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 6/09/2026 have been fully considered.
Rejection under 35 U.S.C. 102(a)(1) as being anticipated by or Mora et al (2012/0232652), in the alternative, under 35 U.S.C. 103 as obvious over Mora et al in view of Burnett et al (2009/0012372).
Mora et al clearly teaches a shell comprising a first layer, a second layer and a filler. Further, said shell is round/spherical under 102/103. Regarding, the functional limitation “wherein the viscosity of the fluid in cooperation with the shell maintains a symmetrical configuration of the shell about at least two planes of symmetry, and the filler in cooperation with the shell maintains a maximum position of projection of the implant along the posterior side of the implant as the implant changes orientation”, which includes responding under no or little force applied to the implant. In contrast, the examiner highly doubts that a gluteal implant (par. 0004) could maintain this functional language when the user is seated. The examiner’s positions are addressed in the grounds of rejection
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 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, 4-9 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or Mora et al (2012/0232652), in the alternative, under 35 U.S.C. 103 as obvious over Mora et al in view of Burnett et al (2009/0012372) or Power-Cooper et al (2020/0330216).
Mora discloses a medical implant comprising a shell formed of a biocompatible material. Mora discloses that “the present implants are suitable for implantation in the human body and the flexible colored shell is accordingly sized and shaped” (par. 21) and that “typical long-term implantable devices, which are often selected for these procedures, include round, anatomical or molded silicone gel filled shapes” (par. 3). Merriam-Webster’s, synonym for “round” is a sphere (spherical). A sphere has an infinite number of planes of symmetry.
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Further, round can be defined as “spherical or shaped like a ball”. Therefore, Mora discloses that the implant can be round (sphere) in shape. Par. 67 of the instant application’s specification explains that round implants have three planes of symmetry with one corresponding to the equator of the implant.
Therefore, it is inherent that the round implant of Mora has at least two planes of symmetry, one of which corresponds to an equator of the implant dividing a posterior side from and an anterior side.
Mora also discloses the shell includes at least one first layer formed from at least one first material (i.e. par. 0014 silicone elastomer) and at least a second layer 2 arranged more inwardly relative to the at least one first layer (as shown in the bottom-right embodiment of fig. 1), the second layer formed from a second material (differently colored silicone elastomer, see pars. 14-15, 17, 20, claims 3-5).
Mora also discloses the implant being “suitable for implantation in the human body” (par. 21), therefore, inherently discloses the implant can be either a breast implant, gluteal implant or tissue expander (which functions as a dissector); see par. 8.
The at least one first layer and at least one second layer forming a cavity filled with silicone gel (see abstract) filler in contact with the at least one second layer;
said filler includes a fluid (silicone gel) having a viscosity, the filler inherently is configured to cooperate with the at least one first layer and the at least one second layer,
“wherein the viscosity of the fluid in cooperation with the shell maintains a symmetrical configuration of the shell about at least two planes of symmetry, and the filler in cooperation with the shell maintains a maximum position of projection of the implant along the posterior side of the implant as the implant changes orientation”. This wherein clause is interpreted as functional language; it does not claim that the implant is implanted in the body, and if implanted, it does not clearly define the conditions of forces being placed said implant.
Finally, Mora et al does not teach the shell with the filler is not configured to maintain a symmetrical configuration. It is the examiner’s position that the implant of Mora et al fulfills the claim language and all limitations.
In the alternative, under 35 U.S.C. 103 as obvious over Mora et al (US 20120232652) in view of Burnett et al (2009/0012372) or Power-Cooper et al (2020/0330216).
If Mora et al does not inherently teach the medical implant includes at least two planes of symmetry and the functional language including “wherein the viscosity of the fluid in cooperation with the shell maintains a symmetrical configuration of the shell about at least two planes of symmetry, and the filler in cooperation with the shell maintains a maximum position of projection of the implant along the posterior side of the implant as the implant changes orientation”:
Burnett et al also teaches a silicone gel-filled implant. Par. 0081 of Burnett et al teaches a medical implant having “a spherical shell 4 (as would be the case for many breast implants and gastric balloons)”. Further, see round or symmetric in par. 0123 and at least par. 0124 teaching a filler.
Further the Burnett et al teaches the shell of the implant is “rigid”; see par. 0036. The implant of Burnett et al is fully capable of under at least no applied force of “wherein the viscosity of the fluid in cooperation with the shell maintains a symmetrical configuration of the shell about at least two planes of symmetry, and the filler in cooperation with the shell maintains a maximum position of projection of the implant along the posterior side of the implant as the implant changes orientation”.
Power-Cooper et al also teaches a spherical breast implant shown below and described in at least the abstract.
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At least par. 0007 teaches, “Silicone breast implants include an outer silicone shell filled with a silicone gel. Silicone breast implants are often considered to provide a more natural feel than saline breast implants. Form-stable breast implants, sometimes referred to as “gummy bear breast implants,” include an outer silicone shell filled with a thicker silicone gel than other silicone breast implants. Form-stable breast implants can be firmer than other breast implants, and can allow breast implants to be manufactured in a greater variety of specifically contoured, stable shapes. Form-stable breast implants can be less likely to break than other breast implants, and can maintain their shape even if the outer silicone shell breaks.”
It would have been obvious to one skilled in the art to have made the implant of Mora et al spherical, round or symmetric having at least two planes of symmetry wherein one plane divides the posterior side from the anterior sided as taught by Burnett et al or Power-Cooper et al for a well-known medical implant shape.
Further, it would have been obvious to have made any of the combinations having a shell of which is “rigid” as taught by Burnett et al or the implant form-stable as taught by Power-Cooper et al to maintain their shape fulfilling “wherein the viscosity of the fluid in cooperation with the shell maintains a symmetrical configuration of the shell about at least two planes of symmetry, and the filler in cooperation with the shell maintains a maximum position of projection of the implant along the posterior side of the implant as the implant changes orientation” under at least little or no force applied to the implant.
Claim 2 is rejected under both 102 and 103. Round, spherical, round or symmetric have three planes of symmetry, as evidenced by specification par. 67 of the instant application.
Claim 4 is rejected under both the 102 and 103 rejections teaching round/spherical.
Claim 5 is rejected under both the 102 and 103 rejections, Mora discloses the implant includes a shell and a filler (par. 14) and a patch (Mora claim 1).
Claims 6 and 8 are rejected under both the 102 and 103 rejections. The implant is round/spherical which inherently has an infinite number of planes of symmetry that divide the implant into a posterior and an anterior half. Mora discloses the implant has a patch (Mora claim 1). There are a numerous number of planes of symmetry dividing the posterior and anterior sides such that the patch is located between an apex and the plane of symmetry.
Claims 7-8 are rejected under 35 U.S.C. 103 only. Mora et al teaches a patch in at least claim 5. Burnett et al also teaches a patch 5. However, neither Mora et al, or Mora et al in view of Burnett et al, explicitly disclose a diameter of the patch. The Courts have held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see MPEP 2144.04(IV) (B)). It appears that the implant of Mora would operate equally as well with the claimed patch diameter since changing the patch diameter to be within the claimed range would not result in a change in the mechanics or function of the device. Further, the applicant has not disclosed that the claimed range solves any stated problem or is for any particular purpose, indicating simply that the patch diameter “may” be within the claimed range or even that it “may range from about 10 mm to about 40 mm” (specification par. 39). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the patch diameter of Mora to be less than or equal to 30mm because it appears to be a mere difference in relative dimension which fails to patentably distinguish over Mora.
Claim 9 is rejection under 35 U.S.C. 103 rejection only. Burnett et al provides evidence that a medical breast implant including a transponder (abstract, par. 104, fig. 9) are known in the art to include a transponder. See all rejections for claim 1 above.
It would have been obvious to one of ordinary skill in the art to modify the implant of Mora et al to include a transponder, as taught by Burnett, to provide the implant with the capability “to communicate with an external device alerting a user or a healthcare provider that the integrity of the implant is failing” (Burnett par. 23).
Claim 14 is rejected under both the 102 and 103 rejections, Mora discloses that the shell may include one low diffusion barrier layer that forms an innermost surface of the shell (pars. 14-15, bottom-right embodiment of fig. 1).
Claim 11 is rejection under 35 U.S.C. 103 as obvious over Mora et al, or, Mora et al in view of Burnett et al (2009/0012372) or Power-Cooper et al, and further in view of Quiros et al (20150282926).
Mora et al, or Mora et al in view of Burnett et al or Power-Cooper et al, do not disclose specifics of the texture of the outside surface of the implant.
Quiros teaches a breast implant, in the same field of endeavor, that has multiple planes of symmetry and at least a first and second layer (par. 0031) and has a nano-textured or micro-textured outer surface (Quiros par. 0005 and 0030).
It would have been obvious to one of ordinary skill in the art to have modified the outer surface of the implant of Mora, or Mora et al in view of Burnett et al, to include a nano-textured or micro-textured, as taught by Quiros, to provide a relatively smooth outer surface that negates the complications that can develop from aggressively textured outer surfaces, such as irritation of the local tissues (Quiros pars. 24 and 30).
Allowable Subject Matter
Claims 15, 18-19, 23, 26-28, 32-34 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 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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