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 .
DETAILED ACTION
Election/Restrictions
Applicant timely traversed the restriction requirement in the reply filed on 04/28/2026 with the election of claims 1-25 and Figs. 1A-C. Therefore, claims 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-25 are presently pending in this application.
Applicant's election with traverse is acknowledged. The traversal is on the ground(s) that a Figs. 2A-2D and Figs. 3A-3C show different views of the embodiment of Figs. 1A-1C. This is not persuasive because Figs. 2A-2D disclose a shell 210 which is different from the shell in Figs. 1A-1C and Figs. 3A-3C disclose crisscrossed structure of filaments (par. 0138 of the PGPub of the present application). If the applicant believes that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one would disclose the other since they are obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-8, 10-17, 20-23 and 25 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Choi et al. (2022/0257365) “Choi”.
Regarding claim 1, Choi discloses a 3D printed nipple implant (par. 0080 and Fig. 2) comprising a macroporous network 100 with an open cell structure 110 (Figs. 2-3 and par. 0051 discloses the pore or interval size is up to 1500 um) comprising a cylindrical shape (par. 0015) for placement under the skin of the patient (par. 0013), wherein the cylindrical shape has first and second ends each with circular bases (the top and bottom ends of the body 100 is cylindrical and circular), a height measured between the two circular bases (height measured from the disc support 200 to the middle of the body 100; Fig. 2), a circumference (circumference of cylindrical body 100; Fig. 2), and wherein the macroporous network comprises at least two adjacent parallel planes of filaments bonded to each other (par. 0063 discloses melt extruding the polymer to form the cylindrical body 100 and par. 0068 discloses forming the body 100 with molten polymeric fibers which are heat bonded once extruded through the 3D printer head).
Regarding claim 4, Choi discloses wherein the implant further comprises a flange component 200 protruding from the circular base on the first end of the cylindrical shape (Fig. 2).
Regarding claims 5-8, Choi discloses wherein the filaments are arranged as chords with endpoints (as shown in Fig. 3, the fibers are straight and have endpoints); wherein the filaments are not continuous and wherein the endpoints of the filaments in a plane of filaments are not connected to another filament that is in the same plane of filaments; and wherein the filaments have endpoints on the circumference of the cylindrical shape, and do not form arcs on the circumference of the cylindrical shape (par. 0017 discloses the filaments are stacked at regular intervals and not continuous nor connected to each other forming arcs at the circumference).
Regarding claims 10, 17 and 21-22, Choi discloses wherein the macroporous network comprises an absorbable polymer (par. 0059 discloses the whole implant including the body 100 and disc 200 is biodegradable); wherein the absorbable polymer has one or more of the following properties: (i) an elongation at break greater than 100%; (ii) an elongation at break greater than 200%; (iii) a melting temperature of 60 *C or higher (par. 0067), (iv) a melting temperature higher than 100 *C, (v) a glass transition temperature of less than 0 *C, (vi) a glass transition temperature between -55 *C and 0 *C, (vii) a tensile modulus less than 300 MPa, and (viii) a tensile strength higher than 25 MPa; and wherein the absorbable polymer comprises, or is prepared from, one or more monomers selected from the group: glycolide, lactide, glycolic acid, lactic acid (par. 0059), 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, 3-hydroxybutyrate, 3- hydroxyhexanoate, 4-hydroxybutyric acid, 4-hydroxybutyrate, 3-hydroxyoctanoate, 8-caprolactone, 1,4-butanediol, 1,3-propane diol, ethylene glycol, glutaric acid, malic acid, malonic acid, oxalic acid, succinic aid, or adipic acid, or the absorbable polymer comprises poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof; and wherein the implant is absorbable (par. 0059 discloses the whole implant including the body 100 and disc 200 is biodegradable).
Regarding claims 11-13, Choi discloses wherein at least two parallel planes of filaments have the same orientation in adjacent planes or nonadjacent planes; wherein a first parallel plane of filaments is organized in a first geometrical orientation, and a second parallel plane of filaments is arranged in a second geometrical orientation such that the implant comprises a macroporous network of crisscrossed filaments; wherein the implant further comprises a third parallel plane of filaments, and the filaments in the first, second and third parallel planes form pores with a triangular shape (as shown in Figs. 2-3 and par. 0047 discloses triangular voids and microfibers are crossed).
Regarding claim 14, Choi discloses wherein the angle between the filaments in the parallel planes is selected from one of the following: between 1 and 90 degrees, or 18, 20, 30, 36, 45 or 60 degrees (par. 0047 discloses cross direction of the fibers and Fig. 3 discloses the angle to be less than 90 degrees).
Regarding claim 15, Choi discloses wherein the macroporous network comprises a plurality of macropores, and the macropores have an average diameter or average width of 75 to 2,000 microns (Figs. 2-3 and par. 0051 discloses the pore or interval size is up to 1500 um).
Regarding claim 16, Choi discloses wherein the filaments have one or more of the following properties: an average diameter or average width of 10 pm to 5 mm (par. 0051), a breaking load of 0.1 to 200 N, an elongation at break of 10 to 1,000%, and an elastic modulus of 0.05 to 1,000 MPa.
Regarding claim 20, Choi discloses wherein the implant further comprises one or more of the following: autologous fat, fat lipoaspirate, injectable fat, adipose cells, fibroblast cells (pars. 0085-0086), stem cells, gels, hydrogels, hyaluronic acid, collagen, antimicrobial agent, antibiotic agent, and bioactive agent.
Regarding claim 23, Choi discloses wherein the implant is manufactured by a process selected from the group comprising: (i) forming the macroporous network by 3D printing the parallel planes of filaments (par. 0080), (ii) forming the macroporous network by melt extrusion deposition 3D printing, and (iii) bonding the filaments in adjacent parallel planes by 3D printing (par. 0068).
Furthermore, regarding claim 23, a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claim 25, Choi discloses wherein the base of the first end comprises an open bottom aperture (par. 0016).
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 2-3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (2022/0257365) “Choi” in view of Van Belleghem et al. (2020/0324021) “Van Belleghem”.
Choi discloses the claimed invention of claim 1; except for wherein the implant further comprises a hemispherical shape at the second end of the cylindrical shape, and optionally, having a stiffness less than or equal to 20 kPa and wherein the macroporous network is enclosed by a shell or coating and wherein the macroporous network is at least partly filled with a hydrogel. However, Van Belleghem teaches a similar 3-D printed nipple implant (par. 0030) comprising a hemispherical shape at the second end of the cylindrical shape (as shown in Figs. 1F and 1G), and optionally (the term optionally does not positively recite the claim limitations it precedes), having a stiffness less than or equal to 20 kPa and wherein the macroporous network is enclosed by a shell or coating (par. 0055 discloses a non-degradable backbone; pars. 0093-0094 discloses a degradable network supported by a skeletal backbone) and wherein the macroporous network is at least partly filled with a hydrogel (par. 0092 discloses the degradable network comprises hydrogel). 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 the implant in Choi to include a hemispherical shape at the second end of the cylindrical shape, and optionally, having a stiffness less than or equal to 20 kPa and wherein the macroporous network is enclosed by a shell or coating and wherein the macroporous network is at least partly filled with a hydrogel, as taught and suggested by Van Belleghem, for providing a biocompatible implant that allows for tissue ingrowth and maintains the complex shape of the nipple (par. 0055).
Claims 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (2022/0257365) “Choi”.
Choi discloses the claimed invention of claim 1; except for wherein the macroporous network has an infill density of filaments of between 1% and 60%, or between 5% and 25% and wherein the implant has a compressive modulus of 0.1 kPa to 10 MPa at 5 to 15% strain. However, Choi does disclose the body having a certain porosity that can be varied and the required diameters of the macropores and dimeter of the filaments (pars. 0050-0051). Furthermore, Choi discloses the compressive strength of the nipple can be modified by porosity (par. 0090). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the macroporous network has an infill density of filaments of between 1% and 60%, or between 5% and 25% and wherein the implant has a compressive modulus of 0.1 kPa to 10 MPa at 5 to 15% strain, since these are result effective variables that contribute to the overall mechanical properties of the nipple implant, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying the implant as suggested, would allow for a nipple implant that closely mimics a natural areola. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “the shell comprises a stack of concentric filaments”, which has not been found anticipated by or obvious over prior art. The closest prior art of Choi et al. and Van Belleghem et al. fail to disclose a shell having stacked concentric filaments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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