DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/10/26 has been entered.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190388118 A1 to Kirn et al. (Kirn) as evidenced by US 20080009886 A1 to Self in view of BR 102017028074 A2 to Hebert (see English language machine translation attached to this or a previous office action).
Regarding claim 1:
Kirn discloses:
A device (figures 1-4) for removing a breast implant (I/M), fill material, and/or a capsule from a patient (D), comprising:
a housing (12/14) having proximal (12) and distal (14) portions which together define an interior chamber (see the interior chamber A in figure 1 below) for receiving the breast implant (I/M), fill material, and/or capsule;
a rigid ring (26) fixed to the proximal portion (12) and defining a funnel (funnel of outer lip 32 (flared, rounded, or rolled outer lip)(¶0048)) for deforming and guiding the breast implant (I/M), fill material, and/or capsule toward an inlet (see the inlet B in figure 1 below) of the interior chamber (A in figure 1 below), the funnel (funnel of outer lip 32) having a continuously tapering inner diameter from a proximal end of the funnel (see the continuously tapering inner diameter of lip 32 from proximal end D to the distal end C (in figure 2 below) which aligns with ¶0048 which indicates lip 32 can be flared (funnel shaped) and as further evidenced by Self which shows a suction cup with a flared end (128; see ¶0011 where this end is described as flared) that is funneled shaped with a continuously tapering inner diameter from a proximal end to a distal end) toward a distal end (see the distal end C in figure 1 below); and
a suction port (34).
Kirn fails to disclose:
The funnel having a continuously tapering inner diameter extending from a proximal end of the proximal portion of the housing toward a distal end of the funnel.
Hebert teaches:
A prothesis applicator that includes different nozzle shapes (figures 6a-6e) including a tapered nozzle (figure 6a), double R nozzle (figure 6B), double V (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6C) and with only a reducing neck (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kirn to further include the funnel having a continuous tapering inner diameter from a proximal end of the proximal portion toward the distal end of the funnel as taught by Hebert in order to match the incision size for removing the breast implant and based on the size and shape of the implant (Hebert, translation, page 10, ¶041 and page 11, ¶049).
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Figure 1 – figure 4 of Kirn, annotated by the examiner
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Figure 2 - figure 4 of Kirn, annotated by the examiner
Regarding claim 2:
Kirn discloses:
The device of claim 1, wherein an inner diameter (see the inner diameter of 12 as shown in figure 1 above) of the proximal portion (12) of the housing (12/14) increases (see the increase in diameter from B to E as shown in figure 1 above) from the inlet (see the inlet B in figure 1 above) of the interior chamber (A in figure 1 above) to a distal end (see the distal end E as shown in figure 1 above) of the proximal portion (12) of the housing (12/14).
Regarding claim 3:
The device of claim 2, wherein an inner diameter (see the inner diameter of 14 as shown in figure 1 above) of the distal portion (14) of the housing (12/14) decreases (see the decrease in diameter form point F to G in figure 1 above) from a proximal end (see the proximal end F in figure 1 above) of the distal portion (14) of the housing (12/14) to a distal end (see the distal end G in figure 1 above) of the distal portion (14) of the housing (12/14).
Regarding claim 4:
The device of claim 3, wherein an inner diameter (the inner diameters at points E and F are the same/overlap since they mate as shown in figure 1 above) of a distal end (end E in figure 1 above) of the proximal portion (12) of the housing (12/14) and an inner diameter of a proximal end (end F in figure 1 above) of the distal portion (14) of the housing (12/14) are the same.
Regarding claim 5:
Kirn discloses:
The device of claim 4, wherein the proximal (12) and distal (14) portions of the housing (12/14) are separable and are separated (“Of course, other types of mechanical connections may be utilized in lieu of the threaded mechanism in alternate embodiments such as, but not limited to, press fit connections, friction fit connections, butt connections with a separate connection ring, or a compression band with each sufficient to maintain the two portions 12, 14 in substantially parallel alignment to ensure a good seal”, ¶0052) by a connecting portion (see the connecting portion H in figure 1 above) having an inner diameter (inner diameter of 12 and 14 at the point that the mate as shown in figure 1 above) substantially the same from a proximal end to a distal end of the connecting portion (see the diameters of the mating portions as shown in figure 1 above at points E and F that are the same allowing for mating of 12 and 14).
Regarding claim 6:
Kirn discloses:
The device of claim 1, wherein a narrowest inner diameter (see the diameter at location B) of the proximal portion (12) of the housing (12/14) is substantially the same (the diameter of the two is the same since the two components blend into one another and therefore must have and overlapping diameter as shown in figure 1 above) as the narrowest inner diameter (see the diameter at lip 32) of the funnel (funnel of outer lip 32) and increases (see increase in diameter form B to E as shown in figure 1 above) from a proximal end (see the proximal end B in figure 1 above) of the proximal portion (12) toward a distal end (see the distal end E in figure 1 above) of the proximal portion (12).
Regarding claim 7:
Kirn discloses:
The device of claim 1, wherein each of the proximal (12) and distal (14) portions of the housing (12/14) provide at least 25% of the total volume (12 and 14 define the whole volume of the interior chamber A as shown in figure 1) of the interior chamber (A in figure 1 above).
Regarding claim 8:
Kirn discloses:
A device for removing a breast implant (I/M), fill material, and/or a capsule from a patient (D), comprising:
a housing (12/14) having proximal (12) and distal (14) portions which together define an interior chamber (A in figure 1 above) for receiving the breast implant (I/M), fill material, and/or capsule;
a ring (26) attached to the proximal portion (12) and defining a continuously tapering funnel (see the continuously tapering inner diameter of lip 32 from proximal end D to the distal end C (in figure 2 above) which aligns with ¶0048 which indicates lip 32 can be flared (funnel shaped) and as further evidenced by Self which shows a suction cup with a flared end (128; see ¶0011 where this end is described as flared) that is funneled shaped with a continuously tapering inner diameter from a proximal end to a distal end) for guiding the breast implant (I/M), fill material, and/or capsule toward an inlet (see the inlet B in figure 1 above) of the interior chamber (A in figure 1 above); and
a suction port (34), wherein an inner diameter (see the inner diameter of 14 as shown in figure 1 above) of the distal portion (14) of the housing (12/14) decreases (see the decrease in diameter form point F to G in figure 1 above) from a proximal end (see the proximal end F in figure 1 above) toward a distal end (see the distal end G in figure 1 above) of the distal portion (14) of the housing (12/14).
Kirn fails to disclose:
A ring attached to the proximal portion and defining a continuously tapering funnel extending from a proximal end of the proximal portion for guiding the breast implant, fill material, and/or capsule toward an inlet of the interior chamber.
Hebert teaches:
A prothesis applicator that includes different nozzle shapes (figures 6a-6e) including a tapered nozzle (figure 6a), double R nozzle (figure 6B), double V (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6C) and with only a reducing neck (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kirn to further include the funnel having extending from a proximal end of the proximal portion for guiding the breast implant, fill material, and/or capsule toward an inlet of the interior chamber as taught by Hebert in order to match the incision size for removing the breast implant and based on the size and shape of the implant (Hebert, translation, page 10, ¶041 and page 11, ¶049).
Regarding claim 9:
Kirn discloses:
The device of claim 8, wherein inner diameters (see the inner diameter of 12 and 14 as shown in figure 1 above) of a distal end (end E in figure 1 above) of the proximal portion (12) of the housing (12/14) and an inner diameter of a proximal end (end F in figure 1 above) of the distal portion (14) of the housing (12/14) are the same (the inner diameters at points E and F are the same/overlap since they mate as shown in figure 1 above) of the distal end (end E in figure 1 above).
Regarding claim 10:
Kirn discloses:
The device of claim 8, wherein the proximal (12) and distal (14) portions of the housing (12/14) are separable and are separated (“Of course, other types of mechanical connections may be utilized in lieu of the threaded mechanism in alternate embodiments such as, but not limited to, press fit connections, friction fit connections, butt connections with a separate connection ring, or a compression band with each sufficient to maintain the two portions 12, 14 in substantially parallel alignment to ensure a good seal”, ¶0052) by a connecting portion (see the connecting portion H in figure 1 above) having a substantially uniform inner diameter (inner diameter of 12 and 14 at the point that the mate as shown in figure 1 above).
Regarding claim 11:
Kirn discloses:
The device of claim 8, wherein a narrowest inner diameter (see the diameter at location B) of the proximal portion (12) of the housing (12/14) is substantially the same (the diameter of the two is the same since the two components blend into one another and therefore must have and overlapping diameter as shown in figure 1 above) as a narrowest inner diameter (see the diameter at lip 32) of the funnel (funnel of outer lip 32) and increases (see increase in diameter form B to E as shown in figure 1 above) from a proximal end (see the proximal end B in figure 1 above) of the proximal portion (12) to a distal end (see the distal end E in figure 1 above) of the proximal portion (12).
Regarding claim 12:
Kirn discloses:
The device of claim 8, wherein each of the proximal (12) and distal (14) portions provide at least 25% of the total volume (12 and 14 define the whole volume of the interior chamber A as shown in figure 1) of the interior chamber (A in figure 1 above).
Regarding claim 13:
Kirn discloses:
A device for removing a breast implant (I/M), fill material, and/or a capsule from a patient (D), comprising:
a housing (12/14) having proximal (12) and distal (14) portions separated by a central portion (see the connecting portion H in figure 1 above) which together define an interior chamber (A in figure 1 above) having a total volume for receiving the breast implant (I/M), fill material, and/or capsule, each of the proximal (12) and distal (14) portions of the housing (12/14) providing at least 25% of the total volume (12 and 14 define the whole volume of the interior chamber A as shown in figure 1) of the interior chamber (A in figure 1 above);
a ring (26) attached to a proximal end (see the proximal end B in figure 1 above) of the proximal portion (12) and defining a continuously tapering funnel (see the continuously tapering inner diameter of lip 32 from proximal end D to the distal end C (in figure 2 above) which aligns with ¶0048 which indicates lip 32 can be flared (funnel shaped) and as further evidenced by Self which shows a suction cup with a flared end (128; see ¶0011 where this end is described as flared) that is funneled shaped with a continuously tapering inner diameter from a proximal end to a distal end) having a narrowing inner diameter (funnel of outer lip 32 (flared, rounded, or rolled outer lip)(¶0048)) for guiding the breast implant (I/M), fill material, and/or capsule toward an inlet (see the inlet B in figure 1 above) of the housing (12/14); and
a suction port (34).
Kirn fails to disclose:
A ring attached to a proximal end of the proximal portion and defining a continuously tapering funnel having a narrowing inner diameter extending from the proximal end for guiding the breast implant, fill material, and/or capsule toward an inlet of the housing.
Hebert teaches:
A prothesis applicator that includes different nozzle shapes (figures 6a-6e) including a tapered nozzle (figure 6a), double R nozzle (figure 6B), double V (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6C) and with only a reducing neck (example of continuously tapering inner diameter extending from the proximal portion of the housing 5 to the ring 7) (figure 6E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kirn to further include the funnel continuously tapering a narrowing inner diameter extending from the proximal end for guiding the breast implant, fill material, and/or capsule toward an inlet of the housing as taught by Hebert in order to match the incision size for removing the breast implant and based on the size and shape of the implant (Hebert, translation, page 10, ¶041 and page 11, ¶049).
Regarding claim 14:
Kirn discloses:
The device of claim 13, wherein an inner diameter (see the inner diameter of 12 as shown in figure 1 above) of the proximal portion (12) of the housing (12/14) increases (see the increase in diameter from B to E as shown in figure 1 above) from the inlet (see the inlet B in figure 1 above) of the housing (12/14) to the central portion (see the distal end E as shown in figure 1 above) of the housing (12/14).
Regarding claim 15:
Kirn discloses:
The device of claim 14, wherein an inner diameter (see the inner diameter of 14 as shown in figure 1 above) of the distal portion (14) of the housing (12/14) decreases (see the decrease in diameter form point F to G in figure 1 above) from a proximal end (see the proximal end F in figure 1 above) of the distal portion (14) of the housing (12/14) toward a distal end (see the distal end G in figure 1 above) of the distal portion (14) of the housing (12/14).
Regarding claim 16:
Kirn discloses:
The device of claim 15, wherein the inner diameters (the inner diameters at points E and F are the same/overlap since they mate as shown in figure 1 above) of the distal end (end E in figure 1 above) of the proximal portion (12) of the housing (12/14) and the proximal end (end F in figure 1 above) of the distal portion (14) of the housing (12/14) are the same.
Regarding claim 17:
Kirn discloses:
The device of claim 16, wherein the proximal (12) and distal (14) portions of the housing (12/14) are separable (“Of course, other types of mechanical connections may be utilized in lieu of the threaded mechanism in alternate embodiments such as, but not limited to, press fit connections, friction fit connections, butt connections with a separate connection ring, or a compression band with each sufficient to maintain the two portions 12, 14 in substantially parallel alignment to ensure a good seal”, ¶0052) and the inner diameters (inner diameter of 12 and 14 at the point that the mate as shown in figure 1 above) of the distal end (end E in figure 1 above) of the proximal portion (12) of the housing (12/14) and the proximal end (end F in figure 1 above) of the distal portion (14) of the housing (12/14) are substantially the same (the inner diameters at points E, F and H are the same/overlap since they mate as shown in figure 1 above) as an inner diameter (center of 12/14 or H in figure 1 above) of the central portion of the housing (12/14).
Regarding claim 18:
Kirn discloses:
The device of claim 13, wherein a narrowest inner diameter (see the diameter at location B) of the proximal portion (12) of the housing (12/14) is substantially the same (the diameter of the two is the same since the two components blend into one another and therefore must have and overlapping diameter as shown in figure 1 above) as a narrowest inner diameter (see the diameter at lip 32) of the funnel (funnel of outer lip 32) and increases (see increase in diameter form B to E as shown in figure 1 above) from a proximal end (see the proximal end B in figure 1 above) of the proximal portion (12) of the housing (12/14) to a distal end (see the distal end E in figure 1 above) of the proximal portion (12) of the housing (12/14).
Regarding claim 19:
Kirn discloses:
The device of claim 13, wherein a plane (see the plane I at the central portion H in figure 1 above) defines the central portion of the housing (12/14).
Regarding claim 20:
Kirn discloses:
The device of claim 19, wherein an inner diameter (see the inner diameter of 14 as shown in figure 1 above) of the distal portion (14) of the housing (12/14) decreases (see the decrease in diameter form point F to G in figure 1 above) from the central portion (see the connecting portion H or portion F in figure 1 above) of the housing (12/14) toward a distal end (see the distal end G in figure 1 above) of the distal portion (14) of the housing (12/14).
Response to Arguments
Applicant’s arguments, see remarks, filed 2/3/26 and 3/10/26, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kirn and Hebert.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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