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 .
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.
Response to Amendment
The amendment filed 06/08/2026 has been entered. Claims 1, 4-5, 10-12, and 14-15 remain pending in the application. Claims 7-8 and 13 have been cancelled.
Response to Arguments
Applicant's arguments filed 0 have been fully considered but they are not persuasive.
Applicant argues that Chitre fails to disclose the newly added limitation, and the Examiner respectfully disagrees. A new interpretation of Chitre has been set forth below in which the shape memory film is now considered to comprise the collective of layers 38, 40, 36, in which layers 36, 38, and 40 imparts the shape memory characteristics of the shape memory film, layer 38 forms the openly exposed layer of the shape memory film, layer 36 forms the interior surface of the shape memory film, and component 26 forms the filler. The shape memory material is considered to give the modified Chitre device the capability of performing the function of recovering the implant’s shape when subject to body temperature of a patient, at least to some degree.
In response to applicant's argument that the implant, and therefore lack motivation of combination, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the argument that the limitation “…shape of the breast tissue removal site after the partial mastectomy…” is a significant amendment that overcomes the prior art, the Examiner respectfully disagrees. The shape of a breast tissue removal site after a partial mastectomy varies widely due to many factors involved with specific patient anatomy, the particular procedure performed, injuries, health, etc. A partial mastectomy encompasses a wide range of percentages of the breast having been removed. Since the modified Chitre device is capable of conforming to at least some existing tissue removal site, the cited prior art renders obvious the significantly broad claim limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 4, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0270391 A1 (hereafter --Chitre--), in view of US 20170258574 A1 (hereafter --Hutmacher--).
Regarding Claim 1, Chitre discloses a patient-specific breast implant configured to be inserted into a breast tissue removal site of a human after a partial mastectomy (see paragraph [0018]), comprising:
a shell portion (36, 38, 40) constituting an outer wall (see the annotated shell portion 38 in Figure 1 below) that bounds a compartment (see annotated compartment in Figure 1 below);
a filler (26) disposed within the compartment bounded by the shell portion (see annotated filler 26 in Figure 1 below), wherein the shell portion has an original shape that is complementary to a shape of the breast tissue removal site after the partial mastectomy (see annotated breast implant in Figure 1 below, being breast shaped),
wherein the shell portion (36, 38, 40) is formed only of shape memory film that is made only of a shape-memory polymer, the shape memory film forming an outer circumferential surface of the shell portion that is openly exposed (see paragraph [0078] denoting layers 36 and 38 are made of elastomeric material, the layer 38 forming an openly exposed layer of the shell, see also paragraph [0080] denoting that the layer 40 comprises of a synthetic polymer like polyurethane or polyethylene, both of which are known within the skill of the art to have shape memory properties).
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Chitre fails to disclose wherein the shape-memory polymer being a polymer material that is changeable in shape according to temperature change, the shape memory film is recoverable in shape when subject to the physiological body-temperature range of a human so that when the breast implant is disposed within the breast tissue removal site and an external force deforms the shell portion to a temporary shape, the shell portion automatically returns to the original shape when the external force is removed.
Hutmacher discloses a breast implant for breast reconstruction or augmentation, on use case being for after a mastectomy (see paragraph [0036], [0076], and [0077]), wherein the implant has a shape memory polymer material (see paragraphs [0109] and [0111]). Hutmacher teaches wherein the shape-memory polymer being a polymer material that is changeable in shape according to temperature change, and wherein the shape memory film is recoverable in shape when subject to the physiological body-temperature range of a human so that when the breast implant is disposed within the breast tissue removal site and an external force deforms the shell portion to a temporary shape, the shell portion automatically returns to the original shape when the external force is removed (see paragraphs [0109] and [0111]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of invention to have modified the shape memory film of Chitre to be comprised of a shape-memory polymer being a polymer material that is changeable in shape according to temperature change, and wherein the shape-memory polymer that is recoverable in shape when subject to the physiological body-temperature range of a human so that when the breast implant is disposed within the breast tissue removal site and an external force deforms the shell portion to a temporary shape, the shell portion automatically returns to the original shape when the external force is removed as taught by Hutmacher, as by as doing so would allow the surgeon to reduce the amount of tissue injury during implantation and thus permits the use of minimally invasive procedures (see paragraph [0111]).
Regarding Claim 4, Chitre as modified discloses the patient-specific breast implant of claim 1, wherein the shape-memory polymer material is polyurethane (see Hutmacher’s paragraph [0039]).
Regarding Claim 12, Chitre as modified discloses the patient-specific breast implant of claim 1.
Chitre as modified fails to disclose further comprising a fixing portion protruding from the outer surface of the shell portion. Chitre teaches in another embodiment a fixing portion protruding from the outer surface of the shell portion (see annotated fixing portion 128 in Figure 6 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of invention to have the implant of Fig. 1 further comprise a fixing portion protruding from the outer surface of the shell portion as taught by Chitre in the embodiment of Fig. 6, as by doing so would facilitate rolling or folding of device during insertion (see paragraph [0110]).
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Regarding Claim 14, Chitre as modified discloses the patient-specific breast implant of claim 1, wherein the shape memory film completely surrounds the compartment in which the filler is disposed so that the shape memory film completely encloses the filler (see annotated filler, compartment, and shape memory film 38 Figure 1 above).
Regarding Claim 15, Chitre as modified discloses the patient-specific breast implant of claim 1, wherein the shape memory film comprises the shape-memory polymer extending from an openly exposed exterior surface (38) of the shape memory film to an opposing interior surface (36) of the shape memory film (see annotated exposed outer surface and annotated interior surface of shape memory film layer 36, 38, and 40 in Figures 1 and 2 above), the interior surface of the shape memory film being disposed directly on the filler (see annotated filler 26, and interior surface of shape memory film 36 in Figure 1 above).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 20110270391 A1 (hereafter --Chitre--) in view of US 20170258574 A1 (hereafter --Hutmacher--), as applied to claim 4 above, and further view of US 20190247180 A1 (hereafter --Limem--)
Regarding Claim 5, Chitre as modified discloses the patient-specific breast implant of claim 4.
Chitre fails to disclose wherein the shape-memory polymer material is the polyester-based polymer, and the polyester-based polymer is any one or a combination of two or more that are selected from polyphosphazene, polyanhydride, poly acetal, polyorthoester, polyphosphoester, polyglycolide, poly-F-caprolactone, polylactide, polycarbonate, and polyamide.
Limem discloses a breast implant with a shell forming an outer wall of the implant (see annotated implant and shell in Figures 6B and 6A below), wherein the shell portion comprises a shape memory polymer (see paragraph [0167]). Limem teaches the polymer material is the polyester-based polymer, and the polyester-based polymer is any one or a combination of two or more that are selected from polyphosphazene, polyanhydride, polyorthoester, polyphosphoester, polylactide, polycarbonate, and polyamide (see paragraph [0104]).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the polymer of Chitre in view of Hutmacher to be a combination of two or more polymers that are selected from polyphosphazene, polyanhydride, polyorthoester, polyphosphoester, polylactide, polycarbonate, and polyamide since they are known materials for breast implants as taught by Limem (see paragraph [0167]) and, further, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The limitation “which are certified to be harmless when inserted into the human body” is inherently disclosed as the materials used for the implants are biocompatible, meaning they are compatible with living tissue and are nontoxic, injurious, or physiologically reactive and not causing immunological rejection (Merriam-Webster online dictionary), and these materials are certified for biocompatibility in medical device manufacturing.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110270391 A1 (hereafter --Chitre--) in view of US 20170258574 A1 (hereafter --Hutmacher--), as applied to claim 1 above, in further view of US 20110276136 A1 (hereafter --Koole--).
Regarding Claim 10, Chitre as modified discloses the patient-specific breast implant of claim 1.
Chitre fails to disclose wherein the filler is made of a shape memory polymer.
Koole discloses a breast implant that has an outer shell portion that is an outer wall that is filled with a core filling material (see Figure 1 below, see also Abstract). Koole teaches that it is well known in the art for the filler of a breast implant to be made of a shape memory polymer (see paragraph [0004] describing the “cohesive gel” filler option having shape memory properties).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the material of the filler of the breast implant of Chitre in view of Hutmacher to be made of a shape memory polymer, as by doing would enable the filler of the implant to retain its shape and volume (due to its shape memory properties) as they reside within the shell cavity in the event of a rupture, compared to implants that are filled with silicone gel (without shape memory) that would escape from the shell and spread into the surrounding tissues in the event of a rupture as taught by Koole (see paragraph [0004]).
Regarding Claim 11, Chitre as modified discloses the patient-specific breast implant of claim 10, wherein the shape memory film of the shell portion is made of a shape memory polymer (see paragraphs see paragraph [0044] denoting that the intermediate layer 26 provides a shape memory characteristic to the assembly, see also paragraph [0080] denoting that the layer 40 comprises of a synthetic polymer like polyurethane or polyethylene, both of which are known within the skill of the art to have shape memory properties, and Hutmacher’s paragraph [0039]). The limitation “formed through 3D printing” is being treated as a product by process limitation; that is the shell portion and the filler are made by 3D printing. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Chitre as modified is silent as to the process used to make the filler and the shell portion, it appears that the breast implant would be the same or similar as that claimed; especially since both applicant’s breast implant and the prior breast implant comprise a shell and filler that are both made of only shape memory polymers.
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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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