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 .
Claim Interpretation
Claim 1 as amended recites “wherein the tether portion and the anchor portion include an axial strand extending therethrough.” Examiner notes that after reading the Applicant’s Specification and Response to Arguments section, Examiner is interpreting this to mean that both the tether portion and the anchor portion include a single strand that extends therethrough in a longitudinal direction (instead of axial). Further, Examiner notes that the claim will be interpreted according to the plain meaning of the word strand, as well as the Applicant’s specification (see para. [00064]), such that the device is made from multiple braided strands.
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.
Claims 1, 2, 7-11, 13, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Rizk et al. (US 2019/0062951 A1—previously cited).
Regarding claim 1, Rizk discloses a tethered anchor (Fig. 1) comprising: a tether portion (Fig. 1 reproduced below) and an anchor portion (Fig. 1 reproduced below) that are continuously braided with one another (Fig. 1; para. [0194]); the tether portion being elongate and extending continuously from the anchor portion (Fig. 1; para. [0194]), wherein the tether portion includes a pick count of from about 50 picks per inch to about 100 picks per inch (para. [0173]) and includes a braid angle of about 15 degrees (para. [0223]); and the anchor portion having a greater width than a width of the tether portion when the anchor portion is collapsed (para. [0188]-[0189] discloses a triaxial braid as opposed to a flat braid, Fig. 1 also discloses a braid that has a flat anchor portion and a round tether portion and varying cross sections such that when flattened, the tethered portion would have a greater width than the flat anchor portion; see also para. [0225] and [0188]), wherein a braid pattern used to form the tether portion varies along the length of the tether portion (para. [0184] discloses the mesh component has a cross-sectional profile that varies over the length of the mesh), wherein the anchor portion includes a pick count of from about 100 picks per inch to about 150 picks per inch (para. [0173] discloses 100 picks per inch and para. [0184] discloses varying the profile); and the intermediate portion positioned between the tether portion and the anchor portion, the intermediate portion including a pick count different from the tether portion and the anchor portion (see Fig. 1 reproduced below which shows the intermediate portion having a pick count that is transitioning between the tether and anchor portion such that the pick count is different than both), wherein the tether portion and the anchor portion include an axial strand extending therethrough (i.e., because the strands are braided, the tether portion and the anchor portion include a plurality of axial strands braided together and extending therethrough see also para. [0032], [0067], additionally para. [0188] discloses pillar inlay strands).
Rizk doesn’t directly disclose a braid angle of about 45 degrees.
Rizk discloses (pp. [0188]) that the braid helix angle needs to be optimized such that theres i an “ inclusion of a third axis of fiber, known as pillar inlay, which is laid down axially along the braiding path.” As seen in Figs. 2-3, and para. [0188], the braid helix angle is disclosed to be a result effective variable in that changing the braid helix angle affects the pilar inlay which is used to stabilize the braid, maintain the round structure of the braid, increase strength and reduce elongation or stretching of the braid. In contrast, a biaxial braid lacking the pillar braids of the triaxial braid will easily collapse, and can easily be stretched. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Rizk et al. device to have a braid angle of about 45 degrees, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rizk by making the braid angle of about 45 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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Regarding, “about 100 picks per inch to about 150 picks per inch,” even if Applicant amends the range to over 100 picks per inch, Examiner notes that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range to be between 100 and 150 pick per inch since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [00081] indicating the angle “may” be within the claimed range).
Regarding claim 2, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein the tether portion defines a rounded transverse profile and the anchor portion defines a flat transverse profile (para. [0225] and Fig. 1 shows one embodiment with a flattened (tape) connected to a round cross-section).
Regarding claim 7, Rizk discloses the tethered anchor of claim 1. Rizk also discloses varying pick counts across the braid pattern for the purposes of improving the fitness of the braid (see para. [0173], [0188]). Rizk doesn’t directly disclose the tether portion is characterized by a first pick count and the anchor portion is characterized by a second pick count that is different than the first pick count. Regarding claim 8, Rizk doesn’t directly disclose a pick count of the tether portion and anchor portion varies. Regarding claim 9, Rizk also discloses Rizk discloses a section of the tether portion (see Fig. 1 transitioning between the anchor and tail portion) and another section of the tether portion (i.e., the tail portion). Rizk doesn’t directly disclose a second pick count that is greater than the first pick count.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a section of the tether portion is characterized by a first pick count and another section of the tether portion is characterized by a second pick count (i.e., different from the first pick count) that is greater than the first pick count since the only two choices are [1) a section of the tether portion is characterized by a first pick count and another section of the tether portion is characterized by a second pick count that is greater than the first pick count, or 2) a section of the tether portion is characterized by a first pick count and another section of the tether portion is characterized by a second pick count that is less than the first pick count]. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at a section of the tether portion is characterized by a first pick count and another section of the tether portion is characterized by a second pick count that is greater than the first pick count.
Regarding claim 10, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein at least part of the anchor portion is characterized by a braid pattern configured to encourage tissue ingrowth (para. [0183]).
Regarding claim 11, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein the anchor portion comprises a plurality of individual braid filaments and the anchor portion is thermally treated to bond the individual braid filaments together (para. [0188] discloses fusing the biaxial braid structure where fibers contact and that the inlay may be additionally fused to other (individual fibers) by heating the fibers with (for example) hot water or solvent).
Regarding claim 13, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein at least one of the tether portion and the anchor portion incorporates an elastomeric axial member (i.e., the pilar inlay as described by para. [0118]) therein.
Regarding claim 44, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein the anchor portion includes a plurality of apertures spaced along at least a longitudinal length of the anchor portion (Figs. 1-3), and wherein the anchor portion includes a narrow portion between adjacent apertures of the plurality of apertures (Fig. 1).
Regarding claim 45, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein the axial strand includes elastomeric material (para. [0184], see also para. [0032]).
Regarding claim 46, Rizk discloses a tethered anchor comprising: a tether portion (Fig. 1 reproduced below) and an anchor portion (Fig. 1 reproduced above) that are continuously braided with one another (Fig. 1; para. [0194]) the tether portion having a greater thickness than the anchor portion when tensioned (i.e., note that as shown in Fig. 1, see also para. [0184], the anchor is a single layer and the tether is a round layer such that when flattened the tether is at least two layers which would be thicker than the anchor portion)), the tether portion being elongate and extending continuously from the anchor portion (Fig. 1; para. [0194]); the tether portion being elongate and extending continuously from the anchor portion (Fig. 1; para. [0194]), wherein the tether portion includes a pick count of from about 50 picks per inch to about 100 picks per inch (para. [0173]) and includes a braid angle of about 15 degrees (para. [0223]); the anchor portion having a greater width than a width of the tether portion when the anchor portion is collapsed (para. [0188]-[0189] discloses a triaxial braid as opposed to a flat braid, Fig. 1 also discloses a braid that has a flat anchor portion and a round tether portion and varying cross sections such that when flattened, the tethered portion would have a greater width than the flat anchor portion; see also para. [0225] and [0188]), wherein a braid pattern used to form the tether portion varies along the length of the tether portion (para. [0184] discloses the mesh component has a cross-sectional profile that varies over the length of the mesh), wherein the anchor portion includes a pick count of from about 100 picks per inch to about 150 picks per inch (para. [0173] discloses 100 picks per inch and para. [0184] discloses varying the profile), the intermediate portion including a pick count different from the tether portion and the anchor portion (see Fig. 1 reproduced below which shows the intermediate portion having a pick count that is transitioning between the tether and anchor portion such that the pick count is different than both).
Rizk doesn’t directly disclose includes a braid angle of about 45 degrees.
Rizk discloses (pp. [0188]) that the braid helix angle needs to be optimized such that theres i an “ inclusion of a third axis of fiber, known as pillar inlay, which is laid down axially along the braiding path.” As seen in Figs. 2-3, and para. [0188], the braid helix angle is disclosed to be a result effective variable in that changing the braid helix angle affects the pilar inlay which is used to stabilize the braid, maintain the round structure of the braid, increase strength and reduce elongation or stretching of the braid. In contrast, a biaxial braid lacking the pillar braids of the triaxial braid will easily collapse, and can easily be stretched. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Rizk et al. device to have a braid angle of about 45 degrees, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rizk by making the braid angle of about 45 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding, “about 100 picks per inch to about 150 picks per inch,” even if Applicant amends the range to over 100 picks per inch, Examiner notes that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range to be between 100 and 150 pick per inch since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [00081] indicating the angle “may” be within the claimed range).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rizk in view of Overes et al. (US 2011/0270278 A1—previously cited).
Regarding claim 6, Rizk discloses the tethered anchor of claim 1. Rizk also discloses wherein the anchor portion defines a plurality of crossing apertures (see Figs. 2-3). Rizk doesn’t directly disclose wherein a length of the tether portion is passed through the crossing apertures of the anchor portion.
In the same field of endeavor, namely anchor assembly including expandable anchor, Overes discloses a tethered anchor (Fig. 2A) comprising: a tether portion 43 and an anchor portion 36 that are continuously braided with one another (Figs. 2A-2C; para. [0179] discloses at least a portion of tether portion and anchor portion are continuously braided); the tether portion being elongate and extending continuously from the anchor portion (Figs. 2A-2B); and the anchor portion having a greater width than a width of the tether portion (Figs. 2A-2C) when the anchor portion is collapsed (i.e., if the anchor portion were to be collapsed, the anchor portion 36 would still be wider than the tether portion (Fig. 2A)). Overes also discloses the anchor portion defines a plurality of crossing apertures 40, and further wherein a length of the tether portion is passed through the crossing apertures of the anchor portion (para. [0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rizk to have the anchor portion defines a plurality of crossing apertures, and further wherein a length of the tether portion is passed through the crossing apertures of the anchor portion as disclosed by Overes for purposes of creating a looped portion (para. [0179])
Claims 42 is rejected under 35 U.S.C. 103 as being unpatentable over Rizk in view of Sjoquist et al. (US 2016/0022403 A1—previously cited).
Regarding claim 42, Rizk discloses the tethered anchor of claim 1. Rizk doesn’t directly disclose wherein the tether portion includes a proximal section having a first pick count, an intermediate section having a second pick count, and a distal section having a third pick count, wherein at least one of the first, second, and third pick counts are different from each other.
In the same field of endeavor, namely implants for treating pelvic conditions, Sjoquist discloses a tether component (i.e., support portion; para. [0035]) which includes holes in the mesh such that the holes may be all the same size of different sizes and may regularly or irregularly spaced.
Therefore, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of having the tether portion includes a proximal section having a first pick count, an intermediate section having a second pick count, and a distal section having a third pick count, wherein at least one of the first, second, and third pick counts are different from each other since the only two choices are [1) at least one of the first, second, and third pick counts are different from each other, or 2) none of the first, second, and third pick counts are different from each other. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the tether portion includes a proximal section having a first pick count, an intermediate section having a second pick count, and a distal section having a third pick count, wherein at least one of the first, second, and third pick counts are different from each other.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Rizk to have the tether portion includes a proximal section having a first pick count, an intermediate section having a second pick count, and a distal section having a third pick count, wherein at least one of the first, second, and third pick counts are different from each other for purposes of allowing certain portions of the tether portion to encourage tissue ingrowth and other portions to discourage tissue ingrowth (para. [0035]).
Response to Arguments
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive.
Applicant argues that the axial strand is not shown or contemplated in Rizk. Examiner disagrees. Examiner notes that the structure in Rizk is braided. Any braided structure requires axial strands. As such, both implicitly and explicitly, Rizk discloses multiple axial strands. Additionally, Rizk discloses a pillar inlay strand (see para. [0188]).
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771