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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, Line 6: the limitation “each channel” should read “each hollow channel” in order to keep the claim language consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hutmacher (US PGPub 2017/0258574).
Regarding Claim 1, Hutmacher teaches a method for forming an implant, the method comprising:
sequential printing layers to form a three-dimensionally (3D) printed structure (Paragraph 0117 discloses fused deposition modeling/fused filament fabrication which is a 3D printing process),
wherein each layer is printed according to an infill pattern, the infill pattern of each layer comprising a set of infill lines (Paragraph 0105 and Paragraph 0117; see Figures 9A-9B for illustration of patterns and infill lines),
wherein the layers are printed on top of one another such that a plurality of hollow channels (voids) are formed within the implant (Paragraph 0100 and Paragraph 0105; Figures 9A-9B),
wherein the walls of each channel are formed by sections of the infill lines of a plurality of layers of the printed structure of layers (as described in Paragraph 0041),
wherein each hollow channel (voids) extends between a first outer surface of the implant and a second outer surface of the implant (as seen in Figures 1-2C), wherein each hollow channel (voids) is oriented in a direction which is tilted (Paragraph 0050)with respect to a reference axis perpendicular to the first outer surface of the implant (as seen in Figure 1A).
Regarding Claim 2, Hutmacher teaches the method of claim 1, further comprising:
providing a channel direction vector defining a tilt of the channels to be formed (Paragraph 0214-0215);
specifying a pore dimension of a first pore of a layer to be formed at a first height, wherein the first pore is represented by a first line segment (Paragraph 0040-0041 and Paragraph 0214; Figures 9A-B); and
specifying a pore dimension of a second pore of a layer to be formed at a second height, wherein the second pore is represented by a second line segment, the first pore and the second pore belonging to the same channel to be formed (Paragraph 0040-0041 and Paragraph 0214; Figures 9A-B).
Regarding Claim 3, Hutmacher teaches a method of tissue reconstruction or tissue augmentation (Paragraph 0134), the method comprising implanting into the body of a subject an implant (Paragraph 0134), wherein the implant comprises:
a three-dimensionally (3D) printed structure of layers (Paragraph 0040; Figures 9A-D and Figures 21-22), wherein each layer comprises an infill pattern of the three-dimensionally printed structure (Figure 9; Paragraph 0105), the infill pattern of each layer comprising a set of infill lines (Figure 9; Paragraph 0105); and
a plurality of hollow channels (Figure 1 and Figures 21-22; Paragraph 0040-0042 and Paragraphs 0046-0050) which describe both holes/pores AND voids, each can be interpreted as a plurality of hollow channels),
wherein the layers are arranged on top of one another such that the plurality of hollow channels are formed within the implant (Paragraphs 0046-0050; Figure 1 and Figure 22), wherein the walls of each channel are formed by sections of the infill lines of a plurality of layers of the printed structure of layers (Figure 1 and Figures 21-22; Paragraph 0054),
wherein at least one hollow channel extends between a first outer surface of the implant and a second outer surface of the implant (Figure 1-4 and Figures 21-22),
wherein the at least one hollow channel is oriented in a direction which is tilted (Paragraph 0050) with respect to a reference axis perpendicular to the first outer surface of the implant (Figures 1-4 and Figures 21-22; Paragraph 0054 and 0191) .
Regarding Claim 4, Hutmacher teaches the method of claim 3, wherein the implant is a breast implant (Paragraph 0040; see Figure 12).
REASONS FOR ALLOWANCE
Claims 5-16 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Hutmacher (US PGPub 2017/0258574) Sharp (US PGPub 2012/0215310), and Gabbrielli (US PGPub 2011/0125284) does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed method of Independent Claims 5, which recite, inter alia "wherein a wall of a first tilted hollow channel is a wall of a second adjacent tilted hollow channel; and wherein each tilted hollow channel comprises slanted walls, wherein a slanted wall is formed by sections of the infill lines of a plurality of alternate layers of the printed structure of layers, wherein the sections of infill lines are oriented in a first direction, and arranged above one another with a lateral offset, wherein the lateral offset is a dimension in a direction parallel to a first outer surface of the implant, wherein the lateral offset is larger than zero and less than 50% of a lateral channel dimension, wherein the plurality of tilted hollow channels extends between a first outer surface of the implant and a second outer surface of the implant, wherein a tilted hollow channel is oriented in a direction which is tilted with respect to a reference axis perpendicular to the first outer surface of the implant.".
The closest prior arts of record disclosed teaches an implant for insertion into a patient similar to that of Claims 5, however the prior art of record does not disclose that the sections of infill lines are arranged above one another with a lateral offset that is larger than zero and less than 50% of a lateral channel dimension.
Because none of the prior art documents of record teach an method of tissue reconstruction or tissue augmentation as recited in Claims 5-20, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to arrive at the technical solutions of Claims 5-20 according to the prior art documents or a combination thereof. Therefore, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771