Prosecution Insights
Last updated: April 19, 2026
Application No. 18/256,919

BALLOON-ANCHORED FLEXIBLE NEEDLE AND CATHETER FOR BIOPSY

Non-Final OA §101§102§103§112
Filed
Jun 10, 2023
Examiner
PARK, EVELYN GRACE
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
The Biofactory Pte. Ltd.
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
45 granted / 80 resolved
-13.7% vs TC avg
Strong +47% interview lift
Without
With
+46.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
33 currently pending
Career history
113
Total Applications
across all art units

Statute-Specific Performance

§101
13.1%
-26.9% vs TC avg
§103
34.1%
-5.9% vs TC avg
§102
31.7%
-8.3% vs TC avg
§112
19.5%
-20.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 80 resolved cases

Office Action

§101 §102 §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 . Information Disclosure Statement The information disclosure statement (IDS) submitted on June 10, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner. Specification The disclosure is objected to because of the following informality: “a second distal exist 135” should read “a second distal exit 135” (page 7, lines 13-14). Appropriate correction is required. Claim Objections Claim 12 is objected to because of the following informality: “centre” should read “center” (line 3). Appropriate correction is required. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 1-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “A catheter for insertion into a subject and navigation to a target organ”, which encompasses an organism as part of the invention. In order to overcome this rejection, the claim could be amended to recite “A catheter configured for insertion into a subject and navigation to a target organ”. Claims 2-29 are rejected based on their dependence on claim 1. Claim 11 recites “a balloon that when inserted into a blood vessel of the target organ of the subject and inflated, anchors the extension in the blood vessel near a biopsy site in the target organ”, which encompasses a portion of the human body as part of the invention. In order to overcome this rejection, the claim could be amended to recite “a balloon configured to be inserted into a blood vessel of the target organ of the subject and inflated, and subsequently anchors the extension in the blood vessel near a biopsy site in the target organ”. 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. Claim 15 is 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 15 recites “its” in line 2. It is unclear what the term “its” is referring to, which renders the claim indefinite. Further clarification is required. For the purpose of examination “its sides” is intended to mean the sides of the extension. Claim 16 is rejected based on its dependence on claim 15. Claim 22 recites “its” in line 2. It is unclear what the term “its” is referring to, which renders the claim indefinite. Further clarification is required. For the purpose of examination “its circumference” is intended to mean the circumference of the stylet needle. Claims 23-26 are rejected based on their dependence on claim 22. Claim 23 recites “they” in line 2. It is unclear what the term “they” is referring to, which renders the claim indefinite. Further clarification is required. For the purpose of examination “they” is intended to mean the notches. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1-10 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6346093 B1 (Allman et al.). Regarding claim 1, Allman teaches a catheter 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 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 having a second lumen (Col. 17, lines 7-8 “Catheter assembly 800 also includes a channel 814 providing access to the guidewire lumen 820”) with a c-shaped cross section forming a channel with a second proximal end and a second distal end, the second elongated tube sharing a common wall with the first elongated tube (Fig. 21C depicts the guidewire lumen 820 with a c-shaped cross section sharing a wall with the ancillary lumen 822). Regarding claim 2, Allman teaches the catheter according to claim 1, wherein the first lumen is a bean-shaped lumen (Fig. 21C depicts ancillary lumen 822 being bean-shaped). Regarding claim 3, Allman teaches the catheter 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 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 according to claim 1, wherein the common wall is located opposite to an opening of the channel 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 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 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 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 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 10, Allman teaches the catheter according to claim 9, further comprising a second tool for insertion into the channel of the second elongated tube (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.”, Co1. 17, lines 47-49 “a short length of the guidewire is constrained in the guidewire lumen proximal of the seal 830”). Regarding claim 15, Allman teaches the catheter according to claim 7, wherein the extension comprises channel walls along its sides (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 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). 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 11-14 and 17-29 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 11, Allman teaches the catheter according to claim 10. Allman does not explicitly teach wherein the second tool is a balloon catheter with a distal tip for insertion into the channel of the second elongated tube, wherein a section of the balloon catheter near the distal tip comprises a balloon that when inserted into a blood vessel of the target organ of the subject and inflated, anchors 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 for insertion into the channel of the second elongated tube, wherein a section of the balloon catheter near the distal tip comprises a balloon that when inserted into a blood vessel of the target organ of the subject and inflated, anchors 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 12, Allman teaches the catheter according to claim 10. 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 centre 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 according to claim 11. 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 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 17, Allman teaches the catheter 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 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 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 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 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 according to claim 18. Allman does not teach wherein the stylet needle comprises notches along its circumference longitudinally along the stylet needle. However, Mangat teaches wherein the stylet needle comprises notches along its circumference 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 according to claim 22. Allman does not teach wherein the notches are under squared such that the notches are deeper than they are wider. However, Mangat teaches wherein the notches are under squared such that the notches are deeper than they are wider (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 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 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 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 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 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 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]. Conclusion 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 W CHEN/Supervisory Patent Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Jun 10, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+46.9%)
3y 11m
Median Time to Grant
Low
PTA Risk
Based on 80 resolved cases by this examiner. Grant probability derived from career allow rate.

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