DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/3/2026 has been entered.
Claim Status
As of the Final Office Action mailed 12/12/2025, claims 1 and 4-5 were pending.
In Applicant's Response filed on 3/12/2026, claim 1 was amended.
As such, claims 1 and 4-5 are pending and have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
Claim Interpretation
Claim 1 was amended to recite “having a major and a minor axis”. The specification does not define what a “major” and “minor” axis is; however, the examiner has interpreted these to mean “length” and “width” respectively (see screenshot below).
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Claim 1 recites “bag-shaped body”. The examiner is interpreting “bag-shaped” to mean a pouch.
Claim Rejections - 35 USC § 103 – Maintained/Modified
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.
Claim(s) 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al (JP 2016140494A, 30 Jan 2015) in view of Mlodinow et al (US 10,363,127 B2, 12 Nov 2018; Published 30 July 2019). Please note that while claim 1 was amended, the rejection remains substantially the same as posited in the final Office action filed 12/12/2025.
Sakamoto teaches a biodegradable (absorbable) adipose tissue reconstruction member capable of reconstructing a breast by regenerating the adipose tissue after partial excision (abstract). The adipose tissue reconstruction member comprises a sponge containing collagen (i.e., has holes) and a porous body (i.e., mesh) containing polylactic acid having a bag shape and internal space where the sponge is accommodated in the space (abstract, see claim 1 of Sakamoto) (“A method of using the adipose tissue regeneration substrate according to claim 1, comprising implanting the adipose tissue regeneration substrate into a defect caused by partial mastectomy” as in instant claim 5). Example 1 of Sakamoto describes a collagen sponge coated with a PLA mesh sheet to form the reconstruction member with an elliptical shape (see example of Sakamoto, see Fig. 2 and 3 of Sakamoto; see screenshots below) (“granular body made of a bioabsorbable material each granular body having an inner space and having on a surface a plurality of openings leading to the inner space; . . . wherein each of the granular bodies is an ellipsoidal body having a major axis and a minor axis and comprising a mesh and a porous body inside the mesh, the mesh contains polylactic acid . . ., and the porous body has holes and is made of a bioabsorbable material” as in instant claim 1 in-part). Please note that while Sakamoto does not explicitly teach a plurality of adipose tissue reconstruction members or that the plurality of granular bodies comprises 5 to 100 granular bodies, it would have been prima facie obvious to make multiple reconstruction members as Sakamoto teaches that the member can advantageously serves as a scaffold for regenerating three-dimensional adipose tissue after implantation. Furthermore, as per MPEP 2144.04, duplication of parts is per se obvious as a routine expedient. Since the sponge has a structure accommodated in the porous body, the peripheral adipose tissue can easily enter the sponge through the pores and supply sufficient nutrients to the adipose tissue adhered to the sponge. Furthermore, the adipose tissue can be regenerated with a sponge while maintaining the shape retaining property of the member with the porous body. Given these advantages taught by the prior art, it would be prima facie obvious to have multiple reconstruction members, reading on “a plurality of granular bodies” as in instant claim 1 in-part.
The difference between Sakamoto and the instant invention is that it does not teach that the plurality of granular bodies are in a bag-shaped body (i.e., additional pouch) made of a bioabsorbable material, the bag-shaped body having openings and wrapping the granular bodies (instant claim 1 in-part). It also does not teach that the bioabsorbable material constituting the bag-shaped body is polyglycolide, a copolymer of polyglycolide and another bioabsorbable material, or a copolymer of lactic acid and another bioabsorbable material (instant claim 4).
Mlodinow teaches a mesh pouch for holding a surgical implant within a patient’s body (see claim 1 of Mlodinow). The mesh is a covering for implants and specifically for support and stabilization of a breast prosthesis using bioabsorbable, flexible mesh pouch (Background para 1). The mesh wall is made of a material selected from a group consisting of polyglycolide (see claim 9 of Mlodinow). The mesh is completely constructed of a bioabsorbable material. Having the entire device constructed from a bioabsorbable material can cut down on complications and infections commonly seen from a non-bioabsorbable mesh implant.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create a granular body for adipose tissue regeneration as taught by Sakamoto, where the breast implant is in a polyglycolide biodegradable mesh as taught by Mlodinow, to arrive at the instantly claimed invention. As Mlodinow shows polyglycolide mesh is biodegradable and can be used as a mesh pouch for implantation, one of ordinary skill would have been motivated to combine the adipose regeneration members of Sakamoto with the polyglycolic acid mesh pouch of Mlodinow according to known methods to yield the predictable result of advantageously having an implant for breast that supports and stabilizes the implant while avoiding complications and infections commonly seen in non-bioabsorbable mesh implants as taught by the prior art.
Finally, as per MPEP 2144.06(I), "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). In this case, it would be prima facie obvious to combine a one granular body as taught by Sakamoto et al with another granular body for breast implantation and regeneration, and put these multiple granular bodies in a mesh pouch to form a composition useful for the same purpose of implantation as taught by the prior art.
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Response to Arguments
Applicant’s arguments regarding the rejection of claims 1 and 4-5 over Sakamoto in view of Mlodinow have been fully considered but are not persuasive.
On p. 4-5 of Remarks, Applicant argues that Sakamoto does not disclose or suggest a plurality of granular bodies and, rather, discloses a single reconstruction member. Applicant argues that even if the sponge scaffold in Sakamoto were divided into multiple pieces, it would result in multiple sponge fragments within a porous bag. Applicant argues that the specification explains that enclosing multiple reconstruction members within a bag-shaped body allows the granular bodies to remain together and maintain the intended shape of the implantation region. Finally, Applicant argues that Mlodinow does not disclose or suggest the granular bodies as recited in claim 1. Applicant argues that the combination of the references would not result in the adipose tissue regeneration substrate as recited in claim 1.
In response, the examiner disagrees. As reiterated in the above rejection, and as shown in the screenshots above, the reconstruction member as described by Sakamoto renders prima facie obvious, the instantly claimed granular body. Sakamoto discloses a singular reconstruction member (as above), however, making multiple reconstruction members is per se prima facie obvious as per MPEP 2144.04. The examiner is not suggesting cutting up the sponge within the member as described by Sakamoto; rather it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to make as many or as few reconstruction members as described by Sakamoto. While Sakamoto does not explicitly disclose placing the reconstruction member(s) in an additional bioabsorbable pouch (although it does contemplate using the member for breast reconstruction), Mlodinow describes a bioabsorbable pouch for implants specifically for support and stabilization of a breast prosthesis. Thus, it would have been prima facie obvious to one of ordinary skill to take reconstruction members for breast implants as taught by Sakamoto and place them in a bioabsorbable mesh pouch made specifically for breast implants as taught by Mlodinow for the purpose of stabilizing the implants. Thus, Applicant’s arguments are not persuasive and the rejection is maintained.
Conclusion
No claim is allowed.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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