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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/30/2025 has been entered.
Response to Arguments
This action is responsive to the Request for Continued Examination and IDS dated 04/01/2026.
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 a 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 silicone-based elastomer over a conventional breast implant mandrel.
It would have been obvious to one having ordinary skill in the art to have substitute 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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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.
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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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