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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 12, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on July 30, 2024 are accepted.
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:
Claim 11: the claim limitation of “an image analysis logic configured to analyze the signal light detected by the camera and detect a change in the signa light relative to a threshold image” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “logic” coupled with functional language “to analyze and detect” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “logic”.
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.
A review of the specification, PG Pub US 2025/0041515 A1 shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 11: “an image analysis logic” is disclosed in [0080] as a software module stored in the memory 154 and executed by one or more processors 140 to perform the recited functions ([0025]). The image analysis logic along, hence is not disclosed to be any type of hardware and does not have structural information disclosed in the specification.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 11: Claim limitation “an image analysis logic configured to analyze the signal light detected by the camera and detect a change in the signa light relative to a threshold image”.
The specification [0081]-[0084] discloses the functions performed by these limitations. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality. The image analysis logic is disclosed in the specification as merely an algorithm, i.e., a software per se.
These limitations fail to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
Claim 26 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 26 recites that “the trained machine learning model configured to…provide an alert to a user”. This limitation is a computer/processor-implemented functional claim limitation as it is directed to a processor-controlled image parsing and analysis. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how does a trained machine learning model is configured to provide an alert to a user, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 11: the limitations of “an image analysis logic”.
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 11-20 and 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 recites “an image analysis logic configured to analyze the signal light detected by the camera and detect a change in the signal light”. Claim 11 is directed to a system, yet the image analysis logic is an algorithm, as disclosed in the specification [0080], therefore, it is unclear as to which of the structural elements of the optical imaging system (i.e., the light source or the camera, which are the only two components of the optical imaging system as recited in claim 1) or a combination of the structural elements of the claimed system that performs the step, thereby rendering the scope of the claim indefinite.
Claim 11 recites “detect a change in the signal light relative to a threshold image” that renders the scope of the claim indefinite. The signal light in the claims refers to the fluorescent emission light that is electromagnetic waves of certain wavelengths. An image, on the other end, is a collection of pixels. It hence is unclear how a signa light may be compared to an image, and what it means by a change in the signal light relative to a threshold image. The same rejection applies to claim 15 for the substantially identical claim language recited in line 10.
Claim 13 recites that the optical imaging system determines “a quantified change” in the signal light. It is unclear what the “quantified change” refers to, and whether it is related to the term “a change” recited in line 3 of claim 11 that claim 13 depends on. A change is a difference or a deviation from a baseline or a reference based on a comparison. Without knowing what the reference or the baseline is, the scope of term “change” is unclear, rendering the scope of the claim indefinite.
Claim 21 recites “a structural abnormality or deposit”. It is unclear what the “structural” and the “deposit” refer to. It is unclear whether the structural abnormality refers to an abnormality associated with the structure of the catheter or the structure of any other components. It is unclear whether the deposit refers to a deposit on the catheter or any other components. Clarification with proper amendment is required.
Claim 26 recites that “the trained machine learning model configured to…provide an alert to a user” that renders the scope of the claim indefinite. A trained machine learning model resembles a mathematical and statistical system. It is unclear how such a system may provide an alert to a user. Note that in the specification, the alert disclosed in [0087] may be a visual, audible, and/or tactile alert. For prior art purpose, this limitation is broadly interpreted such that the analysis result of the image triggers an alert being sent to a user.
Claim 26 recites “a deposit disposed on the medical device”. It is unclear if they refer to the term “a deposit” recited in claim 21, line 16. Note that claim 21 does not recite that the deposit is disposed on the medical device.
Claims 26 and 27 recite “a structural anomaly”. It is unclear whether it refers to or has any association with the term “a structural abnormality” recited in claim 21, line 16.
Claim 27 recites “a medical device” in lines 2 and 3 and “a deposit” in lines 2. It is unclear whether they refer to the identical terms recited in line 2 of claim 21 and line 16 of claim 21, respectively.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 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.
(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.
Claims 1-12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shakhar et al., US 2017/0143236 A1, hereinafter Shakhar.
Claim 1. Shakhar teaches in FIGS.2, 3 and 5 a vascular access device (VAD) monitoring system ([0062]: the imager can also be used to guide the insertion of a PICC line into a peripheral vein while continuously visualizing the PICC line; [0063]: a fluorescent PICC line can be implanted with imaging guidance provided by the imager into the body of a recipient. The imager can be implemented as a catheter viewer and a vein viewer) comprising:
a VAD having a catheter tube (306,503) disposed distally and configured to be disposed subcutaneously ([0062]: the imager can also be used to guide the insertion of a PICC line into a peripheral vein; [0060]: FIG.5: the catheter 530 is implanted into a patient 540) – implanting the catheter into a vein as illustrated in FIG.5 is considered a subcutaneous disposition,
the catheter tube including a dye (308) ([0054]: FIG.3, the catheter 306 and its fluorescent tip 308); and
an optical imaging system (500) including:
a light source configured to emit excitation light ([0059]: FIG.5 – the imager includes four modules: excitation light source, excitation optics, emission optics, and a CCD camera); and
a camera configured to detect signal light emitted from the dye when the dye is exposed to the excitation light ([0060]: Upon excitation of the fluorescent tip of the catheter, the beam 510 is emitted to the imager; and [0061]: the CCD camera captures fluorescence light).
Claim 2. Shakhar further teaches that
the excitation light includes electromagnetic radiation in a range of 700 nm to 1 mm ([0049]: NIR polymer composites can be fabricated into the PICCs by incorporating a fluorescent dye (IR Dye 800 CW, for example) and further visualized using NIR imaging; and [0108]: In FIG.20, samples are imaged at an excitation wavelength of 778 nm).
Claim 3. Shakhar further teaches that
the excitation light includes electromagnetic radiation in a range of 700 nm to 2500 nm ([0049]: NIR polymer composites can be fabricated into the PICCs by incorporating a fluorescent dye (IR Dye 800 CW, for example) and further visualized using NIR imaging; and [0108]: In FIG.20, samples are imaged at an excitation wavelength of 778 nm).
Claim 4. Shakhar further teaches that
the dye is formed integrally with a wall of the catheter tube ([0052]: a second type of fluorescent tip has a polymeric material which contains a fluorescent dye matrix or composite 206; FIG.2).
Claim 5. Shakhar further teaches that
the dye is included in a coating disposed on a surface of the catheter tube ([0052]: a first type of fluorescent tip has a catheter material 202 with a fluorescent dye coating; FIG.2).
Claim 6. Shakhar further teaches that
the excitation light has a first wavelength range and the signal light has a second wavelength range, different from the first wavelength range ([0048]: fluorophores (light-producing molecules), when excited by light of an appropriate wavelength, emits light of a longer wavelength (lower energy), which can be detected by a sensor or a camera system).
Claim 7. Shakhar further teaches that
the VAD further includes a dressing configured to adhere to a skin surface of a patient and includes a fiduciary marker configured to align one or both of the light source and the camera with a portion of the catheter tube disposed subcutaneously therebelow ([0053]: FIGS.3A-3F illustrates a skin patch including multiple infrared marker patterns…The monitoring skin patch 302 comprises fluorescent markers made of near-infrared fluorophores 304. An imaging system detects the light emitted from the fluorescent markers and the implanted device in order to determine if the implanted device is within a user-defined safe range) – the skin patch is the “dressing” as claimed. Since the markers allows the imaging system to detect whether the implanted device is within a particular range, Shakhar is considered at least implicitly teaching that the markers are configured to along the light source (of the imaging system) with the fluorescent tip (i.e., “a portion of the catheter tube” as claimed).
Claim 8. Shakhar further teaches that
the light source and the camera are provided as a single handheld device ([0059]: FIG.5 – the imager includes four modules: excitation light source, excitation optics, emission optics, and a CCD camera; and [0062]: the imager is a compact handheld imager incorporating all the modules).
Claim 9. Shakhar further teaches that
the light source and the camera are provided as separate stand-alone devices ([0070]: FIG.7: the near infrared transmitters 740A-740D and the detectors 750A-750D) – as illustrated in FIG.7, the light source (740A-740D) and the camera (the detectors 750A-750D) are separate and stand-alone devices.
Claim 10. Shakhar further teaches that
the light source is included on the dressing ([0070]: FIG.7: the skin patch 710 includes the near infrared transmitters 740A-740D).
Claim 11. Shakhar further teaches that
the optical imaging system includes an excitation light logic (602: the NIR emission module excites the fluorescent molecules), a signal light logic (604: an NIR detector module detecting the emitted signal), and an image analysis logic (606: an image processing module) configured to analyze the signal light detected by the camera and detect a change in the signal light ([0063]: a drop or increase in NIR signal intensity can give information about relative changes in depth and therefore detect if the device migrates from the intended position; and [0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position) relative to a threshold image (Claim 14: the processor is further configured to store at least one generated image and to compare one or more subsequently generated images to the stored image; and [0068]: a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold…The image processing module of the imager may be configured to determine if the location of the catheter is determined to be within a certain predetermined distance away from the boundaries of the markers).
Claim 12. Shakhar further teaches that
the threshold image generated from one or more previous images of the VAD is generated by the optical imaging system (Claim 14: the processor is further configured to store at least one generated image and to compare one or more subsequently generated images to the stored image; [0068]: a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold…The image processing module of the imager may be configured to determine if the location of the catheter is determined to be within a certain predetermined distance away from the boundaries of the markers).
Claim 14. Shakhar further teaches that
the image analysis logic of the optical imaging system is configured to analyze the signal light and generate an image of the catheter tube and determine one or more of an occlusion, a thrombosis, an abluminal biofilm, an intraluminal biofilm, a fibrin sheath, a catheter tube dislodgement, a loss of patency of the catheter tube, a catheter tube collapse, damage to the catheter tube, a proximity of a distal tip of the catheter tube to a vascular valve, or a proximity of the distal tip of the catheter tube to a vascular bifurcation ([0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position…If the position of the catheter has migrated considerably from its initial position) – the position of the catheter being migrated from its initial position is a catheter tube being dislodged.
Claim 15. Shakhar teaches in FIG.2, 3, 5 and 6 a method of detecting a complication with a vascular access device (VAD) disposed within a patient ([0065]: FIG.6 depicts an exemplary flow diagram 600 illustrating the workflow for monitoring peripherally inserted central catheter), comprising:
providing excitation light to a skin surface of the patient ([0065]: the excitation light source 602 is configured to emit a wavelength in the NIR band of the electromagnetic wave spectrum) impinging the excitation light on a dye included with a catheter tube of the VAD disposed subcutaneously ([0054]: FIG.3, the catheter 306 and its fluorescent tip 308; [0062]: the imager can also be used to guide the insertion of a PICC line into a peripheral vein; [0060]: FIG.5: the catheter 530 is implanted into a patient 540) – implanting the catheter into a vein as illustrated in FIG.5 is considered a subcutaneous disposition;
emitting signal light from the dye ([0066]: after excitation, the fluorophores embedded in the medical device emit light at a longer wavelength);
detecting the signal light by a camera ([0061]: the CCD camera captures fluorescence light; and [0066]: the resulting light illuminates a CCD camera system that converts photos into measureable electricals signals to create an image of the fluorescent device) disposed externally to the patient (FIG.5);
determining an image of the VAD ([0066]: the resulting light illuminates a CCD camera system that converts photos into measureable electricals signals to create an image of the fluorescent device); and
analyzing the image ([0067]: the signal is then processed by an image processing module 606) to determine if the complication is present ([0067]: The image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position) based on a change in the signal light ([0063]: a drop or increase in NIR signal intensity can give information about relative changes in depth and therefore detect if the device migrates from the intended position; and [0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position) relative to a threshold image data (Claim 14: the processor is further configured to store at least one generated image and to compare one or more subsequently generated images to the stored image; and [0068]: a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold…The image processing module of the imager may be configured to determine if the location of the catheter is determined to be within a certain predetermined distance away from the boundaries of the markers).
Claim 16. Shakhar further teaches
providing the excitation light in an infrared (IR) or near infrared (NIR) spectra ([0049]: NIR polymer composites can be fabricated into the PICCs by incorporating a fluorescent dye (IR Dye 800 CW, for example) and further visualized using NIR imaging; and [0108]: In FIG.20, samples are imaged at an excitation wavelength of 778 nm).
Claim 17. Shakhar further teaches that
the dye is formed integrally within a wall of the catheter tube ([0052]: a second type of fluorescent tip has a polymeric material which contains a fluorescent dye matrix or composite 206; FIG.2).
Claim 18. Shakhar further teaches that
the dye is included in a coating disposed on a surface of the catheter tube ([0052]: a first type of fluorescent tip has a catheter material 202 with a fluorescent dye coating; FIG.2).
Claim 19. Shakhar further teaches that
the threshold image data is generated from one or more previous images of the VAD (Claim 14: the processor is further configured to store at least one generated image and to compare one or more subsequently generated images to the stored image; [0068]: a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold…The image processing module of the imager may be configured to determine if the location of the catheter is determined to be within a certain predetermined distance away from the boundaries of the markers).
Claim 20. The method according to claim 15, wherein the complication includes one or more of an occlusion, a thrombosis, an abluminal biofilm, an intraluminal biofilm, a fibrin sheath, a catheter tube dislodgement, a loss of patency of the catheter tube, a catheter tube collapse, damage to the catheter tube, a proximity of a distal tip of the catheter tube to a vascular valve, and a proximity of the distal tip of the catheter tube to a vascular bifurcation ([0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position…If the position of the catheter has migrated considerably from its initial position) – the position of the catheter being migrated from its initial position is a catheter tube being dislodged.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shakhar et al., US 2017/0143236 A1, hereinafter Shakhar, in view of Min et al., US 2014/0275924 A1, hereinafter Min.
Claim 13. Shakhar teaches all the limitations of claim 11.
Shakhar further teaches that
the optical imaging system determines a quantified change in the signal light ([0063]: a drop or increase in NIR signal intensity can give information about relative changes in depth and therefore detect if the device migrates from the intended position; and [0068]: a user-defined safe range could be established to determine how much the implanted device deviates from its original position…a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold) – a determined “how much” and the “magnitude in shift” is a quantified change” as claimed, and
displays the quantified change as a metric on a display of the optical imaging system (608: a monitor display) ([0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position…If the position of the catheter has migrated considerably from its initial position…a signal is generated to be transmitted to a care provider station/monitor 608 and/or to a remote station 618; and [0077]: the notification may be based on the magnitude of deviation of the implanted device. For instance, if the magnitude of deviation is greater than a predetermined threshold, a notification may be transmitted to a monitoring station…if the magnitude of deviation is minimal, a feedback notification to only display the image of the catheter may be performed).
Shakhar does not teach that the quantified change being displayed as a metric on a display.
However, in regard to the feature of displaying the quantified change as a metric, the purpose of displaying the quantified change is to allow the user to visualize and evaluate the change and to act accordingly. Whether to display the change as a metric or some other format is considered merely a design choice for a data presentation. It is a well-known knowledge in the field of art that when displaying a quantified change, the information to be displayed may be various format for it to be suitable for particular applications as desired. For example, displaying it as a magnitude or a metric allows a visualization of the absolute value being measured. Display it as a notification allows a user to easily understand without needing to interpret it. Display it as an audible or hepatic configuration allows the notification to be delivered via different sensing means.
For example, in an analogous catheter-based sensing parameter display field of endeavor, Min teaches such a feature in [0048]: controller 728 determines a difference between magnitude of the pre-ablation output signals and the post-ablation output signals and generates an indication of the determined difference. The indication may be visual or audible indication. For example, controller 728 may display a value of the difference, e.g., an average percentage difference, on display device, may display an indication of the difference using indicators 720, may audibly announce an indication of the difference.
It would have been obvious for one of ordinary skills in the art before the effective filing date of the claimed invention to have alternatives of how the content of the changes to be displayed as taught in Min. Either configuration would reasonably allow the information to be properly delivered, and the provision of such alternative configurations, where needed, involves only routine skill in the art to achieve with reasonable expectation of success.
Claims 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Shakhar et al., US 2017/0143236 A1, hereinafter Shakhar, in view of Tsuchida et al., US 2026/0069722 A1, hereinafter Tsuchida, further in view of Thompson et al., US 2007/0060804 A1, hereinafter Thompson.
Claim 21. Shakhar teaches in FIGS.2-6 a medical device imaging system (FIG.5), comprising:
a medical device having a catheter tube (306,503) and including a distal portion disposed intravascularly ([0062]: the imager can also be used to guide the insertion of a PICC line into a peripheral vein; [0060]: FIG.5: the catheter 530 is implanted into a patient 540) – implanting the catheter into a vein as illustrated in FIG.5 is considered a subcutaneous disposition,
the catheter tube including a dye (308) ([0054]: FIG.3, the catheter 306 and its fluorescent tip 308); and
an optical imaging system disposed externally (500, FIG.5) and including
a light source ([0059]: FIG.5 – the imager includes four modules: excitation light source, excitation optics, emission optics, and a CCD camera),
a camera ([0060]: Upon excitation of the fluorescent tip of the catheter, the beam 510 is emitted to the imager; and [0061]: the CCD camera captures fluorescence light), and
a console (FIG.6) including one or more logic modules stored within a non-transitory storage medium ([0081]: FIG.11, the image processor includes a CPU, which performs the processes described above. The process data and instructions may be stored in memory 1102),
the one or more logic modules ([0059]: FIG.5 – the imager includes four modules: excitation light source, excitation optics, emission optics, and a CCD camera; and [0062]: the imager is a compact handheld imager incorporating all the modules), when executed by one or more processors, perform operations including:
emitting excitation light from the light source ([0065]: the excitation light source 602 is configured to emit a wavelength in the NIR band of the electromagnetic wave spectrum)
to impinge on the dye included with the distal portion of the catheter tube disposed intravascularly ([0054]: FIG.3, the catheter 306 and its fluorescent tip 308; [0062]: the imager can also be used to guide the insertion of a PICC line into a peripheral vein; [0060]: FIG.5: the catheter 530 is implanted into a patient 540) – implanting the catheter into a vein as illustrated in FIG.5 is considered a subcutaneous disposition;
detecting signal light emitted from the dye of the distal portion (604: an NIR detector module detecting the emitted signal; and [0066]: after excitation, the fluorophores embedded in the medical device emit light at a longer wavelength) to provide an image ([0066]: the resulting light illuminates a CCD camera system that converts photos into measureable electricals signals to create an image of the fluorescent device);
parsing the image to determine the distal portion of the medical device ([0054]: FIG.3, the catheter 306 and its fluorescent tip 308; [0063]: a drop or increase in NIR signal intensity can give information about relative changes in depth and therefore detect if the device migrates from the intended position; and [0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position); and
analyzing the parsed image ([0067]: the signal is then processed by an image processing module 606) against threshold data (Claim 14: the processor is further configured to store at least one generated image and to compare one or more subsequently generated images to the stored image; and [0068]: a predetermined deviation threshold could be established and further the shift in position of the catheter from its initial (or last determined) position can be computed to determine if the magnitude in shift of the catheter position is greater than the predetermined threshold…The image processing module of the imager may be configured to determine if the location of the catheter is determined to be within a certain predetermined distance away from the boundaries of the markers)
to determine a presence of a structural feature by analyzing the parsed image against threshold data ([0067]: the image processing module 606 is configured to determine whether the position of the catheter is within pre-defined boundaries and/or whether the catheter is at its last determined position…If the position of the catheter has migrated considerably from its initial position).
Shakhar does not teach that (1) the fluorescent-labeled distal portion is determined in terms of its shape and (2) the structural feature is an abnormality or a deposit.
However, in regard to (1), in an analogous fluorescent-labeling objection detection field of endeavor, Tsuchida teaches
determining a shape of an object by parsing the image ([0014]: in the above biological fluorescence imaging using ICG, it is requested to achieve good compartment identifiability to the extent that enables to accurately identify a structure, a shape, and a state of the observation target such as the fluorescent contrast-enhanced part; and [0017]: the present invention has been developed in response to this situation, aiming to provide a composition for fluorescent labeling, a fluorescent probe….which have good compartment identifiability to the extent that enables to accurately identify an observation target; FIG.1B: near-IR images that shows the shape of the fluorescent-labeled observation target).
Since Shakhar teaches that the tip, i.e., the distal portion, of the catheter is labeled with fluorescent dyes, when Shakhar and Tsuchida are combined, it teaches that the fluorescent imaging can be analyzed to identify the shape of the observation target, which is the distal portion of the catheter.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the image of the fluorescent-labeled distal portion of the catheter of Shakhar employ such a feature of being analyzed to identify its shape as taught in Tsuchida for the advantage of “providing a good compartment identifiability that enables to accurately identity an observation target”, as suggested in Tsuchida, [0017].
In regard to (2), in an analogous fluorescence imaging-based objection identification field of endeavor, Thompson teaches that
the structural feature that the fluorescent image is analyzed to determine is an abnormality or a deposit ([0009]: the device is used for detecting atherosclerotic plaque deposits by means of detecting fluorescent light…The fiber may be used for sending excitation light to the plaque and for receiving fluorescent light from the plaque).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the parsed image of Shakhar and Tsuchida combined employ such a feature of being analyzed to identify a deposit as taught in Thompson for the advantage of “identifying a target object”, as suggested in Thompson, [0009]. Note that though in [0009] it discloses that this system is not suited for diagnosis or treatment, for the purpose of merely determining the presence of a deposit, the teaching is considered sufficient and appropriate.
Claim 22. Shakhar further teaches that
the excitation light includes electromagnetic radiation in an infrared or a near infrared range ([0049]: NIR polymer composites can be fabricated into the PICCs by incorporating a fluorescent dye (IR Dye 800 CW, for example) and further visualized using NIR imaging; and [0108]: In FIG.20, samples are imaged at an excitation wavelength of 778 nm)
.
Claim 23. Shakhar further teaches that
the dye is formed integrally with a wall of the catheter tube ([0052]: a second type of fluorescent tip has a polymeric material which contains a fluorescent dye matrix or composite 206; FIG.2) or
is included in a coating disposed on a surface of the catheter tube ([0052]: a first type of fluorescent tip has a catheter material 202 with a fluorescent dye coating; FIG.2).
Claim 24. Shakhar further teaches that
the excitation light has a first wavelength range and the signal light has a second wavelength range, different from the first wavelength range ([0048]: fluorophores (light-producing molecules), when excited by light of an appropriate wavelength, emits light of a longer wavelength (lower energy), which can be detected by a sensor or a camera system).
Claim 25. Shakhar further teaches that
the medical device further includes a dressing configured to adhere to a skin surface of a patient and includes a fiduciary marker configured to align one or both of the light source and the camera with the distal portion of the catheter tube disposed subcutaneously therebelow ([0053]: FIGS.3A-3F illustrates a skin patch including multiple infrared marker patterns…The monitoring skin patch 302 comprises fluorescent markers made of near-infrared fluorophores 304. An imaging system detects the light emitted from the fluorescent markers and the implanted device in order to determine if the implanted device is within a user-defined safe range) – the skin patch is the “dressing” as claimed. Since the markers allows the imaging system to detect whether the implanted device is within a particular range, Shakhar is considered at least implicitly teaching that the markers are configured to along the light source (of the imaging system) with the fluorescent tip (i.e., “a portion of the catheter tube” as claimed).
Claims 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Shakhar et al., US 2017/0143236 A1, hereinafter Shakhar, in view of Tsuchida et al., US 2026/0069722 A1, hereinafter Tsuchida, further in view of Thompson et al., US 2007/0060804 A1, hereinafter Thompson, further in view of DePaoli et al., US 2925/0078261 A1, hereinafter DePaoli.
Claims 26 and 27. Shakhar, Tsuchida and Thompson combined teaches all the limitations of claim 21.
Sharkhar further teaches that the analysis of the parsed image triggers an alert being sent to the user ([0072]: Once the PICC line is in place and its tip location is confirmed with an augmented image…the skin patch can be applied to the recipient’s skin. Subsequently, the patch can monitor the catheter tip periodically or even continuously to ensure that it has not deviated from its original intended location. If the tip migrates, the patch is configured to transmit a signal to a bedside monitor, which, in term, can relay the alert signal to a central station that is monitored by personnel).
Neither of Shakhar, Tsuchida and Thompson teaches the claimed features associated with the machine learning model.
However, in an analogous imaging analysis for feature identification field of endeavor, DePaoli teaches
analyzing the parsed image against the threshold data further includes training a machine learning model with a plurality of labeled images ([0020]: the machine-learned algorithm has been trained to detect features using labels from either only the first characterization modality or the second characterization modality; [0054]: the training data is labelled with training labels; [0100]: any one or combination of these approaches may be used to generate training labels that are then associated with training data) – since the images are analyzed with the ML model to identified features in the images, the training data associated with the training labels are the “plurality of labeled images” as claimed,
the trained machine learning model configured to determine a structural anomaly or a deposit disposed on the medical device ([0130] that a medical image may be parsed and analyzed using a machine-learned algorithm to detect futures on the images including a deposit 1508, the catheter sheath location 1510, and the inner lumen of the artery 1504, as illustrated in FIG.15), wherein
the plurality of labeled images includes labeled images of a medical device including a deposit, labeled images of a medical device including a structural anomaly, and labeled images of a medical device without either of a deposit or a structural anomaly ([0020]: the machine-learned algorithm has been trained to detect features using labels from either only the first characterization modality or the second characterization modality; [0054]: the training data is labelled with training labels) – since the training data is used to train the machine learning model for identify features on the image, the labeled images would include the images that contain such features and images that do not contain such features in order for the algorithm to properly learn to recognize those features and to distinguish those features from other features.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of the of Shakhar, Tsuchida and Thompson combined employ such features associated with analyzing the images using a trained machine learning model to identify features as taught in DePaoli for the advantage of “providing improved feature detection, feature representation and measurement”, as suggested in DePaoli, Abstract.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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