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
The Amendment filed 11/10/25 has been entered. Claims 1, 3- 5, 11, 18- 19, 21- 22, 24- 26, 37, 39- 40, 42- 44, 47, 50- 51 have been amended. Claims 1- 12, 17- 26 and 37- 51 are being addressed by this Office Action.
Response to Arguments
Applicant’s Amendment addressed only some of the claim objections made in the Non-Final Office Action, mailed 8/12/25. The unaddressed claim objections are reiterated below.
Applicant’s Amendment addressed only some of the rejections under 35 U.S.C. 112(b) made in the Non-Final Office Action, mailed 8/12/25. The unaddressed rejections under 35 U.S.C. 112(b) are reiterated below.
Applicant’s arguments, see p. 10 of applicant’s Remarks, filed 11/10/25, with respect to the rejection(s) of claim(s) 51 under 35 U.S.C. 102 as being anticipated by Lashinski have been fully considered and are persuasive because Lashinski does not disclose the newly added limitation regarding an elongate linear first suspension member having an anchoring member comprising a ladder-shaped textile. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lashinski et al. (US Pub. No. 2010/0137679 A1) in view of Kim (US Pub. No. 2014/0228971 A1). It is noted that the arguments against Lashinski are directed to the elongate linear first suspension member having an anchoring member comprising a ladder-shaped textile feature, for which the Kim reference is relied.
Applicant's arguments, see pp. 11- 12, filed 11/10/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments that Kim fails to teach or suggest an anchoring member comprising a ladder-shaped textile because Kim explicitly states that forming the outer edges of the mesh member with smooth curvatures achieves the desired expandability, the Office respectfully submits that the broadest reasonable interpretation of “ladder-shaped” includes loop ladders having outer edges with smooth curvatures.
For example, Medema et al. (US Pat. No. 10,022,224 B2) teaches loop ladders (Col. 17, l. 54- 57 - - In an embodiment, any of loop members 1203, 1204, 1205, 1206 of FIG. 12(b) may be replaced with loop ladders such as any of the ladders of FIGS. 1-4):
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Additionally, Gillinov et al. (US Pub. No. 2009/0088837 A1) teaches a plurality of loop members can be arranged in a ladder-like configuration (P. [0040]):
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As such, applicant’s argument that Kim does not teach or suggest a ladder-shaped textile because the anchoring member associated with Kim has outer edges with smooth curvatures or are loop-shaped is not persuasive and the limitations of the claim have been met.
Claim Objections
Claim 18 is objected to because of the following informalities: line 2- “an IMF” should be amended to - - an [[IMF]] inframammary fold (IMF) - - . Appropriate correction is required.
Claims 19- 25 and 47- 50 are objected to because they depend off claim 18.
Claim 18 is objected to because of the following informalities: lines 5- 6- “the first support line connected at its second end to a first anchoring member at its first end” should be amended to - - the first support line connected at its second end to [[a]]] the first anchoring member at its first end - - since it is clear that applicant is referring to the same first anchoring member recited in line 5, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 19- 25 and 47- 50 are objected to because they depend off claim 18.
Claim 18 is objected to because of the following informalities: lines 8- 9- “the second support line connected at its second end to a second anchoring member at its first end” should be amended to - - the second support line connected at its second end to [[a]] the second anchoring member at its first end - - since it is clear that applicant is referring to the same second anchoring member recited in line 8, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 19- 25 and 47- 50 are objected to because they depend off claim 18.
Claim 18 is objected to because of the following informalities: line 13- “when implant in the breast is located on the medial side of the breast” should be amended to - - when implanted in the breast is located on the medial side of the breast - - to maintain consistent claim terminology and correct an apparent typographical error. Appropriate correction is required.
Claims 19- 25 and 47- 50 are objected to because they depend off claim 18.
Claim 26 is objected to because of the following informalities: lines 4- 5- “the first support line connected at its second end to a first anchoring member at its first end” should be amended to - - the first support line connected at its second end to [[a]]] the first anchoring member at its first end - - since it is clear that applicant is referring to the same first anchoring member recited in line 3, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: lines 10- 11- “the second support line connected at its second end to a second anchoring member at its first end” should be amended to - - the second support line connected at its second end to [[a]] the second anchoring member at its first end - - since it is clear that applicant is referring to the same second anchoring member recited in line 8, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “and optionally wherein a needle is connected to the first end of one of the first and second arms arm or wherein needles are connected to the first ends of each of the first and second arms” in lines 5- 7. Claim 21 is indefinite because the scope of the claim is unclear. It is not clear whether the entire phrase “and optionally wherein a needle is connected to the first end of one of the first and second arms arm or wherein needles are connected to the first ends of each of the first and second arms” is optional or whether only one of the alternative limitations “wherein a needle is connected to the first end of one of the first and second arms” and “or wherein needles are connected to the first ends of each of the first and second arms” is required. For the purposes of examination, claim 21 is interpreted as making the entire phrase “and optionally wherein a needle is connected to the first end of one of the first and second arms arm or wherein needles are connected to the first ends of each of the first and second arms” optional.
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.
Claim(s) 1- 5, 8- 9, 11- 12, 17 and 37- 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Pub. No. 2014/0228971 A1) in view of Lashinski et al. (US Pub. No. 2010/0137679 A1).
Regarding claim 1, Kim discloses a mastopexy system (P. [0091]- - The mesh member 4 may be inserted into one of face, neck, breast, and hip, and a size of a mesh may be enlarged or reduced depending on a size of the surgical area), comprising:
a suspension member (2) (Figs. 1, 5, 7- 13) comprising a support line (6) (Figs. 1- 15) with a first end and a second end, and an anchoring member (4) (Figs. 1- 15) with a first end and a second end, the support line (6) connected at its second end to the anchoring member (4) at its first end, and wherein the anchoring member (4) is only connected to a support line at one end (See Figs. 1, 9) (P. [0089] - - mesh member 4 may be fixedly coupled to the distal portion of the bioimplantable thread 6); and
wherein the anchoring member (4) comprises a ladder-shaped textile (See Fig. 2 - - showing a loop ladder type textile)
Kim does not disclose
(claim 1) a strut as claimed.
However, Lashinski teaches a system and method for tissue lifting in the same field of endeavor (Abstract, P. [0001])
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(claim 1) a strut (3712) (Figs. 103A- 103S) configured to attach to the support line (S1) (See Annotated Fig. 103S) (Ps. [0462], [0463] - - The next steps comprise coupling the anchor suspension line 3735 with the superior sling 3712. FIG. 103M illustrates, at the lateral exit point 3704, the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchors suspension line 3735 advanced through the lateral exit point 3704 being advanced through a suture loop 3744 at a base of a knot tube 3746. FIG. 103N depicts the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 advanced through the lateral exit point 3704 being pulled through the knot tube 3746 by the suture loop 3744. Once they are pulled through the knot tube 3746, the suture loop 3744 is removed. The knot tube 3746 is then advanced over the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735, and a distal end 3748 of the knot tube 3746 is advanced into opening of the lateral exit point 3704, as illustrated in FIG. 103O. The breast 3726 is then lifted, and a distance D.sub.1 between the sling portion 3718 and an inferior anchor 3734 is decreased (compared with D.sub.2). In some embodiments, the breast 3726 is manually distracted, and in some embodiments, the breast 3726 can be distracted by pulling on the proximal ends 3740 of the anchor suspension line 3735. The proximal ends 3740 of the anchor suspension lines 3735 are independently drawn at a hub 3750 of the knot tube 3746 and secured in position, for example, with a clamp. In some embodiments, the superior sling 3712 is clamped first. The same, or similar, steps are followed with the second end 3716 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 extending from the medial exit point 3702, as illustrated in FIG. 103P; FIG. 103Q depicts the step of securing the superior sling 3712 with the proximal ends 3740 of the anchor suspension line 3735).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the system of claim 1 as disclosed by Kim to include a method of lifting a breast including a strut (3712) configured to attach to the support line (S1) (See Annotated Fig. 103S) according to the teachings of Lashinski because it would predictably provide a superior sling support from which the suspension line associated with Kim can be secured while allowing for manually distracting (lifting) the breast by pulling up on the suspension line associated with Kim (Lashinski - - Ps. [0462], [0463]).
Regarding claim 2, Kim in view of Lashinski discloses the system of claim 1, Kim further disclosing wherein the anchoring member (4) is porous, or comprises a textile (Ps. [0039], [0053] - - The mesh member 4 may be formed by knitting; the mesh member induces tissue ingrowth into pores of the mesh member after an implantation).
Regarding claim 3, Kim in view of Lashinski discloses the system of claim 1, Kim further disclosing wherein further comprising at least one retainer (8) (Figs. 2- 3, 6, 8- 11, 13, 15), and wherein the anchoring member (4) is configured with the retainers (8) to engage and lift tissue (P. [0087] - - the cogs 8 may share the responsibility of tissue lifting with the mesh member 4).
Regarding claim 4, Kim in view of Lashinski discloses the system of claim 3, Kim further disclosing wherein the at least one retainer (8) is selected from one or more of the following: anchors, swivel anchors, hooks, darts, barbs, clasps, projections, extensions, bulges, protuberances, spurs, bumps, points, cogs, surface roughness, surface irregularities, and arrows (P. [0087] - - the cogs 8 may share the responsibility of tissue lifting with the mesh member 4).
Regarding claim 5, Kim in view of Lashinski discloses the system of claim 3, Kim further disclosing wherein the at least one retainer (8) is positioned at an angle on the anchoring member (4), and the at least one retainer (8) is angled at an angle of less than 90 degrees measured between (i) the first end of the anchoring member (4) and a vertex of the angle and (ii) a tip of the at least one retainer (8) and a vertex of the angle (P. [0037] - - when the cogs 8 are incisive cogs, a depth of incision may be 25% or less of the diameter of the bioimplantable thread 6, and an angle of incision may be 10.degree. or less).
Regarding claim 8, Kim further disclosing wherein the second end of the anchoring member (4) is connected to an introducer housing tip (g) with a blunt driving tip, wherein the introducer housing tip (g) is designed for removable connection to a distal tip of an introducer tool (20) (Figs. 16- 19) (Ps. [0046], [0047], [107] - - a guiding portion (g) that extends without the cogs 8 on a surface of the bioimplantable thread 6 to guide a penetration of the bioimplantable thread 6 that is inserted into an inserting cannula 20h; A surgery may be performed by using the graft 2 for tissue lifting that is inserted into the tissue by using an inserting device 20 and a thread guiding needle 23 that hooks onto the guiding portion g of the bioimplantable thread 6 by using a hole formed on a surface or another surface to penetrate the inserting cannula 20h; the thread guiding needle 23 plays a role of hooking a guiding portion g of the bioimplantable thread 6, passing the same through the inserting cannula 20h, and piercing out of a predetermined area of the skin).
Regarding claim 9, Kim in view of Lashinski discloses the system of claim 1, but Kim does not disclose
(claim 9) wherein the suspension member can withstand a load of at least 5 N.
However, Lashinski teaches a system and method for tissue lifting in the same field of endeavor (Abstract, P. [0001])
(claim 9) wherein the suspension member (3735) can withstand a load of at least 5 N (P. [0288] - - the safety release 390 comprises a region engineered to fail at a predetermined limit. In some embodiments the mechanism comprises a necked section to allow for yielding. In some embodiments, a slip disconnection that decouples, or a joint that unlatches can be examples of effective safety releases. In some cases the safety release mechanism can be designed such that it can be reconnected or repaired following release. The loading limit effective to result in release of the suspension members from the support member can range, for example, from about 0.5 kg to about 8 kg, and in particular from about 1 kg to about 3 kg of force).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the suspension member associated with Kim such that it withstand a load of at least 5 N as taught by Lashinski because it would provide an effective safety release mechanism that can be designed such that it can be reconnected or repaired following release (Lashinski - - P. [0288]).
Regarding claim 11, Kim in view of Lashinski discloses the system of claim 1, Kim further disclosing wherein the mastopexy system comprises one or more absorbable polymers, or wherein the mastopexy system comprises one or more absorbable polymers selected from the following: polymers, homopolymers, and copolymers comprising glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, C- caprolactone, 1,4-butanediol, and succinic acid (P. [0044] - - The graft 2 for tissue lifting may include bioabsorbable medical polymer materials such as polydioxanone, poly-(1-lactic) acid, polyglycolic acid, polycaprolactone and a copolymer thereof that are harmless to a human body and are absorbed in vivo over time, or biocompatible medical polymer materials including polypropylene and a mixture thereof).
Regarding claim 12, Kim discloses the system of claim 1, but Kim does not disclose
(claim 12) a removable sheath as claimed;
However, Lashinski teaches a system and method for tissue lifting in the same field of endeavor (Abstract, P. [0001])
(claim 12) wherein the suspension member (3735) is partially or totally inserted in a removable sheath (P. [0466] - - the anchor lines may be dispensed through a sheath to protect the surrounding tissue and can be engaged superior to the nipple for maximum adjustability).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the suspension member associated with Kim such that it is partially or totally inserted in a removable sheath according to the teachings of Lashinski because the removable sheath would allow the suspension line to be protected from the surrounding tissue and can also be engaged superior to the nipple for maximum adjustability (Lashinski - - P. [0466]).
Regarding claim 17, Kim discloses the system of claim 1, but Kim does not disclose
(claim 17) a strut as claimed;
However, Lashinski teaches a system and method for tissue lifting in the same field of endeavor (Abstract, P. [0001])
(claim 17) wherein the strut (3712) (Figs. 103A- 103S) comprises a first arm (3714) (Figs. 103A- 103S), a second arm (3716) (Figs. 103A- 103S), and a textile (3718) (Figs. 103A- 103S) connected to the first arm (3714) and the second arm (3716), wherein the first arm (3714) is configured to attach to the support line (3735) (P. [0462] - -The next steps comprise coupling the anchor suspension line 3735 with the superior sling 3712. FIG. 103M illustrates, at the lateral exit point 3704, the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchors suspension line 3735 advanced through the lateral exit point 3704 being advanced through a suture loop 3744 at a base of a knot tube 3746. FIG. 103N depicts the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 advanced through the lateral exit point 3704 being pulled through the knot tube 3746 by the suture loop 3744. Once they are pulled through the knot tube 3746, the suture loop 3744 is removed. The knot tube 3746 is then advanced over the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735, and a distal end 3748 of the knot tube 3746 is advanced into opening of the lateral exit point 3704, as illustrated in FIG. 103O. The breast 3726 is then lifted, and a distance D.sub.1 between the sling portion 3718 and an inferior anchor 3734 is decreased (compared with D.sub.2). In some embodiments, the breast 3726 is manually distracted, and in some embodiments, the breast 3726 can be distracted by pulling on the proximal ends 3740 of the anchor suspension line 3735. The proximal ends 3740 of the anchor suspension lines 3735 are independently drawn at a hub 3750 of the knot tube 3746 and secured in position, for example, with a clamp. In some embodiments, the superior sling 3712 is clamped first. The same, or similar, steps are followed with the second end 3716 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 extending from the medial exit point 3702, as illustrated in FIG. 103P).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the system associated with Kim in order to include a strut comprising a first arm, a second arm and a textile according to the teachings of Lashinski because it would predictably provide a superior sling support from which the suspension line associated with Kim can be secured while allowing for manually distracting (lifting) the breast by pulling up on the suspension line associated with Kim (Lashinski - - Ps. [0462], [0463]).
Regarding claim 37, claim 38 and claim 39, Kim in view of Lashinski discloses the system of claim 1, but Kim does not disclose
(claim 37, claim 38 and claim 39) a method of lifting a breast and a NAC of a patient as claimed.
However, Lashinski teaches a system and method for tissue lifting in the same field of endeavor (Abstract, P. [0001])
(claim 37) a method of lifting a breast and a NAC of a patient, comprising: providing a stab incision tool (3708), a blunt dissection tool (3728), an introducer tool (3722), and a mastopexy system of claim 1 (see the rejection of claim 1 above), making a stab incision (3706) in the breast, inserting the blunt dissection tool (3728) in the stab incision (3706) and making a defined channel in the breast (3726) on a lateral or medial side of the breast, using the introducer tool (3722) to deliver the mastopexy system into the defined channel so the support line is superior to the anchoring member (see claim 1 rejection), applying a force to the support line (3735) to lift the breast, and securing the support line in a position superior to the NAC of the breast (Ps. [0454], [0459] - - At the superior entry point 3700, a superior port 3706 is inserted, for example, with a trocar and port dilator 3708; FIG. 103G depicts advancement inferiorly of a needle 3720 and cannula 3722 from the lateral exit point 3704 to an exit point 3724 at a base of the breast 3726. FIG. 103H illustrates removal of the needle 3720 from the cannula 3722 and advancement, through the cannula 3722, of a feeder rod 3728 having, for example, a loop 3730 at a proximal end 3732 of the rod 3728. A distal end 3736 of an anchor 3734 is coupled to the proximal end 3732 of the rod 3728, for example, through the loop 3730, and the rod 3728 is further advanced through the cannula 3722, drawing the distal end 3736 of the anchor suspension line 3734 through the cannula 3722, as shown in FIG. 103I. The anchor suspension line 3735 carrying one or more inferior anchors 3734 is advanced through the cannula 3722 until the distal end 3736 emerges from the distal end 3738 of the cannula 3722);
(claim 38) wherein the stab incision (3706) is made superior to the NAC of the patient (See Fig. 103A), and the blunt dissection tool (3708) is used to form a channel starting from a position superior to the NAC of the breast (See Annotated Fig. 103S);
(claim 39) further comprising providing a strut (3712) and using the blunt dissection tool (3728) to form a channel superior to the NAC of the patient for insertion of the strut (3712), and connecting the first end of the support line (S1E1) to the strut (3712) (See Annotated Fig. 103S), and connecting the first end of the support line (S1E1) to the strut (3712) (P. [0462] - - The next steps comprise coupling the anchor suspension line 3735 with the superior sling 3712. FIG. 103M illustrates, at the lateral exit point 3704, the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchors suspension line 3735 advanced through the lateral exit point 3704 being advanced through a suture loop 3744 at a base of a knot tube 3746. FIG. 103N depicts the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 advanced through the lateral exit point 3704 being pulled through the knot tube 3746 by the suture loop 3744; it is noted that “or providing a strut with one or more blunt needles and using the one or more blunt needles to form a channel superior to the NAC of the patient for insertion of the strut” is an optional limitation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the system of claim 1 as disclosed by Kim to include a method of lifting a breast including providing a stab incision tool, blunt dissection tool and an introducer tool to implant the system of claim 1 according to the teachings of Lashinski because it would predictably introduce a superior sling support from which the suspension line associated with Kim can be secured while allowing for manually distracting (lifting) the breast by pulling up on the suspension line associated with Kim (Lashinski - - Ps. [0462], [0463]).
Regarding claim 40, Kim in view of Lashinski discloses the system of claim 1, Kim further disclosing a method of making the mastopexy system of claim1, wherein: the anchoring member (4) is formed by knitting the ladder-shaped textile, and connecting the first end of the ladder-shaped textile to the second end of the support line (6) (See Fig. 2 - - showing a loop ladder type textile) (Ps. [0039] - - The mesh member 4 may be formed by knitting).
Regarding claim 41, Kim in view of Lashinski discloses the method of claim 40, Kim further disclosing wherein the ladder-shaped textile is formed by knitting a monofilament fiber (Ps. [0039], [0054] - - The mesh member 4 may be formed by knitting; the graft for tissue lifting has a monofilament as the mesh member).
Regarding claim 42, Kim in view of Lashinski discloses the method of claim 40, Kim further disclosing wherein the support line (6) is a monofilament fiber (Ps. [0054], [0055] - - the graft for tissue lifting has a monofilament as the mesh member; the graft for tissue lifting has the bioimplantable thread that takes on most of the tension, and the bioimplantable thread has an integrated form with the mesh member as the bioimplantable thread passing through the mesh member takes on the tension; it is noted that since the support line (6) is integrated with the anchoring member (4), the support line (6) is a monofilament fiber; it is noted “and optionally wherein the monofilament fiber is optionally connected to the anchoring member by tying, stapling, or fusion” is an optional limitation).
Regarding claim 43, Kim in view of Lashinski discloses the method of claim 42, Kim further disclosing wherein the mastopexy system further comprises one or more tissue retainers (8), wherein the one or more tissue retainers (8) comprise a base section and a tip, and each base section of the one or more tissue retainer are inserted in the ladder-shaped textile (See Fig. 2 - - showing tissue retainers (8) inside the ladder-shaped textile) (P. [0083] - - a cogged portion t where the cogs 8 protrude from a surface of the bioimplantable thread 6 in a certain direction).
Claim(s) 6- 7 and 45- 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Pub. No. 2014/0228971 A1) in view of Lashinski et al. (US Pub. No. 2010/0137679 A1) as applied to claim 1 and 40 above, and further in view of Martin (US Pub. No. 2012/0197294 A1).
Regarding claims 6- 7 and 45- 46, Kim in view Lashinski disclose the system of claim 1 and the method of claim 40 respectively, but Kim in view of Lashinski does not disclose
(claims 6- 7 and 45- 46) fixation elements as claimed.
However, Martin teaches a warp knitted suture with parallel pillar stitches having increased stability of the suture in tissue to avoid movement of the suture after completion of the surgical process (Ps. [0006], [0061])
(claim 6) wherein the support line (1901) (Fig. 9A) is configured with fixation elements (1905 a, b, c) to fixate the support line (1901) in soft tissue;
(claim 7) wherein the fixation elements (1905 a, b, c) are selected from one or more of the following: braids, warp knits, and warp knits comprising pillar stitches (P. [0061] - -The strands 1910 of each segment can be knitted together in a warp knit, such as a raschel knit, crocheted together, or knitted together with parallel pillar stitches and weft inlays);
(claim 45) wherein the support line (1901) is formed with fixation elements (1905 a, b, c) that can engage tissue (P. [0006] - -having the largest diameter possible for the intended opening is advantageous both because a large diameter suture will provide increased stability of the suture in tissue, a larger suture is stronger, and because space in the surgical device will not be wasted with a partially unfilled opening. Moreover, in certain cases, in order to properly pinch or otherwise restrain the suture to avoid movement of the suture after completion of the surgical process, the suture ideally fills a majority of the opening of the surgical instrument or implant);
(claim 46) wherein the support line (1901) is formed by knitting a textile with a single or double loop pillar stitch (See Fig. 9A) (P. [0061] - -The strands 1910 of each segment can be knitted together in a warp knit, such as a raschel knit, crocheted together, or knitted together with parallel pillar stitches and weft inlays).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the support line associated with Kim in view of Lashinski to include fixation elements formed by knitting a textile with a single or double loop pillar stitch according to the teachings of Martin because it would provide increased stability of the suture in tissue to avoid movement of the suture after completion of the surgical process (Martin - - Ps. [0006], [0061]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Pub. No. 2014/0228971 A1) in view of Lashinski et al. (US Pub. No. 2010/0137679 A1) as applied to claim 1 above, and further in view of Martin et al. (WO 2011/119742 A2) (hereinafter “Martin ‘742”).
Regarding claim 10, Kim in view of Lashinski discloses the system of claim 1, Kim further disclosing that the anchoring member is a mesh manufactured by knitting, but Kim in view of Lashinski does not explicitly disclose
(claim 10) wherein the anchoring member can withstand a burst force of at least 1 N.
However, Martin ‘742 teaches biocompatible knitted woven meshes and braided sutures having low tissue drag that minimizes trauma to the sutured tissues (p. 1, l. 5- 9)
(claim 10) wherein the anchoring member can withstand a burst force of at least 1 N (See Tables 15- 18 - - showing various Burst Strength Peak Loads that are at least 1 N).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the knitted mesh anchoring member associated with Kim to withstand a burst force of at least 1 N according to the teachings of Martin because it would have low tissue drag that minimizes trauma to the sutured tissues (Martin ‘742 - - p. 1, l. 5- 9).
Claim(s) 18- 21, 24- 26 and 47- 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Lashinski et al. (US Pub. No. 2010/0137679 A1) in view of Kim (US Pub. No. 2014/0228971 A1).
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Regarding claim 18, Lashinski discloses a mastopexy system for securing a breast of a patient in a target position, the breast having a nipple areolar complex (NAC), an IMF, a lateral side, and a medial side, the mastopexy system comprising:
a first suspension member comprising a first support line (S1) (See Annotated Fig. 103S) with a first end (S1E1) (See Annotated Fig. 103S) and a second end (S1E2) (See Annotated Fig. 103S);
a second suspension member comprising a second support line (S2) (See Annotated Fig. 103S) with a first end (S2E1) (See Annotated Fig. 103S) and a second end (S2E2) (See Annotated Fig. 103S); and
a strut (3712) (Figs. 103C- 103S) configured to connect to the first suspension member (S1) and the second suspension member (S2) (P. [0462] - - coupling the anchor suspension line 3735 with the superior sling 3712);
wherein the first suspension member (S1) when implanted in the breast is located on the lateral side of the breast (LS) (See Annotated Fig. 103S - - left side of dashed line), and the second suspension member (S2) when implant in the breast is located on the medial side of the breast (MS) (See Annotated Fig. 103S - - right side of dashed line).
Lashinski does not explicitly disclose
(claim 18) first and second anchoring members as claimed.
However, Kim teaches suspension members comprising support lines and anchoring members connected thereto in the same field of endeavor (Abstract, P. [0091])
(claim 18) a suspension member (2) (Figs. 1, 5, 7- 13) comprising a support line (6) (Figs. 1- 15, 18- 20) with a first end and a second end, and an anchoring member (4) (Figs. 1- 15, 18- 20) with a first end and a second end, the support line (6) connected at its second end to the anchoring member (4) at its first end (See Fig. 2 - - showing a loop ladder type textile)
(Ps. [0001], [0025], [0091] - - The present invention relates to an GRAFT for tissue lifting, and more particularly to an GRAFT for tissue lifting that couples or integrates a mesh member having numerous pores on a distal portion of a bioimplantable thread, in one body, to facilitate smoothing of sagged or wrinkled skin; there is provided an graft 2 for tissue lifting that is inserted between sagged or wrinkled skin s and subcutaneous muscle m to pull or smooth tissue. The graft 2 for a tissue lifting may include a bioimplantable thread 6 inserted between the skin s and the subcutaneous muscle m and having a distal portion where pulling is required and a proximal portion that is pulled; a mesh member 4 fixedly coupled to the distal portion of the bioimplantable thread 6 and having a plurality of pores, that are filled as bodily tissues grow; The mesh member 4 may be inserted into one of face, neck, breast, and hip, and a size of a mesh may be enlarged or reduced depending on a size of the surgical area. Also, the number of the mesh does not need to be one, and there may be additional meshes depending on the need).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the first and second suspension member associated with Lashinski to include a first and second anchoring member connected to the first and second support lines at their second ends such that the first and second support lines are located superior to the first anchoring member and the second anchoring member, and the first end of the end of the first support line and the first end of the second support line are located above the NAC according to the teachings of Kim because the anchoring members’ mesh portions having a plurality of pores, that are filled as bodily tissues grow, would facilitate smoothing of sagged or wrinkled skin (Kim - - Ps. [0001], [0025], [0091]).
Regarding claim 19, Lashinski in view of Kim discloses the system of claim 18, Lashinski further disclosing wherein the strut (3712) provides a means for attachment of the strut (3712) to the first support line and the second support line (S1, S2) (P. [0463] - - FIG. 103Q depicts the step of securing the superior sling 3712 with the proximal ends 3740 of the anchor suspension line 3735).
Regarding claim 20, Lashinski in view of Kim discloses the system of claim 19, Lashinski further disclosing wherein the strut (3712) when implanted in the breast is located superior to the NAC of the breast (See Annotated Fig. 103S).
Regarding claim 21 in view of the rejection under 35 U.S.C. 112(b) above, Lashinski in view of Kim discloses the system of claim 19, Lashinski further disclosing wherein the strut (3712) comprises a first arm (3714) with a first end and a second end, a second arm (3716) with a first end and a second end, and a textile (3718) with a first end and a second end, wherein the second end of the first arm (3714) is connected to the first end of the textile (3718) wherein the second end of the second arm (3716) is connected to the second end of the textile (3718). It is noted “and optionally; wherein a needle is connected to the first end of one of the first arm and the second arm; or wherein needles are connected to the first end of each of the first arm and the first end of the second arm” are optional limitations).
Regarding claim 24, Lashinski in view of Kim discloses the system of claim 18, Lashinski further disclosing wherein the first suspension member and the second suspension member (S1, S2) each comprise one or more retainers (3734) designed to engage tissue.
Regarding claim 25, Lashinski in view of Kim discloses the system of claim 18, Lashinski further disclosing wherein the first suspension member and the second suspension member (S1, S2) are at least partially covered by sheaths (P. [0466] - - the anchor lines may be dispensed through a sheath to protect the surrounding tissue and can be engaged superior to the nipple for maximum adjustability).
Regarding claim 26, Lashinski discloses a method of lifting a breast of a patient, comprising the steps of:
a. introducing a first suspension member comprising a first support line (S1) with a first end (S1E1) and a second end (S1E2) (See Annotated Fig. 103S), on the lateral side of the breast (LS) (See Annotated Fig. 103S) (P. [0459] - - A distal end 3736 of an anchor 3734 is coupled to the proximal end 3732 of the rod 3728, for example, through the loop 3730, and the rod 3728 is further advanced through the cannula 3722, drawing the distal end 3736 of the anchor suspension line 3734 through the cannula 3722, as shown in FIG. 103I. The anchor suspension line 3735 carrying one or more inferior anchors 3734 is advanced through the cannula 3722 until the distal end 3736 emerges from the distal end 3738 of the cannula 3722),
b. introducing a second suspension member comprising a second support line (S2) with a first end (S2E1) and a second end (S2E2) (See Annotated Fig. 103S), on the medial side of the breast (MS) (See Annotated Fig. 103S) (P. [0461] - - A plurality of anchor suspension lines 3735 can be inserted through each of the lateral 3704 and medial 3702 exit points, and each can have a different path through the breast 3726 such that a plurality of anchor suspension lines 3735 are disposed radially across the breast 3726, as depicted in FIG. 103L),
c. introducing a strut (3712) (Figs. 103M- 103S) superior to the NAC of the breast, and connecting the first ends of the first and second support lines (S1E1, S2E1) to the strut (3712) (See Fig. 103S) (P. [0462] - - The next steps comprise coupling the anchor suspension line 3735 with the superior sling 3712. FIG. 103M illustrates, at the lateral exit point 3704, the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchors suspension line 3735 advanced through the lateral exit point 3704 being advanced through a suture loop 3744 at a base of a knot tube 3746. FIG. 103N depicts the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 advanced through the lateral exit point 3704 being pulled through the knot tube 3746 by the suture loop 3744).
Lashinski does not disclose
(claim 26) first and second anchoring members as claimed.
However, Kim teaches suspension members comprising support lines and anchoring members connected thereto in the same field of endeavor (Abstract, P. [0091])
(claim 26) a suspension member (2) (Figs. 1, 5, 7- 13) comprising a support line (6) (Figs. 1- 15, 18- 20) with a first end and a second end, and an anchoring member (4) (Figs. 1- 15, 18- 20) with a first end and a second end, the support line (6) connected at its second end to the anchoring member (4) at its first end, the first anchoring member (4) comprising a ladder-shaped textile (See Fig. 2 - - showing a loop ladder type textile) (Ps. [0001], [0025], [0091] - - The present invention relates to an GRAFT for tissue lifting, and more particularly to an GRAFT for tissue lifting that couples or integrates a mesh member having numerous pores on a distal portion of a bioimplantable thread, in one body, to facilitate smoothing of sagged or wrinkled skin; there is provided an graft 2 for tissue lifting that is inserted between sagged or wrinkled skin s and subcutaneous muscle m to pull or smooth tissue. The graft 2 for a tissue lifting may include a bioimplantable thread 6 inserted between the skin s and the subcutaneous muscle m and having a distal portion where pulling is required and a proximal portion that is pulled; a mesh member 4 fixedly coupled to the distal portion of the bioimplantable thread 6 and having a plurality of pores, that are filled as bodily tissues grow; The mesh member 4 may be inserted into one of face, neck, breast, and hip, and a size of a mesh may be enlarged or reduced depending on a size of the surgical area. Also, the number of the mesh does not need to be one, and there may be additional meshes depending on the need).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the method step of introducing a first and second suspension member associated with Lashinski by modifying the suspension members to include a first and second anchoring member connected to the first and second support lines at their second ends according to the teachings of Kim because the anchoring members’ mesh portions having a plurality of pores, that are filled as bodily tissues grow, would facilitate smoothing of sagged or wrinkled skin (Kim - - Ps. [0001], [0025], [0091]).
Regarding claim 47, Lashinski in view of Kim discloses the system of claim 19, Lashinski further disclosing a method of making the strut of claim 19 (see rejection of claim 19 above), wherein the strut (3712) comprises a first arm (3714) with a first end and a second end, a second arm (3716) with a first end and a second end, and a textile (3718) with a first end and a second end, wherein the second end of the first arm (3714) is connected to the first end of the textile (3718), and wherein the second end of the second arm (3716) is connected to the second end of the textile (3718), wherein the textile (3718) is knit from monofilament fiber, and wherein the first arm and second arm (3714, 3716) are formed from monofilament fiber and tied, stapled or fused to the textile (3718) (Ps. [0301], [0477], [0479] - - the support member can be fashioned in the shape of a sling or hammock, an example of which is shown in FIG. 29B … The mesh material can comprise one or more woven or inter-linked filaments or fibers that form multiple fiber junctions throughout the mesh. The fiber junctions can be formed via weaving, bonding, ultrasonic welding or other junction forming techniques, and combinations thereof; Elements of the support system can comprise a number of materials including, … monofilament, or multifilament, and can be braided, woven, or knitted; the mesh material of the support member, for example a sling or hammock, comprises a flexible, polypropylene monofilament that resists weakening or degradation when implanted within a patient).
Regarding claim 48, Lashinski in view of Kim discloses the method of claim 47 which was claimed in the alternative. Since a textile was selected, the limitations of claim 48, which are directed to a non-selected plate, do not further limit claim 47.
Regarding claim 49, Lashinski in view of Kim discloses the method of claim 47 which was claimed in the alternative. Since a textile was selected, the limitations of claim 48, which are directed to a non-selected plate, do not further limit claim 47.
Regarding claim 50, Lashinski in view of Kim discloses the method of claim 47, Lashinski further disclosing wherein a needle (3710) is attached to the first end of the first arm (3714) of the strut (3712) (P. [0455] - - FIG. 103C illustrates a first end 3714 of a superior sling 3712 being advanced, by the needle 3710, through the superior port 3706, and out of the patient at the lateral exit point 3704). It is noted “or needles are attached to the first end of the first arm of the strut and the first end of the second arm of the strut.
Regarding claim 51, Lashinski discloses a method of lifting a breast and a NAC of a patient, comprising:
advancing, in an inferior direction, through a first stab incision (3706) (Figs. 103A- 103S) in the breast an elongate linear first suspension member (S1) (See Annotated Fig. 103S) to a first side of the NAC (P. [0454] - - as depicted in FIG. 103A, the patient is marked preoperatively with a superior entry point 3700 and medial 3702 and lateral 3704 exit points. At the superior entry point 3700, a superior port 3706 is inserted, for example, with a trocar and port dilator 3708);
engaging breast tissue to the first side (LS) (See Annotated Fig. 103S) of the NAC at a plurality of discrete designated locations along the elongate linear first suspension member (S1) (See Fig. 103H);
lifting the breast by pulling superiorly on a first end of the elongate linear first suspension member (S1) (P. [0462] - - The breast 3726 is then lifted, and a distance D.sub.1 between the sling portion 3718 and an inferior anchor 3734 is decreased (compared with D.sub.2). In some embodiments, the breast 3726 is manually distracted, and in some embodiments, the breast 3726 can be distracted by pulling on the proximal ends 3740 of the anchor suspension line 3735);
securing the first end of the elongate linear first suspension member (S1) in a position superior to the NAC of the breast; and
deploying a strut member (3712) (Figs. 103A- 103S) above the NAC, and wherein the first end of the elongate linear first suspension member (S1) is secured to the strut member (3712) during the securing step (P. [0462] - - The next steps comprise coupling the anchor suspension line 3735 with the superior sling 3712. FIG. 103M illustrates, at the lateral exit point 3704, the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchors suspension line 3735 advanced through the lateral exit point 3704 being advanced through a suture loop 3744 at a base of a knot tube 3746. FIG. 103N depicts the first end 3714 of the superior sling 3712 and the proximal ends 3740 of the anchor suspension line 3735 advanced through the lateral exit point 3704 being pulled through the knot tube 3746 by the suture loop 3744).
Claim(s) 22- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski et al. (US Pub. No. 2010/0137679 A1) in view of Kim (US Pub. No. 2014/0228971 A1) as applied to claim 18 above, and further in view of Tannhauser (US Pat. No. 7,083,637 B1).
Regarding claims 22- 23, Lashinski in view of Kim disclose the system of claim 18, but Lashinski in view of Kim does not disclose
(claims 22- 23) an introducer housing tip as claimed.
However, Tannhauser teaches a suspension member (12) (Figs. 3f- g) introducer tool (10) (Figs. 3f- g) providing a minimally invasive approach to adjusting the amount of support on an anatomical structure in the same field of endeavor ( Abstract) further comprising
(claim 22) an introducer housing tip (16a) (Figs. 3f- g), wherein the introducer housing tip (16a) is designed for connection to the distal tip (17a) (Figs. 3f- g) of an introducer tool (10);
(claim 23) wherein the introducer housing tip (16a) comprises a blunt driving tip designed for blunt dissection of tissue (Col. 4, l. 40- 45, Col. 8, l. 27- 30 - - Preferably, tip 16 is blunt, wherein the tip 16 has a radius of about 0.6 millimeters. A blunt tip is preferred since it is less likely to stick in bone or penetrate bladder wall tissue or blood vessel wall tissue as will be appreciated from the method of implanting the tape as described below; FIGS. 3f-g illustrate an alternate embodiment of affixing tape 12 to the distal end 17a of needle 10. A detachable blunt tip 16a having a connecting post 15, attaches to the distal end 17a by means of a mounting hole 15a to accept post 15).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the first suspension member and the second suspension member associated with Lashinski in view of Kim to further comprise an introducer housing tip having a blunt driving tip according to the teachings of Tannhauser because it would provide a minimally invasive approach to adjusting the amount of support on an anatomical structure (Tannhauser - - Abstract).
Claim(s) 22- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski et al. (US Pub. No. 2010/0137679 A1) in view of Kim (US Pub. No. 2014/0228971 A1) as applied to claim 18 above, and further in view of Claren et al. (US Pat. No. 5,899,909).
Regarding claims 22- 23, Lashinski in view of Kim disclose the system of claim 18, but Lashinski in view of Kim does not disclose
(claims 22- 23) an introducer housing tip as claimed.
However, Claren teaches a system for releasably connecting an introducer tool to a suspension member (Abstract)
(claim 22) wherein the first suspension member and the second suspension member (26) (Figs. 12- 15) each further comprise an introducer housing tip (21) (Figs. 12- 15), wherein the introducer housing tip (21) is designed for connection to the distal tip of an introducer tool (10) (Figs. 12- 15);
(claim 23) wherein the introducer housing tip (21) comprises a blunt driving tip (22) designed for blunt dissection of tissue (Col. 2, l. 65- Col. 3, l. 1 - - It tapers slightly towards the free end thereof where the needle forms a point 22 by being conical or, as shown, faceted but it can also be blunt-ended and have a transversely cut end).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to include a housing tip in which an introducer tool may be inserted according to the teachings of Claren because it would allow releasably connecting an introducer tool to a suspension member for implanting the suspension member (Claren - - Abstract).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Pub. No. 2014/0228971 A1) in view of Lashinski et al. (US Pub. No. 2010/0137679 A1) as applied to claim 40 above, and further in view of Claren et al. (US Pat. No. 5,899,909).
Regarding claim 44, Kim in view of Lashinski disclose the method of claim 40, but Kim in view of Lashinski does not disclose
(claim 44) wherein an introducer housing tip is connected to the second end of the anchoring member, and wherein the introducer housing tip is molded with a conical shape having a blunt end at the apex of the conical shape, and a bore in the base for inserting the distal tip of an introducer tool.
However, Claren teaches a system for releasably connecting an introducer tool to a suspension member for implanting the suspension member (Abstract)
(claim 44) wherein an introducer housing tip (21) (Figs. 12- 15) is connected to the second end of the anchoring member (26) (Figs. 12- 15), and wherein the introducer housing tip (21) is molded with a conical shape having a blunt end (22) (Figs. 12- 15) at an apex of the conical shape, and a bore (21’) (Figs. 12- 15) in a base for inserting a distal tip of an introducer tool (10) (Col. 2, l. 65- Col. 3, l. 1 - - It tapers slightly towards the free end thereof where the needle forms a point 22 by being conical or, as shown, faceted but it can also be blunt-ended and have a transversely cut end).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to include a housing tip in which an introducer tool may be inserted according to the teachings of Claren because it would allow releasably connecting an introducer tool to a suspension member for implanting the suspension member (Claren - - Abstract).
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771