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 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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sowards et al. (U.S. Patent Application 2021/0275256 A1) and further in view of Mahmoodabadi et al. (U.S. Patent Application 2014/0100550 A1) and Miller et al. (U.S. Patent 11,656,140 B1)
Claim 1: Sowards teaches –
A system [medical device monitoring system] (Figure 1, Element 100) for determining a catheter length required to extend between an insertion site and a target location prior to placement within a patient body (intended use; See Examiner’s Note), the system comprising:
Examiner’s Note: The Examiner contends that Soward is capable of determining a catheter length to extend between an insertion site and a target location prior to placement within a patient body as the system can be position externally to the patient and shape information obtained [information regarding the optical fiber during and/or after insertion into the patient's body for rendering a shape and orientation of the stylet] (Para 0041) [assist in the positioning of the distal tip 360 of the catheter 195 in a desired position within the patient vasculature](Para 0064) [Information associated with the reflected light signals may be used to determine a three-dimensional representation of the physical state of the stylet within the body of a patient] (Para 0010)
a measurement device [stylet assembly] (Figure 1, Element 120) comprising an optical fiber having one or more core fibers [a multi-core optical fiber 135 positioned within or operating as the stylet 130] (Figure 1, Element 135),
each of the one or more core fivers including an array of reflective grating sensors [each sensor may operate as a reflective grating such as a fiber Bragg grating (FBG)] (Para 0009), and is
configured to be aligned with one or more external landmarks [the stylet 130 illustrating its placement within the catheter 195 as the catheter 195 is being inserted into a vasculature of a patient 400 through a skin insertion site 410] (Figure 4, Element 410 and Para 0064; See claim 3 where the external landmark is an insertion site); and
Examiner’s Note: Figure 1-4 are disclosed as the same embodiment (See Para 0015-0018). Thus, there is no improper combining of different embodiments.
a console [console] (Figure 1, Element 110) including one or more processors [processor] (Figure 1, Element 160) and a non-transitory computer-readable medium [memory] (Figure 1, Element 165) having stored thereon logic [optical logic] (Figure 1, Element 180), when executed by the one or more processors, causes operations [is included to control functionality of the console 110 during operation] (Para 0048) including:
providing an incident light signal to the optical fiber [The light source 182 is configured to transmit the broadband incident light] (Para 0052 and Figure 1, Element 182);
receiving a reflected light signal of the incident light signal [The optical receiver 184 is configured to: (i) receive returned optical signals, namely reflected light signal 150 received from optical fiber-based reflective gratings (sensors) fabricated within each core fiber of the multi-core optical fiber 135 deployed within the stylet 130] (Para 0053);
processing the reflected light signal to determine a location [physical state of the stylet provides information to assist a clinician in guiding a catheter assembly to a desired location within the vasculature] (Para 0045) of a first external landmark (Figure 10, Element a) and a second external landmark (Figure 10, Element b) of the two or more external landmarks [the catheter makes with the skin surface is calculated from its observed length, and thereafter points a and b are located and projected] (Para 0080); and
Examiner’s Note: The landmarks are projected onto the skin externally.
determining a catheter information [Operating as a medical device, the stylet is configured to return information for use in identifying its physical state (e.g., shape length, shape, form, and/or orientation) of…the…catheter within the body of a patient] (Para 0006)
Sowards fails to teach processing the reflected light signal to determine a location of one or more external landmarks in three-dimensional space and determining a predicted catheter length required to extend between the insertion site and the target location.
However, Mahmoodabadi teaches –
processing the reflected light signal [The unabsorbed light 230 is reflected back and is detected by the IR imager/projector 200-5. The reflected image is processed by the image processing subunit 200-3, and then re-projected on the patient's skin in real-time to show the location of vein] (Para 0061) to determine a location of an external landmark of the one or more external landmarks in three-dimensional space [required catheter-related values (e.g. its length, angle and tip) have been determined and the IR imager/projector 200-5 then projects images and information onto the skin in order to assist the clinician in visualizing the catheter insertion process while the catheter is partly in the skin and out of view (step 340) and informs the user when the catheter and needle enter the vein] (Para 0075); and
Examiner’s Note: The external landmark is the site where the needle enters the vein or the insertion site (see Claim 3).
determining a predicted catheter length [performing a calibration operation to estimate the length of said catheter] (Claim 9) [calculate and project a visual indicator, b, indicating the location of cannulation based on the location, a, of needle-skin access point, said orientation angle,
∅
, and a vein depth, xv, according to
→
b
-
→
a
=
→
a
b
=
x
v
.
tan
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] (Claim 15) required to extend intravascularly between the insertion site [needle-skin access point] (Claim 15) and the target location [vein depth] (Claim 15) in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sowards to include the processing and determining as cited above as taught by Mohmoodabadi in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
Sowards and Mohmoodabadi fail to teach the reflective grating sensors and further including a pressure sensor array.
Examiner’s Note: It is understood that fiber Bragg gratings (reflective grating sensors) are used within the art to measure pressure and strain on the fiber. The new claim limitation is being interpreted as requiring two separate elements of a reflective grating sensors and a pressure sensor. This is not an improper final rejection in view of the previous Non-final rejection of Claim 5, mailed 09/22/2025. As the Non-final Claim 5 did not require both reflective grating sensors and a pressure sensor within the claims.
However, Miller teaches –
the measurements device [active apparatus] (Figure 10, Element 310) comprising an optical fiber [optical fiber] (Figure 10, Element 40) and further including a pressure sensor array [pressure sensor array] (Figure 10, Element 20) in order for improvements in terms of sensitivity and operating performance (Col. 1, Line 38-40)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sowards and Mohmoodabadi to include the optical fiber and pressure sensor array as taught by Miller in order for improvements in terms of sensitivity and operating performance (Col. 1, Line 38-40).
Claim 2/1: Sowards teaches wherein the measurement device includes a stylet having a multi-core optical fiber extending therethrough [the multi-core optical fiber 135 is encapsulated within a conductive tubing 900] (Para 0083) and one or both of a magnetic element and an electrically conductive element extending therethrough [operating as a conductive medium for the stylet 130 in the transfer of electrical signals (e.g., ECG signals) to the console, the conductive tubing 900 may be exposed up to a tip 910 of the stylet 130] (Para 0084 and Figure 9a, Element 900).
Examiner’s Note: Figure 9A & 9B is an embodiment of Figure 1 (Para 0083).
Claim 3/1: Sowards teaches wherein the first external landmark of the two or more external landmarks includes one of the insertion site [assists in the placement of a medical device inserted into a body of a patient] (Para 0041) [ascertain information regarding the optical fiber during and/or after insertion into the patient's body for rendering a shape and orientation of the stylet] (Para 41).
Examiner’s Note: The claim only limits the first external landmark to an insertion site.
Claim 4/1: Sowards fails to teach an input to indicate alignment. However, Mahmoodabadi teaches wherein the console is further configured to receive an input to indicate when a portion of the measurement device is aligned with one of the first external landmark of the two or more external landmarks [Alignment of the catheter 210 with the series of dots 1106 can be calculated using a linear regression calculation. Referring to FIG. 13a, the distances of the points 1304 from the tracking line 1300 can be used to calculate an error (e.g., using a sum of squares of the distances). The optimal alignment can be a line of best fit. Weighting factors may be applied to the distances, such that points 1304 closer to the catheter tip 1103 contribute more to the calculated error, as such points may be more important to alignment] (Para 0092) in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
Claim 5/1: Sowards and Mohmoodabadi fail to teach the reflective grating sensors and further including a pressure sensor array. However, Miller teaches –
the pressure sensor array [pressure sensor array] (Figure 1, Element 20) [The at least one transducer 30, 32 includes an acoustic-pressure-sensitive material 130] (Col. 7, Line 56-58) extends along a longitudinal length of the device [wherein the acoustic-pressure-sensitive material 130 coats the optical fiber 40] (Col. 8, Line 1-2) in order for improvements in terms of sensitivity and operating performance (Col. 1, Line 38-40)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sowards and Mohmoodabadi to include the optical fiber and pressure sensor array as taught by Miller in order for improvements in terms of sensitivity and operating performance (Col. 1, Line 38-40).
Sowards fails to teach wherein the activation of a sensor indicates alignment. However, Mahmoodabadi teaches wherein the activation of a sensor [the system locates and updates the tip of the catheter by detecting backscatter light 240] (Para 0074) indicates that the measurement device is aligned with the first external landmark of the two or more external landmarks [The discrimination and guidance unit 200-4 can further be configured to output feedback for aiding alignment of the catheter 210 with the series of dots 1106 indicating the selected vein] (Para 0091) in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
Claim 6/1: Sowards fails to processing the reflected light. However, Mahmoodabadi teaches wherein the console is further configured to process the reflected light signal [The unabsorbed light 230 is reflected back and is detected by the IR imager/projector 200-5. The reflected image is processed by the image processing subunit 200-3, and then re-projected on the patient's skin in real-time to show the location of vein] (Para 0061) to determine a location, angle, and direction of one or more inflections in the measurement device [required catheter-related values (e.g. its length, angle and tip) have been determined] (Para 0075) and determine a location of the first external landmark of the two or more external landmarks in three-dimensional space [required catheter-related values (e.g. its length, angle and tip) have been determined and the IR imager/projector 200-5 then projects images and information onto the skin in order to assist the clinician in visualizing the catheter insertion process while the catheter is partly in the skin and out of view (step 340) and informs the user when the catheter and needle enter the vein] (Para 0075) in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
Claim 7/1: Sowards teaches wherein the measurement device has malleable physical qualities and can be shaped into a shape and remain in that shape until reshaped [a shape-memory alloy such as nitinol] (Para 0083).
Claim 8/1: Sowards teaches one or more external landmarks [the stylet 130 illustrating its placement within the catheter 195 as the catheter 195 is being inserted into a vasculature of a patient 400 through a skin insertion site 410] (Figure 4, Element 410 and Para 0064; See claim 3 where the external landmark is an insertion site). Sowards fails to teach determining a distance. However, Mahmoodabadi teaches wherein determining the predicted catheter length [performing a calibration operation to estimate the length of said catheter] (Claim 9) further includes determining…a distance [Alignment of the catheter 210 with the series of dots 1106 can be calculated…using a sum of squares of the distances] (Para 0092) between the first external landmark and the second external landmark [projected is a vein path indicator for a vein 1104. In this embodiment, the vein path indicator includes a series of dots 1106. The dots 1106 are located along the vein's midline] (Para 0085) of the two or more external landmarks (Figure 10, Element a & b) in order to provide a system for improving intravenous and other vein access procedures by guiding clinicians in achieving optimal intravenous (IV) placement while minimizing infiltration and extravasations effects (Para 0032).
Response to Arguments
Applicant’s arguments, see Page 4, filed 03/09/2026, with respect to the Drawing Objections have been fully considered and are persuasive. The Objection of the Drawings has been withdrawn.
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive. The Applicant submitted arguments that the insertion site of Mahmoodabadi is not external. The Examiner contends Mohmoodabadi teaches the external landmark as the insertion site [to project the points a and b on the skin surface (e.g. using high intensity coloured dots) so that, the clinician is guided to adjust the direction of the catheter from the insertion point a in a straight line following the vein to point b, as shown in the inset portion at the top right of FIG. 8b] (Para 0082). The Examiner contends that the external landmarks is claimed in Claim 3 as the insertion site and that the insertion site is the needle-skin access point of Mohmoodabadi (Page 7 of the Final Office Action (mailed 01/09/2026). The argument is unconvincing.
The Applicant submitted arguments that Mahmoodabadi fails to teach determining a location of an external landmark in three-dimensional space. The Applicant contends that the catheter is out of view and thus the teaching does not read on the claim limitation. The Examiner respectfully disagrees. The system is to guidance insertion of the needle through s disclosed process. As Figure 10 on Page 8 of the Remarks demonstrates the needle before entering the needle skin access point. Mahmoodabadi discloses that the system captures a 2D image above (thus x-y) (para 0063). The needle is inserted at an angle so as to penetrate the vein (thus z). The patient's arm is 3D. The system of Mahmoodabadi needs to be able to guide in a 3D environment in order to practice the invention of Mahmoodabadi. The argument is unconvincing.
The Applicant contends that Sowards and Mahmoodabadi operate differently and thus at not able to be combined. The combination is not to bodily incorporate Mahmoodabadi into Sowards. Rather would the teachings of Mahmoodabadi with respect to external landmarks and three-dimensional space be obvious modifications. The Examiner contends that one of ordinary skill in the art would have found the combination obvious in order to improve intravenous procedures (para 0032). The arguments are unconvincing.
The invention of the Applicant is directed to a processor performing programming operations to predict a catheter length using optical fibers to measure light signals. The traditional method is for the medical staff to get a disposable paper measuring tape and, by placing the paper over the external landmarks on the patient’s chest, using the measured paper length to determine the desired catheter length (Samlimi et al. Page 384, Section Materials and Methods; enclosed herein)1. The invention of the Applicant uses a similar measuring method but uses a processor to detect when compression (or other activation of the device) is applied to the measurement device when laid over the external landmarks. The Examiner acknowledges that the prior art does not teach such a device as disclosed. However, the current claim limitations do not reflect such a device. After performing an updated search and reviewing the claims, the Examiner suggest bringing up the claim subject matter of Claim 3 into parent Claim 1 and replace “includes one” with “includes two” in Claim 3, Line 2-3. Such an amendment would limit the external landmarks to anatomical landmarks and limit the device to an external measurement process instead of the more internal measurement processes of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Southard et al. (U.S. Patent 12,522,101 B2) – Southard teaches systems and methods for tracking medical devices such as needles and catheters. For example, an ultrasound-imaging system is configured to perform a set of operations for accessing a blood vessel, recommending a proper approach angle for approaching the blood vessel with the medical device, recommending a proper insertion angle for inserting the medical device in the blood vessel, ensuring a final placement of a sufficient length of the medical device within the blood vessel, and following, or tracking, a procedure for placing the medical device in the blood vessel. In addition, the ultrasound-imaging system is configured to perform a set of operations for optimizing an ultrasound image about the blood vessel or a targeted location of the blood vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
1 Salimi F, Imani MR et al. The mid-sternal length, a practical anatomical landmark for optimal positioning of long-term central venous catheters. J Res Med Sci. 2013 May;18(5):383-6.
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