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 filed 7/12/2026 have been fully considered but they are not persuasive.
Rejected under 35 U.S.C. 103 as being unpatentable over Bertoli (WO 2018/163223) in view of Chitre et al (2020/0268504).
Applicant argues that Bertoli teaches the wall portion of the medical support device is formed of collagen ECM and not by dipping non-absorbable silicone-elastomer over a conventional breast implant mandrel; the examiner agrees. The rejection uses Chitre et al to teach forming a non-absorbable silicone-elastomer over a conventional breast implant mandrel this is well known in the art. Note that the mandrel limitations are product-by-process limitations in the “medical support device” claims. Applicant’s argues C1-C5 only address Bertoli and not the combination rejection. Applicant’s argues D1-D3 only address Chitre et al and not the combination rejection.
Argument E, Lack of Motivation to Combine Bertoli with Chitre et al.
In making the rejection, the examiner was looking for two major limitations: A) a medical support device comprising a dome shaped wall portion having a perimeter edge located in a plane, and B) the wall portion being made of silicone. Bertoli clearly teaches a dome shaped wall portion having a perimeter edge located in a plane as shown. Bertoli also teaches “implantation of inert biomaterials (or of synthetic meshes) is allow by the scientific community”; see page 3, lines 27-28 of Bertoli. The examiner interprets this as if Bertoli knows synthetic materials are known in the art. Regarding B), breast implants or medical support devices comprising silicone (produced by dipping a mandrel) is so well known to one having ordinary skill in the art. It is the examiner’s position that anyone skilled in the art would see a hemisphere shaped medical support device (breast implant) and think let’s try silicone for the material. As stated in the conclusion of the rejection, it would have been obvious to one having ordinary skill in the art to have substituted silicone elastomer as taught by Chitre et al for the wall portion of Bertoli for a simple substitution of one known material for another to obtain predictable results. See MPEP 2143.
Argument F. The combination, Properly Made, Fails to Address a Permanent Non-Encapulated Medical Support Device.
Bertoli teachs a non-encapsulated medical support device. Chitre et al teaches the silicone material.
Silicone is non-absorable.
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.
Claims 1-2, 5-6, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bertoli (WO 2018/163223) in view of Chitre et al (2020/0268504).
Bertoli teaches medical support device (A-A spherical dome), for use in a woman's breast as an implant without encapsulated material, the medical support device comprising:
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a wall portion having a perimeter edge located in a plane (see at least included figure 1 above and inherent to a hemisphere (see abstract)), the edge inscribing an opening into the medical support device;
wherein the wall portion has a first side and a second side, and the wall portion bulges out of the plane so that the first side is convex and the second side is concave (both self-evident) with a curve of the second side corresponding to a curve of the first side so as to form a cavity (see at least included figure 1 above and figure 5), the cavity forming a hollow volume (Air-volume H) between the second side and the opening and the cavity open to the opening,
wherein the medical support device is configured for placement inside the breast with the opening open to tissue of the breast and with deep gland tissue and/or fat inside the cavity (at least fully capable of), and wherein the medical support device is further configured for attachment to tissue of the breast with sutures (fully capable of).
However, Bertoli fails to teach said solid wall comprising non-absorbable silicone elastomer material.
Chitre et al also teaches a medical support device for a women’s breast comprising an outer shell 22 formed by dipping two or more layers of non-absorbable silicone-based elastomer (interpreted as silicone) over a conventional breast implant mandrel.
It would have been obvious to one having ordinary skill in the art to have substituted silicone elastomer (including the method of dipping on a mandrel if necessary) as taught by Chitre et al for the wall portion of Bertoli for a simple substitution of one known material for another to obtain predictable results. Further Chitre et al teaches the advantage of reinforcing silicone; see par. 0081.
Claim 2, regarding the matrix, see par. 0081 of Chitre et al teaching reinforcing.
Claim 5 is directed to a method of making the device of claim 1. All method steps are addressed in at least par. 0081 of Chitre et al.
Claim 6, a matrix is reinforcing layer 40 which is added to the elastomer after dipping some layers.
Claim 9, the included figure shows a circular edge and is inherent to a hemisphere.
Claim 14, the combination device inherently has a wall portion which is solid in cross-section.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bertoli (WO 2018/163223) in view of Chitre et al (2020/0268504) and further in view of Limem et al (US D927,690 S).
Bertoli in view of Chitre et al teach the medical support device as described above, however, fail to teach a rim extends from the edge in the plane at least partially around the opening.
Limem et al also teaches a medical support device having a rim which extends from the edge in the plane at least partially around the opening.
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It would have been obvious to one having ordinary skill in the art to have incorporated a rim as taught by Limem et al on the medical support device of Bertoli in view of Chitre et al to attach said device to the breast.
Claim 4, it would have been obvious to one skilled in the art to have monolithically made the medical support device and rim for strength and ease of manufacturing.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bertoli (WO 2018/163223) in view of Chitre et al (2020/0268504). Evidenced by Barere et al (2018/0055624).
Claim 7-8 claim a method of using the medical support device of claim 1. It is inherent the at least deep gland tissue and/or fat is separated and the device is positioned such that deep gland tissue and/or fat is inside the cavity. The examiner provides Barere et al as evidence that it is known in the art to attach a medical support device with suture 60 and to breast muscle (see par. 0056). It would have been obvious to one skilled in the art to have used sutures to attach the medical device of claim 1 to increase adherence and to breast muscle.
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Conclusion
THIS ACTION IS MADE FINAL. 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 BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774
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