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 Arguments
Applicant’s arguments, see Pages 7-8, filed 14 August 2026, with respect to the rejection(s) of claim(s) 1, 12, & 21 under 35 U.S.C 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of For claims 1 & 12 US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund; and US 10,470,808 hereinafter Golden in view of an embodiment of Golden.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-3, 5, 8-12, 15, 18, & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund.
In regards to Claim 1: Golden teaches of a surgical method, comprising:
disposing a displacement wrap around at least a portion of a tissue (Golden, Figure 3; Column 12 Lines 27-45);
placing the displacement wrap in a locked position to hold the tissue in at least one of tension or compression (Golden, Figure 4; Column 12 Lines 27-45);
moving the displacement wrap to a displacement location to cause the tissue to move away from its original location to a new location, thereby increasing at least one of access to a surgical site or an available region behind the tissue for a surgical procedure to be performed (Golden, Figure 4; Column 12 Lines 27-45); and
maintaining the displacement wrap at the displacement location, and thus the tissue at the new location, to allow access to at least one of the surgical site or the available region behind the tissue during the surgical procedure (Golden, Figure 4; Column Lines 27-45),
wherein the displacement wrap protects the tissue and distributes load across the displacement wrap and the tissue, thus preventing damage to the tissue (Golden, Column 14 Lines 49-51).
However, Golden does not teach a surgical method for use on soft tissue.
Höglund teaches a surgical method for use on soft tissue (Höglund, Paragraph 73; “The device can also be used in any soft tissues surgery, in or outside the abdominal or thoracic cavity, where a ligation is desired”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the surgical method for use on soft tissue taught in Höglund to the device taught in Golden, the motivation being to provide an alternative to traditional ligatures but also replace devices such as stapling equipment, ultrasonic scalpels, vessel sealing devices, trans fixation ligatures, surgeons knot and other knots, e.g. Miller's knot.
In regards to Claim 2: A modified Golden teaches the method of claim 1, and wherein the displacement wrap comprises:
a first portion that includes a first terminal end and a textile (Golden, Figure 80 Items 864 & 860); and
a second portion that includes a second, opposed terminal end, the second, opposed terminal end being coupled to an introducer (Golden, Figure 80 Item 862; Column 31 Lines 23-31).
In regards to Claim 3: A modified Golden teaches the method of claim 2, further comprising:
passing the introducer under the soft tissue and subsequently sliding the wrap with respect to the soft tissue to move the textile into contact with the soft tissue (Golden, column 12 Lines 41-45; Figure 3 Item 130 & 124),
wherein disposing a displacement wrap around at least a portion of a soft tissue further comprises wrapping the textile around at least a portion of the soft tissue (Golden, Figure 3), and
wherein the textile is wrapped around at least a portion of the soft tissue when the displacement wrap is in the locked position (Golden, Figure 4; Column 12 Lines 27-45).
In regards to Claim 5: A modified Golden teaches the method of claim 1, and wherein placing the displacement wrap in a locked position further comprises:
passing the introducer and a first end of the textile coupled to the introducer through a first end of the textile with a portion of the second end of the textile (Golden, Column 13 Lines 32-47), and
engaging at least one locking feature of the first end of the Textile with a portion of the second end of the textile, proximate to the opening, to hold the soft tissue in at least one of tension or compression (Golden, Column 16 Lines 27-33).
In regards to Claim 8: A modified Golden teaches the method of claim 1, and comprising:
unlocking the displacement wrap from the locked position, the locked position being a first locked position (Golden, Column 11 Lines 24-29);
adjusting an amount of at least one of tension or compression being applied to the soft tissue (Golden, Column 11 Lines 24-29); and
placing the displacement wrap in a second locked position (Golden Column, Column 11 Lines 24-29),
wherein the second locked position is one of a same locked position or a different locked position than the first locked position (Golden, Column 11 Lines 24-29).
In regards to Claim 9: A modified Golden teaches the method of claim 1, and wherein adjusting an amount of at least one of tension or compression being applied to the soft tissue further comprises:
sliding a portion of the displacement wrap with respect to itself (Golden, Column 16 Lines 27-42),
wherein in the first locked position, a first locking feature on a first end of the displacement wrap engages a second end of the displacement wrap (Golden, Column 16 Lines 27-42), and
wherein in the second locked position, a second locking feature on the first end of the displacement wrap engages the second end of the displacement wrap (Golden, Column 16 Lines 27-42).
In regards to Claim 10: A modified Golden teaches the method of claim 1, and wherein maintaining the displacement wrap at the displacement location further comprises:
holding the soft tissue in at least one of tension or compression (Golden, Column 16 Line 27-42); and
attaching a portion of the displacement wrap to an object to maintain the at least one of tension or compression at the displacement location (Golden, Figures 3 & 4).
In regards to Claim 11: A modified Golden teaches the method of claim 1, and wherein placing the displacement wrap in a locked position to hold the soft tissue in at least one of tension or compression further comprises:
passing a first portion of the displacement wrap through a loop formed by a locking suture that is coupled to the displacement wrap (Golden, Figure 4; Column 12 Lines 27-45);
engaging at least one locking feature of the first portion of the displacement wrap with the locking suture to hold the soft tissue in tension (Golden, Figure 4; Column 12 Lines 27-45); and
collapsing the loop against the first portion of the displacement wrap to place the displacement wrap in the locked position (Golden, Figure 4; Column 12 Lines 27-45).
In regards to Claim 12: Golden teaches of a device for manipulating tissue during surgery, comprising:
a textile having a body with a length and a width, the length being greater than the width (Golden, Figure 8a), the body comprising:
a first portion having a plurality of locking features disposed along the length of the textile (Golden, Figure 8a Item 164);
a second portion having a locking opening formed therein, and a width of the second portion being greater than a width of the first portion, and the widths of the first and second portions being disposed in a same orientation as the width of the textile (Golden, Figure 8a Item 162),
wherein the locking opening of the second portion is configured to receive the first portion such that a tissue receiving opening is formed by at least one of the first and second portions and each locking feature of the plurality of locking features is configured to engage with the second portion, proximate to the locking opening, to place the device in a locked configuration in which the location of the first portion is maintained with respect to the second portion and tissue disposed in the tissue-receiving opening is able to be secured within the tissue-receiving opening (Golden, Figure 8b; Column 14 Lines 49-51), and
wherein the textile is configured to protect the tissue it engages and distribute load across the textile and the tissue, thus preventing damage to the tissue (Golden, Column 14 Lines 49-51).
However, Golden does not teach the locking opening positioned along the second portion, away from a terminal end of the second portion, and having a width that is less than a width of the second portion.
Höglund teaches the locking opening positioned along the second portion, away from a terminal end of the second portion, and having a width that is less than a width of the second portion (Höglund, Figure 1 Item 120, Paragraph 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the locking opening being positioned away from the terminal end as taught in Höglund to the device of Golden, the motivation being to provide a smaller radius when the device in encircled around tissue.
In regards to Claim 15: A modified Golden teaches the method of claim 12, and wherein the textile comprises at least one of cotton, nylon, polyester, silk, poly felt, silicone, plastic, rubber, rubber-like materials, biologics, scaffold- type biologics, sutures, filaments, or a combination thereof (Golden, Column 13 Lines 12-20).
In regards to Claim 18: A modified Golden teaches the method of claim 12, and further comprising:
an introducer configured to pass into the locking opening of the second portion of the body (Golden, Column 13 Lines 38-45).
In regards to Claim 19: wherein the introducer is integrally formed with the textile (Golden, Column 13 Lines 38-41; Figure 8a).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund in view of US 2008/0234550 hereinafter Hawkes.
In regards to Claim 6: A modified Golden teaches of the method of claim 1, but does not teach wherein moving the displacement wrap to a displacement location further comprises moving the tissue both superiorly and inferiorly during the surgical procedure without adjusting a positioning of the displacement wrap with respect to the tissue.
Hawkes teaches wherein moving the displacement wrap to a displacement location further comprises moving the tissue both superiorly and inferiorly during the surgical procedure without adjusting a positioning of the displacement wrap with respect to the tissue (Hawkes, Paragraph 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the adjustment of the tissue position taught in Hawkes to the joint repair system taught in Golden, the motivation being to provide versatility for the surgeon to choose the best resection direction for the situation.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund in view of US 2005/0043805 Chudik.
In regards to Claim 7: A modified Golden teaches of the method of claim 1, but does not teach wherein the tissue is a subscapularis tendon.
Chudik teaches wherein the tissue is a subscapularis tendon (Chudik, Paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the device moving the subscapularis taught in Chudik to the joint repair system taught in Golden, the motivation being to provide a rotator cuff surgery that allows for better recovery.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund in view of US 2004/0144395 hereinafter Evans.
In regards to Claim 14: A modified Golden teaches of the device for manipulating tissue during surgery of claim 12 , but does not teach, wherein the plurality of locking features comprises:
a plurality of first diagonal slits formed along a length of a first side of the first portion of the body, the slits of the plurality of first diagonal slits being substantially parallel to each other; and
a plurality of second diagonal slits formed along a length of a second side of the first portion of the body, the slits of the plurality of second diagonal slits being substantially parallel to each other, the second side of the first portion of the body being opposed to the first side of the first portion of the body and the length of the first and second sides of the first portion of the body being disposed in a same orientation as the length of the textile.
Evans teaches wherein the plurality of locking features comprises:
a plurality of first diagonal slits formed along a length of a first side of the first portion of the body, the slits of the plurality of first diagonal slits being substantially parallel to each other (Evans, Figures 25A-C); and
a plurality of second diagonal slits formed along a length of a second side of the first portion of the body, the slits of the plurality of second diagonal slits being substantially parallel to each other, the second side of the first portion of the body being opposed to the first side of the first portion of the body and the length of the first and second sides of the first portion of the body being disposed in a same orientation as the length of the textile (Evans, Figures 25A-C; Paragraph 238).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the retention features being parallel slits taught by Evans to the Joint repair system taught by Golden, the motivation being to provide an easily manufacturable process for fabricating the device.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund in view of US 6,402,680 hereinafter Mortier.
In regards to claim 17: A modified Golden teaches of the device of claim 12, but does not teach wherein the body further comprises at least one of a mesh or net structure having a plurality of holes formed therein.
Mortier teaches wherein the body further comprises at least one of a mesh or net structure having a plurality of holes formed therein (Mortier, Claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the mesh or net-like material found in Mortier to the joint repair system taught by Golden, the motivation being to provide a malleable material that is able to conform to the multiple situations as required.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2010/0292793 hereinafter Höglund.
In regards to Claim 20: A modified Golden teaches of the device of claims 18 & 12, but does not teach wherein the introducer is coupled to the textile.
A separate embodiment of golden teaches wherein the introducer is coupled to the textile (Golden, Figure 79 Item 862; Column 31 Lines 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the introducer tip coupled to the device as taught by a separate embodiment of Golden, the motivation being to provide a modular design to allow for adaptability to the situation.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden.
In regard to Claim 21: Golden teaches of a device for manipulating tissue during surgery, comprising:
a textile having a body with a length and a width, the length being greater than the width (Golden, Figure 8A), the body comprising:
a first portion having a plurality of locking features disposed along the length of the textile (Golden, Figure 8A Item 164);
a second portion having a locking suture coupled thereto and a width of the second portion being greater than a width of the first portion, the widths of the first and second portions being disposed in a same orientation as the width of the textile (Golden, Figure 8A Item 162),
wherein the textile is configured to protect the tissue it engages and distribute load across the textile and the tissue, thus preventing damage to the tissue (Golden, Column 14 Lines 49-51).
However, the current embodiment of golden does not teach wherein the locking suture is configured to engage one or more locking features of the plurality of locking features to form a tissue receiving opening comprised of at least one of the first and second portions and to place the device in a locked configuration in which the location of the first portion is maintained with respect to the second portion and tissue disposed in the tissue- receiving opening is able to be secured within the tissue-receiving opening.
A separate embodiment of Golden teaches wherein the locking suture is configured to engage one or more locking features of the plurality of locking features to form a tissue receiving opening comprised of at least one of the first and second portions and to place the device in a locked configuration in which the location of the first portion is maintained with respect to the second portion and tissue disposed in the tissue- receiving opening is able to be secured within the tissue-receiving opening (Golden, Figure 13; Column 15 Lines 4-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the locking suture taught in an embodiment of Golden to the device of Golden , the motivation being to allow for the device to be easily looped around an object.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,470,808 hereinafter Golden in view of US 2004/0144395 hereinafter Evans.
In regards to Claim 22: A modified Golden teaches of the device of claim 21, but does not teach, wherein the plurality of locking features comprises:
a plurality of first diagonal slits formed along a length of a first side of the first portion of the body, the slits of the plurality of first diagonal slits being substantially parallel to each other; and
a plurality of second diagonal slits formed along a length of a second side of the first portion of the body, the slits of the plurality of second diagonal slits being substantially parallel to each other, the second side of the first portion of the body being opposed to the first side of the first portion of the body and the length of the first and second sides of the first portion of the body being disposed in a same orientation as the length of the textile.
Evans Teaches wherein the plurality of locking features comprises:
a plurality of first diagonal slits formed along a length of a first side of the first portion of the body, the slits of the plurality of first diagonal slits being substantially parallel to each other (Evans, Paragraph 238; Figures 25A-C); and
a plurality of second diagonal slits formed along a length of a second side of the first portion of the body, the slits of the plurality of second diagonal slits being substantially parallel to each other, the second side of the first portion of the body being opposed to the first side of the first portion of the body and the length of the first and second sides of the first portion of the body being disposed in a same orientation as the length of the textile (Evans, Paragraph 238; Figures 25A-C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the retention features being parallel slits taught by Evans to the Joint repair system taught by Golden, the motivation being to provide an easily manufacturable process for fabricating the device
Conclusion
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
