Prosecution Insights
Last updated: October 04, 2026
Application No. 18/256,919

BALLOON-ANCHORED FLEXIBLE NEEDLE AND CATHETER FOR BIOPSY

Final Rejection §103§112
Filed
Jun 10, 2023
Priority
Dec 10, 2020 — SG 10202012399Y +1 more
Examiner
PARK, EVELYN GRACE
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
The Biofactory Pte. Ltd.
OA Round
2 (Final)
52%
Grant Probability
Moderate
3-4
OA Rounds
4m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
47 granted / 91 resolved
-18.4% vs TC avg
Strong +40% interview lift
Without
With
+40.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
36 currently pending
Career history
118
Total Applications
across all art units

Statute-Specific Performance

§101
13.6%
-26.4% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
31.8%
-8.2% vs TC avg
§112
18.2%
-21.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 91 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 . Response to Amendment The amendment filed June 4, 2026 has been entered. Claims 1-9 and 12-29 remain pending in the application, and claims 10-11 were cancelled. Applicant’s amendments to the claims have overcome each and every objection to the specification, objection to the claims, 112 rejection, 101 rejection, and 102 rejection previously set forth in the Non-Final Office Action mailed April 3, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments, 112 Rejections, and 103 Rejections below. Claim Rejections - 35 USC § 112 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. Claims 1-9 and 12-29 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. Claim 1 recites the limitation "the length" in line 18. There is insufficient antecedent basis for this limitation in the 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 1-9 and 12-29 are rejected under 35 U.S.C. 103 as being unpatentable over US 6346093 B1 (Allman et al.) in view of WO 2019/103694 (Mangat et al.). Regarding claim 1, Allman teaches a catheter body assembly configured for insertion into a subject and navigation to a target organ (Col. 2 lines 56-67, Col. 3 line 1 “a biliary catheter including an elongate shaft having a proximal portion defining an ancillary lumen and a distal portion defining a common guidewire and ancillary lumen”), the catheter body assembly comprising: a catheter comprising: a first elongated tube and a second elongated tube (Col. 17, lines 16-17 “an ancillary lumen 822”); the first elongated tube having a first lumen with a first proximal end and a first distal end (Fig. 20A, ancillary lumen 822); and the second elongated tube sharing a common wall with the first elongated tube (Col. 17, lines 7-8 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820”)), the common wall extending to define a second lumen of the second elongated tube, with a second proximal end and a second distal end, the second lumen having a c-shaped cross session and a longitudinally extending side opening ” (Fig. 21C depicts the guidewire lumen 820 with a c-shaped cross section sharing a wall with the ancillary lumen 822, and the side opening being the channel 814 to the c-shape; Col. 17, lines 7-12 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820 from the exterior of the catheter shaft 804. The channel 814, which may be shaped as described with reference to FIGS 1D and 1E, extends from the proximal guidewire port 812 to a proximal channel end 816”; Col. 6, lines 17-20 “Guidewire 36 extends within channel 42 to channel distal end 54, continuing within guidewire lumen 60 through distal tip region 44, and exiting through an opening in distal end 46.”); and a second tool configured for insertion into the second lumen (Col.17, lines 21-27 “The common lumen 824 accommodates the guidewire (not shown) extending through the distal portion 808 of the elongate shaft 804 and also accommodates the passage of fluid from the ancillary lumen 822 of the proximal shaft portion 806. Accordingly, the common lumen 824 is in communication with both the guidewire lumen 820 and the ancillary lumen 822”), wherein the side opening is configured to span substantially the length of the catheter body assembly (Figs. 19C, 20C, and 21C depict the side opening being the channel 814 spanning a length of the catheter body assembly, Col. 17, lines 7-12 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820 from the exterior of the catheter shaft 804. The channel 814, which may be shaped as described with reference to FIGS 1D and 1E, extends from the proximal guidewire port 812 to a proximal channel end 816”). Allman does not explicitly teach wherein the second tool is a balloon catheter with a distal tip configured for insertion into the second lumen of the second elongated tube, wherein a second section of the balloon catheter near the distal tip comprises a balloon configured to, when subsequently inserted into a blood vessel of the target organ of the subject, inflate to anchor the extension in the blood vessel near a biopsy site in the target organ. However, Mangat teaches wherein the second tool is a balloon catheter with a distal tip configured for insertion into the second lumen of the second elongated tube , wherein a second section of the balloon catheter near the distal tip comprises a balloon configured to, when subsequently inserted into a blood vessel of the target organ of the subject, inflate to anchor the extension in the blood vessel near a biopsy site in the target organ (Fig. 10, [0078] “balloon catheter 110 of length L and positioned a predefined distance from a distal tip 125 (e.g. denoted LB).”; [00102] “Once beveled distal exit 130 is positioned at biopsy target site 80 with section 115 of balloon catheter 110 in hepatic vein 77, balloon 120 may inflated to a diameter (e.g., up to 20% larger than the vein diameter) so as to anchor section 115 of balloon catheter 110 in hepatic vein 77”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a balloon catheter. One would have been motivated to make this modification because the balloon catheter can be used to inflate a blood vessel of a user and the anchoring provides stability while performing a biopsy, as suggested by Mangat [0076, 0084, 00108]. Regarding claim 2, Allman teaches the catheter body assembly according to claim 1, wherein the first lumen has a bean-shaped cross-section (Fig. 21C depicts ancillary lumen 822 being bean-shaped). Regarding claim 3, Allman teaches the catheter body assembly according to claim 2, wherein the common wall is located at a concave section of the bean-shaped lumen of the first elongated tube (Fig. 21C depicts the common wall being located at concave session of the bean-shaped lumen. The ancillary lumen 822 is concave compared to the common wall.). Regarding claim 4, Allman teaches the catheter body assembly according to claim 1, wherein the first lumen has a closed curve shape with at least one indentation (Fig. 21C depicts the ancillary lumen 822 having a closed curve shape, and Fig. 20A depicts ancillary lumen having an indentation near the guidewire port 812). Regarding claim 5, Allman teaches the catheter body assembly according to claim 1, wherein the common wall is located opposite to the side opening of the second elongated tube (Fig. 21C depicts the common wall opposite to the opening of guidewire lumen 820.). Regarding claim 6, Allman teaches the catheter body assembly according to claim 1, wherein the common wall has a reduced thickness compared to other walls of the catheter (Fig. 21C depicts the common wall between 822 and 820 having a reduced thickness compared to the walls to the right and left sides of 820). Regarding claim 7, Allman teaches the catheter body assembly according to claim 1, further comprising an extension connected to the first distal end, the extension comprising a third proximal end and a third distal end, wherein the third proximal end is connected to the first distal end of the first elongated tube (Fig. 20A, Col. 17, lines 7-12 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820 from the exterior of the catheter shaft 804. The channel 814, which may be shaped as described with reference to FIGS 1D and 1E, extends from the proximal guidewire port 812 to a proximal channel end 816.”; Col. 17, lines 3-5 “the proximal guidewire port 812 is disposed closer to the distal end of the elongate shaft 804”; Col. 17, lines 52-55 “The guidewire may also be constrained by providing a separate tube extending a short distance proximally from the proximal guidewire port 812.”). Regarding claim 8, Allman teaches the catheter body assembly according to claim 7, wherein the extension is an extension of the common wall (Fig. 20A depicts channel 814 extending from the common wall connected to ancillary lumen 822). Regarding claim 9, Allman teaches the catheter body assembly according to claim 7, further comprising a first tool for insertion into the first lumen of the first elongated tube (Col. 5, lines 64-67 “Additionally or alternatively, ancillary lumen 56 and/or ancillary lumen 58 may be used for or as part of other ancillary devices, such as a cutting wire lumen or a retrieval balloon lumen.”). Regarding claim 12, Allman teaches the catheter body assembly according to claim 1. Allman does not teach wherein the first tool is a biopsy needle configured to exit the first distal end of the first lumen for penetration into tissue of the target organ at a predefined angle between a center axis of the second tool and the extension and to acquire a biopsy sample of the target organ. However, Mangat teaches wherein the first tool is a biopsy needle configured to exit the first distal end of the first lumen for penetration into tissue of the target organ at a predefined angle between a centre axis of the second tool and the extension and to acquire a biopsy sample of the target organ ([0017] “flexible biopsy needle”; [0040] “the flexible biopsy needle is configured to exit the beveled distal exit of the second lumen for penetration into tissue of the target organ at the biopsy site at a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle.”; [00103] “As a result, stylet 200 of flexible Tru-cut needle 190 may be pushed into liver parenchyma 280 at an angle ϕ between a longitudinal axis 191 of flexible Tru-cut needle 190 and longitudinal axis 192 of section 115 (see Fig. 4A) with balloon 120 as shown in Fig. 7B. ϕ may be in the range of 15-45 degrees.”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a biopsy needle. One would have been motivated to make this modification because the biopsy needle can penetrate tissue of a target organ and the position on the distal end of the catheter allows for navigation to the biopsy site for sampling, as suggested by Mangat [0040]. Regarding claim 13, Allman teaches the catheter body assembly according to claim 7. Allman does not explicitly teach wherein the extension further comprises a balloon wrap at the third distal end, the balloon wrap is configured to accept the balloon of the balloon catheter. However, Mangat teaches wherein the extension further comprises a balloon wrap at the third distal end, the balloon wrap is configured to accept the balloon of the balloon catheter ([0080] “an outer tube may be used to hold guide catheter 105 and balloon catheter 110 longitudinally attached 107 to one another over any suitable portion of the length of balloon-stabilized catheter body 100”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a balloon wrap. One would have been motivated to make this modification because the longitudinal attachment of the balloon catheter allows the guide and ballon to move together to navigate the balloon through the venous system, as suggested by Mangat [0080]. Regarding claim 14, Allman teaches the catheter body assembly according to claim 13. Allman does not teach wherein the balloon wrap has a c-shaped cross section. However, Mangat teaches wherein the balloon wrap has a c-shaped cross section ([0080] “Any suitable means may be used to hold guide catheter 105 and balloon catheter 110 longitudinally attached 107 to one another, such that guide catheter 105 and balloon catheter 110 move together with one another when balloon-stabilized catheter body 100 may be navigated through the venous system. A cross-sectional cut 108 of schematically illustrates a lumen 106 of guide catheter 105 and a lumen 109 of balloon catheter 110.”; Figs. 4A-4B). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a balloon wrap with a c-shaped cross section. One would have been motivated to make this modification because the lumen 106 and 109 of Mangat are analogous to the lumen 820 and 822 of Allman, and lumen 820 of Allman is c-shaped as shown in Fig. 21C. Combining the means for holding the ballon taught by Mangat in the shape of the lumen of Allman would be obvious because the longitudinal attachment of the balloon catheter allows the guide and ballon to move together to navigate the balloon through the venous system, as suggested by Mangat [0080]. Regarding claim 15, Allman teaches the catheter body assembly according to claim 7, wherein the extension comprises channel walls disposed along sides of the extension (Fig. 20A, Col. 17, lines 7-12 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820 from the exterior of the catheter shaft 804. The channel 814, which may be shaped as described with reference to FIGS 1D and 1E, extends from the proximal guidewire port 812 to a proximal channel end 816.”; Col. 17, lines 3-5 “the proximal guidewire port 812 is disposed closer to the distal end of the elongate shaft 804”; Channel 814 comprises channel walls as shown in Fig. 20A). Regarding claim 16, Allman teaches the catheter body assembly according to claim 15, wherein the channel walls decrease in height from the third proximal end to the third distal end (Fig. 19C depicts the channel walls of channel 814 decreasing in height distally. The height of the channel walls at the guidewire port 812 are larger than the height of the walls along the remaining length of channel 814). Regarding claim 17, Allman teaches the catheter body assembly according to claim 1. Allman does not teach wherein the first proximal end of the first elongated tube and the second proximal end of the second elongated tube are coupled to a needle biopsy device. However, Mangat teaches wherein the first proximal end of the first elongated tube and the second proximal end of the second elongated tube are coupled to a needle biopsy device ([0008] “Tru-cut biopsy needle 10”; Figs. 4A-4B depicts the adaptor for the needle biopsy device 170 being at the proximal ends of the lumen 106 and 109; [0081]; [0017] the beveled distal exit is at the proximal end of the lumen, Fig. 8A-8B depict the needle moving through a position on the proximal end the lumen). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a needle biopsy device. One would have been motivated to make this modification because the biopsy needle is able to travel through the lumen to navigate and penetrate into tissue of the target organ to take a biopsy, as suggested by Mangat [0017]. Regarding claim 18, Allman teaches the catheter body assembly according to claim 12. Allman does not teach wherein the biopsy needle comprises a coring needle and a stylet needle. However, Mangat teaches wherein the biopsy needle comprises a coring needle ([0008] “cutting cannula 35”) and a stylet needle ([0008] “stylet 40”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a needle biopsy device with a coring needle and a stylet needle. One would have been motivated to make this modification because the stylet is used to navigate toward and push into the soft liver tissue and the cutting cannula is used to shear through the soft tissue of the liver to collect the specimen, as suggested by Mangat ([0008], [0013]). Regarding claim 19, Allman teaches the catheter body assembly according to claim 18. Allman does not teach wherein the coring needle comprises one or more spiral cuts extending circumferentially around and longitudinally along the coring needle. However, Mangat teaches wherein the coring needle comprises one or more spiral cuts extending circumferentially around and longitudinally along the coring needle ([0011] “flexible cutting cannula tube 25”; Fig. 1 depicts cutting cannula 35 having cutting cannula tube 25 with spiral cuts extending along and around the cannula.; [0091-0092]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include spiral cuts along the coring needle. One would have been motivated to make this modification because using a spring, the cutting cannula tube and cutting cannula move forward to shear through the soft tissue of the liver and collect the tissue for liver biospy, as suggested by Mangat [0008]. Regarding claim 20, Allman teaches the catheter body assembly according to claim 19. Allman does not explicitly teach wherein the one or more spiral cuts have a constant pitch. However, Mangat teaches wherein the one or more spiral cuts have a constant pitch ([0091-0092] “cutting cannula 210, threaded over alignment notch 235”; The cutting cannula has a helical ridge, which can have constant pitch). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include spiral cuts with a constant pitch. One would have been motivated to make this modification because threading allows the stylet and the cutting cannula to be self-aligned within the biopsy needle, as suggested by Mangat [0091]. Regarding claim 21, Allman teaches the catheter body assembly according to claim 19. Allman does not teach wherein the one or more spiral cuts have a variable pitch. However, Mangat teaches wherein the one or more spiral cuts have a variable pitch ([0092] “Bonding 230 may be strengthened by using overtube or heat shrink tubing of sufficiently high hardness (>70D), increasing the roughness of the proximal end of cutting cannula 210 (e.g., by sand blasting), and using cutting cannula tube 245 with a coiled wire construction where the overtube can melt into the grooves of the coil, for example”. The cutting cannula may be physically modified by sand blasting or melting of the overtube into the grooves of a coil, thus varying the pitch of the cuts.). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include spiral cuts with variable pitch. One would have been motivated to make this modification because increasing roughness of the cutting cannula and melting the overtube can strengthen the bonding of the cutting cannula and cutting cannula tube, as suggested by Mangat [0092]. Regarding claim 22, Allman teaches the catheter body assembly according to claim 18. Allman does not teach wherein the stylet needle has a circumference having notches disposed longitudinally along the stylet needle. However, Mangat teaches wherein the stylet needle has a circumference having notches disposed longitudinally along the stylet needle ([0090] “Stylet 200 may have a tubular form with notches in two separate sections: a specimen notch 215 and an alignment notch 235.”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a stylet needle with notches. One would have been motivated to make this modification because the specimen notch can help hold the tissue biopsy and the alignment notch aids in alignment of the stylet and cutting cannula, as suggested by Mangat [0090]. Regarding claim 23, Allman the catheter body assembly according to claim 22. Allman does not teach wherein the notches are under squared such that the notches are deeper than the notches are wide. However, Mangat teaches wherein the notches are under squared such that the notches are deeper than the notches are wide (Fig. 5 depicts specimen notch 215 and alignment notch 235 being deeper in the x-direction than they are wide in the y-direction, Figs. 8A-8B). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a stylet needle with under squared notches. One would have been motivated to make this modification because the size of the notches allow for interfacing of the stylet and cutting cannula and retractions as one unit to prepare the needle for insertion into the patient, as suggested by Mangat [00116] Regarding claim 24, Allman teaches the catheter body assembly according to claim 22. Allman does not teach wherein a base of the notches comprises one or more corner fillets. However, Mangat teaches wherein a base of the notches comprises one or more corner fillets (Fig. 5 depicts specimen notch 215 and alignment notch 235 having corner fillets). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include a base of the notches with one or more corner fillets. One would have been motivated to make this modification because the shapes of the notches are intended to align with the cutting cannula to prepare the needle for insertion into the patient, as suggested by Mangat [00116]. Regarding claim 25, Allman teaches the catheter body assembly according to claim 22. Allman does not teach wherein the notches are diametrically opposed. However, Mangat teaches wherein the notches are diametrically opposed Fig. 5 depicts specimen notch 215 and alignment notch 235 being the same shape, but opposite positions from one another to fit the cutting cannula and then fit the specimen). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include diametrically opposed notches. One would have been motivated to make this modification because needle moves after the sample is gathered, so the notches are shaped to fit the cutting cannula in one position and the specific gathered by the cutting cannula in a different position after shearing the soft tissue, as suggested by Mangat [0090]. Regarding claim 26, Allman teaches the catheter body assembly according to claim 22. Allman does not teach wherein the notches are rotated 90 degrees axially. However, Mangat teaches wherein the notches are rotated 90 degrees axially (Fig. 5, [0036] “the flexible biopsy needle is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet remains in a rotated position substantially opposite to the inner stylet.”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include notches rotated 90 degrees. One would have been motivated to make this modification because the stylet rotates to be able to acquire the biopsy sample and the notches are disposed on the stylet, as suggested by Mangat [0035-0036]. Regarding claim 27, Allman teaches the catheter body assembly according to claim 18. Allman does not teach wherein the stylet needle comprises an indentation at a fourth distal end of the stylet needle. However, Mangat teaches wherein the stylet needle comprises an indentation at a fourth distal end of the stylet needle ([00116] “Cutting cannula 210 and stylet 200 may be aligned in the closed configuration as shown in Fig. 8A, with the corresponding position of flattened band 225 in alignment notch 235.”; The alignment notch is an indentation at a fourth distal end of the stylet). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include an indentation on the stylet needle. One would have been motivated to make this modification because the alignment notch is a flat indentation that receives the flattened band to maintain a close fit between the stylet and cutting cannula to ensure rotational alignment, as suggested by Mangat [00123]. Regarding claim 28, Allman teaches the catheter body assembly according to claim 27. Allman does not teach wherein the indentation has a flat base. However, Mangat teaches wherein the indentation has a flat base ([00116] “Cutting cannula 210 and stylet 200 may be aligned in the closed configuration as shown in Fig. 8A, with the corresponding position of flattened band 225 in alignment notch 235.”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include an indentation with a flat base. One would have been motivated to make this modification because the alignment notch is a flat indentation that receives the flattened band to maintain a close fit between the stylet and cutting cannula to ensure rotational alignment, as suggested by Mangat [00123]. Regarding claim 29, Allman teaches the catheter body assembly according to claim 27. Allman does not teach wherein the indentation has a concave base. However, Mangat teaches wherein the indentation has a concave base (Fig. 5 depicts a concave indentation of the alignment notch 235 configured to receive the convex cutting cannula. The “base” may be interpreted to be any portion of the indentation, which may be the concave fillets on the alignment notch 235). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter taught by Allman to include an indentation with a concave base. One would have been motivated to make this modification because the alignment notch is configured to receives the cutting cannula to ensure rotational alignment between the stylet and cutting cannula to ensure rotational alignment, as suggested by Mangat [00123]. Response to Arguments Applicant's arguments filed June 4, 2026 have been fully considered but they are not persuasive. With respect to the 103 Rejections in the Non-Final Office Action (See Pages 10-11 of Applicant’s Response “35 U.S.C. § 103 Rejections”), Applicant argues that Allman teaches away from using long side openings that spans substantially the full catheter length, as recited in claim 1. Applicant also argues that Mangat fails to disclose a second elongated tube with a side opening that spans substantially the length of the catheter body assembly and fails to cure the deficiencies of Allman. There are new grounds of claim rejections that were necessitated by the claim amendments. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The amended claim limitation of claim 1 requires the side opening to be “configured to span substantially the length of the catheter body assembly. Under BRI, “the length of the catheter body assembly” is not defined by the claim and may be interpreted to be any specific length or distance on the catheter body assembly. The claim, as written, does not recite spanning a “full” length as described in Applicant’s arguments, or what would be considered the full length of the catheter body assembly. Additionally, the “side opening” is recited as being “a longitudinally extending side opening”. Under BRI, the longitudinal direction is not defined in the claim, so the side opening may be interpreted to be an opening in any direction on any side of the second lumen. Allman teaches a channel 814 on a side of the guidewire opening 820 (Figs, 19C, 20C, and 21C), which extend in a longitudinal direction spanning a length of the catheter body assembly (Col. 17, lines 7-12). Therefore, claim 1 interpreted under BRI is taught by Allman in view of Mangat, as described above. Claims 2-9 and 12-29 are rejected because the rejection of claim 1 is proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 103 Rejections. 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 EVELYN GRACE PARK whose telephone number is (571)272-0651. The examiner can normally be reached Monday - Friday, 9AM - 5:00PM. 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, Robert (Tse) Chen can be reached at (571)272-3672. 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. /EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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Prosecution Timeline

Jun 10, 2023
Application Filed
Apr 03, 2026
Non-Final Rejection mailed — §103, §112
Jun 04, 2026
Response Filed
Sep 01, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
52%
Grant Probability
92%
With Interview (+40.5%)
3y 7m (~4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 91 resolved cases by this examiner. Grant probability derived from career allowance rate.

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