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 .
Election/Restrictions
Restriction requirement mailed 05/04/2026 is withdrawn, see details in interview summary mailed 06/10/2026. Claims 1-19, 23, 41-58 and 62-63 have been examined, details below.
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.
Claim(s) 1-5, 13-17 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glickman et al. US 20150351900 A1, herein referred to as Glickman.
Regarding claim 1, Glickman discloses an implantable prosthesis (Fig 4a, 400; [0001]) comprising: a body of biocompatible material ([0075]:” present invention is formed of a biocompatible material […] to be used for implantation in the human body”) having a proximal end and a distal end spaced from the proximal end (top and bottom),
the body including: a hollow core structure (412) extending along a core axis (Fig 4a, defined by hollow), the hollow core structure including a proximal opening at a proximal end thereof and a distal opening at a distal end thereof (top and bottom openings);
a plurality of body segments (410) attached to the hollow core structure (Fig 4a), the plurality of body segments being arranged circumferentially about the hollow core structure (Fig 4a), each of the plurality of body segments extending in an outward radial direction away from the core axis (Fig 4a);
and a plurality of cavities (402) formed by the plurality of body segments (Fig 4a), the plurality of cavities arranged in the outward radial direction facing away from the hollow core structure (Fig 4a).
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First Glickman Annotated Fig 2a
Regarding claim 2, Glickman discloses wherein each of the plurality of body segments is connected to an adjacent body segment to form the plurality of cavities (Fig 4a).
Regarding claim 3, Glickman discloses further comprising a distal layer (Fig 4c, 422) of material attached to the distal end of the body (Fig 4c).
Regarding claim 4, Glickman discloses wherein the distal layer is attached to one or more of the body segments (Fig 4c).
Regarding claim 5, Glickman discloses wherein the distal layer overlies the distal opening of the hollow core to prevent access to the hollow core from the distal end thereof ([0105]).
Regarding claim 13, Glickman teaches wherein each body segment includes a plurality of body layers (moving further from the center of the implant forms more layers of body to form more cavities) extending in an outward radial direction away from the core axis (Fig 4a-b).
Regarding claim 14, Glickman teaches wherein each body segment includes a plurality of pairs of body layers coupled together (Figs 4a-b).
Regarding claim 15, Glickman teaches wherein the body layers of each pair of body layers are coupled together (Figs 4a-b).
Regarding claim 16, Glickman teaches wherein the body has a frusto-conical shape (Figs 4a-b).
Regarding claim 23, Glickman teaches wherein the body is configured to augment and/or reconstruct an anatomical shape of a human breast ([0002]).
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(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glickman.
Regarding claim 9, Glickman discloses further comprising a proximal layer (Fig 4c, 412) of material attached to the proximal end of the body opposite the distal end (Fig 4c), but fails to explicitly disclose wherein the proximal layer having an opening therethrough which is aligned with the proximal opening of the hollow core to permit access to the hollow core through the proximal layer.
However, in another embodiment, Glickman further teaches an implant (Fig 5a-b, 500) wherein the proximal layer (504) having an opening (510 mesh) therethrough which is aligned with the proximal opening of the hollow core (Fig 4a, 412; top opening) to permit access to the hollow core through the proximal layer (Figs 5a-b).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman to incorporate wherein the proximal layer having an opening therethrough which is aligned with the proximal opening of the hollow core to permit access to the hollow core through the proximal layer, as taught and suggested by Glickman in order to promote tissue ingrowth (Glickman [0112]).
Regarding claim 10, Glickman discloses the invention substantially as claimed and as discussed above with respect to claim 9, and additionally teaches wherein the opening in the proximal layer is larger than the proximal opening of the hollow core (Fig 5a-b and Fig 4a).
Regarding claim 11, Glickman discloses the invention substantially as claimed and as discussed above with respect to claim 9, and additionally teaches wherein the proximal layer has an annular configuration (Fig 5a-b).
Regarding claim 12, Glickman discloses the invention substantially as claimed and as discussed above with respect to claim 9, and additionally teaches wherein the proximal layer is attached to one or more of the body segments (Fig 4c and Figs 5a-b).
Claim(s) 6-8 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glickman in view of Asefi et al. US 20200246604 A1, herein referred to as Asefi.
Regarding claim 6, Glickman discloses the invention substantially as claimed and as discussed above with respect to claim 4, but fails to explicitly disclose wherein the distal layer includes an opening therethrough which is aligned with the distal opening of the hollow core.
However, in the same field of invention, Asefi discloses an implantable prosthesis (Fig 14d, 2001) comprising: a body (1819) of biocompatible material ([0019]); the body including: a hollow core structure (1807), a plurality of body segments attached to the hollow core structure (1809b); a distal layer ([0045] and [0105]; Fig 14a, 1419). Asefi teaches wherein the distal layer includes an opening (aperture 2025) therethrough which is aligned with the distal opening of the hollow core (Fig 14d).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman to incorporate wherein the distal layer includes an opening therethrough which is aligned with the distal opening of the hollow core, as taught and suggested by Asefi in order to allow fluid flow, such as gas escaping from a delivery balloon used to place said implant as discussed by Glickman in para [0119], therefore providing surgical drainage (Asefi [0105]).
Regarding claim 7, Glickman as modified by Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 6, but fails to explicitly disclose wherein the opening in the distal layer is larger than the distal opening of the hollow core.
However, in another embodiment, Asefi also teaches wherein the opening in the distal layer is larger than the distal opening of the hollow core (Fig 24; [0106]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman as modified by Asefi to incorporate wherein the distal layer includes an opening therethrough which is aligned with the distal opening of the hollow core, as taught and suggested by Asefi in order to control flow rate as needed, such as adjusting the rate of gas escaping from a delivery balloon used to place said implant as discussed by Glickman in para [0119], therefore providing surgical drainage (Asefi [0106]).
Regarding claim 8, Glickman as modified by Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the distal layer has an annular configuration (Asefi Fig 14d).
Regarding claim 17, Glickman as modified by Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 6. Asefi teaches wherein the body is formed of absorbable material ([0080], Asefi teaches using PGA, a well-known absorbable materials).
It would have been obvious to one of ordinary skill in the art to prior to the effective filling date of the claimed invention to modify the material of the body of Glickman to incorporate wherein the body is formed of absorbable material, as taught and suggested by Asefi in order to make the implant absorbable (Asefi [0080]).
Regarding claim 18, Glickman as modified by Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 6. Asefi teaches wherein the body is formed of P4HB (Poly-4-hydroxybutyrate) ([0080]).
It would have been obvious to one of ordinary skill in the art to prior to the effective filling date of the claimed invention to modify the body material of Glickman to incorporate wherein the body is formed of P4HB, as taught and suggested by Asefi in order to make the implant absorbable (Asefi [0080]), and since it is known to one of ordinary skill in the art to substitute one polymer for another.
Regarding claim 19, Glickman as modified by Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 6. Glickman does not teach wherein the body is tissue infiltratable. Asefi teaches wherein the body is tissue infiltratable (Asefi apertures allow filtration).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the body of Glickman to incorporate wherein the body is tissue infiltratable, as taught and suggested by Asefi in order to allow fluid flow, such as gas escaping from a delivery balloon used to place said implant as discussed by Glickman in para [0119], therefore providing surgical drainage (Asefi [0105])
Claim(s) 41-56 and 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glickman in view of Crawley et al. US 20050165447 A1, herein referred to as Crawley.
Regarding claim 41, Glickman discloses an implantable prosthesis (Fig 4a, 400; [0001]) comprising:
a body having a three-dimensional configuration of biocompatible material (annotated Fig 4a below; [0075]), the body including: a hollow core (412) located along a core axis (as defined by hollow of core);
a plurality of body segments (410) arranged circumferentially about the hollow core (Fig 4a), each of the plurality of body segments extending in an outward radial direction away from the core axis (Fig 4a),
and a plurality of cavities (402) formed by the plurality of body segments (Fig 4a), the plurality of cavities facing in the outward radial direction away from the hollow core (Fig 4a).
Glickman does not explicitly disclose each body segment including at least four body layers fabricated from a sheet of material, the sheet being folded about a first fold and a second fold transverse to the first fold.
However, in the same field of invention, Crawley discloses an implantable prosthesis (10) comprising: a body of biocompatible material (Fig 2, 14, [0043]); the body including: a hollow core structure (12), a plurality of body segments (Fig 2a, 34) attached to the hollow core structure (Fig 2). Crawley teaches wherein each body segment including at least four body layers (Fig 2, folds) fabricated from a sheet of material (Fig 2, sheet 32; plurality of layers), the sheet being folded about a first fold and a second fold transverse to the first fold (see annotated Fig 2a below; folds being the corrugation shown).
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Crawley Annotated Fig 2a
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman to incorporate wherein each body segment including at least four body layers fabricated from a sheet of material, the sheet being folded about a first fold and a second fold transverse to the first fold, as taught and suggested by Crawley in order to provide reinforcement to a tissue expander (Crawley [0043]), as retaining shape is as well-known challenge as shown in para [0021] of Glickman; and therefore would lead to a reasonable expectation of success.
Regarding claim 42, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41, and additionally teaches wherein each of the body layers is coupled together along the second fold (see annotated Crawley Fig 2a above).
Regarding claim 43, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 42, and additionally teaches wherein the second fold extends in a direction parallel to the core axis (Crawley Fig 2).
Regarding claim 44, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41, and additionally teaches wherein the second fold bifurcates the first fold into a first fold segment and a second fold segment (Crawley Fig 2), the first and second fold segments extending in a radial direction relative to the core axis (Crawley Figs 2 and 2a).
Regarding claim 45, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 44, and additionally teaches wherein the first fold segment couples a first pair of the body layers together (see annotated Crawley Fig 2a above) and the second fold segment couples a second pair of the body layers together (see annotated Crawley Fig 2a above).
Regarding claim 46, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 45, and additionally teaches wherein each of the first and second pairs of body layers includes an inner body layer (Crawley Fig 2a, 12) and an outer body layer (Crawley Fig 2b, 12), the inner body layers of the first and second pairs of body layers facing each other and being located between the outer body layers of the first and second pairs of body layers (Fig 2, folded orientation in center).
Regarding claim 47, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 46, and additionally teaches wherein each body layer includes an outer periphery (see annotated Fig 2 below) extending from a proximal end to a distal end of the body segment (see annotated Crawley Fig 2a above), the inner and outer body layers of each of the first and second pairs of body layers being attached to each other at a first location (Fig 2a-b, 38) adjacent the outer periphery between the proximal end and the distal end of the body segment (Fig 2).
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Crawley Annotated Fig 2
Regarding claim 48, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 47, Glickman teaches wherein the inner body layers of the body segment are attached to each other at a second location (at least two 38 see [0044]) adjacent the outer periphery between the proximal end and the first location (Fig 2a-b and 2).
Regarding claim 49, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 48, and additionally teaches wherein each outer body layer of the body segment is attached the outer body layer of an adjacent body segment at a second location adjacent the outer periphery between the proximal end and the first location (see annotated Crawley Fig 2 above).
Regarding claim 50, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 48, and additionally teaches wherein each outer body layer of the body segment is attached to the outer body layer of an adjacent body segment at a third location between the first location and the distal end of the body segment (Crawley annotated Fig 2 above).
Regarding claim 51, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 47, and additionally teaches wherein the first and second fold segments are located at the proximal end of the body (Crawley annotated Figs 2 and 2a).
Regarding claim 52, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 51. Glickman teaches further comprising a proximal layer (Fig 2, 32 layers close to center) of material attached to the proximal end of the body at the first and second fold segments of each body segment (see annotated Figs 2 and 2a).
Regarding claim 53, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41. Glickman teaches wherein the second fold is perpendicular to the first fold (corrugation perpendicular to folding of Fig 2).
Regarding claim 54, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 51. Glickman discloses wherein the proximal end has a first diameter and the distal end has a second diameter which is smaller than the first diameter (Glickman annotated Fig 4c below; diameter one is smaller than the second diameter).
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Second Glickman Annotated Fig 2a
Regarding claim 55, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41. Glickman additionally teaches wherein the body has a frusto-conical shape (Glickman Figs 4a-b).
Regarding claim 62, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41, and additionally teaches wherein the body is configured to augment and/or reconstruct an anatomical shape of a human breast (Glickman [0002]).
Regarding claim 63, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41, and additionally teaches further comprising a hollow core structure located along the core axis to form the hollow core (Glickman Fig 4a), the plurality of body segments being connected to the hollow core structure (Glickman Fig 4a).
Claim(s) 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glickman in view of Crawley, and further in view Aesfi.
Regarding claim 56, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 41. Asefi teaches wherein the body is formed of absorbable material ([0080], Asefi teaches using PGA, a well-known absorbable materials).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman as modified by Crawley to incorporate wherein the body is formed of absorbable material, as taught and suggested by Asefi in order to make the implant absorbable (Asefi [0080]).
Regarding claim 57, Glickman as modified by Crawley discloses the invention substantially as claimed and as discussed above with respect to claim 56, but fails to disclose wherein the body is formed of P4HB (Poly-4-hydroxybutyrate).
Asefi teaches and wherein the body is formed of P4HB (Poly-4-hydroxybutyrate) ([0080]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Glickman as modified by Crawley to incorporate wherein the body is formed of P4HB (Poly-4-hydroxybutyrate), as taught and suggested by Asefi in order to make the implant absorbable (Asefi [0080]), and since it is known to one of ordinary skill in the art to substitute one polymer for another.
Regarding claim 58, Glickman as modified by Crawley and Asefi discloses the invention substantially as claimed and as discussed above with respect to claim 56, wherein the body is tissue infiltratable (Asefi teaches apertures that allow tissue to filtratate).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the body of Glickman to incorporate wherein the body is tissue infiltratable, as taught and suggested by Asefi in order to allow fluid flow, such as gas escaping from a delivery balloon used to place said implant as discussed by Glickman in para [0119], therefore providing surgical drainage (Asefi [0105]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
