (microelectrodes 222 and 223 are disposed on outer surface of balloon 122/212; see Figs. 1-2).
However, Tai does not explicitly teach fine protrusions disposed on the outer surface of each electrode and aligned along a longitudinal direction of corresponding electrode to come into contact with the living body, wherein each fine protrusion extends outward from the outer surface in a direction away from the surface of the balloon, wherein at least one of the fine protrusions formed on one of the electrodes is configured to apply a first electrical signal that varies in frequency, and at least one other of the fine protrusions formed on at least one other of the electrodes is configured to detect a second electrical signal that is generated by an application of the first electrical signal that varies in frequency, wherein each electrical signal comprises a current or a voltage, wherein the electrodes have a strip-shape which elongates along the longitudinal direction, and wherein the fine protrusions have a truncated shape in order for the fine protrusions to contact with the living body but not to invade into the living body.
Beeckler teaches fine protrusions disposed on the outer surface of each electrode and aligned along a longitudinal direction of corresponding electrode to come into contact with the living body, wherein each fine protrusion extends outward from the outer surface in a direction away from the surface of the balloon (par.0085 “protrusions 105 and 107 allow the microelectrodes 101 and 102 to be… as close as possible to the tissue contact site, while maintaining physical and electrical isolation”; see also Fig. 15A)… wherein the electrodes have a strip-shape which elongates along the longitudinal direction, and wherein the fine protrusions have a truncated shape in order for the fine protrusions to contact with the living body but not to invade into the living body (Fig. 3 depicts balloon catheter 24 with electrodes 33 formed on leaves/strips 30 evenly distributed about balloon 80).
Ben-Haim teaches one of the electrodes is configured to apply a first electrical signal that varies in frequency, and at least one other of the electrodes is configured to detect a second electrical signal that is generated by an application of the first electrical signal that varies in frequency, wherein each electrical signal comprises a current or a voltage (par.0168 “at least one electrode… current is injected from each electrode, optionally at a plurality of frequencies… to allow separate identification of the electrodes uses”; par.0196-0203 “Measurement data…voltage gradients generated at different frequencies between a multiplicity of electrodes… the tissue change is monitored electrically from a probe electrode: for example as the tissue change affects local influences on impedance at one or more frequencies, the tissue change may be monitored by monitoring the local impedance at the tissue”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Tai to incorporate fine protrusions and electrodes having a strip-shape as part of a balloon catheter in the manner recited for the purpose of providing a combined electrode and sensing member as close as possible to the tissue contact site, as suggested by Beeckler (par. 0058, 0085). Additionally, PHOSITA would have had predictable success when the invention was filed to modify Tai and Beeckler such that first/second electrical signals with varying frequencies are generated in the manner recited for the purpose of allowing separate identification of the electrodes used and monitoring tissue change affected by the varying frequencies, as suggested by Ben-Haim (par.0168, 0196-0203).
With respect to claims 3 and 20, Tai teaches the apparatus is configured to be inserted into any one or more of a blood vessel and a body cavity of the living body to acquire the biological information (par.0005 “catheter is guided to a location proximate to biological tissue. The inflatable balloon is inflated to contact the biological tissue… sensor also becomes in contact with the tissue… and the tissue’s impedance is thereby more accurately measured”).
With respect to claims 12 and 29, Beeckler teaches the fine protrusions have any one form of a cylinder, a prism, a truncated one, a pyramid, a cone, and a prismatoid (protrusions 105 and 107 have a form of a pyramid/cone, as depicted in Fig. 15A). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Tai to incorporate the fine protrusions for the purpose of providing a combined electrode and sensing member as close as possible to the tissue contact site, as suggested by Beeckler (par. 0085).
With respect to claim 13, Beeckler teaches the fine protrusions include a conductive material (par.0085). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Tai to incorporate the fine protrusions including a conductive material for the purpose of providing a combined electrode and sensing member as close as possible to the tissue contact site, as suggested by Beeckler (par. 0085).
With respect to claim 16, Beeckler teaches wherein the electrodes are disposed in one or more pairs spaced apart from each other on a surface circumference of the balloon (Fig. 3 depicts balloon catheter 24 with electrodes 33 disposed in pairs in relation to leaves/strips 30 that are evenly distributed about balloon 80). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Tai to have electrodes disposed in pairs spaced apart from each other on a surface circumference of the balloon for the purpose of providing a combined electrode and sensing member as close as possible to the tissue contact site, as suggested by Beeckler (par. 0085).
With respect to claim 17, Tai teaches a guide tube through which a fluid flows in or out to expand or contract the balloon; and a wire connected to the electrodes (par.0041 “enable the electrical ribbon cables 226 and 227 to move with inflation and deflation of the balloon 212”; Note: inflation/deflation of balloon inherently requires a fluid flowing in/out of balloon).
With respect to clam 21, Beeckler teaches the fine protrusions have a form of a pyramid or a cone (protrusions 105 and 107 have a form of a pyramid/cone, as depicted in Fig. 15A). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Tai to incorporate the fine protrusions for the purpose of providing a combined electrode and sensing member as close as possible to the tissue contact site, as suggested by Beeckler (par. 0085).
With respect to claim 30, Ben-Haim teaches wherein the fine protrusions formed on the one electrode and the other electrode are further configured to form a path for the electrical signals that varies vary in frequency via the living body (par.0168 “at least one electrode… current is injected from each electrode, optionally at a plurality of frequencies… to allow separate identification of the electrodes uses”; par.0196-0203 “Measurement data…voltage gradients generated at different frequencies between a multiplicity of electrodes… the tissue change is monitored electrically from a probe electrode: for example as the tissue change affects local influences on impedance at one or more frequencies, the tissue change may be monitored by monitoring the local impedance at the tissue”). Therefore, PHOSITA would have had predictable success when the invention was filed to modify Tai and Beeckler to incorporate a path for the electrical signals that varies vary in frequency via the living body for the purpose of allowing separate identification of the electrodes used and monitoring tissue change affected by the varying frequencies, as suggested by Ben-Haim (par.0168, 0196-0203).
With respect to claim 31, Ben-Haim teaches wherein the processing unit provides the electrical signal that varies in frequency to the one electrode and receives the electrical signal that is generated by applying the electrical signal that varies in frequency, and calculates an electrical impedance of a path that the electrical signal that varies in frequency travels (par.0168 “at least one electrode… current is injected from each electrode, optionally at a plurality of frequencies… to allow separate identification of the electrodes uses”; par.0196-0203 “Measurement data…voltage gradients generated at different frequencies between a multiplicity of electrodes… the tissue change is monitored electrically from a probe electrode: for example as the tissue change affects local influences on impedance at one or more frequencies, the tissue change may be monitored by monitoring the local impedance at the tissue”). Therefore, PHOSITA would have had predictable success when the invention was filed to modify Tai and Beeckler to incorporate provides the electrical signal that varies in frequency to the one electrode and receives the electrical signal that is generated by applying the electrical signal that varies in frequency, and calculates an electrical impedance of a path that the electrical signal that varies in frequency travels for the purpose of allowing separate identification of the electrodes used and monitoring tissue change affected by the varying frequencies, as suggested by Ben-Haim (par.0168, 0196-0203).
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action 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. Please see prior art section above for more detail, updated citations (new references: Tai, Beeckler, and Ben-Haim), and updated obviousness rationale.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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