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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al (US 2012/0065503 A1).
Regarding claim 11, Rogers discloses a method of manufacturing a radiopaque identifier for a breast implant, the method comprising:
providing a first layer of material (see Rogers, Figures 1 and 8, item 200; paragraph 0065 discloses that the first layer is cutout to make a positive radiopaque marker),
the first layer of material having a radiopaque material (paragraph 0054 discloses radiopaque materials forming the first layer 200);
attaching a second layer of non-radiopaque material to the first layer of material (see Rogers, Figure 1 depicts attaching a second layer 100 to the first layer of material; paragraph 0059 discloses that the material is non-radiopaque (i.e. visually opaque)),
wherein the radiopaque material is interposed between an outer surface of the first layer and the second layer (the radiopaque layer of the first layer forming the radiopaque marker 200 is interposed between an outer surface of the first layer 200 and the second layer 100, due to the first layer being entirely formed of radiopaque material, therefore the outer surface to inner surface of radiopaque marker 200 is radiopaque material);
and removing at least a portion of the radiopaque material to form the radiopaque identifier including readable characters defined by the removed portion of radiopaque material (Figure 8 depicts removing at least a portion of the radiopaque material to form the identifier into readable characters; paragraph 0074),
wherein the readable characters are viewable in vivo using X-ray imaging techniques (paragraph 0078).
Regarding claim 12, Rogers discloses wherein the attaching the second layer of non-radiopaque material (Figure 1, item 100; Figures 13A-C) to the first layer of material (Figure 1, item 200; Figures 13A-C) comprises laminating the second layer of non-radiopaque material to the first layer of material (paragraph 0114 states “Additionally or alternatively, a layer of epoxy or other lamination may be applied over a portion of the surface of the radiopaque articles and the object carrying those articles to affix the articles to the object.”).
Regarding claim 13, Rogers discloses wherein the removing at least a portion of the radiopaque material comprises controllably marking and cutting out the portion of the radiopaque material of the first layer with a laser (paragraph 0122).
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.
Claims 14-16, 18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al (US 2012/0065503 A1) in view of Carter (US Patent No. 4,863,470).
Regarding claim 14, Rogers discloses providing the first layer of material comprises a radiopaque material (see Rogers, Figure 1, item 200; paragraph 0054)
However, Rogers does not disclose wherein providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet.
Carter teaches a breast implant (see Carter, Figure 1) with a radiopaque marker (see Carter, Figures 1 and 2, item 16) wherein providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet (see Carter, column 2, lines 30-34).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the radiopaque material of the first layer of Rogers by providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet as taught by Carter because the selection of a known material based on its suitability for its intended use is considered obvious. (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See MPEP 2144.07. The radiopaque material taught by Carter was suitable for use as a radiopaque marker in an implant that will be viewed on an x-ray, therefore, it would possess the biocompatibility, radiopacity, and other properties that would make it obvious to be used in the implant of Rogers.
Regarding claim 15, as set forth supra, the combination discloses wherein the first layer of material comprises silicone incorporating barium sulfate (see Carter, column 2, lines 3-34, when the material used in the radiopaque marker of Carter is residing in combination with the radiopaque material of the first layer of Rogers), and the attaching a second layer of non-radiopaque material comprises attaching a clear silicone sheet to the first layer of silicone incorporating the barium sulfate (see Rogers, paragraph 0051 discloses that silicone may be used as the molded material for the second layer; Figure 1, item 100 “molded desiccant article”).
Regarding claim 16, Rogers discloses a method of manufacturing an implant (abstract), comprising:
forming an implant marker having readable characters for identifying a characteristic of the implant while in vivo (Figure 1, item 200; paragraph 0059), the forming comprising:
providing a first layer of material (Figures 1 and 8, item 200; Figure 14A, item 1306) having an inner surface and an outer surface with a radiopaque material incorporated between the inner and outer surfaces (see Rogers, Figure 1, item 200; paragraph 0065 discloses that the first layer is cutout to make a positive radiopaque marker, radiopaque material that forms radiopaque marker 200 has a depth to it, therefore, it has an inner and outer surface with the radiopaque material incorporated between them);
attaching a second layer of non-radiopaque material to the inner surface of the first layer of material (see Rogers, Figure 1 depicts attaching a second layer 100 to the first layer of material; paragraph 0059 discloses that the material is non-radiopaque (i.e. visually opaque); Figure 14A, item 1302);
and removing at least a portion of the radiopaque material from the first layer of material to form readable characters defined by absence of the portion of radiopaque material (Figure 8 depicts removing at least a portion of the radiopaque material to form the identifier into readable characters; paragraph 0074);
providing a face of an implantable medical device (Figure 14B, item 1312, paragraph 0112) ;
and attaching implant marker to the face (Figure 14A, item 1300 depicts an implant marker formed in the same manner as Figure 1; paragraph 0111 discloses that that second shot of material 1304 need not be disposed (paragraph 0113); paragraph 0112 discloses that the marker object 1300 may be affixed to, embedded within, or otherwise carried, by another component of an implantable medical device; paragraph 0112 discloses that another shot of material may be applied to embed marker object 1300 into larger object 1312 (by over-molding)),
wherein the first layer of material having the readable characters is interposed between the anterior face and the second layer of non-radiopaque material (paragraph 0112, when the image marker 1300 formed in Figure 14A is affixed to implantable medical device 1312, the first layer of material having the readable characteristics 1306 as can be seen in Figure 14A would be interposed between the anterior face 1312 and the second layer of non-radiopaque material 1302),
and the readable characters are viewable in vivo using conventional imaging techniques (paragraph 0078).
Rogers discloses the invention substantially as claimed.
However, Rogers does not disclose manufacturing a breast implant, comprising; forming a breast implant marker, the forming comprising: providing a shell having an anterior face; and attaching the breast implant marker to the anterior face of the shell.
Carter discloses a breast implant (see Carter, Figures 1, item 10), comprising; forming a breast implant marker (see Carter, Figures 1 and 2, item 16; column 2, lines 30-34) the forming comprising: providing a shell having an anterior face (see Carter, Figure 1, item 12; column 2, lines 15-20); and attaching the breast implant marker to the anterior face of the shell (when the surface of the implantable device 1312 of Figure 14B of Rogers is residing in combination with the shell 12 of Carter, the breast implant marker 1300 of Rogers (Figure 14A) would be attached to the anterior face of the shell 12 of Carter).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the method of manufacturing a breast implant by forming a breast implant marker, the forming comprising: providing a shell having an anterior face; and attaching the breast implant marker to the anterior face of the shell as taught by Carter because Rogers discloses that the radiopaque marker can be used in an implantable medical device, therefore, utilizing the technology of Rogers in a breast implant to allow that the breast implant's size be readily ascertainable after it has been separated from its packaging would have been obvious to a person having ordinary skill in the art. The use of the techniques of forming a radiopaque marker attached to a surface taught by Rogers in the invention of Carter would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of providing a radiopaque marker in the anterior shell; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 18, as set forth supra, the combination discloses wherein the attaching the breast implant marker to the anterior face of the shell comprises attaching the breast implant marker to an inner surface of the anterior face of the shell (see Carter, Figure 1 depicts the breast implant marker 16 attached to the anterior face of the shell 12 to an inner surface of the anterior shell as shown in Figure 2 of Carter).
Regarding claim 20, as set forth supra, the combination wherein the attaching the second layer of non-radiopaque material (see Rogers, Figure 1, item 100; Figures 13A-C) to the first layer of material (see Rogers, Figure 1, item 200; Figures 13A-C) comprises laminating the second layer of non-radiopaque material to the first layer of material (see Rogers, paragraph 0114 states “Additionally or alternatively, a layer of epoxy or other lamination may be applied over a portion of the surface of the radiopaque articles and the object carrying those articles to affix the articles to the object.”).
Regarding claim 21, as set forth supra, the combination discloses wherein the removing at least a portion of the radiopaque material comprises controllably marking and cutting out the portion of the radiopaque material from the first layer of material with a laser (see Rogers, paragraph 0122).
Regarding claim 22, Rogers discloses wherein the first layer of material is a radiopaque material see Rogers, Figure 1, item 200; paragraph 0054, and the attaching a second layer of non-radiopaque material comprises attaching a clear silicone sheet to the silicone sheet having the radiopaque material (see Rogers, paragraph 0051 discloses that silicone may be used as the molded material for the second layer; Figure 1, item 100 “molded desiccant article”).
However, Rogers does not disclose wherein providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet.
Carter teaches a breast implant (see Carter, Figure 1) with a radiopaque marker (see Carter, Figures 1 and 2, item 16) wherein providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet (see Carter, column 2, lines 30-34).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the radiopaque material of the first layer of Rogers by providing the radiopaque material comprises incorporating barium sulfate into a silicone sheet as taught by Carter because the selection of a known material based on its suitability for its intended use is considered obvious. (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See MPEP 2144.07. The radiopaque material taught by Carter was suitable for use as a radiopaque marker in an implant that will be viewed on an x-ray, therefore, it would possess the biocompatibility, radiopacity, and other properties that would make it obvious to be used in the implant of Rogers.
Claims 17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al (US 2012/0065500 A1) in view of Carter (U.S. Patent No. 4,863,470) as applied to claim 16, and further in view of Quiros et al (US 2019/0142574 A1).
Regarding claim 17, as set forth supra, the combination discloses wherein the anterior face includes an upper pole region and a lower pole region, and a midline of the flexible shell extends from the upper pole region to the lower pole region (see Carter, Figure 1 annotated below).
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However, the combination does not disclose wherein the marker is positioned on the midline to indicate orientation of the breast implant during surgery.
Quiros discloses a breast implant (see Quiros, with a radiopaque marker wherein the marker is positioned on the midline to indicate orientation of the breast implant during surgery (see Martin, Figure 4, paragraph 0031).
Quiros discloses a breast implant (see Quiros, abstract) with a radiopaque marker (see Quiros, Figure 10B, item 1002) wherein the marker is positioned on the midline to indicate orientation of the breast implant during surgery (see Quiros, paragraph 0133).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the combination by providing wherein the marker is positioned on the midline to indicate orientation of the breast implant during surgery as taught by Quiros because this allows for measuring device rotation post-implantation (see Quiros, paragraph 0133).
Regarding claim 23, as set forth supra, the combination discloses attaching the breast implant marker to the anterior face of the shell (see Carter, Figure 2).
However, the combination does not disclose attaching the breast implant marker to an outer surface of the anterior face of the shell.
Quiros discloses a breast implant (see Quiros, abstract) with a marker with information useful in identifying and/or characterizing the implant (see Quiros, Figures 7A-G, item 706, paragraph 0095) attached to the shell (see Quiros, Figures 7A-G, item 104 “outer surface”) wherein attaching the breast implant marker comprises attaching to an outer surface of the anterior face of the shell (se Quiros, paragraph 0095 “may comprise a separate material adhered or otherwise affixed to a portion of the outer surface 104”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the attachment location of the breast implant marker of the combination by attaching the breast implant marker to an outer surface of the anterior face of the shell as taught by Quiros because this would be a predictable result. The marker would continue to be identifiable by x-ray, except now it would be located on the outside surface of the shell. This would be within the skill of a person having ordinary skill in the art.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al (US 2012/0065500 A1) in view of Carter (U.S. Patent No. 4,863,470) as applied to claim 16, and further in view of Huo et al (US Patent No. 6,464,999).
Regarding claim 19, as set forth supra, the combination discloses attaching the marker (see Carter, Figure 2, item 16) to the inner surface of the anterior face (see Carter, Figure 2, item 12).
However, the combination does not disclose wherein the attaching the marker comprises silicone vulcanizing the marker.
Huo discloses a medical device (see Huo, abstract) with radiopaque markers (see Huo, Figures 21-23, item 355; column 17, lines 17-21, and 25-29) wherein the attaching the marker comprises silicone vulcanizing the marker (see Huo, column 19, lines 34-37).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the attachment method of the combination by providing wherein the attaching the marker comprises silicone vulcanizing the marker as taught by Huo because the use of the technique of silicone vulcanizing taught by Huo in the invention of Rogers in view of Carter would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of adhering the marker to the breast implant; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al (US 2012/0065500 A1) in view of Carter (U.S. Patent No. 4,863,470) in view of Quiros et al (US 2019/0142574 A1) as applied to claim 23, and further in view of Huo et al (US Patent No. 6,464,999).
Regarding claim 24, as set forth supra, the combination discloses attaching the marker (see Carter, Figure 2, item 16) to the outer surface of the anterior face (see Quiros, Figures 7A-G; paragraph 0095).
However, the combination does not disclose wherein the attaching the marker comprises silicone vulcanizing the marker.
Huo discloses a medical device (see Huo, abstract) with radiopaque markers (see Huo, Figures 21-23, item 355; column 17, lines 17-21, and 25-29) wherein the attaching the marker comprises silicone vulcanizing the marker (see Huo, column 19, lines 34-37).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the attachment method of the combination by providing wherein the attaching the marker comprises silicone vulcanizing the marker as taught by Huo because the use of the technique of silicone vulcanizing taught by Huo in the invention of Rogers in view of Carter would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of adhering the marker to the breast implant; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Conclusion
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774