DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 17-20 are objected to because of the following informalities: the claim recites “the method of claim 1” however, claim 1 is a medical device positioner claim and claim 16 is a method claim. Therefore, it is assumed applicant meant the medical device positioner of claim 1. Appropriate correction is required.
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) 1-5, 8-10, 12 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Young U.S. Patent 11,090,146 B1.
Regarding Claim 1, Young discloses a medical device positioner 10 configured to position and/or hold an implantable device in place in the body of a subject during a surgical procedure (abstract), comprising: a first enclosure 14, 16 surrounding an implantable device 80 (as seen in Figure 3); a second enclosure 40 that mates with the first enclosure 14, 16 (as seen in Figures 2-4, 8); wherein the first, second, or first and second enclosures can be adhered in the body thereby holding the implantable device in an anatomically desired position (as seen in Figure 14 and column 5, lines 4-32); and wherein optionally the positioner is removed from the body following the surgical procedure (portions of the positioned, such as the tabs 16 can be removed, see column 7, lines 35-55).
Regarding Claim 2, Young discloses further comprising an overlying mold 21A, 21B that is attached to the first or second enclosure 14, 16 (see Figures 1, 3-4, 7-8).
Regarding Claim 3, Young discloses wherein the positioner surrounds an implantable device 80 and temporarily or permanently positions the implantable device in the chest (as seen in Figure 14 and column 5, lines 4-32).
Regarding Claim 4, Young discloses wherein the positioner has one or more attachment points 24a, 24b on either or both of the first or second enclosures that allow for mating and/or attachment of the first enclosure to the second enclosure (as seen in Figures 1-8 and 13, column 4, lines 59-67, column 5, lines 36-67 and column 6, lines 12-26).
Regarding Claim 5, Young discloses wherein the enclosures are comprised of a non-biological, biodegradable, or absorbable material (column 4, lines 33-46).
Regarding Claim 8, Young discloses wherein the enclosure size is adjustable (column 2, lines 62-67).
Regarding Claim 9, Young discloses wherein the one or more enclosures are circular, oval, square, rectangular, triangular, elliptical, or a modification thereof (as seen in Figures 1-8 and 13, the enclosure forms circular shape, outer circle 22 and inner circle 20 and column 4, lines 31-47).
Regarding Claim 10, Young discloses wherein the attachment point 24a, 24b comprises a tightening-type device (as seen in Figures 1-4 and 7-13 and column 5, lines 35-67).
Regarding Claim 12, Young discloses wherein the wherein the attachment point comprises nested enclosures (as seen in Figures 1-4, 7-13, the attachment points allow for the tightening of the fringe 16 and allow the fringe to be nested).
Regarding Claim 18, Young discloses wherein the enclosure size is adjustable (column 2, lines 62-67).
Regarding Claim 19, Young discloses wherein the one or more enclosures are circular, oval, square, rectangular, triangular, elliptical, or a modification thereof (as seen in Figures 1-8 and 13, the enclosure forms circular shape, outer circle 22 and inner circle 20 and column 4, lines 31-47).
Regarding Claim 20, Young discloses has one or more attachment points 24a, 24b on either or both of the first or second enclosures that allow for mating and/or attachment of the first enclosure to the second enclosure (as seen in Figures 1-8 and 13, column 4, lines 59-67, column 5, lines 36-67 and column 6, lines 12-26).
Claim(s) 1-7, 11, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Limem U.S. Publication 2021/0153997 A1.
Regarding Claim 1, Limem et al. discloses a medical device positioner 200 configured to position and/or hold an implantable device in place in the body of a subject during a surgical procedure (abstract and as seen in Figures 1A-1D), comprising: a first enclosure surrounding an implantable device (the rim of the dome that has a plurality of attachment features 240 surrounding an implantable device 120 as seen in Figure 1D); a second enclosure 220 that mates with the first enclosure (as seen in Figures 2 and 6-7, the rim of the dome mates with the second enclosure via the attachment features); wherein the first, second, or first and second enclosures can be adhered in the body thereby holding the implantable device in an anatomically desired position (paragraphs [0051-0053]); and wherein optionally the positioner is removed from the body following the surgical procedure (this limitation is optional and does not seem to be required, only optional).
Regarding Claim 2, Limem discloses further comprising an overlying mold 210 (dome) that is attached to the first or second enclosure 240 (see Figure 2).
Regarding Claim 3, Limem discloses wherein the positioner surrounds an implantable device 120 and temporarily or permanently positions the implantable device in the chest (as seen in Figure 1 and paragraphs [0051-0053] and [0089-0090]).
Regarding Claim 4, Limem discloses wherein the positioner has one or more attachment points 240 (slits/slots on the rim/ring) on either or both of the first or second enclosures that allow for mating and/or attachment of the first enclosure to the second enclosure (as seen in Figures 2 and 6 and paragraph [0090-0091]).
Regarding Claim 5, Limem discloses wherein the enclosures are comprised of a non-biological, biodegradable, or absorbable material (paragraphs [0063], [0065] and [0099]).
Regarding Claim 6, Limem discloses wherein the enclosures are round and have the same circumference (as seen in Figure 6).
Regarding Claim 7, Limem discloses wherein the enclosures are round and a fixed circumference (see Figure 6).
Regarding Claim 11, Limem discloses wherein the attachment point comprises one or more of a peg and hole system, interlocking pegs, or a hinge 250 (as seen in Figure 2 and paragraph [0052]).
Regarding Claim 13, Limem discloses wherein the first and/or second enclosures contains attachment points that can are used to secure the enclosure in the body wherein the attachment points can be removed from the enclosure (the tabs can be removed from the rim/enclosure of the dome, see Figure 6).
Regarding Claim 14, Limem discloses wherein the implantable device is one or more of a breast implant, a breast sizer, acellular dermal matrix, or an absorbable or non-absorbable mesh (abstract and paragraph [0019]).
Regarding Claim 15, Limem discloses wherein the overlying mold (dome 210) is placed over the implantable device 120 and attached to the first or second enclosure (the dome having the rim having a plurality of slits are attached together to be further attached to the second enclosure the tabs 230).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bresnick U.S. Patent 11,116,620 in view of Becker U.S. Publication 2011/0106249.
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Regarding Claim 16, Bresnick discloses a method for positioning an implantable medical device 1100 in a human, see Figs. 27-34, surrounding the device with a first enclosure 100, positioning the first enclosure with the device within the body (see Figs. 33-34 illustrating portion 110 of the first enclosure 100 with the device 1100 being inserted within the body), mating the first enclosure with the device with a second enclosure 175 that attaches to the first enclosure (see Fig. 24 and column 24, lines 59-63). The limitation “removing the first and second enclosures from the body” is inherent, since enclosure 100 is used as a “delivery device” (see column 25, lines 60-67), it is inherent that it is removed from the body once the breast implant is implanted so that the breast can be closed and the patient can heal. Bresnick fails to expressly disclose the implantable device is covered in a biologic mesh creating a wrapped device, and adhering the implantable device covered in biologic mesh to the body. Becker teaches a method for positioning an implantable medical device 81 (paragraphs [0010], [0036]) in the same field of endeavor for reducing capsular contraction, comprising an implantable device 81 (breast implant) covered in a biologic mesh 80 creating a wrapped device (see Fig. 8, paragraph [0037]), and the step of adhering the implantable device covered in biologic mesh to the body (see paragraphs [0010] and [0037]) for the purpose of providing a breast implant with a smooth outer surface that is adaptable to surround and support the implant in position to better anchor the implant and provide shape enhancement (paragraphs [0010-0011]). 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 Bresnick’s implantable device to be further covered in a biologic mesh creating a wrapped device and perform the step of adhering the implantable device covered in biologic mesh to the body as taught by Becker in order to provide better anchoring of the implant, shape enhancement, reduction of capsular contraction, and improvement in the rate of healing (paragraphs [0008] and [0010-0011]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young U.S. Patent 11,090,146 B1.
Regarding Claim 17, Young discloses a first enclosure 14, 16 is adhered within the body using sutures (column 7, lines 43-46) and wherein the first enclosure comprises a plurality of attachment points 24a, 24b integrated into the first enclosure 14, 16. Although, Young does not expressly disclose the first enclosure 16 is adhered to the body using the attachment points, Young discloses attachment points are openings to allow suture thread to be passed through the opening (abstract and column 4, lines 59-67 and column 6, lines 27-35 and as seen in Figure 13). 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 Young’s first enclosure having said attachment points to be the opening that receives the suture thread for the purpose of securing the suture to the enclosure and allowing attachment of the enclosure within the body.
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.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson 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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774