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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The claim amendments filed on 10/06/2025 have been entered. Claims 7-28 remain pending in the application.
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive.
Applicant's argument on pages 8 and 9 states that Gellman teaches slings of non-synthetic material which are directed to incontinence treatment. Applicant asserts that slings for incontinence treatment differ greatly from a pre-shaped, meshed ADM graft in the configuration for the pelvic organ
prolapse repair. Regarding this argument, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. If there is a structural difference between the pre-shaped, meshed acellular dermal matrix (ADM) graft of the claimed invention and the mesh of Gellman in view of Kocak which provides a structural difference that allows it to you be used for pelvic prolapse repair and not incontinence treatment, this structural difference should be provided in the claims.
Further regarding the limitation “meshed ADM graft in the configuration for the pelvic organ prolapse repair”. Paragraph 004 of Gellman states “Hypermobility is a condition where the pelvic floor is weakened or damaged causing the bladder neck and proximal urethra to rotate and descend in response to increases in intraabdominal pressure”. The definition of descend is “to move down or go down” (Cambridge Essential American English Dictionary). The definition of prolapse is “the falling down or slipping of a body part from its usual position or relations” (Merriam-Webster Dictionary). Gellman is describing in paragraph 004 wherein the bladder is prolapsed. Paragraph 0005 states the mesh of Gellman is used “to support, elevate or provide a "back stop" to the bladder neck and proximal urethra”. Elevating the bladder neck and proximal urethra would function to repair a symptom of the prolapsed bladder neck and proximal urethra, therefore, the mesh of Gellman is used for pelvic organ prolapse repair, however, more importantly, this is intended use, and the structure of Gellman in view of Kocak is able to be used in the same region for pelvic organ prolapse repair without any structure, size, or shape differentiating it from the claimed invention.
Applicant’s arguments on page 10, states that that the pre-defined shape is configured for an anterior approach procedure of the pelvic organ prolapse repair, and that the pre-defined shape is configured for a posterior approach procedure of the pelvic organ prolapse repair. As stated above, this is intended use, and if the structure of the “pre-defined shape” of the claimed invention differs from the structure of Gellman in view of Kocak which allows it to be configured for a posterior or anterior approach, this structure should be included in the claims.
In response to applicant’s arguments directed to the newly amended limitations, these arguments are fully addressed in the rejection above.
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.
Claims 7-14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gellman et al (US 2004/0039246 A1) in view of Kocak et al (US 2021/0085443 A1).
Regarding claim 7, Gellman discloses a pre-shaped, meshed acellular dermal matrix (ADM) graft (Figure 3, paragraph 0082 discloses acellular dermal matrix, paragraph 0103 and 0104 discloses a pre-shaped mesh) configured for a pelvic organ prolapse repair (paragraphs 0004 and 0155) and stored as a packaged graft product (paragraph 0024) prepared by a process comprising the steps of:
providing a portion of ADM tissue (paragraph 0082) having a thickness between 1 mm and 2 mm (paragraph 0081 discloses the thickness may be .01 in= 0.254 mm to .2 in= 5.08 mm);
fenestrating the portion of the ADM tissue in a mesh pattern extending over a central portion of the ADM tissue (Figure 3, item 10B; paragraph 0103-0104 discloses fenestrating the portion of the ADM tissue in a mesh pattern of a central portion);
forming the portion of the ADM tissue into a pre-defined shape to form the pre-shaped, meshed ADM graft in the configuration for the pelvic organ prolapse repair (paragraphs 0079 and 0122 discloses the mesh is formed into a pre-defined shape; paragraph 0004 discloses the use for pelvic organ prolapse);
packaging the pre-shaped, meshed ADM graft in a medical sterilization pouch (paragraph 0130);
and irradiating the pre-shaped, meshed ADM graft within the medical sterilization pouch (paragraph 0085 “Sterilization may be accomplished using one or more of the following treatments: glutaraldehyde, alcohol, propylene oxide or irradiation sterilization.”).
Gellman discloses the invention substantially as claimed.
However, Gellman does not disclose scoring the portion of the ADM tissue into a pre-defined shape; verifying the thickness of the pre-shaped, meshed ADM; and irradiating the pre-shaped, meshed ADM graft to a sterility assurance level of 10-6.
Kocak discloses a meshed acellular dermal matrix (ADM) graft (see Kocak, paragraph 0006); verifying the thickness of the pre-shaped, meshed ADM (see Kocak, paragraph 0006, lines 13-14); scoring the portion of the ADM tissue into a pre-defined shape (see Kocak, paragraph 0032); and irradiating the pre-shaped, meshed ADM graft to a sterility assurance level of 10-6 (see Kocak, paragraph 0008).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the acellular dermal matrix (ADM) graft by verifying the thickness of the pre-shaped, meshed ADM; scoring the portion of the ADM tissue into a pre-defined shaped, and irradiating the pre-shaped, meshed ADM graft to a sterility assurance level of 10-6 as taught by Kocak because verifying the thickness of the pre-shaped would ensure the ADM graft can be used for the intended purpose, Gellman teaches the claimed thickness, therefore, verifying the thickness would be within the skill set of a person having ordinary skill in the art. Scoring the ADM tissue into a pre-defined shape saves the surgeon valuable time during a surgical procedure because there is no (or minimal) need for the surgeon to shape, cut, or otherwise form the ADM graft into a desired shape during surgical preparation (see Kocak, paragraph 0033). Irradiating the ADM to a sterility assurance level of 10-6 allows it to be stored at room temperature for up to two years (see Kocak, paragraph 0045).
Regarding claim 8, as set forth supra, the combination discloses wherein the pre- defined shape is configured for an anterior approach procedure of the pelvic organ prolapse repair (see Gellman, paragraph 0134).
Regarding claim 9, as set forth supra, the combination discloses wherein the pre-defined shape is configured for a posterior approach procedure of the pelvic organ prolapse repair (the combination of Gellman and Kocak discloses a pre-shaped mesh with the structural limitations as defined in claim 7, therefore, the pre-defined shape of the combination would be capable of being used for a posterior approach procedure of the pelvic organ prolapse).
Regarding claim 10, as set forth supra, Gellman discloses adding one or more antimicrobial agents to the portion of the ADM tissue (see Gellman, paragraph 0177).
However, Gellman does not disclose prior to the scoring, adding one or more antimicrobial agents to the portion of the ADM tissue.
Kocak discloses prior to scoring, adding one or more antimicrobial agents to the portion of the ADM tissue (see Kocak, claim 11).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM tissue of Gellman by providing wherein prior to scoring, adding one or more antimicrobial agents to the portion of the ADM tissue as taught by Kocak because the antimicrobial agents mitigate the risk for post-surgical infections (see Kocak, paragraph 0009) and would protect the graft from microbes during the scoring process.
Regarding claim 11, Gellman discloses the mesh pattern, however, Gellman does not disclose wherein the mesh pattern has an ADM tissue: space ratio of 1:1.
Kocak discloses wherein the mesh pattern has an ADM tissue: space ratio of 1:1 (see Kocak, paragraph 0035).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh pattern of Gellman by providing wherein the mesh pattern has an ADM tissue: space ratio of 1:1 as taught by Kocak because the tissue: space ratio ensures an optimal mesh ratio to provide maximum fluid egress, or drainage, from the surgical site to prevent seroma formation and a maximum graft surface area for improved integration into the body post procedure (see Kocak, paragraph 0034).
Regarding claim 12, as set forth supra, the combination discloses wherein the packaged graft product has a shelf-life of two years (see Kocak, paragraph 0045).
Regarding claim 13, as set forth supra, the combination discloses wherein the ADM graft has a central mesh region (see Gellman, see Figure 3, mesh region 10 is centrally located), uniform meshing contained in the central mesh region (see Gellman, the mesh region 10 of Figure 3 is uniform).
The embodiment of Figure 3 of Gellman discloses the invention substantially as claimed, however, the embodiment of Figures does not disclose a suture border region surrounding at least a portion of the central mesh region.
The embodiment of Figure 2 of Gellman discloses a suture border region (see Gellman, Figure 2; paragraph 0019) surrounding at least a portion of the central mesh region (see Gellman, Figure 2 depicts eyelet 48 which a suture is run through, when the embodiment of Figure 3 is in combination with the of Figure 2 of Gellman, the area surrounding the mesh region of Figure 3 would include a suture border region).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the embodiment of Figure 3 of Gellman by providing a suture border region surrounding at least a portion of the central mesh region as taught in Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Regarding claim 14, as set forth supra, the combination discloses wherein the ADM graft has a central mesh region (see Gellman, Figure 3, central mesh region 10), uniform meshing contained in the central mesh region (as can be seen depicted in Figure 3 of Gellman the central mesh region is uniform)), however, the embodiment of Figure 3 of Gellman does not disclose a plurality of suture punch points or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product.
The embodiment of Figure 2 of Gellman discloses a plurality of suture punch points (see Gellman, Figure 2, item 48) or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product (Figure 2 of Gellman depicts the suture punch points 48 placed in non-meshed region between the central mesh region 10 and perimeter edge of the ADM graft product 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM tissue of the embodiment of Figure 3 of Gellman by providing a plurality of suture punch points or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product as taught by the embodiment of Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Regarding claim 16, Gellman discloses an acellular dermal matrix (ADM) graft product (Figure 3, paragraph 0082 discloses acellular dermal matrix) configured for a pelvic organ prolapse repair (paragraphs 0004 and 0155), comprising:
an ADM graft derived from full-thickness skin (see Gellman, paragraph 0040),
the ADM graft having a pre-formed shape (see Gellman, paragraph 0103 and 0104 discloses a pre-shaped mesh) with a mesh pattern formed therein (see Gellman, Figure 3, mesh pattern 10);
and the pre-formed shape in the configuration for the pelvic organ prolapse (the acellular dermal matrix graft product of Gellman is able to be used for pelvic organ prolapse repair, a structure is not disclosed which would differentiate it from being used for pelvic organ prolapse); and
and a medical sterilization pouch sealed about the ADM graft (see Gellman, paragraph 0130),
and irradiating the meshed ADM graft within the medical sterilization pouch (paragraph 0085 “Sterilization may be accomplished using one or more of the following treatments: glutaraldehyde, alcohol, propylene oxide or irradiation sterilization.”).
Gellman discloses the invention substantially as claimed.
However, Gellman does not disclose wherein when the medical sterilization pouch and the ADM graft are irradiated to a sterility assurance level of 10-6, the ADM graft product has a shelf-life of two years.
Kocak discloses a meshed acellular dermal matrix (ADM) graft (see Kocak, paragraph 0006) and irradiating the medical sterilization pouch and ADM graft to a sterility assurance level of 10-6 (see Kocak, paragraph 0008), the ADM graft product having a shelf-life of two years (see Kocak, paragraph 0045)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the acellular dermal matrix (ADM) graft by irradiating the medical sterilization pouch and ADM graft to a sterility assurance level of 10-6, the ADM graft product having a shelf-life of two years as taught by Kocak because irradiating the ADM to a sterility assurance level of 10-6 allows it to be stored at room temperature for up to two years (see Kocak, paragraph 0045).
Regarding claim 17, as set forth supra, the combination discloses wherein the pre-defined shape is configured for an anterior approach procedure of the pelvic organ prolapse repair (see Gellman, paragraph 0134).
Regarding claim 18, as set forth supra, the combination discloses wherein the pre-defined shape is configured for a posterior approach procedure of the pelvic organ prolapse repair (the combination of Gellman and Kocak discloses a pre-shaped mesh with the structural limitations as defined in claim 16, therefore, the pre-defined shape of the combination would be capable of being used for a posterior approach procedure of the pelvic organ prolapse).
Regarding claim 19, as set forth supra, the combination discloses wherein the mesh pattern extends across a central portion of the pre-formed shape (see Gellman, Figure 3, mesh 10 extends across a central portion of the pre-formed shape 6).
However, Gellman does not disclose wherein the mesh pattern has a material: space ratio of 1:1.
Kocak discloses wherein the mesh pattern has an ADM tissue: space ratio of 1:1 (see Kocak, paragraph 0035).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh pattern of Gellman by providing wherein the mesh pattern has an ADM tissue: space ratio of 1:1 as taught by Kocak because the tissue: space ratio ensures an optimal mesh ratio to provide maximum fluid egress, or drainage, from the surgical site to prevent seroma formation and a maximum graft surface area for improved integration into the body post procedure (see Kocak, paragraph 0034).
Regarding claim 20, as set forth supra, the combination discloses wherein the ADM graft has a thickness between 1 mm and 2 mm (see Gellman, paragraph 0081 discloses the thickness may be .01 in= 0.254 mm to .2 in= 5.08 mm).
Regarding claim 21, as set forth supra, the combination discloses wherein the ADM graft has a central mesh region (see Gellman, see Figure 3, mesh region 10 is centrally located), uniform meshing contained in the central mesh region (see Gellman, the mesh region 10 of Figure 3 is uniform).
The embodiment of Figure 3 of Gellman discloses the invention substantially as claimed, however, the embodiment of Figures does not disclose a suture border region surrounding at least a portion of the central mesh region.
The embodiment of Figure 2 of Gellman discloses a suture border region (see Gellman, Figure 2; paragraph 0019) surrounding at least a portion of the central mesh region (see Gellman, Figure 2 depicts eyelet 48 which a suture is run through, when the embodiment of Figure 3 is in combination with the of Figure 2 of Gellman, the area surrounding the mesh region of Figure 3 would include a suture border region).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the embodiment of Figure 3 of Gellman by providing a suture border region surrounding at least a portion of the central mesh region as taught in Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Regarding claim 22, as set forth supra, the combination discloses wherein the ADM graft has a central mesh region (see Gellman, Figure 3, central mesh region 10), uniform meshing contained in the central mesh region (as can be seen depicted in Figure 3 of Gellman the central mesh region is uniform)), however, the embodiment of Figure 3 of Gellman does not disclose a plurality of suture punch points or suture slits placed in a non-meshed region between the central mesh region and a perimeter edge of the ADM graft product.
The embodiment of Figure 2 of Gellman discloses a plurality of suture punch points (see Gellman, Figure 2, item 48) or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product (Figure 2 of Gellman depicts the suture punch points 48 placed in non-meshed region between the central mesh region 10 and perimeter edge of the ADM graft product 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM tissue of the embodiment of Figure 3 of Gellman by providing a plurality of suture punch points or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product as taught by the embodiment of Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Claims 15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gellman et al (US 20040039246 A1) in view of Kocak et al (US 2021/0085443 A1), as applied to claims 7 and 16 above, respectively, and further in view of Chu (US 2009/0319053 A1).
Regarding claim 15, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the ADM graft has a perimeter with a series of radii edges having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft.
Chu discloses a graft (see Chu, paragraph 0024) configured for a pelvic organ prolapse repair (see Chu, paragraph 0007) wherein the graft has a perimeter with a series of radii edges (see Chu, Figures 1-4) having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft (the graft of Cahu in Figures 1-4 has radii edges having a rounded configuration therefore they would be capable of decreasing stress so as to avoid tearing).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM graft of the combination by providing wherein the graft has a perimeter with a series of radii edges having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft as taught by Cahu because such a modification would involve a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04.4.B). Additionally, the implant of Chu is shaped for treating a condition within the body of a patient, such as uterine prolapse, vaginal vault prolapse, rectocele, and/or cystocele (see Chu, paragraph 0017).
Regarding claim 23, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the ADM graft has a perimeter with a series of radii edges having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft.
Chu discloses a graft (see Chu, paragraph 0024) configured for a pelvic organ prolapse repair (see Chu, paragraph 0007) wherein the graft has a perimeter with a series of radii edges (see Chu, Figures 1-4) having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft (the graft of Cahu in Figures 1-4 has radii edges having a rounded configuration therefore they would be capable of decreasing stress so as to avoid tearing).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM graft of the combination by providing wherein the graft has a perimeter with a series of radii edges having a rounded configuration to provide decreased stress so as to avoid tearing of the ADM graft as taught by Cahu because such a modification would involve a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04.4.B). Additionally, the implant of Chu is shaped for treating a condition within the body of a patient, such as uterine prolapse, vaginal vault prolapse, rectocele, and/or cystocele (see Chu, paragraph 0017).
Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Gellman et al (US 20040039246 A1).
Regarding claim 24, Gellman discloses an acellular dermal matrix (ADM) graft product (see Gellman, Figure 3, paragraph 0082 discloses acellular dermal matrix) configured for a pelvic organ prolapse repair (paragraphs 0004 and 0155), comprising:
an ADM graft derived from full-thickness skin (see Gellman, paragraph 0040),
the ADM graft having a pre-formed shape (see Gellman, paragraph 0103 and 0104 discloses a pre-shaped mesh) with a mesh pattern (see Gellman, Figure 3, mesh pattern 10) formed in a central mesh region (see Gellman, mesh region 10 in Figure3 is centrally located),
the mesh pattern is uniform meshing contained in the central mesh region (see Gellman, as can be seen in Figure 3 the mesh pattern 10 is uniform); and
the pre-formed shape in the configuration for the pelvic organ prolapse repair (the acellular dermal matrix graft product of Gellman is able to be used for pelvic organ prolapse repair, a structure is not disclosed which would differentiate it from being used for pelvic organ prolapse).
The embodiment of Figure 3 of Gellman discloses the invention substantially as claimed, however, the embodiment of Figures does not disclose a suture border region surrounding at least a portion of the central mesh region.
The embodiment of Figure 2 of Gellman discloses a suture border region (see Gellman, Figure 2; paragraph 0019) surrounding at least a portion of the central mesh region (see Gellman, Figure 2 depicts eyelet 48 which a suture is run through, when the embodiment of Figure 3 is in combination with the of Figure 2 of Gellman, the area surrounding the mesh region of Figure 3 would include a suture border region).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the embodiment of Figure 3 of Gellman by providing a suture border region surrounding at least a portion of the central mesh region as taught in Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Regarding claim 25, as set forth supra, the combination discloses wherein the pre- defined shape is configured for an anterior approach procedure of the pelvic organ prolapse repair (see Gellman, paragraph 0134).
Regarding claim 26, as set forth supra, the combination discloses wherein the pre- defined shape is configured for a posterior approach procedure of the pelvic organ prolapse repair (the combination of Gellman discloses a pre-shaped mesh with the structural limitations as defined in claim 24, therefore, the pre-defined shape of the combination would be capable of being used for a posterior approach procedure of the pelvic organ prolapse) .
Regarding claim 27, as set forth supra, the combination discloses wherein the ADM graft has a central mesh region (see Gellman, Figure 3, central mesh region 10), uniform meshing contained in the central mesh region (as can be seen depicted in Figure 3 of Gellman the central mesh region is uniform)), however, the embodiment of Figure 3 of Gellman does not disclose a plurality of suture punch points or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product.
The embodiment of Figure 2 of Gellman discloses a plurality of suture punch points (see Gellman, Figure 2, item 48) or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product (Figure 2 of Gellman depicts the suture punch points 48 placed in non-meshed region between the central mesh region 10 and perimeter edge of the ADM graft product 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the ADM tissue of the embodiment of Figure 3 of Gellman by providing a plurality of suture punch points or suture slits placed in a non- meshed region between the central mesh region and a perimeter edge of the ADM graft product as taught by the embodiment of Figure 2 of Gellman because this allows for a suture to be included with the ADM tissue. The suture anchors the ADM tissue to the muscular and fascial support. Once the first end portion of ADM tissue is anchored to the anatomical structure using the suture (see Gellman, paragraph 0143).
Regarding claim 28, as set forth supra, Gellman discloses wherein the ADM graft has a plurality of sutures (see Gellman, paragraph 0094 discloses that sutures 46 can be placed in the suture punch points 48 of Figure 2, Figure 5 shows the suture 46) pre-placed in the suture border region between the central mesh region and a perimeter edge of the ADM graft product (see Gellman, as can be seen in Figures 2 and 5 the suture is pre-placed in the suture border region between central mesh region 10 (when the mesh region 10 of Figure 3 is residing in combination with the suture punch points 48 of Figure 2 and suture slits of Figure 5) and a perimeter edge of the ADM graft product).
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 REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774