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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "460A" & “460B” in Figure 3B and "406", “406A” & "406B" in Para 0078 of the Specification have both been used to designate sensor. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 in three-dimensional space [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) [catheter tip guidance is employed to enable tracking and guidance of the stylet/catheter tip to a desired position with respect to a node of the patient's heart] (Para 0045); and
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 external landmark of the one 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).
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 the external landmark of the one 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 external landmark of the one 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 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) 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 a first external landmark and a 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) 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 12/11/2025, with respect to the 35 USC § 112(b) rejections have been fully considered and are persuasive. The 35 USC § 112(b) rejections of the Claims has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on the manner in which the references were applied in the prior rejection of record. The Applicant submitted arguments with respect to the measurement device comprising an optical fiber…including an array of reflective grating sensors…further including a pressure sensor array. Specifically the Applicant asserts that the claims require both an array of reflective grating sensors and ana array of pressure sensors. In response to the Applicant’s amendment to the claims above, the rejection is now:
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)
The arguments are unconvincing. The rejection is deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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