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 .
Allowable Subject Matter
Claims 9-11 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach nor render obvious wherein the detachable barrel tip comprises a latch receptacle for securing the attachment feature of the member to the detachable barrel tip and a terminal blunt dissection tip or cutting tip. Furthermore, the prior art fails to teach nor render obvious wherein the fastening mechanism comprises one or more mounting pins that attach the detachable barrel tip to the first end of the tubular section of the introducer tool, and a disengagement notch for releasing the detachable barrel tip from the first end of the tubular section of the introducer tool.
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 8 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 8 recites the limitation "the assembly of the member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 14, 16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guterman U.S. Publication 2015/0289969 A1.
Regarding Claim 1, Guterman discloses in Figure 2, a breast implant 36 comprising a unitary elongate member (paragraphs [0006], [0092]) with a first end and a second end to circumnavigate the breast beneath the skin (see Figures 4A-4D).
Regarding Claim 2, Guterman discloses wherein the member is a tape, film, porous film, textile, braid, knitted, woven or nonwoven mesh or fabric or mesh (paragraphs [0039-0040], [0051], [0053]).
Regarding Claim 3, Guterman discloses a mastopexy system as seen in Figure 2-4D comprising an implantable unitary elongate member 36, with a first and a second end, sized to circumnavigate the breast beneath the skin (see Figures 4A-4D), and a sheath 34 connected to the elongate member 36 and at least partially enclosing the member (see figures 2-4D and paragraphs [0072], [0080] and [0086-0089]).
Regarding Claim 14, Guterman discloses wherein the unitary elongate member is a tape, film, porous film, textile, braid, knitted, woven or nonwoven mesh or fabric or mesh (paragraphs [0039-0040], [0051], [0053]).
Regarding Claim 16, Guterman discloses wherein the unitary elongate member 36 further comprises one or more fastening anchors 64, 68 (as seen in Figure 5 and paragraphs [0108], [0113], [0115]).
Regarding Claim 18, Guterman discloses a method of lifting or cinching a breast (abstract and paragraphs [0003], [0104]), comprising providing one or more introducer tools 34 and the breast implant (see claim rejections above), using the one or more introducer tools 34 to insert the breast implant 36 in a breast so that the breast implant circumnavigates the upper and lower poles of the breast beneath the skin (as seen in Figures 2-4D), removing the one or more introducer tools from the breast (paragraph [0089]), and using the breast implant to lift or cinch the breast (paragraphs [0003], [0009], [0047]).
Regarding Claim 19, Guterman discloses a method of lifting or cinching a breast (abstract and paragraphs [0003], [0104]), comprising providing one or more introducer tools 34 and a breast implant comprising an assembly of an implantable unitary elongate member 36 (paragraphs [0006], [0092]), with a first and a second end, sized to circumnavigate the upper and lower poles of the breast beneath the skin, and one or more sheaths 34 connected to the member 36 near one or more ends of the member (the end of the member 36 exits through the end of the sheath, therefore the sheath indirectly is coupled/connected to the end of the member as the member is enclosed within the sheath) and at least partially enclosing the member (as seen in Figure 2), using the one or more tools to insert the assembly in the breast so that the member circumnavigates the upper and lower poles of the breast beneath the skin (as seen in Figure 4A-4D and paragraphs [0087-0089]), removing the one or more introducer tools from the breast, removing the one or more sheaths from the breast (paragraphs [0088-0089] and [0101]), and using the member to lift or cinch the breast (paragraphs [0003], [0009], [0047]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4-7, 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guterman U.S. Publication 2015/0289969 A1 in view of Patankar et al. U.S. Publication 2016/0051354 A1.
Regarding Claim 4, Guterman discloses an elongate member 36 and a sheath 34. However, Guterman does not expressly disclose the sheath is fused to the member. Patankar et al. teaches a system for delivery of an elongate member 315, the system comprising an implantable unitary elongate member 315 with a first and second end and a sheath 316 fused to the elongate member 315 (paragraph [0105]) for the purpose of securing the sheath to the outer surface of the elongate member (paragraph [0105]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Guterman to further include a mechanical or other securing means to secure the sheath to the elongate member as taught by Patankar for the purpose of securing the sheath to the outer surface of the elongate member to prevent displacement of the sheath during delivery.
Regarding Claim 5, 6, Guterman does not expressly disclose an introducer tool, and wherein the elongate member comprises an attachment feature to connect the elongate member to the introducer tool and the attachment features at or adjacent to the first and second ends of the member, each attachment feature is connected to the introducer tool. Patankar et al. discloses a system for delivery of an elongate member 315, the system comprising attachment features 211 at or adjacent to the first and second ends of the member, and each attachment feature is connected to the introducer tool 302 (paragraphs [0103-0104]) to secure the elongate member to the introducer tool and prevent twisting of the elongate member during delivery (paragraphs [00103-0104]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Guterman to further include an introducer tool and an attachment feature that connects the elongate member to the introducer tool as taught by Patankar et al. for the purpose of securing the elongate member to the introducer tool and prevent twisting of the elongate member during delivery.
Regarding Claim 7, Guterman does not expressly disclose wherein the introducer tool comprises a tubular section, with a first end and a second end, and a barrel tip detachably connected to the first end of the tubular section, and the second end of the tubular section is connected to a handle, and wherein the tubular section comprises a slit running at least part of its length. Patankar et al. teaches a system 301 for delivery of an elongate member 315, the system comprising an implantable unitary elongate member 315 with a first and second end and a sheath 316 fused to the elongate member 315 (paragraph [0105]) and an introducer tool 302 comprising a tubular section having a first end 303 and a second end 304 and a barrel tip 202 detachably connected to a first end 303 of the tubular section (see annotated Figures 30, 30A above) and a second end of the tubular section connected to a handle (indirectly connected to a handle, as seen in Figure 31), wherein the tubular section comprises a slit (as seen in Figures 32A-32B) running at least part of its length for the purpose of using an inside-out approach for the sling system to connect the right and left handle of the delivery system to the sling (paragraph [0010]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Guterman to further include an introducer tool having a tubular section with a slit and a barrel tip detachably coupled to the introducer tool length for the purpose of using an inside-out approach for the sling system to connect the right and left handle of the delivery system to the sling.
Regarding Claim 12, Guterman discloses wherein the introducer tool comprises a fastening mechanism (protrusion 306 and groove 307) for attachment and detachment of the detachable barrel tip from the first end of the tubular section (as seen in Figure 28A-30A).
Regarding Claim 20, Guterman does not expressly disclose providing the member with an attachment feature, and using an introducer tool to insert the member in the breast by connecting the attachment feature to the introducer tool. Patankar et al. discloses a system for delivery of an elongate member 315, the system comprising attachment features 211 at or adjacent to the first and second ends of the member, and each attachment feature is connected to the introducer tool 302 (paragraphs [0103-0104]) to secure the elongate member to the introducer tool and prevent twisting of the elongate member during delivery (paragraphs [00103-0104]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Guterman to further include an introducer tool and an attachment feature that connects the elongate member to the introducer tool as taught by Patankar et al. for the purpose of securing the elongate member to the introducer tool and prevent twisting of the elongate member during delivery.
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guterman U.S. Publication 2015/0289969 A1 in view of Moses et al. U.S. Publication 2012/0283826 A1.
Regarding Claim 15, Guterman discloses the elongate member comprises one or more polymers, thermoplastic polymers (paragraphs [0073] and [0075]). However, Guterman does not expressly disclose wherein the unitary elongate member comprises polymers [that] are synthesized from, or comprise, one or more of the following monomers: glycolic acid, lactic acid, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 4-hydroxybutyric acid, ε-caprolactone, 1,4-butanediol, adipic acid, and succinic acid. Moses et al. teaches a mastopexy system for maintaining the breast in an elevated position comprising an unitary elongated member 311 comprising a polymer formed from a biodegradable thermoplasty polymer such as glycolic acid, lactic acid (paragraphs [0058], [0061]) for the purpose of being capable of being partially to completely biodegradable and does not cause physiological hard to the body (paragraphs [0058-0059]) while maintaining sufficient strength and durability to be conformable into a shape needed to elevate the breast tissue (paragraph [0062]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Guterman to further include an elongate member formed of thermoplastic polymer in the form of glycolic acid, lactic acid as taught by Moses et al. for the purpose of being capable of being partially to completely biodegradable and does not cause physiological hard to the body while maintaining sufficient strength and durability to be conformable into a shape needed to elevate the breast tissue.
Regarding Claim 17, Guterman et al. does not expressly disclose the unitary elongate member comprises at least one property selected from the group consisting of a pore diameter of 5 micrometer to 10 mm. Moses et al. teaches a mastopexy system for maintaining the breast in an elevated position comprising a unitary elongated member 311 comprising a polymer and having a pore size of about 1 mm (paragraph [0104]) for the purpose of forming porous mesh construct that can be folded into a 3D shape (paragraph [0104]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Guterman to further include a unitary elongate member having a pore size of about 1 mm as taught by Moses for the purpose of forming porous mesh construct that can be folded into a 3D shape.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774