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 .
Applicant’s election without traverse of Group I in the reply filed on 5/15/26 is acknowledged.
Claims 49-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/26.
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.
Claims 32, 38, 45, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL document Title: Mechanically Robust Gelatin-Alginate IPN Hydrogels by a Combination of Enzymatic and Ionic Crosslinking Approaches.
The NPL document discloses a three-dimensional body implant which comprises a hydrogel comprising cross-linked gelatin and cross-linked alginate (see abstract and page 506), wherein said hydrogel has a mechanical strength of from 1 kPa to 1000 kPa (see Figs. 2-4 and second paragraph in page 508) and that said implant has at least one porous zone, the porous zone comprising a plurality of pores each having a pore size, the porous zone having an overall porosity of from 100 micron to 10000 micron (see page 512 Figure 11 disclosing a scale of 10 microns), the overall porosity corresponding to an average of the pore sizes measured in the porous zone.
Regarding claims 38 and 45, the reference discloses at least one layer of porous material.
Claim Rejections - 35 USC § 103
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 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.
Claims 33-37, 39, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over NPL document Title: Mechanically Robust Gelatin-Alginate IPN Hydrogels by a Combination of Enzymatic and Ionic Crosslinking Approaches in view of Mathisen et al US Patent Pub. 2018/0228598A1.
The NPL reference discloses the invention substantially as claimed. However, the NPL reference is silent regarding the porous configuration of the implant, such as the homogeneous pore sizes/shape, how the pores are distributed, the 3D structure of the pores (shape), the implant volume and if the implant is a breast implant.
Regarding claims 33, 34, 36 and 39, see paragraphs 71, 72 and 75 disclosing an homogeneous pore zones having an homogeneous porous interior and made with a 3D printer capable of having any particular shape. Additionally, paragraph 72 discloses a porous zone having a combination of open pores or slits for the purpose of promoting the growth of tissue around the implant.
It would have been obvious to one ordinary skill in the art to have homogeneous pore zones, homogeneously distribute and having pores having different shapes in order to promote the growth of tissue around the implant.
Regarding claims 47 and 48, the Mathisen et al reference discloses a breast implant (see paragraphs 13 and 14). It is inherent to have a volume range from 0.05mL to 3L when using a breast implant.
Allowable Subject Matter
Claims 40-44 and 46 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 7/14/26
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