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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 15th, 2025 has been entered.
Claims 1-2, 6-8, 11, 12, 15, 17, 18, and 21-26 remain pending in the application. Claims 3-5, 9, 10, 13, 14, 16, 19, and 20 are cancelled.
Response to Arguments
Applicant’s arguments, filed December 15th, 2025, with respect to the rejections under 35 U.S.C. 103 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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “transducer … configured to output an electrical signal in response to sound and to capture a synchronicity of the sound” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Each transducer is defined, in para. [0041], as a micro-electromechanical systems (MEMS) microphone, an electret diaphragm microphone, a millimeter scale microphone, or a flexible membrane transducer.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
Claims 7-8, 11, 12, 15, 17, 18, 22, 24, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 7 and 17 follows.
STEP 1
Regarding claims 7 and 17, the claim recites a series of structural elements and/or a series of steps or acts, including a system. Thus, the claim is directed to a machine and/or a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
the interface device including a controller configured to process the electrical signal and to record the sound;
wherein, in processing the electrical signal, the controller is configured to determine a location of the sound, wherein the location of the sound is a location at which the electrical signal has the largest amplitude,
the diagnosing tool configured to automatically diagnose the abnormality of the blood vessel based on the plurality of entries of the database, wherein the abnormality is at least one of an atherosclerosis, a dissection, an aneurysm, a dural arteriovenous fistula, an arteriovenous malformation, or pulsatile tinnitus.
processing the electrical signal at a controller to determine location of the sound, wherein the location of the sound is a location at which the electrical signal has the largest amplitude; and
comparing the sound at the controller to a database of a plurality of sounds and corresponding parameters to automatically diagnose the abnormality, wherein the abnormality is at least one of an atherosclerosis, a dissection, an aneurysm, a dural arteriovenous fistula, an arteriovenous malformation, or pulsatile tinnitus.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
Claim 7 and 17 recites a catheter including an elongated body defining an elongated lumen therethrough and at least one transducer disposed on an outer surface of the elongated body, the at least one transducer configured to output an electrical signal in response to sound; an interface device coupled to the at least one transducer, the interface device including a controller configured to process the electrical signal and to record the sound, and a memory device configured to store a database of a plurality of entries, which is merely adding insignificant pre-solution activity to the judicial exception (MPEP 2106.05(g)). The output an electrical signal in response to sound/measuring a sound using the catheter does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the measured sound, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a catheter including an elongated body defining an elongated lumen therethrough and at least one transducer disposed on an outer surface of the elongated body, the at least one transducer configured to output an electrical signal in response to sound;
an interface device coupled to the at least one transducer, the interface device including a controller configured to process the electrical signal and to record the sound, and
a memory device configured to store a database of a plurality of entries
The outputting an electrical signal/measuring and storing a database of a plurality of entries steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the outputting an electrical signal/measuring and storing a database of a plurality of entries steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 6, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited catheter and transducer are generic sensors configured to perform pre-solutional data gathering activity, the interface comprising the memory is configured to perform insignificant pre-solution activity, and the interface comprising the controller is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. See C. L. Merdes and P. D. Wolf, "Locating a catheter transducer in a three-dimensional ultrasound imaging field," in IEEE Transactions on Biomedical Engineering, vol. 48, no. 12, pp. 1444-1452, Dec. 2001, doi: 10.1109/10.966603.
The dependent claims also fail to add something more to the abstract independent claims. Claims 8, 11, 12, 15, 18, 22, 24, and 26 are directed to catheters for data-gathering and/or more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Paul (US 20170312553 A1 – previously cited) in view of Howat (US 20100217257 A1 – previously cited), further in view of Garbini (US 20080125661 A1- – previously cited), and further in view of Van Bruggen (US 20180168540 A1).
Regarding claim 1, Paul discloses a catheter (“catheter”, para. [0025]) for diagnosing an abnormality of a blood vessel (“diagnostic or therapeutic procedure … to sense tissue modification”; “blood vessels”, “assessing … quantized … amount of energy in the tissue”, para. [0027-0028, 0038, 0071]), the catheter (catheter 10/210, figs. 1a-1b & 3b) comprising: an elongated body (flexible catheter shaft 18/118/218, figs. 1a-ab & 3a-3b) defining an elongated lumen therethrough (“fluid tubes … extend through the catheter”, para. [0054]), and an array of transducers (“micro-electro mechanical systems (MEMS)”; “transducer … array”, para. [0034, 0041-0042], figs. 2a-2h) disposed on an outer surface of the elongated body (as seen in fig. 3b, “transducers … provided on the outer surface of the catheter shaft 218”, para. [0049, 0057]), each transducer of the array configured to (Examiner’s Note: functional language, i.e., capable of) output an electrical signal in response to sound (“transmit … soundwaves … electrical signals”; “electrical (voltage) signals para. [0034, 0080]).
Paul does not disclose wherein the elongated body is formed from a multi-layer, laminated sheath.
However, Howat directed to a catheter discloses the catheter comprising a catheter shaft (Examiner note: the catheter shaft is being interpreted as the elongated body) including an ultrasound transducer (para. [0013]), wherein the elongated body is formed from a multi-layer, laminated sheath (“catheter shaft … includes an inner layer … an outer layer … a braid assembly … dual-laminate coating over the braid members”, para. [0032], fig. 8). Howat further discloses that the dual laminate coating is also advantageous in that it allows the braid wire assembly to bond to an outer catheter layer to create a significant increased substrate structure between the braid assembly and the outer layer, and further that the improved bonding of the braid assembly to the outer layer increases the effectiveness of catheter articulation (para. [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paul such that the elongated body is formed from a multi-layer, laminated sheath, in view of the teachings of Howat, as such a modification would have been merely a substitution of the flexible catheter shaft of Paul for the catheter shaft of Howat as this would aid in creating a significant increased substrate structure and increasing the effectiveness of catheter articulation.
Paul, as modified by Howat hereinabove, does not disclose a spiral array of transducers, wherein each transducer of the spiral array is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance, and wherein the predetermined radial distance is different from the predetermined longitudinal distance.
However, Garbini directed to a multi-twisted acoustic array for medical ultrasound discloses a spiral array of transducers (acoustic transducer array 12 having a plurality of elements 24, fig. 2; “helical or spiral pattern of elements 24”, para. [0044]), wherein ach transducer of the spiral array is separated by a predetermined longitudinal distance and a predetermined radial distance (elements 24 … wavelengths or less spacing between the centers of adjacent elements”; “adjacent elements 24 are arranged in a helix along the azimuth axis 32 … angle … rotation provide 0.47 degrees per element 24”, para. [0040, 0044-0045, 0065]), wherein the predetermined radial distance is different from the predetermined longitudinal distance (“spacing between elements 24 along the elevation dimension is … different than along the azimuth dimension”; figs. 4-5 … spiral pattern … offset from each other in the elevation dimension, para. [0042, 0065]). Garbini further discloses the twisted array may allow for three-dimensional scanning (para. [0030-0031, 0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paul, as modified by Howat hereinabove, such that the array is a spiral array wherein each of the plurality of transducers is separated by a predetermined longitudinal distance and a predetermined radial distance, wherein the predetermined radial distance is different from the predetermined longitudinal distance, in view of the teachings of Garbini, as this would aid in enabling three-dimensional scanning.
Paul further discloses that exemplary acoustic sensors may implement micro-electro mechanical systems (MEMS) or any other suitable acoustic energy generating and/or receiving means that are now known or later developed to generate electrical signals representative of the environment (para. [0034]). Paul, as modified by Howat and Garbini hereinabove, does not disclose each transducer of the spiral array configured to output an electrical signal in response to sound and to capture a synchronicity of the sound.
However, Van Bruggen directed to a catheter comprising arrays of speaker and/or microphone elements discloses each transducer of the array (“array”; “microphone elements … MEMs microphones”, para. [0043, 0048]) configured to (Examiner’s Note: functional language, i.e., capable of) output an electrical signal in response to sound (“outputs … acoustic signals”, para. [0019, 0077]) and to capture a synchronicity of the sound (Examiner note: The instant application discloses, in para. [0041] that the transducers may be a micro-electromechanical systems (MEMS) microphone, an electret diaphragm microphone, any other millimeter scale microphone, or a flexible membrane transducer. Therefore, the MEMs microphones of Van Bruggen are capable of outputting electrical signals in response to sound and capturing a synchronicity of sound).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paul, as modified by Howat and Garbini hereinabove, such that each transducer of the spiral array configured to output an electrical signal in response to sound and to capture a synchronicity of the sound, in view of the teachings of Van Bruggen, as such a modification would have been merely a substitution of the MEMs transducers of Paul for the MEMs microphones of Van Bruggen to generate electrical signals/outputs representative of the environment/intensities of each of the acoustic signals (Van Bruggen, para. [0019]).
Regarding claim 21, Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, discloses the catheter according to claim 1, wherein the catheter is further configured to capture at least one of an amplitude of the sound, a frequency of the sound, a rhythm of the sound, a duration of the sound, or an intermittency of the sound (“arrival time … relative amplitude”; “transit time, frequency, wavelength, velocity, pressure, and/or intensity”, para. [0027, 0068]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Paul in view of Howat, Garbini, and Van Bruggen, as applied to claim 1 above, and further in view of Stigall (US 20190053781 A1 – previously cited).
Regarding claim 2, Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, discloses the catheter according to claim 1. Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, does not expressly disclose wherein the elongated body has an outer diameter from 0.5 mm to 1.0 mm.
However, Stigall directed to an intraluminal ultrasound device including a flexible elongate member configured to be positioned within a body lumen of a patient discloses wherein the elongated body has an outer diameter from 0.5 mm to 1.0 mm (“catheter … outer diameter … for positioning within the anatomy 102 … approximately 1 Fr (0.33 mm) and approximately 15 Fr (5 mm) ”, para. [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, such that the elongated body has an outer diameter from 0.5 mm to 1.0 mm, in view of the teachings of Stigall, as this would aid in positioning the elongated member within the anatomy by configuring the catheter of Paul to have a suitable outer diameter for positioning within the anatomy.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Paul in view of Howat, Garbini, and Van Bruggen, as applied to claim 1 above, and further in view of Ramos (US 20150366462 A1 – previously cited).
Regarding claim 6, Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, discloses the catheter according to claim 1. Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, does not expressly disclose the catheter further comprising: a battery disposed within the elongated lumen, the battery coupled to at least one transducer of the spiral array of transducers.
However, Ramos directed to a catheter comprising a sensor 20 discloses a battery (“small battery”, para. [0044]) disposed within the elongated lumen (“circuit near the proximal end … battery powered”, para. [0046]), the battery coupled to at least one sensor (“sensor 20 … energized … small battery”, para. [0044-0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paul, as modified by Howat, Garbini, and Van Bruggen hereinabove, such that the catheter further comprises a battery disposed within the elongated lumen, the battery coupled to at least one transducer of the spiral array of transducers, in view of the teachings of Ramos, as this would aid in providing a wireless battery powered sensing catheter.
Claims 7, 15, 22, 17-18, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Piccolo (WO 2019046769 A1 – previously cited) in view of Paul, further in view of Vilkomerson (US 5161536 A – previously cited), and further in view of Paak (US 20200397324 A1).
Regarding claim 7, Piccolo discloses a system for diagnosing an abnormality of a blood vessel (“system”, Abstract, para. [0114, 0284]), the system comprising: a catheter (“vascular catheter navigation device 102”, para. [0114], figs. 3 & 47) including: an elongated body (“elongate body”; “vascular catheter navigation device 102”, Abstract, para. [0114, 0116]) defining an elongated lumen therethrough (“infusion/sampling lumen 110”, Abstract, para. [0114, 0118], figs. 1 & 3); and at least one transducer (“ 2 sensors,”; sensing element 302; “sensor … microphone”, para. [0121, 0116, 0252], figs. 3, 5C & 47), the at least one transducer (“ 2 sensors,”; sensing element 302; “sensor … microphone”, para. [0121, 0116, 0252], figs. 3, 5C & 47) configured to (Examiner’s Note: functional language, i.e., capable of) output an electrical signal in response to sound (“sensor signal”; “sound waves … microphone”, para. [0116, 0252]); and an interface device (controller 114, fig. 1, “computer system 5200”, para. [0293], fig. 52) coupled to the at least one transducer (as seen in figs. 1 & 3, “wired or wireless”; “controller may be in communication with the one or more sensors”, para. [0021, 0033]), the interface device including a controller (controller 114, fig. 1, “ microprocessor 5203”, para. [0293], fig. 52) configured to process the electrical signal and to record the sound (“controller which records and/or analyzes the signal from the sensor(s)”; “sound waves”; “analyzed”, para. [0021, 0025, 0116]), and a memory device (“non-volatile memory 5206 … magnetic optical drive … random access memory”; “computer-readable media”, para. [0293-0294, 0298]) configured to (Examiner’s Note: functional language, i.e., capable of) store a database of a plurality of entries (Examiner note: para. [0046] of the published instant application discloses that the memory device 166 may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically-erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. Therefore, the non-volatile memory 5206 of Piccolo would be capable of storing a database of a plurality of entries, fig. 97), each of which pertains to a record of the sound (“record … signal from the sensor(s)”; “records the sound waves”; “parameter … reflected sound intensity”, para. [0021, 0025, 0252], fig. 97), and wherein the memory device (“non-volatile memory 5206 … magnetic optical drive … random access memory”; “computer-readable media”, para. [0293-0294, 0298]) stores a diagnosing tool executable by the controller (“diagnose”; “code and data stored and executed on one or more electronic devices”, para. [0116, 0281, 0298]), the diagnosing tool (“diagnose”; “code and data stored and executed on one or more electronic devices”, para. [0116, 0281, 0298]) configured to automatically diagnose the blood vessel based on the plurality of entries of the database (“parameters”; “diagnose a stenosis, blockage, narrowings or disease of a blood vessel”, para. [0129, 0281, 0283] (see also para. [0009])), wherein the abnormality is at least one of an atherosclerosis, a dissection, an aneurysm, a dural arteriovenous fistula, an arteriovenous malformation, or pulsatile tinnitus (“aneurysms, blockages, narrowings, stenosis, para. [0284-0285, 0414]).
Piccolo does not disclose the at least one transducer disposed on an outer surface of the elongated body.
However, Paul discloses a catheter (catheter 210, fig. 3B) including an elongated body (catheter shaft 218, fig. 3b); and at least one transducer (acoustic transducers 220a, 220b, fig. 3b) disposed on an outer surface of the elongated body (as seen in fig. 3b, “provided on the outer surface of the catheter shaft 218”, para. [0057]). Paul further discloses that positioning the acoustic transducers off-center and closer to the outer diameter of the catheter 110 enables the acoustic transducers to receive stronger (higher amplitude) reflected signals (para. [0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo such the at least one transducer disposed on an outer surface of the elongated body, in view of the teachings of Paul, as this would aid in receiving stronger (higher amplitude) reflected signals.
Piccolo further discloses that the controller can determine whether the distal end of the vascular catheter navigation device is in an artery instead of a vein, based on magnitude and direction of blood flow around the vascular catheter navigation device by measuring and analyzing the measurable parameter (para. [0116]).
Piccolo, as modified by Paul hereinabove, does not disclose wherein, in processing the electrical signal, the controller is configured to determine a location of the sound, wherein the location of the sound is a location at which the electrical signal has the largest amplitude.
However, Vilkomerson directed to an ultrasound system for locating the position of an object within a body discloses an interface device including a controller (receiving processing circuitry 19, fig. 1) configured to process the electrical signal and to record the sound (“electrical signal provided by the transducer 13 … processing circuitry module 19 … capable of determining the exact position of the transducer”, fig. 1, col. 4 lines 1-58), wherein, in processing the electrical signal, the controller is configured to determine a location of the sound (“determine the exact location of the catheter … determining the exact position of the transducer”, Abstract, col. 4 lines 1-58 & col. 8 lines 14-36), wherein the location of the sound is a location at which the electrical signal has the largest amplitude (“largest signal … exactly locating the position of the catheter … position of the maximum amplitude signal”, Abstract, col. 4 lines 18-27 & col. 8 lines 14-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul hereinabove, such that the interface device includes a controller configured to process the electrical signal and to record the sound, and, in processing the electrical signal, the controller is configured to determine a location of the sound, wherein the location of the sound is a location at which the electrical signal has the largest amplitude, in view of the teachings of Vilkomerson, as this would aid in determining and displaying the exact position of the transducer and catheter so that the physician knows exactly where the catheter is being moved and knows the position of the catheter.
Piccolo, as modified by Paul and Vilkomerson hereinabove, does not disclose wherein each entry of the plurality of entries includes a property describing the sound, wherein the property includes a synchronicity of the sound.
However, Paak directed to methods and systems facilitate one or more dynamical analyses that can characterize and identify synchronicity between acquired signals to predict/estimate presence, non-presence, localization, and/or severity of abnormal cardiovascular conditions or disease discloses (Abstract, para. [0003, 0012, 0143]) discloses a memory device (“memory … non-volatile”; “memory”; “repository 112”, para. [0058, 0307, 0311], figs. 1 & 12) configured to store a database of a plurality of entries (“stored database”; “data set”, para. [0026, 0058, 0285]), each of which pertains to a record of the sound (“acoustic signal”; “biophysical signal data set”, para. [0003, 0026, 0058, 0070, 0143]), wherein each entry of the plurality of entries includes a property describing the sound (“synchronicity dynamical properties”; “synchronicity feature sets”, para. [0058, 0070, 0143, 0285]), wherein the property includes a synchronicity of the sound (“synchronicity dynamical properties”; “synchronicity feature sets”, para. [0058, 0070, 0143, 0285]). Paak further discloses that the processor determines a histogram of the synchronicity of the first and second biophysical signal data sets, extracts a statistical parameter of the histogram, and that the extracted first statistical parameter is used in the determining of the estimated value for the presence, non-presence, severity, and/or localization (where applicable) of the disease state and further that the example analysis can be used in the diagnosis and treatment of cardiac-related pathologies and conditions and/or neurological-related pathologies and conditions including hemorrhagic injury, etc., tinnitus and other hearing-related diseases/conditions and vision-related diseases/conditions (para. [0052-0053, 0070-0071, 0321]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul and Vilkomerson hereinabove, such that each entry of the plurality of entries includes a property describing the sound and the property includes a synchronicity of the sound, in view of the teachings of Paak, as this would aid in determining and diagnosing the presence, non-presence, severity, and/or localization (where applicable) of the disease state (Paak, para. [0052-0053, 0070-0071]).
Regarding claim 15, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7, wherein each entry of the plurality of entries further includes at least one additional property describing the sound (“various properties … parameter”, para. [0009, 0116, 0129]), the at least one additional property selected from the group consisting of amplitude, frequency, rhythm, duration, and intermittency (“pulsatility”, “curve amplitude, noise, standard deviation, shape, slope, value, area under the curve, Fourier transform, frequencies, harmonics”, para. [0009, 0116, 0129], fig. 97).
Regarding claim 22, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7, wherein the controller (controller 114, fig. 1, “ microprocessor 5203”, para. [0293], fig. 52) is configured to record the sound while the catheter is being withdrawn from the blood vessel (“flow direction, characteristics, profiles … information … during catheter withdrawal”;”; “signal … magnitude … retracted back … withdraws the catheter … magnitude”, para. [0009-0010, 0025, 0381-0384], fig. 97).
Regarding claim 17, Piccolo discloses a method for diagnosing an abnormality of a blood vessel (“diagnose”, para. [0281, 0284]), the method comprising: placing a catheter (vascular catheter navigation device 102, para. [0114]) into the blood vessel near a cochlea (“jugular access”; “navigate through, other vessels such as those in the brain”, para. [0004, 0136, 0284]) (Examiner note: para. [0037] of the published instant application specification discloses that “the catheter 10 is configured to pass into the jugular vein 4, the carotid artery 5, or other blood vessels near the cochlea”. Therefore, the jugular access for catheterization of Piccolo discloses a blood vessel near the cochlea), the catheter (vascular catheter navigation device 102, para. [0114]) including an elongated body (elongate body, Abstract) defining an elongated lumen therethrough (lumen … length of the elongate body, Abstract); measuring a sound at a transducer disposed on the elongated body (sound detector, or microphone, records the sound waves; sensing element 302; “sensor … microphone”, para. [0025, 0121, 0252], figs. 3, 5A-C & 47 (see also para. [0030])), the transducer (sound detector, or microphone, para. [0025, 0252]) configured to (Examiner’s Note: functional language, i.e., capable of) output an electrical signal in response to sound (“sensor signal”; “sound waves … microphone”, para. [0116, 0252]); processing the electrical signal at a controller to determine location of the sound (“sensor signals are communicated … to the controller where the signal(s) are analyzed based on the measured parameter”, para. [0256]), and comparing the sound at the controller to a plurality of sounds and corresponding parameters to automatically diagnosing the abnormality (“parameters may be compared between and among multiple parameter vs. time/location curves”; “navigate, identify, and assess the health of various vascular or other anatomies … diagnose”, para. [0129, 0280-0284]), wherein the abnormality is at least one of an atherosclerosis, a dissection, an aneurysm, a dural arteriovenous fistula, an arteriovenous malformation, or pulsatile tinnitus (“aneurysms, blockages, narrowings, stenosis, para. [0281, 0284-0285, 0414]).
Piccolo does not expressly disclose the transducer disposed on an outer surface of the elongated body.
However, Paul discloses a catheter (catheter 210, fig. 3B) including an elongated body (catheter shaft 218, fig. 3b); and at least one transducer (acoustic transducers 220a, 220b, fig. 3b) disposed on an outer surface of the elongated body (as seen in fig. 3b, “provided on the outer surface of the catheter shaft 218”, para. [0057]). Paul further discloses that positioning the acoustic transducers off-center and closer to the outer diameter of the catheter 110 enables the acoustic transducers to receive stronger (higher amplitude) reflected signals (para. [0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo such the at least one transducer disposed on an outer surface of the elongated body, in view of the teachings of Paul, as this would aid in receiving stronger (higher amplitude) reflected signals.
Piccolo, as modified by Paul hereinabove, does not expressly disclose wherein the location of the sound is a location at which the electrical signal has the largest amplitude.
However, Vilkomerson directed to an ultrasound system for locating the position of an object within a body discloses processing the electrical signal at a controller (receiving processing circuitry 19, fig. 1) to determine location of the sound (“electrical signal provided by the transducer 13 … processing circuitry module 19 … capable of determining the exact position of the transducer”; “determine the exact location of the catheter … determining the exact position of the transducer”, Abstract, col. 4 lines 1-58 & col. 8 lines 14-36), wherein the location of the sound is a location at which the electrical signal has the largest amplitude (“largest signal … exactly locating the position of the catheter … position of the maximum amplitude signal”, Abstract, col. 4 lines 18-27 & col. 8 lines 14-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul hereinabove, such that the location of the sound is a location at which the electrical signal has the largest amplitude, in view of the teachings of Vilkomerson, as this would aid in determining and displaying the exact position of the transducer and catheter so that the physician knows exactly where the catheter is being moved and knows the position of the catheter.
Piccolo, as modified by Paul and Vilkomerson hereinabove, does not disclose the measurement including a synchronicity of the sound; and a database of a plurality of sounds and corresponding parameters.
However, Paak directed to methods and systems facilitate one or more dynamical analyses that can characterize and identify synchronicity between acquired signals to predict/estimate presence, non-presence, localization, and/or severity of abnormal cardiovascular conditions or disease discloses (Abstract, para. [0003, 0012, 0143]) discloses the measurement including a synchronicity of the sound (“synchronicity dynamical properties”; “synchronicity feature sets”, para. [0058, 0070, 0143, 0285]); and a database (“stored database”; “data set”, para. [0026, 0058, 0285]) of a plurality of sounds and corresponding parameters (“acoustic signal”; “biophysical signal data set”; “feature sets extracted … 94 synchronicity feature sets”, para. [0003, 0026, 0058, 0070, 0143, 0277, 0288]). Paak further discloses that the processor determines a histogram of the synchronicity of the first and second biophysical signal data sets, extracts a statistical parameter of the histogram, and that the extracted first statistical parameter is used in the determining of the estimated value for the presence, non-presence, severity, and/or localization (where applicable) of the disease state and further that the example analysis can be used in the diagnosis and treatment of cardiac-related pathologies and conditions and/or neurological-related pathologies and conditions including hemorrhagic injury, etc., tinnitus and other hearing-related diseases/conditions and vision-related diseases/conditions (para. [0052-0053, 0070-0071, 0321]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul and Vilkomerson hereinabove, such that disclose the measurement including a synchronicity of the sound and the method comprises a database of a plurality of sounds and corresponding parameters, in view of the teachings of Paak, as this would aid in determining and diagnosing the presence, non-presence, severity, and/or localization (where applicable) of the disease state (Paak, para. [0052-0053, 0070-0071]).
Regarding claim 18, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7, wherein the controller (controller 114, fig. 1, “ microprocessor 5203”, para. [0293], fig. 52) is configured to record the sound while the catheter is being withdrawn from the blood vessel (“flow direction, characteristics, profiles … information … during catheter withdrawal”;”; “signal … magnitude … retracted back … withdraws the catheter … magnitude”, para. [0009-0010, 0025, 0381-0384], fig. 97).
Regarding claim 26, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the method according to claim 17, wherein the measurement further includes at least one of an amplitude of the sound, a frequency of the sound, a rhythm of the sound, a duration of the sound, or an intermittency of the sound (“pulsatility”, “curve amplitude, noise, standard deviation, shape, slope, value, area under the curve, Fourier transform, frequencies, harmonics”, para. [0009, 0116, 0129], fig. 97).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Piccolo in view of Paul, Vilkomerson, and Paak, as applied to claim 7 above, and further in view of Stigall.
Regarding claim 8, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7. Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not expressly disclose wherein the elongated body has an outer diameter from 0.5 mm to 1.0 mm.
However, Stigall discloses wherein the elongated body has an outer diameter from 0.5 mm to 1.0 mm (“catheter … outer diameter … for positioning within the anatomy 102 … approximately 1 Fr (0.33 mm) and approximately 15 Fr (5 mm) ”, para. [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the elongated body has an outer diameter from 0.5 mm to 1.0 mm, in view of the teachings of Stigall, as this would aid in positioning the elongated member within the anatomy by configuring the catheter of Piccolo to have a suitable outer diameter for positioning within the anatomy.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Piccolo in view of Paul, Vilkomerson, and Paak, as applied to claim 7 above, and further in view of Ramos.
Regarding claim 11, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7. Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not expressly disclose the system further comprising: a battery disposed within the elongated lumen, the battery coupled to the at least one transducer.
However, Ramos directed to a catheter comprising a sensor 20 discloses a battery (“small battery”, para. [0044]) disposed within the elongated lumen (“circuit near the proximal end … battery powered”, para. [0046]), the battery coupled to the at least one sensor (“sensor 20 … energized … small battery”, para. [0044-0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the system further comprises: a battery disposed within the elongated lumen, the battery coupled to the at least one transducer, in view of the teachings of Ramos, as this would aid in providing a wireless battery powered sensing catheter.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Piccolo in view of Paul, Vilkomerson, and Paak, as applied to claim 7 above, and further in view of Sliwa (US 20100168572 A1 – previously cited).
Regarding claim 12, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7. Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not expressly disclose wherein the controller is further configured to output the electrical signal through an audio output.
However, Sliwa directed to methods for acoustically monitoring diagnostic and therapeutic procedures discloses a controller (monitoring unit 800 … control operation, para. [0014, 0062]) wherein the controller (monitoring unit 800 … control operation, para. [0014, 0062]) is further configured to output the electrical signal through an audio output (800 may include … speaker 806 to provide … audible output … of the sensed data para. [0014, 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the controller is further configured to output the electrical signal through an audio output, in view of the teachings of Sliwa, as this would aid in acoustically monitoring diagnostic and therapeutic procedures by providing audible output of the sensed data regarding the diagnostic parameters.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Piccolo in view of Paul, Vilkomerson, and Paak, as applied to claim 7 above, and further in view of Garbini.
Regarding claim 23, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the system according to claim 7 and the at least one transducer include transducers disposed on an outer surface of the elongated body (Paul, fig. 3b, “receiving stronger (higher amplitude) reflected signals”; “provided on the outer surface of the catheter shaft 218”, para. [0055, 0057] – see claim 7 above). Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not disclose wherein the at least one transducer includes a spiral array of transducers disposed on an outer surface of the elongated body, wherein each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance, and wherein the predetermined radial distance is different from the predetermined longitudinal distance.
However, Garbini directed to a multi-twisted acoustic array for medical ultrasound discloses a spiral array of transducers (acoustic transducer array 12 having a plurality of elements 24, fig. 2; “helical or spiral pattern of elements 24”, para. [0044]), wherein each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance (elements 24 … wavelengths or less spacing between the centers of adjacent elements”; “adjacent elements 24 are arranged in a helix along the azimuth axis 32 … angle … rotation provide 0.47 degrees per element 24”, para. [0040, 0044-0045, 0065]), and wherein the predetermined radial distance is different from the predetermined longitudinal distance (“spacing between elements 24 along the elevation dimension is … different than along the azimuth dimension”; figs. 4-5 … spiral pattern … offset from each other in the elevation dimension, para. [0042, 0065]). Garbini further discloses the twisted array may allow for three-dimensional scanning (para. [0030-0031, 0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the at least one transducer includes a spiral array of transducers disposed on an outer surface of the elongated body, each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance, and the predetermined radial distance is different from the predetermined longitudinal distance, in view of the teachings of Garbini, as this would aid in enabling three-dimensional scanning.
Regarding claim 25, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the method according to claim 17 and the transducer is disposed on an outer surface of the elongated body (Paul, fig. 3b, “receiving stronger (higher amplitude) reflected signals”; “provided on the outer surface of the catheter shaft 218”, para. [0055, 0057] – see claim 17 above). Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not disclose wherein the transducer is one of a spiral array of transducers disposed on an outer surface of the elongated body, wherein each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance, and wherein the predetermined radial distance is different from the predetermined longitudinal distance.
However, Garbini directed to a multi-twisted acoustic array for medical ultrasound discloses a spiral array of transducers (acoustic transducer array 12 having a plurality of elements 24, fig. 2; “helical or spiral pattern of elements 24”, para. [0044]), wherein each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance (elements 24 … wavelengths or less spacing between the centers of adjacent elements”; “adjacent elements 24 are arranged in a helix along the azimuth axis 32 … angle … rotation provide 0.47 degrees per element 24”, para. [0040, 0044-0045, 0065]), and wherein the predetermined radial distance is different from the predetermined longitudinal distance (“spacing between elements 24 along the elevation dimension is … different than along the azimuth dimension”; figs. 4-5 … spiral pattern … offset from each other in the elevation dimension, para. [0042, 0065]). Garbini further discloses the twisted array may allow for three-dimensional scanning (para. [0030-0031, 0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the transducer is one of a spiral array of transducers disposed on an outer surface of the elongated body, each transducer of the spiral array of transducers is separated from another transducer of the spiral array by a predetermined longitudinal distance and a predetermined radial distance, and the predetermined radial distance is different from the predetermined longitudinal distance, in view of the teachings of Garbini, as this would aid in enabling three-dimensional scanning.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Piccolo in view of Paul, Vilkomerson, and Paak, as applied to claim 7 above, and further in view of Brandt (US 20080195355 A1).
Regarding claim 24, Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, discloses the method according to claim 17. Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, does not disclose after measuring the sound at the transducer, storing the sound and corresponding parameters in the database of the plurality of sounds and corresponding parameters.
However, Brandt directed to a monitoring system (10) including at least one sensor to monitor sound discloses after measuring the sound at the sensor (“sensor … sound”; “data from the sensors”, Abstract, para. [0033, 0043]), storing the sound and corresponding parameters in the database of the plurality of sounds and corresponding parameters (“sensor … desired parameter … populate the database with monitored information”; “data from the sensors is stored in a relational database 84 … queries data from database 84 and processes it per a rules-based algorithm … data acquisition and retention”, para. [0033, 0043-0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Piccolo, as modified by Paul, Vilkomerson, and Paak hereinabove, such that the method comprises after measuring the sound at the transducer, storing the sound and corresponding parameters in the database of the plurality of sounds and corresponding parameters, in view of the teachings of Brandt, as this would aid data acquisition and retention and retrieving the data for processing (Brandt, para. [0043-0044]).
Conclusion
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791