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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Response to Arguments
Applicant argues in the response filed 10/22/2025 that prior art Golden does not disclose the systems comprising the elongate tubular element is configured to be inserted through a lumen of an endoscope or the needle with a lumen, or the method directed to sealing in opening in a tissue where the first and second tissue portions are of the same tissue. The rejections have been withdrawn.
The applicant argues Yoon and Wardle does not disclose the closed shape. The examiner maintains that since the devices of both Yoon and Wardle do form circular loops in the unconstrained configuration, the device will be able to read on the closed shape. Teaching references Pyka/Golden will further teach/provide evidence on the closed shape and teach the limitations with respect to the free end of the first portion and the free end of the second portion extend away from the closed shape and the first end portion and the second end portion which are crossed over each other. See rejections below.
Claim Rejections - 35 USC § 102
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.
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.
Claims 11-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden.
As to claim 11, Yoon discloses a method of closing an opening in tissue between a first tissue portion and a second tissue portion of the tissue (figure 23-26, col. 5 ll. 53-58, the opening is the tissue between tissue portions T1 and T2), the method comprising: delivering a tissue closure device (522) to the first tissue portion in an constrained configuration (figure 23) within a delivery device lumen (546), the tissue closure device having a first end portion (portion between 532 and the middle of 522) with a first end and a free end (figure 24); a second end portion (portion between 530 and the middle of 522) with first end and a free end (figure 24), and a body portion (middle of 522) with a first end coupled to the first end of the first end portion and a second end coupled to the first end of the second end portion (figure 24), penetrating the first tissue portion and the second tissue portion to extend the tissue closure device therethrough (figure 23, col. 13 ll. 20-43); extending the first end portion through the penetrated first tissue portion and the penetrated second tissue portion (figure 23-24); and releasing the first end portion to transition from the constrained configuration to an unconstrained configuration engaging the first tissue portion with the free end thereof extended toward the second end portion (24), and releasing the second end portion to transition from the constrained configuration to an unconstrained configuration engaging the second tissue portion with the free end extended toward the first end portion to form a closed shape (figure 24, 26 the closure device forms a closed loop), thereby urging the first tissue portion and the second tissue portion together to seal the opening in the tissue (figure 24, 25, col. 13 ll. 20-43).
If, however, it would not be known that the Yoon can read on the closed shape, Pyka teaches a similar device in a method (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where the tissue closure device forms a closed shape for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration comprising a closed shape (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Yoon comprise an unconstrained configuration with a closed shape, in order for helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 12, with the method of Yoon and Pyka/Golden above, Yoon discloses a tissue penetrating tip is formed on the free end of the first portion (col. 14 ll. 20-24), the method further comprising penetrating the first tissue portion and the second tissue portion with the tissue-penetrating tip formed on the first end portion free end of the first end portion is shaped to penetrate tissue as it is moved out of the delivery device (col. 14 ll. 20-24). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a-c).
As to claim 13, with the method of Yoon and Pyka/Golden above, Yoon discloses penetrating the first tissue portion and the second tissue portion with a tissue-penetrating tip (544) formed on a sheath in which the a tissue closure device is housed (the lumen 524 can be the lumen of the “sheath 524”).
As to claim 14, with the method of Yoon and Pyka/Golden above, Yoon discloses releasing the first end portion and the second end portion comprises allowing the first end portion and the second end portion to cross over each other (figure 23-26, col. 13 ll. 1-13). Pyka (Figure 7B1, 2, 3, col. 8 ll. 36-61) and Golden (figure 12a) can further teach or provide evidence on the claim limitations.
As to claim 15, with the method of Yoon and Pyka/Golden above, Yoon discloses releasing the second end portion further comprises allowing the second end portion to transition to the unconstrained configuration with the free end thereof extend toward the first end portion (figure 23-26), so that the first tissue portion and the second tissue portion are urged together by the first end portion and the second end portion, respectively, to seal the opening. Pyka (c Figure 7B1, 2, 3) and Golden (figure 13a) can further teach or provide evidence on the claim limitations.
Claims 11, 12, 14-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent U.S. Patent Publication 2003/0225420 to Wardle in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden.
As to claim 11, Wardle discloses a method of closing an opening in a tissue between a first tissue portion and a second tissue portion of the tissue (figure 1, 65-68), the method comprising: delivering a tissue closure device (10/300) to the first tissue portion in an constrained configuration (figure 65, 66, paragraph 208-209) within a delivery device lumen (lumen 310), the tissue closure device having a first end portion (portion of 10/300 from the tip to the middle) with a first end and a free end (18, tip of 300); a second end portion (portion from the end of 10/300 to the middle) with first end and a free end (24, end of 300), and a body portion (middle of 10/300) with a first end coupled to the first end of the first end portion and a second end coupled to the first end of the second end portion (figure 3, 68), penetrating the first tissue portion and the second tissue portion to extend the tissue closure device therethrough (figure 65-66, paragraph 208-209); extending the first end portion through the penetrated first tissue portion and the penetrated second tissue portion (figure 66-67); and releasing the first end portion to transition from the constrained configuration to an unconstrained configuration engaging the first tissue portion with the free end thereof extended toward the second end portion (figure 67-68, paragraph 183), and releasing the second end portion to transition from the constrained configuration to an unconstrained configuration engaging the second tissue portion with the free end extended toward and crossing over the first end portion to form a closed shape (figure 68, the device forms loops which form a circular shape), thereby urging the first tissue portion and the second tissue portion together to seal the opening in the tissue (figure 67-68, paragraph 183). The system that closes the wound as disclosed in figure 63-68 can be used with the plurality of preloaded clips of paragraph 182, 200. Alternatively, the system with the preloaded clips can be used to close the wound as seen in figure 1 with the step of penetrating of the first and second tissue portions. If it would not be known that the preloaded delivery device can be used to deliver the closure device to seal the opening, it would have been obvious to combine the embodiments as disclosed in paragraph 235 in order to allow the device to seal a closure of a wound as desired by the user.
If it would not be known that the loop shape configuration of figure 67-68 would be able read on a closed shape, Pyka teaches a similar device in a method (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where the tissue closure device forms a closed shape for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration comprising a closed shape (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Wardle comprise an unconstrained configuration with a closed shape, in order for helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 12, with the method of Wardle and Pyka/Golden above, Wardle discloses a tissue penetrating tip is formed on the free end of the first portion (18), the method further comprising penetrating the first tissue portion and the second tissue portion with the tissue-penetrating tip formed on the first end portion free end of the first end portion is shaped to penetrate tissue as it is moved out of the delivery device (figure 1, 67, 68). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a- c).
As to claim 14, with the method of Wardle and Pyka/Golden above, Wardle discloses releasing the first end portion and the second end portion comprises allowing the first end portion and the second end portion to cross over each other (figure 2, 68). Pyka (Figure 7B1, 2, 3, col. 8 ll. 36-61) and Golden (figure 12a) can further teach or provide evidence on the claim limitations.
As to claim 15, with the method of Wardle and Pyka/Golden above, Wardle discloses releasing the second end portion further comprises allowing the second end portion to transition to the unconstrained configuration with the free end thereof extend toward the first end portion (figure 1, 67, 68, paragraph 12, 173, 183), so that the first tissue portion and the second tissue portion are urged together by the first end portion and the second end portion, respectively, to seal the opening. Pyka (Figure 7B1, 2, 3) and Golden (figure 13a) can further teach or provide evidence on the claim limitations.
As to claim 16, with the method of Wardle and Pyka/Golden above, Wardle discloses sequentially delivering a plurality of tissue closure device preloaded within the delivery device lumen (paragraph 182, 200).
Claims 1-3, 5, 6, 8-10, 17-20 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2003/0225420 to Wardle in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden.
As to claim 1, Wardle discloses a tissue closure system for sealing an opening between a first tissue portion and a second tissue portion (figure 1), the tissue closure system comprising: a delivery device (138) comprising an elongate tubular element (142) with a delivery device lumen therethrough, the elongate tubular device configured to be inserted through a lumen of an endoscope (paragraph 203); and a tissue closure device (10/140) positioned within the delivery device lumen (paragraph 193, 200), the tissue closure device configured to transition between a first configuration (paragraph 200, the straightened delivery configuration) when positioned within the delivery device lumen and a second configuration (figure 2,3,44, paragraph 198) when positioned outside the delivery device lumen, the tissue closure device comprising: a body portion (middle of 10/140) having a first end and second end, a first end portion (portion between the tip 18 and the middle) having a first end coupled to the first end of the body portion, and a free end (18); and a second end portion (portion between 24 and the middle) having a first end coupled to the second end of the body portion, and a free end (24); wherein the first end portion transitions to an unconstrained configuration when moved out of said delivery device lumen to engage the first tissue portion with said free end thereof extending toward the second end portion (figure 3, 43, paragraph 198), said second end portion transitions to an unconstrained configuration when moved out of said delivery device lumen to engage the second tissue portion with second free end thereof extending toward the first end body portion (figure 1), the first end portion and second end portion, in respective unconstrained configurations, are biased toward each other to draw together the first tissue portion engaged the first end portion and the second tissue portion engaged by the second end portion and to cross over each other when in an unconstrained configuration forming a closed shape (figure 1, 3, paragraph 173, 186, 199) to seal the opening in the tissue (figure 1, 3, paragraph 12, 173). If it would not be known that the delivery device 138 can be used to deliver the closure device 10 that can seal the opening, it would have been obvious to combine the embodiments as disclosed in paragraph 235 in order to allow the device to seal a closure of a wound as desired by the user. However, Wardle is silent about in the unconstrained configuration, the free end portion of the first portion and the free end of the second portion extend away from the closed shape and the first end portion and second portion which are crossed over each other.
Pyka teaches a similar device (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each other (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Wardle comprise an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 2, with the system of Wardle and Pyka/Golden above, Wardle discloses the first end portion, the second end portion and the body portion are formed from a shape memory material to form spring biased elements when in respective unconstrained configurations biasing the first tissue portion and the second tissue portion together to seal the opening in the tissue (paragraph 186). Golden can further teach or provide evidence on the claim limitations (paragraph 160).
As to claim 3, with the system of Wardle and Pyka/Golden above, Wardle discloses the body portion is substantially elongated when constrained within the delivery device (figure 35, 39, paragraph 200). Pyka (col. 5 ll. 33-35) and Golden (figure 13a) can further teach or provide evidence on the claim limitations
As to claim 5, with the system of Wardle and Pyka/Golden above, Wardle discloses the free end of the first end portion is shaped to penetrate tissue as it is moved out of the delivery device (figure 2). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a-c).
As to claim 6, with the system Wardle and Pyka/Golden above, Wardle discloses a pusher (174, paragraph 196) within the delivery device lumen movable to push the tissue closure device out of the delivery device lumen to pass the free end of the first end portion through the first tissue portion and the second tissue. Golden can further teach or provide evidence on the claim limitations (124, figure 13a-c).
As to claim 8, with the system Wardle and Pyka/Golden above, Wardle discloses wherein the tissue closure device and the delivery device lumen are configured such that a plurality of tissue closure devices may be preloaded within the delivery device lumen for delivery (paragraph 182, 200).
As to claim 9, with the system Wardle and Pyka/Golden above, Wardle discloses wherein the delivery device has a tip (150, paragraph 193) configured to penetrate through the first tissue and the second tissue portion. If it would not be known that the delivery device 138 can be used to deliver the closure device 10 that can seal the opening, it would have been obvious to combine the embodiments as disclosed in paragraph 235 in order to allow the device to seal a closure of a wound as desired by the user.
As to claim 10, Wardle and Pyka/Golden above, Wardle discloses more than one tissue closure device is preloaded within the delivery device (paragraph 182, 200).
As to claim 17, Wardle discloses a tissue closure system for sealing an opening between a first tissue portion and a second tissue portion (figure 1), the tissue closure system comprising a needle (142) with a lumen therethrough, a tissue closure device (10/140) positioned within the needle lumen (paragraph 193, 200), the tissue closure device configured to transition between a first configuration (paragraph 200, the straightened delivery configuration) when positioned within the needle lumen and a second configuration (figure 2,3,44, paragraph 198) when positioned outside the needle lumen, the tissue closure device comprising: a body portion (middle of 10/140) having a first end and second end, a first end portion (portion between the tip 18 and the middle) having a first end coupled to the first end of the body portion, and a free end (18); a second end portion (portion between 24 and the middle) having a first end coupled to the second end of the body portion, and a free end (24); wherein the first end portion is configured to transition from a constrained configuration to an unconstrained configuration engaging the first tissue portion (figure 3, 43, paragraph 198), said second end portion is configured to transition from a constrained configuration to an unconstrained configuration engaging the second tissue portion (figure 3, 43, paragraph 198), and in the respective unconstrained configurations of the first end portion and the second end portion, the free end of the first end portion and the free end of the second end portion extend toward and cross over each other to form a closed shape to urge together the first tissue portion and the second tissue portion positioned therebetween to seal the opening (figure 1, 3, paragraph 12, 173, 186, 199). However, Wardle is silent about the free end portion of the first portion and the free end of the second portion extend away from the closed shape and the first end portion and second portion which are crossed over each other.
Pyka teaches a similar device (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each other (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Wardle comprise an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 18, with the system of Wardle and Pyka/Golden above, Wardle discloses the first end portion and the second ed portion are substantially elongated when in the constrained configuration (figure 35, 39, paragraph 200). Pyka (col. 5 ll. 33-35) and Golden (figure 13a) can further teach or provide evidence on the claim limitations
As to claim 19, with the system of Wardle and Pyka/Golden above, Wardle discloses wherein the tissue closure device and the delivery device lumen are configured such that a plurality of tissue closure devices may be preloaded within the delivery device lumen for delivery (paragraph 182, 200). If it would not be known that the delivery device 138 can be used to deliver the closure device 10 that can seal the opening, it would have been obvious to combine the embodiments as disclosed in paragraph 235 in order to allow the device to seal a closure of a wound as desired by the user.
As to claim 20, with the system of Wardle and Pyka/Golden above, Wardle discloses the free end of the first end portion is shaped to penetrate tissue (figure 2). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a- c).
Claims 1-3, 5, 6, 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent Publication 2015/0272558 to Smith, U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden.
As to claim 1, Yoon discloses a tissue closure system for sealing an opening between a first tissue portion and a second tissue portion (figure 23-26), the tissue closure system comprising: a delivery device (524) comprising an tubular element (536) with a delivery device lumen (546) therethrough; and a tissue closure device (522) positioned within the delivery device lumen (figure 23), the tissue closure device configured to transition between a first configuration (figure 23) when positioned within the delivery device lumen and a second configuration (figure 24, 25) when positioned outside the delivery device lumen, the tissue closure device comprising: a body portion (middle of 522) having a first end and second end, a first end portion (portion between the 532 and the middle) having a first end coupled to the first end of the body portion, and a free end (532); a second end portion (portion between 530 and the middle) having a first end coupled to the second end of the body portion, and a free end (530); wherein the first end portion transitions to an unconstrained configuration when moved out of said delivery device lumen to engage the first tissue portion with said free end thereof extending toward the second end portion (figure 24, 25, col. 13 ll. 1-43), said second end portion transitions to an unconstrained configuration when moved out of said delivery device lumen to engage the second tissue portion with second free end thereof extending toward the first end body portion (figure 24, 25, col. 13 ll. 1-43), the first end portion and second end portion, in respective unconstrained configurations, are biased toward each other to draw together the first tissue portion engaged the first end portion and the second tissue portion engaged by the second end portion and to cross over each other when in an unconstrained configuration forming a closed shape (figure 24, 25, col. 13 ll. 1-13) to seal the opening in the tissue (figure 24, 25, col. 13 ll. 4-13), but is silent about the elongate tubular device configured to be inserted through a lumen of an endoscope and in the unconstrained configuration, the free end portion of the first portion and the free end of the second portion extend away from the closed shape and the first end portion and second portion which are crossed over each other. Yoon does disclose the device can be used to perform different types of procedures approximating different types of tissue (col. 5 ll. 43-67, col. 8 ll. 19-24). Yoon also discloses the device can be used in endoscopic procedures (col. 2 ll.39-43). Yoon further discloses the ends of the first and second portions can overlap (col. 14 ll. 50-51).
Smith teaches a similar device (tissue approximation) having an elongated delivery device (120n) configured to be inserted through a lumen (110c) of an endoscope (110 figure 1, paragraph 29, 30) in order to provide access to a location for tissue approximation. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the elongate the elongate tubular device of Yoon be configured to be inserted through a lumen of an endoscope in order for providing access to a location for tissue approximation as desired.
Pyka teaches a similar device (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each other (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Yoon comprise an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 2, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses the first end portion, the second end portion and the body portion are formed from a shape memory material to form spring biased elements when in respective unconstrained configurations biasing the first tissue portion and the second tissue portion together to seal the opening in the tissue (col. 6 ll. 30-34, col. 13 ll. 1-13). Golden can further teach or provide evidence on the claim limitations (paragraph 160).
As to claim 3, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses the body portion is substantially elongated when constrained within the delivery device (figure 23). The body portion conforms to the delivery device which will be elongated. Pyka (col. 5 ll. 33-35) and Golden (figure 13a) can further teach or provide evidence on the claim limitations.
As to claim 5, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses the free end of the first end portion is shaped to penetrate tissue as it is moved out of the delivery device (col. 14 ll. 20-24). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a-c).
As to claim 6, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses a pusher within the delivery device lumen movable to push the tissue closure device out of the delivery device lumen to pass the free end of the first end portion through the first tissue portion and the second tissue portion (col. 3 ll. 14-19, col. 15 ll. 66-col 16 ll. 12). Golden can further teach or provide evidence on the claim limitations (124, figure 13a-c). If it would not be known that Yoon can read on the pusher, it would have been obvious in order to help deliver the tissue closure device.
As to claim 9, with the system of Yoon, Smith, and Pyka above, Yoon discloses wherein the delivery device has a tip (544) configured to penetrate through the first tissue portion and second tissue portion (figure 23, col. 13 ll. 20-43).
Claims 17, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden.
As to claim 17, Yoon discloses a tissue closure system for sealing an opening between a first tissue portion and a second tissue portion (figure 23-26), the tissue closure system comprising: a needle (524) with a lumen (546) therethrough; and a tissue closure device (522) positioned within the needle lumen (figure 23), the tissue closure device configured to transition between a first configuration (figure 23) when positioned within the needle lumen and a second configuration (figure 24, 25) when positioned outside the needle lumen, the tissue closure device comprising: a body portion (middle of 522) having a first end and second end, a first end portion (portion between the 532 and the middle) having a first end coupled to the first end of the body portion, and a free end (532); a second end portion (portion between 530 and the middle) having a first end coupled to the second end of the body portion, and a free end (530); wherein the first end portion is configured to transition from a constrained configuration to an unconstrained configuration engaging the first tissue portion (figure 24, 25, col. 13 ll. 1-43), said second end portion is configured from a constrained configuration to an unconstrained configuration when engaging the second tissue portion (figure 24, 25, col. 13 ll. 1-43), in the respective unconstrained configurations of the first end portion and the second end portion, the free end of the first end portion and the free end of the second end portion extend toward and crossover each other to form a closed shape (figure 24, 25, col. 13 ll. 1-13) to urge together the first tissue portion and the second tissue portion positioned therebetween to seal the opening (figure 24, 25, col. 13 ll. 4-13), but is silent about the free end portion of the first portion and the free end of the second portion extend away from the closed shape and the first end portion and second portion which are crossed over each other. Yoon further discloses the ends of the first and second portions can overlap (col. 14 ll. 50-51).
Pyka teaches a similar device (suturing a wound, abstract) having a tissue closure device (10) comprising a linear constrained configuration (col. 5 ll. 33-35) and an unconstrained configuration (figure 7B1, 2, 3, col. 8 ll. 36-61), where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation. Golden can further teach (or provide evidence on) a tissue closure device comprising an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over (figure 12c). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tissue closure device of Yoon comprise an unconstrained configuration, where a free end portion of a first portion and a free end of a second portion extend away from a closed shape and a first end portion and second portion which are crossed over each over for the purpose of helping to approximate the tissue surfaces yet minimize tissue irritation.
As to claim 18, with the system of Yoon and Pyka/Golden above, Yoon discloses the first end portion and the second end portion are substantially elongated when constrained within the delivery device (figure 23). The body portion conforms to the delivery device which will be elongated. Pyka (col. 5 ll. 33-35) and Golden (figure 13a) can further teach or provide evidence on the claim limitations
As to claim 20, with the system of Yoon and Pyka/Golden above, Yoon discloses the free end of the first end portion is shaped to penetrate tissue as it is moved out of the delivery device (col. 14 ll. 20-24). Golden can further teach or provide evidence on the claim limitations (figure 12a, 13a- c).
Claims 4, 7, are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0225420 to Wardle in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden as applied to claims 1-3, 5, 6, 8-10, 17-20 above, and further in view of U.S. Patent Publication 2003/0105473 to Miller.
As to claim 4, with the system of Wardle and Pyka/Golden above, Wardle discloses the first end portion and the second end portion are made from a super-elastic material (paragraph 186) such that the first end portion and second end portion function as a spring. If the memory characteristics of the clip wouldn’t be known to read on the super-elastic material which will act like a spring, Miller teaches a similar device (fastener, abstract) having a shape memory clip being formed from a super-elastic material (paragraph 62) which allow the end portions to act like a spring. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the first end portion the second end portion of Wardle and Pyka/Golden be made of a super-elastic material such that the first and portion and the second end portion function as a spring since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
As to claim 7, with the system of Wardle and Pyka/Golden above, Wardle discloses the body portion, the first end portion, and the second end portion are comprised of a super-elastic material (paragraph 160). If the memory characteristics of the clip wouldn’t be known to read on the super-elastic material, Miller teaches a similar device (fastener, abstract) having a shape memory clip being formed from a super-elastic material (paragraph 62). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the body portion, the first end portion, and the second end portion of Wardle and Pyka/Golden be comprised of a super-elastic material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 4, 7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent Publication 2015/0272558 to Smith, U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden as applied to claims 1-3, 5, 6, 9 above, and further in view of U.S. Patent Publication 2003/0105473 to Miller.
As to claim 4, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses the first end portion and the second end portion are made from a super-elastic material (col. 6 ll. 30-34, col. 13 ll. 1-13, Golden also teaches the shape-memory material, paragraph 160) such that the first end portion and second end portion function as a spring. If the memory characteristics of the clip wouldn’t be known to read on the super-elastic material which will act like a spring, Miller teaches a similar device (fastener, abstract) having a shape memory clip being formed from a super-elastic material (paragraph 62) which allow the end portions to act like a spring. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the first end portion and the second end portion of Yoon, Smith, and Pyka/Golden be made of a super-elastic material such that the first and portion and the second end portion function as a spring since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
As to claim 7, with the system of Yoon, Smith and Pyka/Golden above, Yoon discloses the body portion, the first end portion, and the second end portion are comprised of a super-elastic material (col. 6 ll. 30-34, col. 13 ll. 1-13, Golden also teaches the shape-memory material, paragraph 160). If the memory characteristics of the clip wouldn’t be known to read on the super-elastic material, Miller teaches a similar device (fastener, abstract) having a shape memory clip being formed from a super-elastic material (paragraph 62). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the body portion, the first end portion, and the second end portion of Yoon, Smith, and Pyka/Golden be comprised of a super-elastic material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 8, 10, 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent Publication 2015/0272558 to Smith, U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by)U.S. Patent Publication 2004/0068276 to Golden as applied to claims 1-3, 5, 6, 9 above, and further in view of U.S. Patent Publication 2003/0225420 to Wardle.
As to claim 8, 10, 19, with the system of Yoon, Smith, and Pyka/Golden above, Yoon discloses the tissue closure device and the delivery lumen are configured so that a plurality of tissue closure device (more than one) is preloaded within the delivery device lumen for delivery (col. 2 ll. 53-57). If however it would not be known that Yoon would be able to read on the plurality of tissue closure device preloaded within the delivery device, Wardle teaches a similar device (surgical coil for anchoring) having plurality of tissue closure device preloaded within the delivery device (paragraph 200) for the purpose of efficiently delivering multiple tissue closure device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the system of Yoon, Smith, and Pyka/Golden comprise a plurality of tissue closure device (more than one) is preloaded within the delivery device lumen for delivery in order for efficiently delivering multiple tissue closure device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,810,851 to Yoon in view of U.S. Patent 5,002,563 to Pyka, and/or (or as evidenced by) U.S. Patent Publication 2004/0068276 to Golden as applied to claims 11-15 above, and further in view of U.S. Patent Publication 2003/0225420 to Wardle.
As to claim 16, with the method of Yoon and Pyka/Golden above, Yoon discloses the sequentially delivering a plurality of tissue closure devices preloaded within the delivery device lumen (col. 2 ll. 53-57, figure 25 multiple devices are loaded and delivered). If however it would not be known that Yoon would be able to read on sequentially delivering a plurality of tissue closure devices preloaded within the delivery device lumen, Wardle teaches a similar method (anchoring surgical coils) comprising sequentially delivering a plurality of tissue closure devices preloaded within the delivery device lumen (paragraph 200) for the purpose of efficiently delivering multiple tissue closure device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of Yoon, Smith, and Pyka/Golden sequentially delivering a plurality of tissue closure devices preloaded within the delivery device lumen in order for efficiently delivering multiple tissue closure device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2012/0232569 to Wright, U.S. Patent Publication 2004/0167546 to Saadat and U.S. Patent 4,595,007 to Mericle (as cited reference B in the 892 filed 04/01/205) all disclose similar subject matter capable of rendering obvious and/or providing evidence on the claims of record.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771