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 statements (IDS) submitted on 10/23/23, 3/12/24, 8/28/24, 4/14/25, 8/18/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 61 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 61 states “wherein the average diameter of the pores in the cover section is smaller than the average diameter of the pores in the plurality of base sections.”. Claim 61 depends on claim 60 which does not require pores in the cover section and the plurality of base sections. Claim 61 only requires that at least one of the cover or plurality of base sections comprises pores. Correction is required to provide proper antecedent basis for both pores in the cover section and a plurality of pores in the base section.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 60, 62, and 80 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nanni et al (US 2020/0405473 A1).
Regarding claim 60, Nanni discloses a breast implant wrap for limiting movement of the breast implant in a patient (Figure 14; paragraph 0017) comprising:
a two dimensional first configuration (Figure 12),
said first configuration further comprising a cover section (Figure 12, cover section annotated below),
and a plurality of base sections radially extending from the cover (Figure 12, item 4 (annotated below)); and
a second three dimensional configuration (Figures 13a-b) comprising a shape and size to at least partially cover the breast implant (Figures 13a-b, item 1) when each of the base sections is folded around the breast implant and secured to one another (Figure 12, the base sections 4 are secured to one another through wire 20),
and wherein at least one of the plurality of base sections and cover section comprises a plurality of pores (Figures 3 and 10, paragraph 0125).
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Regarding claim 62, Nanni discloses wherein the wrap has one or more of the following pore sizes: an average pore diameter in the cover section of the wrap between 0.1 and 1 mm , and an average pore diameter in the plurality of base sections between 0.5 and 3 mm (see Nanni, Figure 10, item 18, paragraphs 0190-0191).
Regarding claim 80, Nanni discloses a method of making a breast implant fixation device to limit movement of a breast implant in a patient (Figure 14; paragraph 0017) comprising:
forming a two-dimensional wrap (Figure 12) in a shape and size (Figures 13a-b, item 1) to at least partially cover the breast implant (Figure 12, the base sections 4 are secured to one another through wire 20),
wherein the wrap comprises a plurality of base sections (Figure 12, base sections annotated above) and a cover section (Figure 12, item 4, cover section annotated above), and
wherein at least one of the plurality of base sections and the cover section comprises a plurality of pores (Figures 3 and 10, paragraph 0125).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Egnelov et al (US 2015/0250574 A1).
Regarding claim 61, Nanni discloses the invention substantially as claimed.
However, Nanni does not disclose wherein the average diameter of the pores in the cover section is smaller than the average diameter of the pores in the plurality of base sections.
Egnelov teaches a three-dimensional mesh structure for supporting a breast implant (see Egnelov, abstract) wherein the diameter of the pores varies in different sections to alter mechanical properties (see Egnelov, Figure 1A, paragraph 0018).
Therefore, 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 porosity of the cover section and base section of Nanni by providing wherein the average diameter of the pores in the cover section is smaller than the average diameter of the pores in the plurality of base sections as taught by Egnelov to provide strength, elasticity and stability which is suitable for the mechanical requirements of the different regions of the breast implant wrap (see Egnelov, paragraph 0013).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Mathisen et al (US 2020/0107921 A1).
Regarding claim 63, as set forth supra, Nanni discloses the invention substantially as claimed.
However, Nanni does not disclose wherein the plurality of base sections are formed from a first mesh, and the cover section is formed from a second mesh, and wherein the first and second meshes are formed from fibers and the average diameter of the fibers forming the first mesh is larger than the average diameter of the fibers forming the second mesh.
Mathisen discloses a mesh implant for use in a breast wrap (see Mathisen, paragraph 0001; paragraph 0042) wherein a first and second mesh (see Mathisen, Figure 3, paragraph 0022 “which can be made from different materials or different techniques, such as but not limited to electrospinning, knitting, weaving”), wherein the first and second mesh are formed from fibers and the average diameter of the fibers forming the first mesh is larger than the average diameter of the fibers forming the second mesh (paragraph 0033, lines 25-44 discloses wherein regions of the mesh (first and second mesh) can be formed from different fiber diameters to allow for different height and flexibility).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the base section and cover section of Nanni by providing wherein the first and second meshes are formed from fibers and the average diameter of the fibers forming the first mesh is larger than the average diameter of the fibers forming the second mesh, as taught by Mathisen, because this provides for a certain flexibility allowing the mesh to follow body contours and to create minimal modulus mismatch and tissue friction. Using more rigid connecting elements in certain areas or in the whole medical implant would allow the medical implant to attain a three-dimensional shape which goes beyond the three-dimensional height given to the implant by the height of each individual scaffold (see Mathisen, paragraph 0042). This allows for the modification of the cover section and base section to reach the desired flexibility to wrap the breast implant.
Claims 64, 74, 76, and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Seidner et al (US 2021/0353831 A1).
Regarding claim 64, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the thickness of the cover section is greater than the thickness of the plurality of base sections.
Seidner discloses a breast implant wrap for limiting movement of the breast implant (see Seidner, paragraph 0007) wherein the thickness of the cover section is greater than the thickness of the plurality of base sections (paragraph 0040 discloses that thicknesses of the breast implant wrap may vary, such that the thickness of the cover section may be greater than the thickness of the plurality of base sections).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of Nanni to modify the breast implant wrap of the combination by providing wherein the thickness of the cover section is greater than the thickness of the plurality of base sections as taught by Seidner because varying the thickness may provide greater support around certain areas of the implant. The cover section would benefit from a greater thickness below the implant, e.g., to better support the weight of tissue and/or the implant due to gravity when a patient is standing (see Seidner, paragraph 0040).
Regarding claim 74, Nanni discloses a breast implant wrap for limiting movement of the breast implant in a patient (Figure 14; paragraph 0017) comprising:
a two dimensional first configuration (Figure 12),
said first configuration further comprising a cover section (Figure 12, cover section annotated below), and
a plurality of base sections radially extending from the cover (Figure 12, item 4 (annotated below)); and
a second three dimensional configuration (Figures 13a-b) comprising a shape and size to at least partially cover the breast implant (Figures 13a-b, item 1) when each of the base sections is folded around the breast implant and secured to one another (Figure 12, the base sections 4 are secured to one another through wire 20).
Nanni discloses the invention substantially as claimed.
However, the combination does not disclose wherein the thickness of the cover section is greater than the thickness of the plurality of base sections.
Seidner discloses a breast implant wrap for limiting movement of the breast implant (see Seidner, paragraph 0007) wherein the thickness of the cover section is greater than the thickness of the plurality of base sections (paragraph 0040 discloses that thicknesses of the breast implant wrap may vary, such that the thickness of the cover section may be greater than the thickness of the plurality of base sections).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of Nanni to modify the breast implant wrap of the combination by providing wherein the thickness of the cover section is greater than the thickness of the plurality of base sections as taught by Seidner because varying the thickness may provide greater support around certain areas of the implant. The cover section would benefit from a greater thickness below the implant, e.g., to better support the weight of tissue and/or the implant due to gravity when a patient is standing (see Seidner, paragraph 0040).
Regarding claim 76, as set forth supra, the combination discloses wherein the thickness of the cover section is wider in the area in contact with the top of the breast implant than in the area in contact with the bottom of the breast implant (see Nanni, Figure 14 depicts the cover section thickness in contact with the top of the breast as wider than the base section thickness shown in Figures 13a-b which is in contact with the bottom of the breast implant).
Regarding claim 79, as set forth supra, the combination discloses wherein at least one of the plurality of base sections and cover section comprises a plurality of pores (see Nanni, Figures 3 and 10, paragraph 0125).
Claims 65, 67-70 are rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Doucet et al (US 2016/0310262 A1).
Regarding claim 65, Nanni discloses the invention substantially as claimed.
However, Nanni does not disclose wherein the cover section has a greater elasticity than the plurality of base sections.
Doucet discloses a breast implant wrap for limiting movement of the breast implant (see Doucet, paragraph 0003) in a patient wherein the cover section (see Doucet, Figures 11 and 12, item 101; paragraph 0267) has a greater elasticity than the plurality of base sections (see Doucet, Figures 11 and 12, item 102, paragraph 0168 discloses that the second fabric formed the fixation part 102, paragraphs 0294-0296 discloses that the elasticity of the cover section 101 is greater than the elasticity of the base section 102).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the cover section and the base section of the Nanni such that the cover section has a greater elasticity than the plurality of base sections as taught by Doucet because this allows for a good suture pull out and a good tear strength in the fixation region (see Doucet, paragraph 0169). This increase pull out and tear strength allows in particular the fixation part to be sutured in a reliable manner to the pectoral muscle (see Doucet, paragraph 0174).
Regarding claim 67, Nanni discloses a breast implant wrap for limiting movement of the breast implant (Figure 14; paragraph 0017) in a patient comprising:
a two dimensional first configuration (Figure 12),
said first configuration further comprising a cover section (Figure 12, cover section annotated below), and
a plurality of base sections radially extending from the cover section (Figure 12, item 4 (annotated above)); and
a second three dimensional configuration (Figures 13a-b) comprising a shape and size to at least partially cover the breast implant (Figures 13a-b, item 1) when each of the base sections is folded around the breast implant and secured to one another (Figure 12, the base sections 4 are secured to one another through wire 20).
Nanni discloses the invention substantially as claimed.
However, Nanni does not specifically disclose wherein the cover section has a greater elasticity than the plurality of base sections.
Doucet discloses a breast implant wrap for limiting movement of the breast implant (see Doucet, paragraph 0003) in a patient wherein the cover section (see Doucet, Figures 11 and 12, item 101; paragraph 0267) has a greater elasticity than the plurality of base sections (see Doucet, Figures 11 and 12, item 102, paragraph 0168 discloses that the second fabric formed the fixation part 102, paragraphs 0294-0296 discloses that the elasticity of the cover section 101 is greater than the elasticity of the base section 102).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the cover section and the base section of the Nanni such that the cover section has a greater elasticity than the plurality of base sections as taught by Doucet because this allows for a good suture pull out and a good tear strength in the fixation region (see Doucet, paragraph 0169). This increase pull out and tear strength allows in particular the fixation part to be sutured in a reliable manner to the pectoral muscle (see Doucet, paragraph 0174).
Regarding claim 68, as set forth supra, the combination discloses wherein the cover section has an elasticity range selected from the group consisting of 15-75% and 30-65% (see Doucet, paragraph 0033, E1 is the elasticity of the cover section 101 in Figure 12), and/or wherein the plurality of base sections have an elasticity range selected from the group consisting of 5-25% and 8-20% (see Doucet, paragraph 0035, E2 is the elasticity of the base section 102 of Figure 12).
Regarding claim 69, as set forth supra, the combination discloses wherein the plurality of base sections are formed from a first mesh (see Doucet, Figure 12, item 102 is formed of second fabric, paragraph 0078 discloses that the second fabric may be a porous knit, (i.e. mesh), and the cover section is formed from a second mesh (see Doucet, Figure 12, item 101 is formed of first fabric, paragraph 0062 discloses that the first fabric may be a porous knit), and wherein the elasticity of the second mesh is greater than the elasticity of the first mesh (paragraphs 0294-0296 discloses that the elasticity of the cover section 101 is greater than the elasticity of the base section 102).
Regarding claim 70, as set forth supra, the combination discloses wherein at least one of the plurality of base sections and cover section comprises a plurality of pores (see Nanni, Figures 3 and 10, paragraph 0125).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Harrah et al (US 2014/0276997 A1).
Regarding claim 66, Nanni discloses wherein the wrap is formed of one or more of the following:(i) a textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh (paragraph 0103), and (ii) a resorbable polymer, wherein the resorbable polymer is poly-4- hydroxybutyrate or copolymer thereof (see Nanni, paragraph 0047), or poly(butylene succinate) or copolymer thereof, wherein the endotoxin content of the wrap is less than 20 endotoxin units, and/or wherein the wrap is sterile (see Nanni, paragraph 0123).
However, Nanni does not specifically disclose wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid.
Harrah discloses a mesh implant wrap (see Harrah, paragraph 0021) wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid (see Harrah, paragraphs 0064-0067).
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 wrap of Nanni by providing wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid as taught by Harrah because such substances may be provided to reduce the risk of microbial infection (including biofouling of the mesh and infection in surrounding tissue) upon implantation of the mesh (see Harrah, paragraph 0066).
Claims 71 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Doucet et al (US 2016/0310262 A1) as applied to claim 67, and further in view of Seidner et al (US 2021/0353831 A1).
Regarding claim 71, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the thickness of the cover section is greater than the thickness of the plurality of base sections.
Seidner discloses a breast implant wrap for limiting movement of the breast implant (see Seidner, paragraph 0007) wherein the thickness of the cover section is greater than the thickness of the plurality of base sections (paragraph 0040 discloses that thicknesses of the breast implant wrap may vary, such that the thickness of the cover section may be greater than the thickness of the plurality of base sections).
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 breast implant wrap of the combination by providing wherein the thickness of the cover section is greater than the thickness of the plurality of base sections as taught by Seidner because varying the thickness may provide greater support around certain areas of the implant. The cover section would benefit from a greater thickness below the implant, e.g., to better support the weight of tissue and/or the implant due to gravity when a patient is standing (see Seidner, paragraph 0040).
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Doucet et al (US 2016/0310262 A1) as applied to claim 67, and further in view of Young et al (US 2021/0251738 A1).
Regarding claim 72, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose further comprising one or more tabs for anchoring the wrap to the patient's chest wall to prevent movement of the breast implant.
Young discloses a breast implant wrap for limiting movement of the breast implant (see Young, Figures 1 and 2, paragraph 0032) further comprising one or more tabs (see Young, Figure 2, item 16 “stabilization tab”, paragraph 0034) for anchoring the wrap to the patient's chest wall to prevent movement of the breast implant (see Young, 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 wrap of the combination by providing one or more tabs for anchoring the wrap to the patient's chest wall to prevent movement of the breast implant as taught by Young because the tabs anchor the cover and the implantable device at a correct implant position (see Young, paragraph 0035).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Doucet et al (US 2016/0310262 A1) as applied to claim 67, and further in view of Harrah et al (US 2014/0276997 A1).
Regarding claim 73, as set forth supra, the combination discloses wherein the wrap is formed of one or more of the following:(i) a textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh (see Nanni, paragraph 0103), and (ii) a resorbable polymer, wherein the resorbable polymer is poly-4- hydroxybutyrate or copolymer thereof (see Nanni, paragraph 0047), or poly(butylene succinate) or copolymer thereof, wherein the endotoxin content of the wrap is less than 20 endotoxin units, and/or wherein the wrap is sterile (see Nanni, paragraph 0123).
However, the combination does not specifically disclose wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid.
Harrah discloses a mesh implant wrap (see Harrah, paragraph 0021) wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid (see Harrah, paragraphs 0064-0067).
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 wrap of the combination by providing wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen, and hyaluronic acid as taught by Harrah because such substances may be provided to reduce the risk of microbial infection (including biofouling of the mesh and infection in surrounding tissue) upon implantation of the mesh (see Harrah, paragraph 0066).
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Seidner et al (US 2021/0353831 A1) as applied to claim 74, and further in view of Doucet et al (US 2016/0310262 A1).
Regarding claim 75, as set forth supra, the combination discloses wherein the thickness of the cover section is greater than the thickness of the plurality of base sections (see Seidner, paragraph 0040).
However, the combination does not disclose wherein the wrap has one or more of the following thicknesses: a thickness of the cover section of the wrap being 0.5-10 mm, and a thickness of the plurality of base sections being 0.2-0.6 mm.
Doucet discloses a breast implant wrap for limiting movement of the breast implant (see Doucet, paragraph 0003) in a patient with a cover section (see Doucet, Figures 11 and 12, item 101; paragraph 0267) and a plurality of base sections (see Doucet, Figures 11 and 12, item 102, paragraph 0168 discloses that the second fabric formed the fixation part 102) wherein the wrap has one or more of the following thicknesses: a thickness of the cover section of the wrap being 0.5-10 mm (see Doucet, paragraph (see Doucet, paragraph 0107), and a thickness of the plurality of base sections being 0.2-0.6 mm (see Doucet, paragraph 0172).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the thickness of the wrap of the implant by providing wherein the wrap has one or more of the following thicknesses: a thickness of the cover section of the wrap being 0.5-10 mm, and a thickness of the plurality of base sections being 0.2-0.6 mm as taught by Doucet because Seidner discloses that one or more portions of the scaffolding may have a greater thickness to provide more support around certain areas of the implant, therefore modifying the thickness of the mesh within known thicknesses would be within the ordinary skill of a person having ordinary skill in the art, and modifying the thicknesses would provide known benefits to the mesh, making them "results-effective variables". Regarding results-effective variables, it has been held that “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” Peterson 2144,05, Section U, Pari A.
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Seidner et al (US 2021/0353831 A1) as applied to claim 74, and further in view of Limem et al (WO 2016172094 A1).
Claim 77, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the cover section has a pre-set or shape memory that matches the curvature of the top of the breast implant.
Limem discloses a mesh used in breast implant procedures (see Limem, Figures 14A-C, page 10, line 20-page 11, line 2) wherein the cover section has a pre-set or shape memory that matches the curvature of the top of the breast implant (see Limem, page 12, lines 7- 20).
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 of the combination by providing wherein the cover section has a pre-set or shape memory that matches the curvature of the top of the breast implant as taught by Limem because these shape memory implants would have the ability to be temporarily deformed, and then to open or spring into a shape after they are delivered in vivo into a suitably shaped tissue plane. This property eliminates the need for the surgeon to unroll, for example, a flat mesh after implantation in vivo, and remove wrinkles in the mesh, and also further enables minimally invasive procedures. Additionally, the shape memory implants would be designed to confer shape to the breast unlike other implants previously disclosed that must be shaped or draped around the breast (see Limem, page 12, lines 7-20).
Claim 78 are rejected under 35 U.S.C. 103 as being unpatentable over Nanni et al (US 2020/0405473 A1) in view of Seidner et al (US 2021/0353831 A1) as applied to claim 74, and further in view of Doucet et al (US 2016/0310262 A1).
Regarding claim 78, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the cover section has a greater elasticity than the plurality of base sections.
Doucet discloses a breast implant wrap for limiting movement of the breast implant (see Doucet, paragraph 0003) in a patient wherein the cover section (see Doucet, Figures 11 and 12, item 101; paragraph 0267) has a greater elasticity than the plurality of base sections (see Doucet, Figures 11 and 12, item 102, paragraph 0168 discloses that the second fabric formed the fixation part 102, paragraphs 0294-0296 discloses that the elasticity of the cover section 101 is greater than the elasticity of the base section 102).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the cover section and the base section of the combination such that the cover section has a greater elasticity than the plurality of base sections as taught by Doucet because this allows for a good suture pull out and a good tear strength in the fixation region (see Doucet, paragraph 0169). This increase pull out and tear strength allows in particular the fixation part to be sutured in a reliable manner to the pectoral muscle (see Doucet, paragraph 0174).
Conclusion
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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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774