DETAILED ACTION
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7, 10-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsiai et al. (US 2019/0183392).
Hsiai discloses (see Figs. 4A-21C) a system and method for electric impedance measurements of biomaterials of vascular walls comprising the following claim limitations:
(claim 1) A method for characterizing biological tissue for an endoluminal procedure (see Abstract; plaque level characterization of blood vessels), the method comprising: positioning a first electrode (220a, Figs. 4A-4B) within an endoluminal space adjacent to a region of biological tissue (as expressly shown in Fig. 5D); positioning a second electrode (220d, Figs. 4A-4B) spatially separated from the first electrode (220a) (as expressly shown in Figs. 4A-4B); applying a variable-frequency input electrical signal across the first electrode and the second electrode to generate an electrical field corresponding to the region ([0044]; [0121]; [0130]; [0136]; express disclosure of a “frequency sweep” electric signal being sent between the electrodes generating an electric field); measuring a voltage response between the first electrode and the second electrode based on the electric field (see Figs. 9A-9D; [0036]; [0124]; [0126]; [0145]; computer platform expressly includes impedance analyzer for measuring/analyzing tissue impedance values received); determining a voltage phasor based on the voltage response relative to the variable-frequency input electrical signal (see Figs. 9D and 11E-11F; [0036]; [0066]; [0079]; [0092]; [0102]; [0104]; [0114]; [0136]; computer platform expressly disclosed to receive, record, interpret, and perform automated calculations on the received signals to output data); and determining a characteristic of the region based on the voltage phasor (see Abstract; [0066]; [0079]; determination and quantification of varying degrees of plaque burden and predicting plaque rupture in blood vessels expressly disclosed wherein the computer platform expressly may output data including to a digital display for to an operator);
(claim 2) further comprising: positioning a third electrode (220b, Figs. 4B and 5B) and a fourth electrode (220e, Figs. 4B and 5B) that are each spatially separated from the first electrode (220a) (as expressly shown in Figs. 4B and 5B); wherein the variable-frequency input electrical signal is applied across the third electrode (220b) and the fourth electrode (220e) (see Figs. 4B and 5B; [0027]; [0076]; [0124]; utilizing a 6-ponit electrode system and method to perform a “frequency sweep” to obtain measurements of biomaterials and tissues is expressly disclosed); and wherein the voltage response is measured between the first electrode (220a) and the second electrode (220d) (see Figs. 9A-9D; [0036]; [0124]; [0126]; [0145]; computer platform expressly includes impedance analyzer for measuring/analyzing tissue impedance values received);
(claim 3) wherein: the first electrode (220a) is carried by an elongated member (i.e., balloon catheter 212/214, Figs. 4A-4B); and the elongated member (212/214) comprises a guidewire, a catheter, or a sheath (as shown in Figs. 4A-6E; first electrode expressly carried by an elongated balloon catheter);
(claim 5) wherein the region of biological tissue comprises a body vessel (see Figs. 5D, 11A-11B and 14A-14F; plaque level characterization of tissue comprising blood vessels (e.g., aorta depicted) expressly disclosed);
(claim 7) wherein the variable-frequency input electrical signal comprises a frequency sweep across a test frequency band (see claims 20 and 40; [0009]; [0018]; [0044]; [0136]; express disclosure of a “frequency sweep” electric signal being sent across a frequency band);
(claim 10) further comprising: displaying, on a user interface, a graphical representation of the characteristic ([0066]; [0079]; determination and quantification of varying degrees of plaque burden and predicting plaque rupture in blood vessels expressly disclosed wherein the computer platform expressly may output data including to a digital display and/or images to a screen for an operator);
(claim 11) wherein the biological tissue comprises cardiovascular, neurological, hepatic, renal, or musculoskeletal structures (as expressly shown in Figs. 5D, 11A-11B and 14E-14F; plaque level characterization of cardiovascular tissue comprising blood vessels (e.g., aorta) expressly disclosed);
(claim 12) wherein the characteristic identifies the region of biological tissue as one or more materials selected from a group comprising blood, subintimal layer, vessel wall, plaque, myocardium, pericardial space, fat, muscle, and clot (as expressly shown in Figs. 5D, 11A-11B and 14E-14F; plaque level characterization of cardiovascular tissue comprising blood vessels (e.g., aorta) expressly disclosed);
(claim 13) further comprising: navigating the first electrode (220a) through a vascular pathway based on the characteristic ([0044]-[0045]; [0129]; [0136]; [0139]; steps expressly disclosed for finding, navigating to, and taking and comparing tissue measurements from at least three locations including mild, moderate, and severe plaque locations for study data recordation);
(claim 14) A system for characterizing biological tissue for an endoluminal procedure (see Abstract), the system comprising: an elongated member (i.e., balloon catheter 212/214, Figs. 4A-4B) having a first electrode (220a, Figs. 4A-4B), wherein the first electrode (220a) is configured for positioning within an endoluminal space adjacent to a region of the biological tissue (as expressly shown in Fig. 5D); a second electrode (220d, Figs. 4A-4B) configured for positioning to be spatially separated from the first electrode (220a) (as expressly shown in Fig. 5D); a signal generator (i.e., computer platform systems and software and its sub-components; [0065]-[0066]; [0078]-[0079]; [0124]; computer platform expressly disclosed for sending signals and emissions for utilizing the EIS system) operatively coupled to each of the first electrode (220a) and the second electrode (220d) ([0105]; [0126]; conductive wires expressly connect electrodes proximally to the computer platform/impedance analyzer), wherein the signal generator (i.e., computer platform systems and software) is configured to provide a variable-frequency input electrical signal across the first electrode and the second electrode to generate an electric field through the region ([0044]; [0121]; [0130]; [0136]; express disclosure of a “frequency sweep” electric signal being sent between the electrodes generating an electric field); a measurement unit operatively coupled to each of the first electrode and the second electrode, wherein the measurement unit is configured to measure a voltage response between the first electrode and the second electrode based on the electric field (see Figs. 9A-9D; [0036]; [0124]; [0126]; [0145]; computer platform expressly includes impedance analyzer for measuring/analyzing tissue impedance values received); and a processor (i.e., computer platform systems and software) operatively coupled to each of the measurement unit and the signal generator, wherein the processor is configured to receive data indicating the voltage response ((see Figs. 9A-9D; [0036]; [0066]; [0079]; [0124]; [0126]; [0145]; computer platform expressly includes impedance analyzer for measuring/analyzing tissue impedance values received and the computer platform expressly disclosed to record received signals and interpret those signals); determine a voltage phasor based on the voltage response relative to the variable-frequency input electrical signal (see Figs. 9D and 11E-11F; [0036]; [0066]; [0079]; [0092]; [0102]; [0104]; [0114]; [0136]; computer platform expressly disclosed to receive, record, interpret, and perform automated calculations on the received signals to output data); and generate output data comprising a characteristic of the region based on the voltage phasor ([0066]; [0079]; determination and quantification of varying degrees of plaque burden and predicting plaque rupture in blood vessels expressly disclosed wherein the computer platform expressly may output data including to a digital display and/or images to a screen for an operator);
(claim 15) wherein: the elongated member (212/214) includes a proximal electrical interface (i.e., proximal electrical interface with the computer platform systems); and the first electrode (220a) is electrically coupled to the proximal electrical interface via a conductor (i.e., conductive wires proximally extending from catheter 212 tip) disposed in the elongated member (212) ([0066]; [0079]; [0105]; [0126]; conductive wires of catheter 212 expressly connect electrodes 220 proximally to the computer platform/impedance analyzer);
(claim 16) further comprising: a user interface configured to receive the output data from the processor and provide a visual representation of the characteristic ([0066]; [0079]; computer platform expressly capable of outputting data to a digital display for to an operator);
(claim 17) wherein the first electrode (220a) comprises a conductive surface on the elongated member (212/214) that is electrically isolated from a body (i.e., ballon 214) of the elongated member by an insulating material (as shown in Figs. 4A-6E; [0076]; [0126]; distal tip of conductive electrodes 220 exposed on the exterior of the resilient material of balloon 214 of the catheter 212 with the electrodes attached to balloon 214 with silicone adhesive and the remainder of the electrodes covered/encapsulated by insulating heat-shrink tube);
(claim 18) wherein the processor is further configured to generate a control signal that, when received by the signal generator, causes the signal generator to adjust one or more of an excitation frequency or a signal amplitude of the variable-frequency input electrical signal based on the voltage response ([0066]; [0079]; computer platform and its components expressly capable of recording received signals, interpreting received signals, and controlling/changing parameters such as frequency and amplitude); and
(claim 20) further comprising: a third electrode (220b, Figs. 4B and 5B); a fourth electrode (220e, Figs. 4B and 5B); and wherein the signal generator is operatively coupled to the third electrode (220b) and the fourth electrode (220d) and configured to apply the variable-frequency input electric signal across the third electrode (220b) and the fourth electrode (220d) ([0066]; [0079]; [0105]; [0126]; conductive wires of catheter 212 expressly connect electrodes 220 proximally to the computer platform/impedance analyzer).
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) 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hsiai as applied to claims 1 and 3 above, and further in view of Toth et al. (US 2015/0289929).
Hsiai, as applied above, discloses a system and method for electric impedance measurements of biomaterials of vascular walls comprising all the limitations of the claim except for wherein the elongated member comprises an insulating sheath, and the method further comprises retracting the insulating sheath relative to a body of the elongated member to adjust a length of an exposed region of the first electrode, and wherein positioning the second electrode comprises positioning the second electrode on an external skin surface of a subject.
However, Toth teaches (see Fig. 15a) a similar system and method for monitoring electrode feedback signals including impedance comprising the elongated member (1512) comprises an insulating sheath (1516) ([0333]; insulated inner layer of sheath 1516 expressly taught), and the method further comprises retracting (at 1522) the insulating sheath (1516) relative to a body of the elongated member (1512) to adjust a length of an exposed region of the first electrode (1514) ([0021]; [0160]; [0238]; [0332]-[0333]) in order to beneficially provide structural support and enhance protection, delivery, and deployment of at least one electrode therefrom once positioned at a desired tissue site ([0021]; [0160]; [0238]; [0332]-[0333]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Hsiai to have the elongated member comprising an insulating sheath, and the method further comprises retracting the insulating sheath relative to a body of the elongated member to adjust a length of an exposed region of the first electrode in order to beneficially provide structural support and enhance protection, delivery, and deployment of at least one electrode therefrom once positioned at a desired tissue site, as taught by Toth.
Additionally, Toth teaches a similar system and method for monitoring electrode feedback signals including impedance comprising the second electrode being positioned on an external skin portion of the subject ([0130]; [0141]; [0193]; [0274]; [0277]; [0282]; [0327]; [0385]). Accordingly, Toth teaches that it is known that a second electrode within the subject and a second patch electrode on the skin of the subject are elements that are functional equivalents for providing means for delivering/receiving current from another electrode and further monitoring impedance. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the skin patch electrode taught by Toth for the second internal electrode of Hsiai because both elements were known equivalents for providing means for delivering/receiving current from another electrode and further monitoring impedance within the tissue characterization art. The substitution would have resulted in the predictable results of providing means for delivering/receiving current from another electrode and further monitoring impedance to the system/method of Hsiai.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hsiai as applied to claim 7 above, and further in view of Abdolahad et al. (US 2022/0022771).
Hsiai, as applied above, discloses a system and method for electric impedance measurements of biomaterials of vascular walls including the test frequency band being within a range of 1 kHz to 300 kHz (Hsiai, see [0044]; [0121]; [0130]; [0136]). Hsiai fails to expressly disclose the input electrical signal having a current amplitude within a range of 0.1 microamperes to 10 milliamperes.
However, Abdolahad teaches a system and method for monitoring and evaluating tissue impedance comprising an input electrical signal having a current amplitude within a range of 0.1 microamperes to 10 milliamperes ([0119]; current amplitude of 5 mA or less expressly taught) in order to beneficially stimulate the impedance-monitored tissue without detrimentally providing a shock to the human body ([0119]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Hsiai to have the input electrical signal having a current amplitude within a range of 0.1 microamperes to 10 milliamperes in order to beneficially stimulate the impedance-monitored tissue without detrimentally providing a shock to the human body, as taught by Abdolahad.
Claim(s) 9 and 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hsiai as applied to claims 1 and 14 above, and further in view of Bort et al. (US 2022/0344025).
Hsiai, as applied above, discloses a system and method for electric impedance measurements of biomaterials of vascular walls comprising all the limitations of the claim, including collecting datasets except for wherein determining the characteristic of the region comprises comparing the determined voltage phasor to a reference dataset using a machine learning model.
However, Bort teaches a system and method for diagnosing tissue locations with disorders comprising wherein determining the characteristic of the region comprises comparing the determined voltage phasor to a reference dataset using a machine learning model (see claims 13 and 40; [0051]; [0079]; [0099]; [0137]) in order to beneficially allow for learning model tissue characterization predictions and advanced pattern recognition via comparisons to the reference dataset while further continuing to improve future machine learning performance (see claims 13 and 40; [0051]; [0079]; [0099]; [0137]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Hsiai to have wherein determining the characteristic of the region comprises comparing the determined voltage phasor to a reference dataset using a machine learning model in order to beneficially allow for learning model tissue characterization predictions and advanced pattern recognition via comparisons to the reference dataset while further continuing to improve future machine learning performance, as taught by Bort.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Packard et al. (Two-Point Stretchable Electrode Array for Endoluminal Electrochemical Impedance Spectroscopy Measurements of Lipid-laden Atherosclerotic Plaques; Ann. Biomed Eng. 44(9): 2965-2706, 2016) (copy provided herein).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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