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 Objections
Claim 1 is objected to because of the following informalities: use of icons (dashes and bullet points) instead of indentations Appropriate correction is required.
Claim Interpretation
Regarding claim 11, the “first principle of operation” and “second principle of operation” are broad limitations. For the purpose of continued examination, the limitations have been interpreted as follows:
First principle of operation: device is powered on
Second principle of operation: device is on and actively searching for/detecting a blood vessel
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:
Fixation structure in claim 1: interpreted as an adhesive surface, belt, or strap (pg. 3, pgph. 8 – pg. 4, pgph. 1)
Detection structure in claims 1, 10-11: interpreted as a sensor and a computing unit (pg. 5, pgph. 3)
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.
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 § 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) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrath et al. (US Pre-Grant Publication 2021/0220059), hereinafter ‘McGrath’.
Regarding claim 1, McGrath teaches a blood vessel detection device ([0025], locating a target location within a blood vessel, Fig. 1B), further comprising:
a housing or frame ([0176], Fig. 1A, housing 100);
a fixation structure (Fig. 26A, adhesive layer 702, Fig. 25F, strap 508F) for fixation of the housing or frame to a skin surface of an anatomical region of a living being ([0208-0210]), the anatomical region selected from a group consisting of:
frontal part of a thigh, frontal part of a pelvis, frontal part of a groin, a wrist, a frontal part of an arm and a frontal part of a neck ([0023], body regions), and
a detection structure for detecting presence of a blood vessel ([0225], sensor or sensor array 4004, Fig. 65A), the detection structure defining a detection path along the skin surface, and comprising:
at least one sensor arranged to provide a signal indicative of the presence of a blood vessel along the detection path ([0225], sensor or sensor array 4004 locates suitable blood vessel);
a computing unit configured to:
receive the signal ([0333], processor generates image using data);
and to define an insertion procedure defining an entry location on the skin surface where a percutaneous needle and/or cannula can be inserted into the blood vessel ([0302], insertion path and insertion point location),
wherein the computing unit comprises an interface (Fig. 3B, visualization device 200’, [0303]) configured to communicate the entry location to a user for manual insertion or to an insertion structure for automatic insertion of the percutaneous needle and/or cannula ([0341], autonomous or semi-autonomous insertion of needle into patient).
Regarding claim 2, McGrath teaches the device according to claim 1, further comprising:
the insertion structure (inserter assembly 300, Fig. 1A) for automatic insertion ([0341], needle is automatically inserted into patient) for the percutaneous needle and/or cannula.
Regarding claim 3, McGrath teaches the device according to claim 1, further comprising:
wherein the at least one sensor comprises at least one receiver configured to receive an output signal from the anatomical region ([0293], transducers 1002’ receive ultrasonic signals, Fig. 45).
Regarding claim 4, McGrath teaches the device according to claim 1, further comprising:
wherein the at least one sensor comprises at least one emitter capable of emitting an input signal into the patient ([0293], transducers 1002’ transmit ultrasonic signals, Fig. 45).
Regarding claim 5, McGrath teaches the device according to claim 4, further comprising:
wherein the sensor is configured to detect the output signal in the form of an echo of the input signal emitted by the emitter ([0276], ultrasonic images generated based on echoes).
Regarding claim 6, McGrath teaches the device according to claim 5, further comprising:
wherein the computing unit is configured to determine an echo return time, from emission of input signal to detection of the output signal and to use the change in time to detect the location of the blood vessel ([0336], visualization device 47002 uses quantitative ultrasound (QUS) to quantify returning echoes).
Regarding claim 7, McGrath teaches the device according to claim 3, further comprising:
wherein the computing unit is configured to determine a change in frequency between the input signal emitted by the signal emitter and the output signal received by the sensor, and to detect the location of the blood vessel based on the change in frequency ([0337], QUS used to analyze radio-frequency signals).
Regarding claim 8, McGrath teaches the device according to claim 1, further comprising:
wherein the computing unit is configured to a provide a blood flow measure or recognition, indicating a blood flow in the blood vessel ([0263], detection and display of blood flow to precisely identify puncture sites).
Regarding claim 9, McGrath teaches the device according to claim 7, further comprising:
wherein the computing unit is configured to determine the blood flow direction based on the frequency shift of the output signal relative to the input signal ([0335], visualization device 47002 can utilize the Doppler effect to detect blood flow).
Regarding claim 10, McGrath teaches the device according to claim 1, further comprising:
wherein the detection structure is configured to provide a depth measure indicating a depth of said blood vessel below the outer skin surface ([0263], identify vein depth).
Regarding claim 11, McGrath teaches the device according to claim 4, further comprising:
wherein the detection structure is configured to provide the depth measure and/or the blood flow measure by exiting the emitter in accordance with a first principle of operation or a second principle of operation ([0388], manual override button 46006 stops insertion procedure, Fig. 126).
Regarding claim 12, McGrath teaches the device according to claim 8, further comprising:
wherein the at least one sensor comprises a flow sensing probe for providing the blood flow measure ([0263], detection and display of blood flow to precisely identify puncture sites) and a separate depth probe for providing the depth measure ([0261], secondary sensor).
Regarding claim 13, McGrath teaches the device according to claim 12, further comprising:
wherein the flow sensing probe defines a first measuring axis along which it emits and receives signals, the depth probe defines a second measuring axis along which it emits and receives signals, and wherein the flow sensing probe and the depth probe are arranged such that the first and second measuring axes intersect below the skin surface ([0261], first and second transverse array of ultrasound transducers to map veins).
Regarding claim 14, McGrath teaches the device according to claim 8, further comprising:
wherein the computing unit is configured to compare the blood flow measure and the depth measure to verify a location of a blood vessel ([0347], guiding the needle to the correct location using data from multiple sensors).
Regarding claim 15, McGrath teaches the device according to claim 1, further comprising:
a carriage (carriage 18012, Fig. 87) which holds the at least one sensor and which is configured to be moved along the detection path ([0364], carriage moves along x axis).
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.
Claims 1-7, 10, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pre-Grant Publication 2015/0065916), hereinafter ‘Maguire’, in view of McGrath et al. (US Pre-Grant Publication 2021/0220059), hereinafter ‘McGrath’.
Regarding claim 1, Maguire teaches a blood vessel detection device (Fig. 1B, [0034], detect vessels), further comprising:
a housing or frame (Fig. 1B, housing unit(s) 5);
a detection structure (Figs. 2A-2B, 3A-3C, [0103], sensors/processors) (Figs. 9A-9B, [0077], ultrasound components) for detecting presence of a blood vessel, the detection structure defining a detection path (Fig. 3A, path defined by gear railing 11) along the skin surface, and comprising:
at least one sensor ([0103], position sensors 18, 21) (Figs. 9A-9B, [0077], ultrasound probe and computer) arranged to provide a signal indicative of the presence of a blood vessel along the detection path;
a computing unit configured to:
receive the signal (Fig. 1A, computer 1);
and to define an insertion procedure defining an entry location on the skin surface where a percutaneous needle and/or cannula can be inserted into the blood vessel (Fig. 5, step 1, [0103], first processor 19 determines target puncture position).
Maguire does not teach a structure for skin fixation or an interface that communicates insertion information to a user or insertion structure.
McGrath teaches an apparatus for inserting a needle ([0012]), further comprising:
a fixation structure (Fig. 26A, adhesive layer 702, Fig. 25F, strap 508F) for fixation of the housing or frame to a skin surface of an anatomical region of a living being ([0208-0210]), the anatomical region selected from a group consisting of:
frontal part of a thigh, frontal part of a pelvis, frontal part of a groin, a wrist, a frontal part of an arm and a frontal part of a neck ([0023], body regions), and
wherein the computing unit comprises an interface (Fig. 3B, visualization device 200’, [0303]) configured to communicate the entry location to a user for manual insertion or to an insertion structure for automatic insertion of the percutaneous needle and/or cannula ([0341], autonomous or semi-autonomous insertion of needle into patient).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to incorporate the teachings of McGrath to include a fixation structure and a communication interface for automatic or manual needle insertion. Doing so would provide a way to attach the device to a patient and to ensure precise placement of a cannula, as recognized by McGrath ([0208], [0303]).
Regarding claim 2, Maguire and McGrath teach the device according to claim 1. Maguire teaches the device further comprising:
the insertion structure (Fig. 3B, needle device carrier 12) for automatic insertion for the percutaneous needle and/or cannula ([0105], movement of needle device carrier driven by servo motors 15, 16).
Regarding claim 3, Maguire and McGrath teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the at least one sensor comprises at least one receiver configured to receive an output signal from the anatomical region ([0077], ultrasound transducer includes signal pulser/receiver).
Regarding claim 4, Maguire and McGrath teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the at least one sensor comprises at least one emitter capable of emitting an input signal into the patient ([0077], ultrasound transducer includes signal pulser/receiver).
Regarding claim 5, Maguire and McGrath teach the device according to claim 4. Maguire teaches the device further comprising:
wherein the sensor is configured to detect the output signal in the form of an echo of the input signal emitted by the emitter ([0129], processing of returning echoes).
Regarding claim 6, Maguire and McGrath teach the device according to claim 5. Maguire teaches the device further comprising:
wherein the computing unit is configured to determine an echo return time, from emission of input signal to detection of the output signal and to use the change in time to detect the location of the blood vessel ([0021], ultrasound Doppler imaging) ([0081], conversion of echo waveforms).
Regarding claim 7, Maguire and McGrath teach the device according to claim 3. Maguire teaches the device further comprising:
wherein the computing unit is configured to determine a change in frequency between the input signal emitted by the signal emitter and the output signal received by the sensor, and to detect the location of the blood vessel based on the change in frequency ([0021], ultrasound Doppler imaging) ([0081], conversion of echo waveforms).
Regarding claim 10, Maguire and McGrath teach the device according to claim 1. Maguire teaches the device further comprising:
wherein the detection structure is configured to provide a depth measure indicating a depth of said blood vessel below the outer skin surface ([0024], depth of vessel).
Regarding claim 15, Maguire and McGrath teach the device according to claim 1. Maguire teaches the device further comprising:
comprising a carriage which holds the at least one sensor (Fig. 3B) and which is configured to be moved along the detection path ([0105], front to back movement within gear railing 11).
Claims 8-9, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pre-Grant Publication 2015/0065916) in view of McGrath et al. (US Pre-Grant Publication 2021/0220059), further in view of Liu et al. (US Pre-Grant Publication 2013/0090600), hereinafter ‘Liu’.
Regarding claim 8, Maguire and McGrath teach the device according to claim 1, but do not teach the limitations of claim 8.
Liu teaches a vessel access device (Fig. 7) further comprising:
wherein the computing unit ([0039], control device (unlabeled), Fig. 7) is configured to a provide a blood flow measure or recognition, indicating a blood flow in the blood vessel ([0026], ultrasound scanning in CFM mode to display blood flow information).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a computing unit that can recognize or measure blood flow. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 9, Maguire and McGrath teach the device according to claim 7, but do not teach the limitations of claim 9. Liu teaches the device further comprising:
wherein the computing unit is configured to determine the blood flow direction based on the frequency shift of the output signal relative to the input signal ([0026], ultrasound scanning in CFM mode to determine if blood is flowing towards or away from probe).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a computing unit that can determine the blood flow direction. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 11, Maguire and McGrath teach the device according to claim 4, further comprising:
wherein the detection structure is configured to provide the depth measure by exiting the emitter in accordance with a first principle of operation or a second principle of operation (Maguire, [0117-0118], position disagreement results in termination of runtime loop).
Maguire and McGrath do not teach the detection structure being configured to provide the blood flow measure.
Liu teaches a vessel access device (Fig. 7) further comprising:
wherein the detection structure is configured to provide the blood flow measure ([0026], ultrasound scanning in CFM mode to display blood flow information).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a detection structure that can provide a measure of blood flow. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 12, Maguire, McGrath, and Liu teach the device according to claim 8, further comprising:
wherein the at least one sensor comprises a flow sensing probe for providing the blood flow measure (Liu, [0026], scanning in CFM mode displays information about blood flow) and a separate depth probe for providing the depth measure (Maguire, [0024], position sensors 18, 21 are separate from ultrasound electronics).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a probe that can provide a measure of blood flow. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 13, Maguire, McGrath, and Liu teach the device according to claim 12, further comprising:
wherein the flow sensing probe (Liu, [0026], scanning in CFM mode displays information about blood flow) defines a first measuring axis along which it emits and receives signals,
the depth probe defines a second measuring axis along which it emits and receives signals (Maguire, [0103], position sensors),
and wherein the flow sensing probe and the depth probe are arranged such that the first and second measuring axes intersect below the skin surface (Maguire, [0103], measurements coincide, Fig. 5, step 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a probe that can provide a measure of blood flow. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Regarding claim 14, Maguire, McGrath, and Liu teach the device according to claim 8, further comprising:
wherein the computing unit is configured to compare the blood flow measure (Liu, [0026], scanning in CFM mode displays information about blood flow) and the depth measure (Maguire, [0103], position sensors), to verify a location of a blood vessel (Maguire, [0117-0118], needle position agreement).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and McGrath to incorporate the teachings of Liu to include a computing unit that can determine the blood flow direction. Doing so would allow for the determination of the vessel type, as recognized by Liu [0027].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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/E.L.O./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796