DETAILED ACTION
Notice of 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 13 is objected to because of the following informalities: “or the catheter”, should be, “of the catheter”. Appropriate correction is required.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), 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), 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) 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) 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.
Claim limitation(s):
Base unit that is configured to receive
has/have been interpreted under 35 U.S.C. 112(f) because it uses/they use generic placeholder(s):
unit
coupled with functional language:
receive
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder(s) is/are not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) claim(s) %% has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f):
Circuitry for communicating with ultrasound probe; image processor
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), 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 wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 20, the use of artificial intelligence is not described in a way to support possession. The Specification only describes the use of artificial intelligence in a generic non-descript manner without providing how one of ordinary skill in the art would configure artificial intelligence to determine the claimed parameters.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim(s) 20 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 20, it is unclear as to how exactly artificial intelligence is being used.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 10 is/are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 10, since the limitation “wired or wireless” encompasses all possible configurations involving wiring, the claim does not further limit claim 9. The language of the claim also does not further recite a further step in the method.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5-10, 12-14, and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel).
Regarding claims 1, 9, and 12, Saugel discloses a vascular access system and monitoring method comprising: a vascular access device comprising a catheter; an ultrasound assembly comprising an ultrasound probe that is configured to be positioned overtop the catheter when the catheter is inserted into a patient's vasculature; and a base unit that is configured to receive images from the ultrasound probe (Figs. 5 and 7: ultrasound imaging device is wired and provides images of an inserted catheter’s position to confirm proper placement).
Regarding claims 2 and 10, Saugel discloses wired connections between ultrasound assembly and processing electronics (Saugel @ Figs. 5 and 7).
Regarding claims 5-8, 13, 14, and 19, Saugel discloses that a base unit is configured to generate display content from the images and the readings and transmit the display content to one or more monitoring devices, wherein the content includes parameters that display catheter geometry or position, and movement or displacement (Saugel @ Figs. 5 and 7).
Regarding claim 16, Saugel discloses that determining one or more parameters comprises detecting thrombus (Fig. 7: “use compression ultrasound to exclude venous thrombosis”).
Regarding claim 17, Saugel discloses that determining one or more parameters comprises determining blood administration flow characteristics (Fig. 7: “confirm the patency of the vein and to quantify blood flow”).
Regarding claim 18, Saugel discloses that determining one or more parameters comprises detecting a procedural event (Fig. 7: both proper and improper placement are considered to be a “procedural event”).
Claim Rejections - 35 USC § 103
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 3, 4, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel) in view of Hageman (US 2018/028159).
Regarding claim 3, Saugel does not explicitly disclose wirelessly connecting the ultrasound probe and sensor to a base unit. However, Hageman teaches wireless transmission from an ultrasound probe to an external receiver ([0042]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the wireless ultrasound probe of Hageman to the ultrasound probe of Saugel, as to provide a robust wireless configuration of an ultrasound probe.
Regarding claims 4 and 11, Saugel does not explicitly disclose a securement dressing that is configured to secure the ultrasound probe and the sensor array overtop the catheter. However, Hageman teaches a dressing that provides securement of the probe housing to a patient’s skin ([0042]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the dressing of Hageman to the ultrasound probe of Saugel, as to provide a robust securing means for an ultrasound probe housing.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel), as applied to claim 12 above, in view of “Confirming extravasation from a peripheral venous catheter: another role for ultrasonography” by J. Dolan. Anaesthesia. 2012 (Dolan).
Regarding claim 15, Saugel does not explicitly disclose determining one or more parameters comprises detecting extravasation or infiltration. However, Dolan teaches detecting extravasation using ultrasound (Fig 1: “Velocity colour Doppler confirming fluid extravasation”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the extravasation detection of Dolan to the system of Saugel, as to provide robust image-based detection of venous anomalies.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice” by B. Saugel et al. Critical Care. 21:225, pp.1-11, 2017 (Saugel), as applied to claim 12 above, in view of “An Open-Source Wearable Sensor System for Detecting Extravasation of Intravenous Infusion” by H. Lee et al. IEEE Trans Instrument Measure. Vol. 70, 2021 (Lee).
Regarding claim 20, Saugel does not explicitly disclose that the one or more parameters are determined using artificial intelligence. However, Lee teaches the use of deep learning to detect extravasation (“deep learning techniques, including the use of a convolution neural network”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the artificial intelligence of Lee to the system of Saugel, as to provide robust AI capabilities.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Ip whose telephone number is (571) 270-5387. The examiner can normally be reached Monday - Friday 9a-5p PST.
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/JASON M IP/Primary Examiner, Art Unit 3793