Prosecution Insights
Last updated: July 17, 2026
Application No. 17/557,586

PRESSURE SENSOR MODULE FOR AN INTERVENTIONAL MEDICAL DEVICE

Final Rejection §103§112
Filed
Dec 21, 2021
Examiner
GLOVER, NELSON ALEXANDER
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Creganna Unlimited Company
OA Round
4 (Final)
36%
Grant Probability
At Risk
5-6
OA Rounds
0m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants only 36% of cases
36%
Career Allowance Rate
9 granted / 25 resolved
-34.0% vs TC avg
Strong +57% interview lift
Without
With
+57.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
31 currently pending
Career history
72
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
67.2%
+27.2% vs TC avg
§102
16.4%
-23.6% vs TC avg
§112
13.0%
-27.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 25 resolved cases

Office Action

§103 §112
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 . Claims Accounting Applicant's arguments, filed 03/13/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicants have amended claims 1, 16, and 18, filed 03/13/2026. Rejections newly made in the instant Office action have been necessitated by those amendments. Claims 1-22 are the current claims hereby under examination. Claim Rejections - 35 USC § 112 Claims 16-17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 16, the claim recites “the pressure sensor is contained within an interior of the carrier inside a perimeter of the carrier, the carrier having an open area above, below and on the sides of the pressure sensor within an interior of the carrier” in lines 17-19. It is unclear whether the second recitation of “an interior of the carrier” in line 19 is supposed to correspond to the first recitation of the same in lines 17-18, or a different interior of the carrier. Clarification is requested. For the purposes of examination, the claim is interpreted as “the pressure sensor is contained within an interior of the carrier inside a perimeter of the carrier, the carrier having an open area above, below and on the sides of the pressure sensor within the interior of the carrier”. All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim. 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. Claims 1-2, 4-8, 10-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2020/0077905 by Melanson et al. – previously cited (hereinafter “Melanson”) in view of US Patent Publication 2015/0148693 by Burkett – previously cited (hereinafter “Burkett”). Regarding claim 1, Figure 4 of Melanson teaches an interventional medical device comprising: an insertion tube (working channel of the endoscope [0057]) extending between a proximal end and a distal end ([0014]), the distal end configured to be inserted into internal tissues of a patient during a medical procedure ([0057]), the insertion tube having an internal channel (needle 202 is inserted through the working channel of the endoscope [0057]); a tool received in the internal channel of the insertion tube (system 200), the tool having a tool body (202) and a needle at an end of the tool body forming a tip of the tool (sharp tip 210), the tool body forming a tool channel (channel 208); and a pressure sensor module (pressure sensing device 206) received in the tool channel, the pressure sensor module including a pressure sensor (pressure sensor 212) and a carrier (distal portion 114 of the body 120 including recess 126 shown in Fig. 2) holding the pressure sensor, the carrier being coupled to the tool body to position the pressure sensor in the tool channel proximate to the tip of the tool for measuring pressure of fluid of the internal tissues of the patient ([0058]). It is noted that pressure sensing device 206 in Fig. 4 is substantially similar to pressure sensing device 106, shown in Fig. 2 ([0058]). Melanson does not teach the carrier being rigid or the pressure sensor being contained within an interior of the carrier inside a perimeter of the carrier, the carrier having an open area above, below and on all sides of the pressure sensor within the interior of the carrier. Burkett teaches a sensor mounting assembly (Fig. 4; element 111), holding the sensor (sensor block 212) via rails 148, and the internal sensor mount 110 being formed of a rigid material, such as stainless steel ([0035]). The sensor mounting assembly includes side walls flanking the sensor (Fig 5; outer boundaries 158) with the side walls being located between the sensor and the tool body (Fig 4; 158 is lateral to the sensor and would be between the sensor and any external component). Figs. 5 and 7 of Burkett teach that the internal sensor mount holds the sensor such that the pressure sensor has open area above (Fig. 7; lumen 152), below (Fig. 7; space 200), and on all sides (Fig. 5; the lateral sides have open area proximate to the cutouts and the front and back have open area). Burkett teaches that the internal sensor mount 110 has an outer diameter 196 (this can be considered the perimeter of the carrier, and all the area inside of this perimeter can be considered the interior of the carrier). Annotated Fig. 7 of Burkett shows that the entire pressure sensor is contained within an interior of this perimeter. The sensor mounting assembly is configured to increase repeatability and consistency of sensor placement during the manufacturing process ([0027]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the carrier taught by Melanson to include the sensor mounting assembly, such that the carrier being rigid or the pressure sensor being contained within an interior of the carrier inside a perimeter of the carrier, the carrier having an open area above, below and on all sides of the pressure sensor within the interior of the carrier, as the sensor mounting assembly would increase repeatability and consistency in the manufacturing process, as taught by Burkett ([0027]). It is noted that the device of Burkett is an intravascular device with flexible portions (Abstract), therefore it is meant to be used within veins and is in the same field as endeavor as the invention taught by Melanson. PNG media_image1.png 456 648 media_image1.png Greyscale Annotated Fig. 7 of Burkett Regarding claim 2, Melanson in view of Burkett teaches the interventional medical device of claim 1, wherein the tool body includes at least one opening in flow communication with the pressure sensor (Melanson, Fig.4; distal end of needle 202 comprises an opening allowing flow communication with the pressure sensor), the opening configured to allow fluid flow into the tool channel (Melanson, Fig. 4; Fluid can flow into the tool channel after tool insertion as shown in step 3). Regarding claim 4, Melanson in view of Burkett teaches the interventional medical device according to claim 1, wherein the carrier includes side walls flanking the pressure sensor (Burkett, Fig 5; outer boundaries 158), the side walls being located between the pressure sensor and the tool body (The combination of Melanson and Burkett would result in the carrier being located within the tool body and the pressure sensor being located within the side walls of the carrier. Therefore the side walls would be between (i.e., flanking) the pressure sensor and the tool body). Regarding claim 5, Melanson in view of Burkett teaches the interventional medical device of claim 1, further teaching wherein the carrier includes a chamber (Burkett, Fig. 4; chamber formed by external housing 110; [0038]) configured to receive the fluid (Burkett, Fig. 4; via openings 166 [0038]), the pressure sensor extending into the chamber (Burkett; Fig. 4). Regarding claim 6, Melanson in view of Burkett teaches the interventional medical device of claim 5, wherein the chamber is open above, below and along sides of the pressure sensor. Figures 5-7 of Burkett show the sensor within the chamber defined by external housing, with the sensor 110 in fluid communication of the chamber above, below, and on the sides of the sensor. Regarding claim 7, Melanson in view of Burkett teaches the interventional medical device of claim 1, but does not teach wherein the carrier includes a locating feature, the locating feature engaging the tool body to locate the pressure sensor module in the internal channel. Melanson further teaches locating features (Melanson, Figs. 9-11, [0067]; fins 532) that locate the tip of the sensor at a predetermined distance from the tip of the tool body. The locating features, in conjunction with a handle member of the system may cause the distal end to protrude only a predetermined distance (Melanson, [0072]), preventing the pressure sensing device from contacting and/or piercing a far wall of a portal vein, preventing damage to the vein (Melanson, [0066]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the medical device taught by Melanson in view of Burkett to include locating features engaging the tool body to locate the pressure sensor module in the internal channel to control the protruding distance and prevent the pressure sensor from damaging a vein, as taught by Figs. 9-11 of Melanson ([0066]). Regarding claim 8, Melanson in view of Burkett teaches the interventional medical device of claim 1, nut does not teach wherein the carrier includes an exterior surface having a curved profile having a radius of curvature corresponding to a radius of curvature of the tool body. Fig. 6 of Melanson shows a schematic view of the carrier and the tool body, where the carrier is fully enveloped by the tool body. It would be obvious to one of ordinary skill in the art at the time of the effective filing date that the needle piercing carrier and needle would be circular in cross section. These elements being circular and fully enveloped imply that they would also have corresponding radii of curvature. Further regarding the particular shape, according to MPEP 2144.04, the court held that the configuration of the claimed element was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element was significant. As applicant has failed to provide details of criticality and/or unexpected results in their specification with regard to the claimed shape of the exterior surface of the carrier, the shape of the exterior surface of the carrier would have been a matter of obvious design choice. Regarding claim 10, Melanson in view of Burkett teaches the interventional medical device of claim 1, further teaching wherein the pressure sensor module includes wires coupled to the pressure sensor (conductors 250 attach to the sensor within the carrier as taught by Burkett; Fig. 13-14), the carrier supporting ends of the wires relative to the pressure sensor (Burkett, conductors are supported on the ends laterally via proximal portion 142), the wires routed through the internal channel to the proximal end of the insertion tube (Melanson Fig. 4, connection cable 124; the wires/conductors are routed through the internal channel of the body, which is inside the tool and inside the internal channel of the insertion tube). Regarding claim 11, Melanson in view of Burkett teaches the interventional medical device of claim 1, wherein the needle includes a lumen (Melanson, Fig. 4; internal channel of body 202), the pressure sensor module located within the lumen (Melanson, Fig. 4; pressure module is shown within the internal channel of 202 in steps 1-3). Regarding claim 12, Melanson in view of Burkett teaches the interventional medical device of claim 11, wherein the tool includes a stylet received in the tool channel (Melanson, Fig. 4; body 120 of the pressure sensing module 206), the stylet being extendable from the end of the needle (Melanson, Fig. 4, step 4), the pressure sensor module coupled to, and movable with, the stylet (Melanson, Fig. 4, steps 1-4), wherein the pressure sensor is configured to be located exterior of the tool body with the stylet when the stylet is extended (Melanson, Fig. 4, step 4), the pressure sensor being located interior of the tool body with the stylet when the stylet is retracted into the needle (Melanson, Fig 4, steps 1-3). Regarding claim 13, Melanson in view of Burkett teaches the interventional medical device of claim 11, wherein the lumen includes a lumen port at the end of the needle, the lumen port being open to allow the fluid to flow into the lumen (as applied in claim 11), the pressure sensor positioned upstream of the lumen port to measure the pressure of the fluid inside the lumen (Melanson; Fig. 4, step 3 depicts the pressure sensor positioned upstream the lumen port. Upstream is considered proximal to the distal lumen port). Regarding claim 16, Melanson in view of Burkett, teaches an interventional medical device comprising: a handle (See the rejection of claim 7 above); an insertion tube extending between a proximal end and a distal end (See the rejection of claim 1 above), the proximal end extending from the handle (Melanson; the distal end is to extend into the vein, and the proximal end must terminate external to the body where the handle would be located), the distal end configured to be inserted into internal tissues of a patient during a medical procedure, the insertion tube having an internal channel (See the rejection of claim 1 above); a light transmitter received in the internal channel of the insertion tube and extending to the distal end for illuminating the internal tissues of the patient; a camera at the distal end for imaging the internal tissues of the patient, the camera having a cable extending form the camera through the internal channel (Melanson, Par. [0057] discloses the system being received in the working channel of an endoscope. One of ordinary skill in the art would readily recognize that an endoscope comprises a light transmitter and a camera, wherein the camera comprises a cable extending from the camera through the internal channel); a tool received in the internal channel of the insertion tube, the tool having a tool body and a needle at an end of the tool body forming a tip of the tool, the tool body forming a tool channel (See the rejection of claim 1 above); and a pressure sensor module received in the tool channel, the pressure sensor module including a pressure sensor and a carrier holding the pressure sensor (See the rejection of claim 1 above), the carrier being rigid and coupled to the tool body to position the pressure sensor in the tool channel proximate to the tip of the tool for measuring pressure of fluid of the internal tissues of the patient (See the rejection of claim 1 above), the carrier holding the pressure sensor such that the pressure sensor is contained within an interior of the carrier inside a perimeter of the carrier, the carrier having an open area above, below, and on the sides of the pressure sensor within the interior of the carrier (See the rejection of claim 1 above). Regarding claim 17, Melanson in view of Burkett, teaches the interventional medical device of claim 16, wherein the tool body includes at least one opening in flow communication with the pressure sensor (Melanson; Fig. 4, distal end of needle 202 comprises an opening allowing flow communication with the pressure sensor), the opening configured to allow fluid flow into the tool channel (Melanson, Fluid can flow into the tool channel after tool insertion as shown in step 3 of Fig. 4). Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable Melanson in view of Burkett, as applied to claim 1, further in view of US Patent 6,394,896 by Millar et al. – previously cited (hereinafter “Millar”). Melanson in view of Burkett teaches the interventional medical device of claim 1, but does not teach wherein the pressure sensor includes a strain gauge diaphragm coupled to the carrier and conductive sensing elements on the strain gauge diaphragm measuring changes in resistance to provide a measure of pressure applied to the strain gauge diaphragm. Fig. 2 of Millar teaches a semiconductor pressure sensor module 200 for use in a catheter pressure transducer comprising a diaphragm with a cutout matching the same size of the diaphragm (Col. 4, line 54- Col. 5, line 5). Millar teaches that semiconductor pressure sensors such as strain gauge sensors provide high-fidelity pressure measurements (Col. 1, lines 36-50). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensor of Melanson in view of Burkett to be a strain gauge diaphragm pressure sensor with conductive sensing elements on the strain gauge diaphragm measuring changes in resistance to provide a measure of pressure applied to the strain gauge diaphragm, in order to obtain high-fidelity pressure measurements, as taught by Millar (Col. 1, lines 36-50). Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Melanson in view of Burkett, as applied to claim 1, further in view of US Patent Publication 2006/0004255 by Iddan et al. – previously cited (hereinafter “Iddan”). The combination of Melanson and Burkett teaches the interventional medical device of claim 1, but does not teach wherein the carrier is either transparent or translucent, the pressure sensor module including a lighting element transmitting light when operating, the light passing through the carrier. Iddan teaches a housing (Fig. 1, element 110) for a pressure sensor that is transparent and an illumination source (Fig. 1, element 118). The transparent housing is beneficial as it can allow passage of wavelengths used for imaging or illumination ([0022]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the carrier of the combination of Melanson and Burkett to be translucent to allow the passing of illumination and imaging wavelengths as taught by Iddan ([0022]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the carrier of the combination of Melanson and Burkett to further include a light transmitter, as par. [0057] of Melanson discloses the system being received in the working channel of an endoscope. One of ordinary skill in the art at the time of the effective filing date would recognize that an endoscope comprises a light transmitter, therefore it would be obvious to include a light transmitter. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Melanson in view of Burkett, as applied to claim 1, in view of US Patent Publication 2016/0249821 by Boye et al. – previously cited (hereinafter “Boye”). Regarding claim 14, the combination of Melanson and Burkett teaches the interventional medical device of claim 1, and further teaches wherein the carrier includes a front (Burkett, distal end 143)) and a rear (Burkett, proximal end 141), but does not teach wherein the pressure sensor extending forward of the front of the carrier. Figs. 3-4 of Boye teaches a guidewire with a sensor mount (i.e., carrier) housing a sensor therein. The sensor mount taught by Boye features a pressure sensor cantilevered from a shelf portion, providing a free space and allowing the distal part of the sensor chip to protrude freely, even in a case where the wire tip is bent or deflected ([0080]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Melanson in view of Burkett such that the pressure sensor is cantilevered, in order to provide a free space and allowing the distal part of the sensor chip to protrude freely, even in a case where the wire tip is bent or deflected, as taught by Boye ([0080]). The combination of Melanson, Burkett, and Boye does not teach the wherein the pressure sensor extending forward of the front of the carrier. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the combination of Melanson, Burkett, and Boye such that the pressure sensor extending forward of the front of the carrier. This modification would comprise a mere rearrangement of parts as an obvious matter of design choice. See MPEP 2144.04.VI.C. In this rearranged combination of Melanson, Burkett, and Boye, the carrier would extend over the pressure sensor as far as the shelf supporting the sensor extends. Therefore, the distal end would extend as far as the shelf, and the pressure sensor would extend forward of the front of the carrier. The distal end of the carrier, as taught by Burkett is attached to a flexible portion of the guidewire. However, the carrier of Melanson is at the distal end of the tool channel, and therefore the modified carrier does not need to be coupled to a further element. Further, the shortened carrier taught by the modified combination of Melanson, Burkett, and Boye still provides the benefit of increasing repeatability and consistency in the manufacturing process, as taught by Burkett ([0027]). Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Melanson in view of Burkett, as applied to claim 1, in view of US Patent Publication 2019/0254543 by Hartholt et al. – previously cited (hereinafter “Hartholt”). Melanson in view of Burkett teaches the interventional medical device of claim 1, but does not teach wherein the pressure sensor is a first pressure sensor, the pressure sensor module including a second pressure sensor remote from the first pressure sensor, the pressure sensor module determining a pressure difference between the first pressure sensor and the second pressure sensor. Figs. 1 and 2 of Hartholt teach a catheter with two pressure sensor elements along the body of the catheter, capable of measuring the pressure in different locations ([0037-0039]). The multiple pressure sensors are used to measure detect fluid pressures, and the reported in-situ pressure measurement is one pressure measurement relative to another pressure measurement ([0037]). The two pressure sensors provide reliable, accurate and high spatial and temporal resolution pressure information with respect to two locations and would benefit the clinician in minimally invasive diagnostic interrogation of stenosis present in the circulatory system ([0019]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensor module as taught by Melanson in view of Burkett to include a first pressure sensor, the pressure sensor module including a second pressure sensor remote from the first pressure sensor, the pressure sensor module determining a pressure difference between the first pressure sensor and the second pressure sensor to provide reliable, accurate and high spatial and temporal resolution pressure information with respect to two locations and help the clinician in minimally invasive diagnostic interrogation of stenosis present in the circulatory system as taught by Hartholt ([0019]). Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Melanson in view of Burkett in view of Hartholt. Regarding claim 18, Melanson in view of Burkett teaches an interventional medical device comprising an insertion tube extending between a proximal end and a distal end, the distal end configured to be inserted into internal tissues of a patient during a medical procedure, the insertion tube having an internal channel; a tool received in the internal channel of the insertion tube, the tool having a tool body and a needle at an end of the tool body forming a tip of the tool, the tool body forming a tool channel; and a pressure sensor module received in the tool channel, the pressure sensor module including a pressure sensor configured to measure pressure of fluid in the internal tissues, and at least one carrier holding the pressure sensor, the carrier being rigid and coupled to the tool body, the at least one carrier holding the pressure sensor such that the pressure sensor is contained within an interior of the at least one carrier inside a perimeter of the at least one carrier, the at least one carrier having an open area above, below and on the sides of the pressure sensor within the interior of the at least one carrier (See the rejection of claim 1 above). The combination of Melanson and Burkett does not teach wherein the pressure sensor is a first pressure sensor, the pressure sensor module including a second pressure sensor remote from the first pressure sensor, and the pressure sensor module determining a pressure difference between the first pressure sensor and the second pressure sensor. Figs. 1 and 2 of Hartholt teach a catheter with two pressure sensor elements along the body of the catheter, capable of measuring the pressure in different locations ([0037-0039]). The multiple pressure sensors are used to measure direct fluid pressures, and the reported in-situ pressure measurement is one pressure measurement relative to another pressure measurement ([0037]). The two pressure sensors provide reliable, accurate and high spatial and temporal resolution pressure information with respect to two locations and would benefit the clinician in minimally invasive diagnostic interrogation of stenosis present in the circulatory system ([0019]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensor module as taught by Melanson in view of Burkett to wherein the pressure sensor is a first pressure sensor, the pressure sensor module including a second pressure sensor remote from the first pressure sensor, the pressure sensor module determining a pressure difference between the first pressure sensor and the second pressure sensor to provide reliable, accurate and high spatial and temporal resolution pressure information with respect to two locations and help the clinician in minimally invasive diagnostic interrogation of stenosis present in the circulatory system, as taught by Hartholt ([0019]). Regarding claim 19, the combination of Melanson, Burkett, and Hartholt teaches the interventional medical device of claim 18, Melanson further teaching wherein the tool body includes at least one opening in flow communication with the pressure sensor (Melanson; distal end of needle 202 comprises an opening allowing flow communication with the pressure sensor), the opening configured to allow fluid flow into the tool channel (Melanson; Fluid can flow into the tool channel after tool insertion as shown in step 3). Regarding claim 20, the combination of Melanson, Burkett, and Hartholt teaches the interventional medical device of claim 18, wherein the carrier includes a front (Burkett, element 143) and a rear (Burkett, element 141), and the first pressure sensor is located proximate to the front, the second pressure sensor is located proximate to the rear (the combination of Melanson, Burkett, and Hartholt includes two pressure sensors spaced apart longitudinally (i.e., one more distal and one more proximal) to enable the pressure readings from different locations as taught in claim 18. The configuration would require one pressure sensor to be closer to the front and the other pressure sensor to be closer to the rear). Regarding claims 21, the combination of Melanson, Burkett, and Hartholt teaches the interventional medical device of claim 18, but does not teach wherein the carrier includes a first carrier element supporting the first pressure sensor and a second carrier element supporting the second pressure sensor, the first carrier element being separate from the second carrier element. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing to have modified the carrier taught by the combination of Melanson, Hartholt, and Burkett to include separate carriers, to allow for measurements to be taken by the pressure sensors at larger distances from each other. According to MPEP § 2144.04-VI-B, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Regarding claim 22, the combination of Melanson, Burkett, and Hartholt teaches the interventional medical device of claim 18, wherein the pressure sensor module determines a pressure difference between the first pressure sensor and second pressure sensor. The combination of Melanson and Hartholt teaches determining a pressure measurement by comparing one pressure measurement relative to another pressure. Hartholt teaches this is a differential pressure measurement ([0016]), therefore the pressure measurement is obtained by taking the difference between the two pressure sensors. Response to Arguments Applicant's arguments filed 03/13/2026 have been fully considered. The amendments to claims 1, 16, and 18 overcome the rejections of record under 35 U.S.C. 112(b), however the amendments to the claims necessitate a new rejection to claim 16 under 35 U.S.C. 112(b). Regarding the rejections of the claims in view of prior art, Applicant states that the previously cited art fails to disclose, teach or suggest the features of independent claims 1, 16, and 18 as amended. This statement is considered but is moot because the new grounds of rejection are necessitated by the amendments to the independent claims. Applicant’s arguments that the body 120 of Melanson is a flexible body and teaches away from a rigid carrier as taught by Burkett because the invention of Melanson must have flexibility sufficient to enable the body to be passed through the working channel of a flexible endoscope as the endoscope traverses a tortuous path are not found persuasive. This argument is substantively the same argument presented in the reply filed 11/20/2025. It is reiterated that Melanson teaches that the flexible body must be able capable of traversing tortuous paths, but does not preclude the flexible body from having any rigid components. A single rigid component does not disable the flexibility of Melanson. Further, the invention of Burkett is directed towards a device that is intended to be used in coronary arteries and blood vessels (Burkett; [0003]). Blood vessels and contain tortuous paths, and therefore the rigid carrier of Burkett does not teach away from this function of Melanson. Rather, the intended use of Burkett implies that the rigid carrier would be compatible with the principle of operation of Melanson, as both inventions are directed towards devices intended to be used in blood vessels. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791 /ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Show 2 earlier events
Jun 03, 2025
Response Filed
Jul 22, 2025
Final Rejection mailed — §103, §112
Sep 22, 2025
Response after Non-Final Action
Nov 20, 2025
Request for Continued Examination
Dec 03, 2025
Response after Non-Final Action
Dec 19, 2025
Non-Final Rejection mailed — §103, §112
Mar 13, 2026
Response Filed
May 05, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
36%
Grant Probability
93%
With Interview (+57.4%)
3y 7m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 25 resolved cases by this examiner. Grant probability derived from career allowance rate.

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