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 with respect to claim(s) 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Dreyfuss (US 2014/0052179 A1) (previously of record) is not relied upon to provide a disclosure of the amended limitations of “wherein a material and diameter of the section is selected to be different than a material and diameter of the first section”.
Applicant's arguments filed 6/8/2026, with regards to the amended limitations to claim 1, have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that one of ordinary skill in the art would not have been motivated to modify the sleeve (35) of Petry (US 2019/0365366 A1) to act as a finger trap, as taught and suggested by Anderson (US 2019/0008507 A1) on the grounds that, since Petry already discloses a robust, well-defined locking mechanism (i.e., the suture anchor), one of ordinary skill in the art would not have looked for an additional or alternative locking feature within the suture construct itself as doing so would introduce unnecessary complexity.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner respectfully contends that the benefit of a finger trap, disclosed by Anderson as acting as a self-cinching trap to provide a cinching forces to the sutures extending therethrough in one direction while preventing inadvertent release of the applied suture tension (see Abstract and Para. [0065]), would be readily applicable to the device of Petry as Petry discloses an analogous repair suture system having a cinching region through with an additional suture segment may extend. Petry does not appear to provide any teaching that would render the disclosed benefit as posing a negative impact on the functionality of the device, leading one of ordinary skill in the art to have a reasonable expectation that the inclusion of a finger trap would provide a readily-applicable function benefit in constraining movement of the transfer suture (33) therethrough to one desired direction.
Applicant additionally contends that the splice (35) of Petry is configured to be destroyed during the repair procedure, thus rendering the component a temporary feature that must be severable. One of ordinary skill in the art would not have been motivated to include a permanent finger trap into the splice region of Petry as doing so would potentially render the device non-functional in preventing the splice from being severed.
The Examiner respectfully disagrees that the inclusion of the finger trap, taught and suggested by Anderson, would result in a permanent, non-severable splice region. The Examiner respectfully contends that the inclusion of a finger trap component would impart no permanence into the splice region of Petry and the splice region would therefore remain severable. As the finger trap of Anderson is not disclosed to be formed of a material or require a structure that prevent severability, one of ordinary kill in the art would have been able to modify the splice region of the repair suture of Petry to behave in the manner of a finger trap while maintaining severability.
Lastly, Applicant contends that none of either Petry or Anderson provide adequate disclosure or reasonable suggestion regarding the amended limitations of “wherein the transfer suture is configured such that, upon pulling of the second end of the transfer suture, the first section and a portion of the second section are drawn through the spliced region to form a repair loop, and wherein the finger trap prevents loosening of the repair loop” on the grounds that Petry’s repair suture construct contains no secondary structure that is threaded through its splice for the purpose of drawing and portion of the primary suturing contact back through itself to form a repair loop.
The examiner respectfully disagrees and notes that, as these newly-amended limitations are recited as function language, the device of Petry merely need be capable of performing the recited function (see MPEP 2114). The Examiner contends that, upon modification of the spliced sleeve region 35 of Petry to incorporate a self-cinching component therein, as taught and suggested by Anderson, the device of Petry would be reasonably capable of performing the function of “upon pulling of the second end of the transfer suture (i.e., portion of transfer suture located at element “33” as identified in Fig. 4), the first section and a portion of the second section are drawn through the spliced region to form a repair loop”. Specifically, under a condition wherein transfer suture 33 is cinched and fixedly secured to the repair suture 12 at the spliced sleeve region 35 (via the cinching mechanism incorporated therein), applying tension to transfer suture at the location of “33”, as designated in Fig. 4, would apply a tensile force to the “Second Section” and “First Section” of the repair suture 12, located on the opposite side of the spliced sleeve region 35, such that the first section and second sections may be pulled through the spliced sleeve region 35 to form a repair loop around a desired tissue.
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.
Claim(s) 1, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petry (US 2019/0365366 A1) (previously of record) in view of Anderson (US 2019/0008507 A1) (previously of record).
Regarding claim 1, Petry discloses:
A tissue repair construct (see Fig. 4) comprising:
a repair suture (suture 12, see Fig. 4), the repair suture comprising:
a first section (see Examiner’s Diagram of Fig. 4 below showing a “First Section” of the suture);
a second section connected to the first section (see Examiner’s Diagram of Fig. 4 below showing a “Second Section” of the suture connected to the “First Section”); and
a third section connected to the second section opposite the first section (see Examiner’s Diagram of Fig. 4 below showing a “Third Section” of the suture connected to the “Second Section” opposite the “First Section”), the third section comprising a spliced region adjacent to the second section (sleeve 35, see Fig. 4; see also Para. [0023] mentioning wherein the sleeve has two open ends allowing a flexible material suture 33 to pass therethrough); and
a transfer suture (flexible material suture 33, see Fig. 3), a portion of the transfer suture extending through the spliced region (see Fig. 4 and Para. [0023]) such that first and second ends of the transfer suture extend from opposite ends of the spliced region (see Fig. 4).
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Examiner’s Diagram of Fig. 4
However, while Petry discloses the spliced region is disposed along the length of the repair suture (12), Petry does not expressly disclose:
wherein the spliced region forms a finger trap that prevents loosening of material passing therethrough, such that the spliced region allows movement of the transfer suture through the spliced region in a first direction, but prevents movement of the transfer suture through the spliced region in a second direction opposite the first direction; and
wherein the transfer suture is configured such that, upon pulling of the second end of the transfer suture, the first section and a portion of the second section are drawn through the spliced region to form a repair loop.
In the same field of endeavor, namely suturing devices for closing wounds in tissue, Anderson teaches wherein a suture (see Fig. 2) comprises a spliced region (sleeve 40, see Fig. 2 and Para. [0045]-[0047]) allowing passage of another portion of suture to extend therethrough (see Fig. 2 and Para. [0045]-[0047]); wherein the spliced region acts as a self-cinching trap to provide a cinching forces to the suture material(s) extending therethrough in one direction while preventing inadvertent release of the applied suture tension (see Abstract and Para. [0045]-[0047] and [0065]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the spliced sleeve region 35 of the repair suture 12 of Petry to act as a one-directional cinching trap as taught and suggested by Anderson to, in this case, allow for tensioning of the suture(s)/material extending therethrough to occur in a desired direction while preventing inadvertent release of the applied suture tension (see Anderson Abstract and Para. [0065]).
Upon modification of the spliced sleeve region 35 of Petry to incorporate a self-cinching component therein, as taught and suggested by Anderson, the device of Petry would be reasonably capable of performing the function of “upon pulling of the second end of the transfer suture (i.e., portion of transfer suture located at element “33” as identified in Fig. 4), the first section and a portion of the second section are drawn through the spliced region to form a repair loop”. Specifically, under a condition wherein transfer suture 33 is cinched and fixedly secured to the repair suture 12 at the spliced sleeve region 35 (via the cinching mechanism incorporated therein), applying tension to transfer suture at the location of “33”, as designated in Fig. 4, would apply a tensile force to the “Second Section” and “First Section” of the repair suture 12, located on the opposite side of the spliced sleeve region 35, such that the first section and second sections may be pulled through the spliced sleeve region 35 to form a repair loop around a desired tissue.
Regarding claim 6, the combination of Petry and Anderson disclose the invention of claim 1, Petry further discloses wherein the second comprises suture tape (see Para. [0008] mentioning wherein the suture may be formed from suture tape).
Regarding claim 8, the combination of Petry and Anderson disclose the invention of claim 1, Petry further discloses wherein the first end of the transfer suture includes a transfer loop (loops 22, see Fig. 4).
Claim(s) 2-5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petry (US 2019/0365366 A1) (previously of record) in view of Anderson (US 2019/0008507 A1) (previously of record), further in view of Khairkhahan (US 2015/0366556 A1) (previously of record).
Regarding claim 2, the combination of Petry and Anderson disclose all of the limitations of the invention of claim 1.
However, while Petry discloses wherein the suture may be formed from “for example, a flexible strand such as a suture, or tape such as suture tape” (see Para. [0008]), none of either Petry or Anderson expressly disclose wherein a material of the second section is selected to be different than a material of the first section.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Petry expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device (per Para. [0008]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “Second Section” of the suture of Petry from suture tape, as disclosed by Petry see Para. [0008]) while having formed the “First Section” be formed from 2-0 suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Petry discloses wherein the suture can be formed from any number of different materials without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Petry to function equally well with the suture formed entirely of suture tape, or from a combination of suture tape and 2-0 suture material, as modified by Khairkhahan. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 3, the combination of Petry and Anderson disclose all of the limitations of the invention of claim 1.
However, while Petry discloses wherein the suture may be formed from “for example, a flexible strand such as a suture, or tape such as suture tape” (see Para. [0008]), none of either Petry or Anderson expressly disclose wherein a material of the third section is selected to be different than a material of the first section.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Petry expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device (per Para. [0008]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “Third Section” of the suture of Petry from suture tape, as disclosed by Petry see Para. [0008]) while having formed the “First Section” be formed from 2-0 suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Petry discloses wherein the suture can be formed from any number of different materials without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Petry to function equally well with the suture formed entirely of suture tape, or from a combination of suture tape and 2-0 suture material, as modified by Khairkhahan. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 4, the combination of Petry and Anderson disclose all of the limitations of the invention of claim 1.
However, while Petry discloses wherein the suture may be formed from “for example, a flexible strand such as a suture, or tape such as suture tape” (see Para. [0008]), none of either Petry or Anderson expressly disclose wherein a material of the third section is selected to be different than a material of the second section.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Petry expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device (per Para. [0008]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “Second Section” of the suture of Petry from suture tape, as disclosed by Petry see Para. [0008]) while having formed the “Third Section” be formed from 2-0 suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Petry discloses wherein the suture can be formed from any number of different materials without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Petry to function equally well with the suture formed entirely of suture tape, or from a combination of suture tape and 2-0 suture material, as modified by Khairkhahan. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 5, the combination of Petry and Anderson discloses all of the limitations of the invention of claim 1.
However, while Petry discloses wherein the suture may be formed from “for example, a flexible strand such as a suture, or tape such as suture tape” (see Para. [0008]), none of either Petry or Anderson expressly disclose wherein the first section of the suture comprises a 2-0 suture.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Petry expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “First Section” of the suture of Petry from 2-0 suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Petry discloses wherein the suture can be formed from “any flexible strand such as suture or suture tape” without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Petry to function equally well with the suture formed of either suture tape or from 2-0 suture material as both are known materials within the art. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 7, the combination of Petry and Anderson discloses all of the limitations of the invention of claim 1.
However, while Petry discloses wherein the suture may be formed from “for example, a flexible strand such as a suture, or tape such as suture tape” (see Para. [0008]), none of either Petry or Anderson expressly disclose wherein the third section of the suture comprises a No. 2 suture.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Petry expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “Third Section” of the suture of Petry from 2-0 (No. 2) suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Petry discloses wherein the suture can be formed from “any flexible strand such as suture or suture tape” without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Petry to function equally well with the suture formed of either suture tape or from 2-0 (No. 2) suture material as both are known materials within the art. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 9, 11-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dreyfuss (US 2014/0052179 A1) (previously of record) in view of Avelar (US 2011/0264138 A1), further in view of Hernandez (US 2013/0103080 A1).
Regarding claim 9, Dreyfuss discloses:
A tissue repair construct (see Fig. 15) comprising:
a repair suture (suture 11, see Fig. 15), the repair suture comprising:
a first section (see Examiner’s Diagram of Fig. 15 below showing a “First Section” of the suture);
a second section connected to the first section (see Examiner’s Diagram of Fig. 15 below showing a “First Section” of the suture connected to the “First Section”); and
a third section connected to the second section opposite the first section (see Examiner’s Diagram of Fig. 15 below showing a “Third Section” of the suture connected to the “Second Section” opposite the “First Section”), the third section comprising a spliced region adjacent to the second section (splice 53, see Fig. 15);
wherein the first section and a portion of the second section extends through the spliced region (see Examiner’s Diagram of Fig. 15 below showing wherein a portion of both the “First Section” and “Second Section” pass through the splice), forming a repair loop (loop 55A, see Fig. 15); and
wherein the spliced region forms a finger trap, such that the repair loop can be tightened around a repair but not loosened (see Para. [0040]).
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Examiner’s Diagram of Fig. 15
However, while Dreyfuss provides disclosure of wherein the suture-based anchors may have either the same width or different widths (see Para. [0045]) and/or be made from either the same material or different materials (see Para. [0021] and [0045]), Dreyfuss does not expressly disclose wherein a material and diameter of the second section is selected to be different than a material and diameter of the first section (i.e., different sections of the same repair suture may have different widths and/or different materials).
In the same field of endeavor, namely tissue repair constructs, Avelar teaches a repair suture (see Fig. 1A) comprising a plurality of sections (sections 140, 142, 144, 146 and 148, see Para. [0062]; see also Fig. 1A); wherein the different portions of the repair suture may comprise different diameters for use with different layers/depth and type of tissue (see Para. [0059]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the diameter of the first section, second section and third section of the repair suture of Dreyfuss to comprise different widths as taught and suggested by Avelar to, in this case, allow different portions of the repair suture to be better suited to a particular layer/depth and/or type of tissue within which they may operate (see Avelar Para. [0059]). As Dreyfuss additionally provides disclosure that the materials of the repair suture may comprise either uniform widths or different widths (see Dreyfuss Para. [0021] and [0045]), one of ordinary skill in the art would have expected the repair suture of Dreyfuss to function appropriately should the first section, second section and third sections thereof be formed to have different widths better tailored to a particular layer/depth and/or type of tissue, as disclosed by Avelar.
Additionally, in the same field of endeavor, namely tissue repair constructs, Hernandez teaches a tissue repair construct (suture 90’, see Fig. 1C) comprising various sections along the length thereof (see Para. [0057] and Fig. 1C); wherein the different sections of the tissue repair construct may be formed from different materials to provide distinct advantages based on interaction zones along the length of the particular section (see Para. [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the repair suture of Dreyfuss to have the first portion, second portion and third portion thereof be formed from different materials as taught and suggested by Hernandez to, in this case, provide each portion with advantages distinct and beneficial to their location along the length of the repair suture (see Hernandez Para. [0057]). Additionally, Dreyfuss provides express disclosure that the repair suture may be made from a “combination” of the materials disclosed in Para. [0021] and [0045]), leading a user to have a reasonable expectation of success that forming different portions of the repair suture from different materials would not impact or hinder the overall functionality of the repair suture.
Regarding claim 11, the combination of Dreyfuss, Avelar and Hernandez discloses all of the limitations of the invention of claim 9, Dreyfuss, as modified by Avelar and Hernandez, further discloses wherein a diameter of the third section is selected to be different than a diameter of the first section (see rejection of claim 9 above; it would have been obvious to one of ordinary skill in the art to have formed all three sections of the repair suture of Dreyfuss to have different widths, as taught and suggested by Avelar, to allow different portions of the suture to be better suited to a particular layer/depth of tissue within which they may operate (see Avelar Para. [0059]); and wherein a material of the third section is selected to be different from a material of the first section (see rejection of Claim 9 above; it would have been obvious to one of ordinary skill in the art to have formed all three sections of the repair suture of Dreyfuss from different materials, as taught and suggested by Hernandez, provide each portion with advantages distinct and beneficial to their location along the length of the repair suture (see Hernandez Para. [0057]).
Regarding claim 12, the combination of Dreyfuss, Avelar and Hernandez discloses all of the limitations of the invention of claim 9, Dreyfuss, as modified by Avelar and Hernandez, further discloses wherein a diameter of the third section is selected to be different than a diameter of the second section (see rejection of claim 9 above; it would have been obvious to one of ordinary skill in the art to have formed all three sections of the repair suture of Dreyfuss to have different widths, as taught and suggested by Avelar, to allow different portions of the suture to be better suited to a particular layer/depth of tissue within which they may operate (see Avelar Para. [0059]); and wherein a material of the third section is selected to be different from a material of the second section (see rejection of Claim 9 above; it would have been obvious to one of ordinary skill in the art to have formed all three sections of the repair suture of Dreyfuss from different materials, as taught and suggested by Hernandez, provide each portion with advantages distinct and beneficial to their location along the length of the repair suture (see Hernandez Para. [0057]).
Regarding claim 14, the combination of Dreyfuss, Avelar and Hernandez discloses the invention of claim 9, Dreyfuss further discloses wherein the second section comprises suture tape (see Para. [0039]).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dreyfuss (US 2014/0052179 A1) (previously of record) in view of Avelar (US 2011/0264138 A1), further in view of Hernandez (US 2013/0103080 A1), further in view of Khairkhahan (US 2015/0366556 A1) (previously of record).
Regarding claim 13, the combination of Dreyfuss, Avelar and Hernandez discloses all of the limitations of the invention of claim 9.
However, while Dreyfuss, as modified by Hernandez, discloses wherein different sections of the repair suture 11 may be formed from different materials, none of ether Dreyfuss of Hernandez expressly disclose wherein the first section comprises a 2-0 suture.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Dreyfuss expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “First Section” of the suture of Dreyfuss from 2-0 suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Dreyfuss discloses wherein the suture can be formed from “any flexible strand such as suture or suture tape” without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Dreyfuss to function equally well with the suture formed of either suture tape or from 2-0 suture material as both are known materials within the art. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 15, the combination of Dreyfuss, Avelar and Hernandez discloses all of the limitations of the invention of claim 9.
However, while Dreyfuss, as modified by Hernandez, discloses wherein different sections of the suture 11 may be formed from different materials, none of ether Dreyfuss of Hernandez expressly disclose wherein the third section comprises a No. 2 suture.
In the same field of endeavor, namely surgical suture devices, Khairkhahan teaches wherein a surgical suture may be formed as a 2-0, 3-0, 4-0 or 5-0 suture (see Para. [0152]).
Since Dreyfuss expressly discloses wherein the material used to form the suture of the disclosed device is not a critical feature to the functioning of the device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known suture material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the “Third Section” of the suture of Dreyfuss from 2-0 (No. 2) suture material as disclosed to be a known alternative material within the art by Khairkhahan (see Para. [0152]). Since Dreyfuss discloses wherein the suture can be formed from “any flexible strand such as suture or suture tape” without affecting the functionality of scope of the disclosed device, one of ordinary skill in the art would have expected the device of Dreyfuss to function equally well with the suture formed of either suture tape or from 2-0 (No. 2) suture material as both are known materials within the art. Further, it has also been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Allowable Subject Matter
Claims 16-20 are allowed over the prior art (previously-presented in the “Non-Final Rejection”, dated 3/20/2026).
Regarding claim 16, the closest prior art of record, namely Petry (US 2019/0365366 A1) discloses:
A method of tissue repair comprising:
forming a tunnel through a bone adjacent a tissue in need of repair (see Para. [0026] and [0034] mentioning wherein a bone socket or tunnel is formed within bone (i.e., of a rotator cuff) before use of the suture device);
passing a tissue repair construct (see Fig. 4) through the tunnel (see Figs. 8-9 and Para. [0026] and [0034]) and through the tissue (see Para. [0026] and [0034] mentioning wherein the suture construct is passed through tissue before insertion into a bone socket/tunnel) such that a first end of a third section and a second end of a transfer suture (flexible suture 33, see Fig. 4) of the tissue repair construct extend from the tunnel (see Figs. 12-13 showing wherein a middle portion of the suture (33) is inserted into a bone hole/tunnel; the middle portion of said suture (33) defines a connection between a first and second ends of the suture), and a first section and a first end of the transfer suture of the tissue repair construct extend from of the tissue (see Figs. 12-13), the tissue repair construct further comprising:
a repair suture (suture 12, see Fig. 4), the repair suture comprising:
the first section (a first section (see Examiner’s Diagram of Fig. 4 below showing a “First Section” of the suture);
a second section connected to the first section (see Examiner’s Diagram of Fig. 4 below showing a “Second Section” of the suture connected to the “First Section”); and
the third section connected to the second section opposite the first section (see Examiner’s Diagram of Fig. 4 below showing a “Third Section” of the suture connected to the “Second Section” opposite the “First Section”), the third section comprising a spliced region adjacent to the second section (sleeve 35, see Fig. 4; see also Para. [0023] mentioning wherein the sleeve has two open ends allowing a flexible material suture 33 to pass therethrough);
wherein a portion of the transfer suture extends through the spliced region (see Fig. 4 and Para. [0023]) such that the first and second ends of the transfer suture extend from opposite ends of the spliced region (see Fig. 4);
tensioning the sutures to secure the tissue against the bone (see Para. [0070]).
However, while Petry discloses the spliced region is disposed along the length of the repair suture (12), Petry does not expressly disclose:
wherein the spliced region forms a finger trap, such that the repair loop can be tightened along the surface of the tissue and the bone, but not loosened;
wherein the first end of the transfer suture including a transfer loop;
passing the first section of the tissue repair construct through the transfer loop;
using the second end of the transfer suture, pulling the first section and a portion of the second section through the spliced region to form a repair loop extending along a surface of the tissue and the bone.
In the same field of endeavor, namely suturing devices for closing wounds in tissue, Anderson teaches wherein a suture (see Fig. 2) comprises a spliced region (40, see Fig. 2 and Para. [0045]-[0047]) allowing passage of another portion of suture to extend therethrough (see Fig. 2); wherein the spliced region acts as a self-cinching trap to provide a cinching forces to the sutures extending therethrough in one direction while preventing inadvertent release of the applied suture tension (see Abstract and Para. [0065]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the spliced sleeve region of the repair suture (12) of Petry to act as a one-directional cinching trap as taught and suggested by Anderson to, in this case, allow for tensioning of the suture(s) extending through said sleeve to occur in a desired direction while preventing inadvertent release of the applied suture tension (see Anderson Abstract and Para. [0065]).
While including loops onto ends of suture devices is common and known within the prior art (i.e., for attaching the suture to another device and/or suture), it would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized a transfer loop attached to the transfer suture of Petry to perform the method steps of “passing the first section of the tissue repair construct through the transfer loop; using the second end of the transfer suture, pulling the first section and a portion of the second section through the spliced region to form a repair loop extending along a surface of the tissue and the bone” without an express teaching from the prior art. While it may have been possible to utilize said transfer loop in the to perform the recited method steps, none of the prior art of record, including those cited on the attached PTO-892 expressly discloses, teaches or suggests, in combination with the additional structural limitations of claim 16, wherein a suture loop is used to perform the above-cited method steps.
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Examiner’s Diagram of Fig. 4
Claims 17-20 are additionally viewed to be allowable due to their dependency from and further modification of claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2021/0259686 A1 to Kim, US 2011/0319932 A1 to Avelar, US 2024/0164769 A1 to Nawrocki, US 2015/0173754 A1 to Norton, US 2016/0051245 A1 to Spenciner and US 2015/0216662 A1 to Medema all disclose surgical suture devices comprising at least one suture having different sections along the length thereof that may comprise either different widths and/or different materials.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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