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
Claims 1-12 and 19-30 are pending in the application. Claims 13-18 have been canceled. Claims 4, 5, 8-12, 22, 23, and 25-30 have been amended.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/23/25 and 5/20/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 6, 7, 9, 11, 12, 24, 25, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the one or more actuators” in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 7 recites the limitation "the outer shaft” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 9 recites the limitation "the extension" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 11 recites the limitation "the tubular body" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 recites the limitation "the tubular body" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 24 recites the limitation "the one or more actuators” in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 25 recites the limitation "the outer shaft” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 27 recites the limitation "the extension" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 1-10, 19-24, 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin et al. (US 2018/0028176 A1) (“Raybin”) in view of Schaller et al. (US 2007/0112425 A1) (“Schaller”).
Regarding claims 1, 4, 9, and 10, Raybin discloses (Figures 1-22) an apparatus comprising: a tubular grasper comprising resilient tines (104) that are configured to expand outwardly when unbiased (paragraph 0045); a needle (106) disposed inside the tubular grasper (paragraph 0042), and configured to penetrate tissue (paragraph 0060); an anchor (110) disposed on the needle; and a surgical thread (112).
Raybin fails to disclose that the anchor is tubular, and the surgical thread is threaded through the tubular anchor. Raybin fails to disclose the tubular anchor comprises a tubular body and a resilient extension that is configured to expand outwardly from the tubular body when unbiased, and wherein the extension comprises a ring through which the surgical thread is threaded. Raybin fails to disclose the extension is a cut through the wall of the tubular anchor. Raybin fails to disclose a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7.
In the same field of endeavor, Schaller teaches (Figures 1-15) a tubular anchor (Figures 11-14); and a surgical thread (64) threaded through the tubular anchor. Schaller teaches that the tubular anchor comprises a tubular body and a resilient extension (104) that is configured to expand outwardly from the tubular body when unbiased (Figures 11 and 12), and wherein the extension comprises a ring through which the surgical thread is threaded (Figure 15). Raybin teaches that the extension is a cut through the wall of the tubular anchor and a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7 (paragraphs 0102-0103).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor disclosed by Raybin to comprises a tubular body and a resilient extension that is configured to expand outwardly from the tubular body when unbiased, wherein the extension comprises a ring through which the surgical thread is threaded, wherein the extension is a cut through the wall of the tubular anchor, and wherein a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7, as taught by Schaller. These modifications would provide an anchor arrangement with an extension that, once deployed, extends partially or completely through the tissue such that adjustment of the surgical thread will be less affected by friction (Schaller, paragraph 0105).
Regarding claim 2, Raybin as modified by Schaller teaches one or more actuators capable of: pushing the tubular grasper distally, out of a distal end of an endoscope, such that the tines expand outwardly, penetrate tissue, and secure the tissue to the grasper; pulling the tubular grasper proximally, such that the tissue that is secured to the grasper is pulled proximally while the needle and the tubular anchor penetrate the tissue so as to position the anchor at the distal side of the tissue; pulling the flexible needle proximally and release the tubular anchor beyond the tissue; and tensioning the surgical thread at the proximal side of the tissue, thereby causing the tubular anchor to pull the tissue proximally (Raybin, paragraph 0043).
Regarding claim 3, Raybin as modified by Schaller teaches the one or more actuators are comprised at least partially in a handle (Raybin, paragraph 0043).
Regarding claim 5, Raybin as modified by Schaller teaches an inner shaft (118) to which the tubular grasper is affixed; and a flexible, tubular, outer shaft (120) configured to enclose the inner shaft (Raybin, paragraph 0044).
Regarding claim 6, Raybin as modified by Schaller teaches the one or more actuators are comprised at least partially in a handle, and wherein the inner shaft extends to the handle (Raybin, paragraphs 0043-0046).
Regarding claim 7, Raybin as modified by Schaller teaches a tubular grasper collector (endoscope) mounted over the outer shaft and configured to enclose the tubular grasper (Raybin, paragraph 0060).
Regarding claim 8, Raybin as modified by Schaller teaches (Raybin, Figures 19-22) that each of the tines of the tubular grasper has a blunt edge (paragraph 0063).
Regarding claims 19, 22, 27, and 28, Raybin discloses (Figures 1-22) a method comprising:
a) inserting a flexible endoscope through a body orifice of a patient, the flexible endoscope comprising a work channel having a distal opening (paragraphs 0043, 0060);
b) providing a tubular grasper which comprises resilient tines (104) that are configured to expand outwardly when unbiased (paragraph 0045);
c) exposing the tubular grasper from the distal opening of the work channel, and unbiasing the tines such that the tines penetrate and secure a tissue as they expand outwardly;
d) providing a needle (106) that is disposed inside the tubular grasper, and an anchor (110) that is disposed on and secured to the needle, and wherein a surgical thread (112) is attached to the anchor;
e) pulling the tubular grasper proximally, such that the secured tissue forms a sleeve, the tissue is punctured by the needle, and the anchor passes to the distal side of the tissue while still secured to the needle (Figure 9; paragraph 0060);
f) withdrawing the needle proximally and releasing the anchor from the flexible needle at the distal side of the tissue, within the formed sleeve (paragraph 0060);
g) biasing the tines of the tubular grasper such that the tissue is released from the tines (paragraphs 0060, 0061);
h) loading a new anchor (110) onto the flexible needle (106), and repeating steps c, e, f, and g with respect to the new anchor (Figure 10; paragraph 0061);
i) tensioning the surgical thread so as to form a suture extending between the anchor and the new anchor (paragraph 0061); and
j) securing the surgical thread relative to the new anchor, such that the tension is maintained (paragraph 0061).
Raybin fails to disclose that the anchor and the new anchor are tubular, and the surgical thread is threaded through the tubular anchor. Raybin fails to disclose the tubular anchor comprises a tubular body and a resilient extension that is configured to expand outwardly from the tubular body when unbiased, and wherein the extension comprises a ring through which the surgical thread is threaded. Raybin fails to disclose the extension is a cut through the wall of the tubular anchor. Raybin fails to disclose a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7.
In the same field of endeavor, Schaller teaches (Figures 1-15) a tubular anchor (Figures 11-14); and a surgical thread (64) threaded through the tubular anchor. Schaller teaches that the tubular anchor comprises a tubular body and a resilient extension (104) that is configured to expand outwardly from the tubular body when unbiased (Figures 11 and 12), and wherein the extension comprises a ring through which the surgical thread is threaded (Figure 15). Raybin teaches that the extension is a cut through the wall of the tubular anchor and a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7 (paragraphs 0102-0103).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchors disclosed by Raybin to be tubular and to comprise a tubular body and a resilient extension that is configured to expand outwardly from the tubular body when unbiased, wherein the extension comprises a ring through which the surgical thread is threaded, wherein the extension is a cut through the wall of the tubular anchor, and wherein a length ratio between the tubular body of the anchor and the extension of the anchor is between 1:0.3 and 1:0.7, as taught by Schaller. These modifications would provide an anchor arrangement with an extension that, once deployed, extends partially or completely through the tissue such that adjustment of the surgical thread will be less affected by friction (Schaller, paragraph 0105).
Regarding claim 20, Raybin as modified by Schaller teaches one or more actuators configured to facilitate steps c, e, f, and g (Raybin, paragraph 0043).
Regarding claim 21, Raybin as modified by Schaller teaches the one or more actuators are comprised at least partially in a handle (Raybin, paragraph 0043).
Regarding claim 23, Raybin as modified by Schaller teaches an inner shaft (118) to which the tubular grasper is affixed; and a flexible, tubular, outer shaft (120) configured to enclose the inner shaft (Raybin, paragraph 0044).
Regarding claim 24, Raybin as modified by Schaller teaches the one or more actuators are comprised at least partially in a handle, and wherein the inner shaft extends to the handle (Raybin, paragraphs 0043-0046).
Regarding claim 26, Raybin as modified by Schaller teaches (Raybin, Figures 19-22) that each of the tines of the tubular grasper has a blunt edge (paragraph 0063).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin et al. (US 2018/0028176 A1) (“Raybin”) in view of Schaller et al. (US 2007/0112425 A1) (“Schaller”) as applied to claim 1 above, and further in view of Vargas (US 2015/0250470 A1).
Regarding claim 11, Raybin as modified by Schaller teaches the invention substantially as claimed. However, the combined teaching fails to teach the tubular body of the anchor has a chamfered distal edge to facilitate penetration of the tissue together with the needle.
In the same field of endeavor, Vargas teaches (Figure 4) a tubular anchor (1300) with a chamfered distal edge (1310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of the anchor taught by Raybin in view of Schaller to have a chamfered distal edge to facilitate penetration of the tissue together with the needle, as taught by Vargas. This modification would provide an anchor configuration that assists tissue penetration in order to place the anchor into or through the desired tissue and then functions to anchor a suture by rotating into a broad surface area T position with respect to the entry hole (Vargas, paragraph 0098).
Regarding claim 12, Raybin as modified by Schaller teaches the invention substantially as claimed. However, the combined teaching fails to teach the tubular body of the anchor has a beveled distal edge to facilitate penetration of the tissue together with the needle.
In the same field of endeavor, Vargas teaches (Figure 4) a tubular anchor (1300) with a beveled distal edge (1310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of the anchor taught by Raybin in view of Schaller to have a beveled distal edge to facilitate penetration of the tissue together with the needle, as taught by Vargas. This modification would provide an anchor configuration that assists tissue penetration in order to place the anchor into or through the desired tissue and then functions to anchor a suture by rotating into a broad surface area T position with respect to the entry hole (Vargas, paragraph 0098).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Raybin et al. (US 2018/0028176 A1) (“Raybin”) in view of Schaller et al. (US 2007/0112425 A1) (“Schaller”) as applied to claim 19 above, and further in view of Hauschild et al. (US 2002/0120277 A1) (“Hauschild”).
Regarding claim 25, Raybin as modified by Schaller teaches the invention substantially as claimed. However, the combined teaching fails to teach a tubular grasper collector mounted over the outer shaft and configured to enclose the tubular grasper.
Hauschild teaches (Figures 1-15) an analogous tubular grasper which comprises resilient tines that are configured to expand outwardly when unbiased (paragraph 0050). Hauschild teaches (Figure 1) an inner shaft (20) to which the tubular grasper (24) is affixed and an outer shaft (40) disposed over the inner shaft (paragraph 0051). Hauschild teaches that the distal end (41) of the outer shaft (40) engages inclined portions (25) of the resilient tines to cam the tines toward the closed position (paragraph 0051). Hauschild further teaches a tubular grasper collector (50) mounted over the outer shaft and configured to enclose the tubular grasper (paragraph 0047).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Raybin in view of Schaller to provide a tubular grasper collector mounted over the outer shaft and configured to enclose the tubular grasper, as taught by Hauschild. This modification would provide a sheath to afford rotation as well as sliding passage of the tubular grasper and outer shaft while in the closed position (Hauschild, paragraph 0047).
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin et al. (US 2018/0028176 A1) (“Raybin”) in view of Schaller et al. (US 2007/0112425 A1) (“Schaller”) as applied to claim 19 above, and further in view of Vargas (US 2015/0250470 A1).
Regarding claim 29, Raybin as modified by Schaller teaches the invention substantially as claimed. However, the combined teaching fails to teach the tubular body of the anchor has a chamfered distal edge to facilitate penetration of the tissue together with the needle.
In the same field of endeavor, Vargas teaches (Figure 4) a tubular anchor (1300) with a chamfered distal edge (1310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of the anchor taught by Raybin in view of Schaller to have a chamfered distal edge to facilitate penetration of the tissue together with the needle, as taught by Vargas. This modification would provide an anchor configuration that assists tissue penetration in order to place the anchor into or through the desired tissue and then functions to anchor a suture by rotating into a broad surface area T position with respect to the entry hole (Vargas, paragraph 0098).
Regarding claim 30, Raybin as modified by Schaller teaches the invention substantially as claimed. However, the combined teaching fails to teach the tubular body of the anchor has a beveled distal edge to facilitate penetration of the tissue together with the needle.
In the same field of endeavor, Vargas teaches (Figure 4) a tubular anchor (1300) with a beveled distal edge (1310).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular body of the anchor taught by Raybin in view of Schaller to have a beveled distal edge to facilitate penetration of the tissue together with the needle, as taught by Vargas. This modification would provide an anchor configuration that assists tissue penetration in order to place the anchor into or through the desired tissue and then functions to anchor a suture by rotating into a broad surface area T position with respect to the entry hole (Vargas, paragraph 0098).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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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.
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/C.D.K/Examiner, Art Unit 3771 /DIANE D YABUT/Primary Examiner, Art Unit 3771
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