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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 24-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The examiner fails to delineate between 3D body segments and 2D body segments. All 2D objects inherently have a third dimension making them 3D.
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 1-30, 33, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rolfe et al (7,208,222).
Referring to all embodiments and figures, including figures 4-6A-1, Rolfe et al teaches an implantable prosthesis comprising:
a tissue infiltratable body 900 having a plurality of voids 930 configured to receive fat and/or tissue (column 12, lines 58-65),
the body 900 including a proximal end (generally 920) and a distal end (generally 930) spaced from the proximal end, the body including:
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a plurality of three-dimensional (3D) body segments (pores or layers) arranged in a stacked configuration (at least figure 6A-1) along a longitudinal axis extending in a direction from the proximal end to the distal end of the body, wherein each of the 3D body segments include one or more outwardly facing voids (as shown; outward is any direction).
Claims 2, 9, the plurality of body segments is interpreted as including a honeycomb structure. Also, see figure 1D2 and interpretation for claim 24.
Claim 3, as shown, each of the plurality of 3D body segments is in direct contact with an adjacent 3D body segment.
Claim 4, further comprising a plurality of two-dimensional (2D) body segments 910 arranged in the stacked configuration with the plurality of 3D body segments.
Claim 5, wherein each of the plurality of 2D body segments includes a planar sheet as shown.
Claim 6, wherein a first 3D body segment is stacked on top of a first 2D body segment.
Claim 7, see the included figure above showing the first 3D body segment (below 910) is in direct contact with the first 2D body segment.
Claim 8, see the including figure above showing a second 3D body segment is stacked on top of and is in direct contact with the second 2D body segment.
Claim 10, referring to figure 11G, a width of the body decreases in a direction from the proximal end to the distal end (increases than decreases fulfilling the claiming language). Also see figure 14E wherein distal end is generally 1460.
Claim 11, it is self-evident that the longitudinal axis coincides with a central axis of the prothesis.
Claim 12, further comprising a support structure coupled to the body and configured to support the body; see at least figure 6B stiffening members 65 and figure 14D solid core 1407.
Claim 13: See claim 1 above. Wherein each of the plurality of body segments is a toroidal shape; wherein each of the plurality of body segments is in direct contact with an adjacent body segment.
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Applicant’s plurality of body segments is a toroidal shape shown as a hole through the middle. The examiner interprets “a toroidal shape” accordingly. The transitionary phrase “comprising” allows for 1407 in figure 14D.
Claim 14, as shown and described in the specification, each of the body segments includes an opening.
Claim 15, further, as shown the openings of each of the plurality of body segments are aligned along the longitudinal axis to form a hollow core.
Claim 16, see column 12, lines 63-65.
Claim 17, hub 1407.
Claim 18, referring to figure 11G, a width of the body decreases in a direction from the proximal end to the distal end (increases than decreases fulfilling the claiming language). Also see figure 14E wherein distal end is generally 1460.
Claim 19, figure shows a body substantially hemispherical in shape. “Comprising” allows for a second body substantially hemispherical in shape. Also, see figure 12G and 20A.
Claim 20, the plurality of body components can be arbitrarily divided into a first body segment and a second body segment, wherein the second body segment is placed within an opening of the first body.
Claim 21, Rolfe et al teaches a coating or encapsulating which fulfills, “an outer layer defining a cavity, the body being located in the cavity”. See at least column 7, lines 22-29.
Claim 22, Rolfe et al teaches a coating or encapsulating which fulfills “further comprising an outer layer that covers the body”. See at least column 7, lines 22-29.
Claim 23, further comprising a support structure coupled to the body and configured to support the body; see at least figure 6B stiffening members 65 and figure 14D solid core 1407.
Claim 24, see at least column 2, lines 5-23. A method of fabricating an implantable prosthesis having a plurality of voids configured to receive fat and/or tissue, the method comprising acts of:
(a) stacking a first three-dimensional (3D) body segment (at least two sheets) along a longitudinal axis of a body extending in a direction from a proximal end to a distal end of the body;
(b) stacking a first two-dimensional (2D) body segment (the next single sheet) along the longitudinal axis of the body;
(c) stacking a second 3D body segment (the next at least two sheets) along the longitudinal axis of the body; and
(d) attaching the first 3D body segment, the first 2D body segment, and the second 3D body segment together (see at least step 6010 “bond sheet” in figure 6A-1),
the first 2D body segment is chosen and positioned in between the first 3D body segment and the second 3D body segment.
Claim 25, wherein act (b) includes stacking a planar sheet along the longitudinal axis (generally perpendicular to the sheets) of the body.
Claim 26, wherein each of the first and second 3D body segments includes one or more voids (pores) for receiving fat and/or tissue. For example, see figure 2D.
Claim 27, wherein the first and second 3D body segments have the same configuration; see figure 1D2.
Claim 28, wherein the first and second 3D body segments have different configurations; see figure 2D.
Claim 29, see at least column lines 3-23 and column 13, lines 42-56 teaching at least glueing fulfilling (d) includes suturing, gluing, and/or ultrasonically welding the first 3D body segment, the first 2D body segment, and the second 3D body segment together.
Claim 30, an act of (e) forming each of the first 3D body segment and the second 3D body segment is inherent.
Claim 33, see at least figure 1D2, wherein act (e) includes forming first and second 3D body segments having honeycomb structures.
Claim 35, wherein act (e) includes forming first a first and second 3D body segment having a toroidal shape; see discussion for claim 13 above.
Claim 36, the body is configured to augment and/or reconstruct the anatomical shape of a human breast; fully capable of augment/reconstruct the shape of a human breast. See column 12, lines 58-65 and column 2, lines 20-24.
Claims 1-12, 23-30, 33-34 and 36 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Offray et al (6,432,138; applicant cited).
Offray et al teaches an implantable prosthesis and method of fabricating capable of all the functional language. Said prosthesis comprising stacked 3D body segments and planar 2D body segments (depicted). As shown, the 3D body segments are pleated or honeycombed structure. See column 5, line 12-22.
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Claim 12, see support structure 10 or 12.
Claim 27, same configuration of style.
Claim 28, different configuration as far as size.
Claim 29, ultrasonic welding.
All other limitations are self-evident.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774
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