Prosecution Insights
Last updated: October 23, 2026
Application No. 18/777,323

BEVELED TISSUE ANCHOR DELIVERY NEEDLES

Final Rejection §103
Filed
Jul 18, 2024
Priority
Sep 06, 2018 — provisional 62/727,628 +3 more
Examiner
JAFFRI, ZEHRA
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
1y 1m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
51 granted / 88 resolved
-12.0% vs TC avg
Strong +49% interview lift
Without
With
+49.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
51 currently pending
Career history
152
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
44.8%
+4.8% vs TC avg
§102
26.6%
-13.4% vs TC avg
§112
23.1%
-16.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 88 resolved cases

Office Action

§103
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 In light of Applicant’s amendment, claim(s) 18-26 and 29-35 is/are amended. Claims 18-37 are pending examination. The objections to the claims are withdrawn in light of Applicant’s amendment. The rejection(s) under 35 U.S.C. 112(a) to claim(s) 33 is/are withdrawn. Response to Arguments Applicant’s arguments, filed 6/25/2026, with respect to the rejection(s) of claim(s) 18, 21, and 31 under U.S.C 102 and 103 have been fully considered and are persuasive. Examiner agrees the newly added limitation “a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. Additionally, a new interpretation of Cheng is presented to include the newly added limitations of a radiused edge and un-radiused edge. Thus, upon further consideration, a new ground(s) of rejection is made in view of Cheng in view of Crainch. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 18, 20, 31-32, 34, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20110060349 A1) (previously of record) in view of Crainch et al. (US 20090118762 A1). Regarding claim 18, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising: advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including: a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and a needle tip (240) including a sharp distal beveled portion (labeled in Annotated Figure 9) and a smooth proximal beveled portion (labeled in Annotated Figure 9), the sharp distal beveled portion having an edge that is un-radiused and the smooth proximal beveled portion having an edge that is radiused(labeled in Annotated Figure 9) (Figure 9; Paragraph 0101); puncturing the target tissue with the sharp distal beveled edge of the needle tip to form an opening in the target tissue (Paragraph 0097; 0106); the un-radiused edge of the sharp distal beveled portion configured to cut the target tissue (Paragraph 0101); stretching the opening by advancing the smooth proximal beveled edge at least partially through the opening (according to the claim, advancing the smooth proximal beveled edge at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled edge through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and deploying a tissue anchor (352+350) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108). Cheng fails to expressly disclose a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. However, Crainch is directed to a needle assembly and teaches needle 52 and side walls 90 pierce, cut, and or dilate the hole in the tissue allowing for smooth introduction of the needle through the tissue, and specifically teaches making a small portion of needle tip 92 sharp (using one or more beveled surfaces), the resulting hole is creating partly through direct injury (cutting by the tip 92) and partly through dilation (stretching of tissue around needle 52 and side walls 90) (Figure 15; Paragraph 0083), in turn, the un-radiused edge of the sharp distal beveled portion configured to cut the target tissue and a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue, as taught by Crainch, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Crainch by incorporating a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue in order to minimize resulting tissue injury (Crainch Paragraph 0083). PNG media_image1.png 296 550 media_image1.png Greyscale Regarding claim 20, Cheng further discloses wherein the radius of the radiused edge of the smooth proximal portion is 0.015", which is included in the range of being at least 130 µm (Paragraph 0101). Regarding claim 31, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising: advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including: a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and a needle tip (240) (Figure 9-10; Paragraph 0101) including: a pointed tip (distal tip of 240) (Figure 9-10; Paragraph 0101); a sharp distal beveled portion (labeled in Annotated Figure 9) (Figure 9; Paragraph 0101); and a smooth proximal beveled portion (labeled in Annotated Figure 9) proximally adjacent the sharp distal beveled portion (Figure 9; Paragraph 0101), the sharp distal beveled portion being sharper than the smooth proximal beveled portion (the distalmost edge of the distal beveled portion pierces the tissue; therefore, the distal beveled portion is sharper than the proximal beveled portion), the smooth proximal beveled portion having an edge that is radiused (the edge is curved, thus is radiused) (Figure 9; Paragraph 0101); puncturing the target tissue with the pointed tip and the sharp distal beveled portion to form an opening in the target tissue (Paragraph 0097; 0106); stretching the opening by advancing the smooth proximal beveled portion at least partially through the opening (Paragraph 0097; 0101); and deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108). Cheng fails to expressly disclose a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. However, Crainch is directed to a needle assembly and teaches needle 52 and side walls 90 pierce, cut, and or dilate the hole in the tissue allowing for smooth introduction of the needle through the tissue, and specifically teaches making a small portion of needle tip 92 sharp (using one or more beveled surfaces), the resulting hole is creating partly through direct injury (cutting by the tip 92) and partly through dilation (stretching of tissue around needle 52 and side walls 90) (Figure 15; Paragraph 0083), in turn, the un-radiused edge of the sharp distal beveled portion configured to cut the target tissue and a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue, as taught by Crainch, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Crainch by incorporating a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue in order to minimize resulting tissue injury (Crainch Paragraph 0083). Regarding claim 32, Cheng further discloses wherein: the sharp distal beveled portion has a first angle relative to an axis of the hollow shaft (Figure 9; Paragraph 0101); and at least a portion of the smooth proximal beveled portion has a second angle relative to the axis of the hollow shaft that is less than the first angle (Figure 9; Paragraph 0101). Regarding claim 34, Cheng further discloses wherein the sharp distal beveled portion is un-radiused (Annotated Figure 9). Regarding claim 36, Cheng further discloses wherein the hollow shaft includes a bend proximal of the needle tip that deflects the needle tip to align the pointed tip with an axis of the hollow shaft (Figure 6, 21; Paragraph 0106). Claim(s) 19, 21-28, 30 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Crainch and Higaki et al. (WO 2015105162 A1) (in text citations correspond with attached Espacenet translation) (previously of record). Regarding claim 19, Cheng as modified by Crainch teaches the method of claim 18 and Cheng further discloses wherein: the sharp distal beveled edge has a first angle relative to an axis of the hollow shaft (Figure 9; Paragraph 0101); and at least a portion of the smooth proximal beveled edge has a second angle relative to the axis of the hollow shaft (Figure 9; Paragraph 0101), but fails to explicitly disclose the second angle is less than the first angle. However, Higaki is directed to a needle device and teaches wherein: the sharp distal beveled edge (4+6) has a first angle (angle the distal edge of 6 at 90°) relative to an axis of the hollow shaft and at least a portion of the smooth proximal beveled edge (3) has a second angle (angle of 3) relative to the axis of the hollow shaft that is less than the first angle (angle of inclination towards the proximal end is less than 2°) (Figure 7; Page 14). A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng as modified by Crainch such that the second angle is less than the first angle, as taught by Higaki, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng as modified by Crainch with the teachings of Higaki by incorporating the second angle is less than the first angle in order to mitigate pain to the patient during insertion and reduce tissue damage (Higaki Page 14). Regarding claim 21, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising: advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including: a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and a needle tip (240) (Figure 9-10; Paragraph 0101) including: a pointed tip (distal tip of 240) (Figure 9-10; Paragraph 0101); a distal beveled portion (labeled in Annotated Figure 9) positioned adjacent the pointed tip, the distal beveled edge having a first angle relative to an axis of the hollow shaft, the distal beveled portion having an edge that is radiused (labeled in Annotated Figure 9) (Figure 9; Paragraph 0101); and a proximal beveled portion (labeled in Annotated Figure 9) positioned proximal of the distal beveled portion, the proximal beveled portion having a second angle relative to the axis of the hollow shaft, the proximal beveled portion having an edge that is radiused (Labeled in Annotated Figure 9) (Figure 9; Paragraph 0101); puncturing the target tissue with the pointed tip to form an opening in the target tissue (Paragraph 0097; 0106); stretching the opening by advancing the proximal beveled portion at least partially through the opening (according to the claim, advancing the smooth proximal beveled portion at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled portion through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108). Cheng fails to explicitly disclose the second angle is less than the first angle and a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. However, Crainch is directed to a needle assembly and teaches needle 52 and side walls 90 pierce, cut, and or dilate the hole in the tissue allowing for smooth introduction of the needle through the tissue, and specifically teaches making a small portion of needle tip 92 sharp (using one or more beveled surfaces), the resulting hole is creating partly through direct injury (cutting by the tip 92) and partly through dilation (stretching of tissue around needle 52 and side walls 90) (Figure 15; Paragraph 0083), in turn, the un-radiused edge of the sharp distal beveled portion configured to cut the target tissue and a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue, as taught by Crainch, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Crainch by incorporating a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue in order to minimize resulting tissue injury (Crainch Paragraph 0083). Further, Higaki is directed to a needle device and teaches wherein: the sharp distal beveled edge (4+6) has a first angle (angle the distal edge of 6 at 90°) relative to an axis of the hollow shaft and at least a portion of the smooth proximal beveled edge (3) has a second angle (angle of 3) relative to the axis of the hollow shaft that is less than the first angle (angle of inclination towards the proximal end is less than 2°) (Figure 7; Page 14). A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the second angle is less than the first angle, as taught by Higaki, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Higaki by incorporating the second angle is less than the first angle in order to mitigate pain to the patient during insertion and reduce tissue damage (Higaki Page 14). PNG media_image2.png 315 550 media_image2.png Greyscale Regarding claim 22, Cheng further discloses wherein the distal beveled edge includes: a sharp distal portion having an un-radiused edge (labeled in Annotated Figure 9) (Annotated Figure 9); and a smooth proximal portion (labeled in Annotated Figure 9) having the radiused edge, wherein the radiused edge of the smooth proximal portion is less sharp than the un-radiused edge of the sharp distal portion (Annotated Figure 9; Figure 9-10). Regarding claim 23, Cheng further discloses wherein the radius of the radiused edge of the proximal beveled portion has the same radius as the radiused edge of the smooth proximal portion of the distal beveled edge (Figure 9-10). Regarding claim 24, Cheng further discloses wherein radiused edge of the smooth proximal portion of the distal beveled portion has a radius of 0.015", which is included in the range of being at least 130 µm (Paragraph 0101). Regarding claim 25, Cheng further discloses wherein the radiused edge of the smooth proximal beveled portion has a radius of 0.015", which is included in the claimed range of 130 to 400 µm (Paragraph 0101). Regarding claim 26, Cheng discloses the method of claim 22, but fails to explicitly disclose wherein the smooth proximal portion of the distal beveled portion is electropolished. However, Higaki is directed to a needle device and teaches electropolishing a beveled end (4) of a needle (T) (Page 10, end of 1st paragraph). As a result of modifying the edge of the needle, the smooth proximal portion of the distal beveled edge of Cheng would also be electropolished. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the beveled portion is electropolished, as taught by Higaki, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Higaki by incorporating the beveled portion is electropolished in order to remove minute burrs and irregularities, creating a smooth finish (Higaki Page 10, end of 1st paragraph). Regarding claim 27, Cheng further discloses wherein the pointed tip of the needle tip is coincident with an interior lumen wall of the needle tip (Figure 9-10). Regarding claim 28, Cheng further discloses wherein the hollow shaft includes a bend proximal of the needle tip that deflects the needle tip to align the pointed tip with an axis of the hollow shaft proximal of the bend (Figure 6; 21; Paragraph 0106). Regarding claim 30, Cheng further discloses wherein an inflection point (Labeled in Annotated Figure 9) separates the distal beveled portion from the proximal beveled portion (Annotated Figure 9). Regarding claim 35, Cheng discloses the method of claim 31 but fails to explicitly disclose wherein the smooth proximal beveled portion is electropolished. However, Higaki is directed to a needle device and teaches electropolishing a beveled end (4) of a needle (T) (Page 10, end of 1st paragraph). As a result of modifying the edge of the needle, the smooth proximal beveled edge of Cheng would also be electropolished. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the beveled portion is electropolished, as taught by Higaki, as both references and the claimed invention are directed to needle devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Higaki by incorporating the beveled portion is electropolished in order to remove minute burrs and irregularities, creating a smooth finish (Higaki Page 10, end of 1st paragraph). Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Higaki as applied to claim 21 above and further in view of Utterberg (US 20040122380 A1) (previously of record). Regarding claim 29, Cheng as modified by Crainch and Higaki discloses the method of claim 21 but fails to explicitly disclose wherein a portion of the needle tip opposite the distal beveled portion is deflected to position the pointed tip towards an axis of the hollow shaft. However, Utterberg is directed to a needle and teaches wherein a portion (41) of the needle tip (14) is deflected to position the pointed tip towards an axis of the hollow shaft (Figure 4; Paragraph 0029). As a result of the modification to Cheng, the portion of the needle tip would be opposite the distal beveled edge as it is located at the distalmost point of the needle tip. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng as modified by Crainch and Higaki such that a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft, as taught by Utterberg, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng as modified by Crainch and Higaki with the teachings of Utterberg by incorporating a portion of the needle tip opposite the distal beveled edge is deflected to position the pointed tip towards an axis of the hollow shaft in order to reduce the forces acting upon the tissue during penetration to prevent excessive damage to the tissue (Utterberg Paragraph 0029). Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over alternative interpretation of Cheng (US 20110060349 A1) in view of Crainch. Regarding claim 31, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising: advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including: a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and a needle tip (240) (Figure 9-10; Paragraph 0101) including: a pointed tip (labeled in Annotated Figure 9(2)) (Figure 9-10; Paragraph 0101); a sharp distal beveled edge (labeled in Annotated Figure 9(2)) (Figure 9; Paragraph 0101); and a smooth proximal beveled edge (labeled in Annotated Figure 9(2)) proximally adjacent the sharp distal beveled edge (Figure 9; Paragraph 0101), the sharp distal beveled edge being sharper than the smooth proximal beveled edge (the distalmost edge of the distal beveled edge pierces the tissue; therefore, the distal beveled edge is sharper than the proximal beveled edge) (Figure 9; Paragraph 0101); puncturing the target tissue with the pointed tip and the sharp distal beveled edge to form an opening in the target tissue (Paragraph 0097; 0106); stretching the opening by advancing the smooth proximal beveled edge at least partially through the opening (according to the claim, advancing the smooth proximal beveled edge at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled edge through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108). Cheng fails to explicitly disclose a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. However, Crainch is directed to a needle assembly and teaches needle 52 and side walls 90 pierce, cut, and or dilate the hole in the tissue allowing for smooth introduction of the needle through the tissue, and specifically teaches making a small portion of needle tip 92 sharp (using one or more beveled surfaces), the resulting hole is creating partly through direct injury (cutting by the tip 92) and partly through dilation (stretching of tissue around needle 52 and side walls 90) (Figure 15; Paragraph 0083), in turn, the un-radiused edge of the sharp distal beveled portion configured to cut the target tissue and a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue, as taught by Crainch, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Crainch by incorporating a radius of the radiused edge of the smooth proximal beveled portion configured to induce stretching of the target tissue rather than cutting the target tissue in order to minimize resulting tissue injury (Crainch Paragraph 0083). PNG media_image3.png 286 604 media_image3.png Greyscale Regarding claim 33, Cheng further discloses wherein: a first portion (labeled in Annotated Figure 9(2)) of the smooth proximal beveled portion has the first angle relative to the axis of the hollow shaft; and a second portion (labeled in Annotated Figure 9(2)) of the smooth proximal beveled portion has the second angle relative to the axis of the hollow shaft (Annotated Figure 9(2)). Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng as applied to claim 31 above, in view of Utterberg (US 20040122380 A1) (previously of record). Regarding claim 37, Cheng as modified by Crainch discloses the method of claim 31 but fails to explicitly disclose wherein a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft. However, Utterberg is directed to a needle and teaches wherein a portion (41) of the needle tip (14) is deflected to position the pointed tip towards an axis of the hollow shaft (Figure 4; Paragraph 0029). A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng as modified by Crainch such that a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft, as taught by Utterberg, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng as modified by Crainch with the teachings of Utterberg by incorporating a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft in order to reduce the forces acting upon the tissue during penetration to prevent excessive damage to the tissue (Utterberg Paragraph 0029). 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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM. 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, DARWIN EREZO can be reached at (571) 272-4695. 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. /Z.J./Examiner, Art Unit 3771 /SHAUN L DAVID/Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Jul 18, 2024
Application Filed
Mar 25, 2026
Non-Final Rejection mailed — §103
Jun 25, 2026
Response Filed
Oct 01, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+49.1%)
3y 4m (~1y 1m remaining)
Median Time to Grant
Moderate
PTA Risk
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