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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 11 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. “According to claims 6 and 7” in claims 8 and 11 is an improper form of claiming multiple dependency. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 16 and 22 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Chhaya et al. (2021/0186678) “Chhaya”.
Regarding claims 1-2, Chhaya discloses an implantable device 200 (Fig. 2B) comprising a main shell 105 and a chamber 101 for treating at least one soft tissue (abstract), said device is further configured to receive at least one vascular pedicle (par. 0145 discloses the implant comprises channels 118 to allow for high degree of vascularization), the main shell comprising a set of through-openings (porous interconnected cells and channels 102/118) and being bioresorbable (par. 0106 discloses biodegradable implant), wherein said main shell comprises at least one bioresorbable (co)polymer having an elongation at break greater than or equal to 200% and bioresorbable copolymer is a copolymer of ¢-caprolactone and L-, D- or DL-lactide (par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide which inherently has an elongation at break greater than or equal to 200%).
Regarding claim 16, Chhaya discloses wherein the main shell comprises at least two vertical arches 118 and transverse sections 102 extending between said vertical arches and connected thereto (Fig. 2F).
Regarding claim 22, Chhaya discloses a method for manufacturing an implantable device according to claim 1 (claim 1) wherein it comprises a step of additive or subtractive manufacturing of said main shell (par. 0359 discloses sequentially 3D printing layers), with at least one yarn comprising said (co)polymer having an elongation at break greater than or equal to 200% (par. 0051 discloses a mesh which comprises threads; par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide which inherently has an elongation at break greater than or equal to 200%).
Claim Rejections - 35 USC § 102 or 35 USC § 103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-5, 16 and 22 are rejected under 35 U.S.C. 103(a) as obvious over Chhaya et al. (2021/0186678) “Chhaya”.
Regarding claims 1 and 22, Chhaya discloses an implantable device 200 (Fig. 2B) comprising a main shell 105 and a chamber 101 for treating at least one soft tissue (abstract), said device is further configured to receive at least one vascular pedicle (par. 0145 discloses the implant comprises channels 118 to allow for high degree of vascularization), the main shell comprising a set of through-openings (porous interconnected cells and channels 102/118) and being bioresorbable (par. 0106 discloses biodegradable implant); a method for manufacturing an implantable device according to claim 1 (claim 1) wherein it comprises a step of additive or subtractive manufacturing of said main shell (par. 0359 discloses sequentially 3D printing layers), with at least one yarn comprising (co)polymer (par. 0051 discloses a mesh which comprises threads; par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide); except for explicitly discloses wherein said main shell comprises at least one bioresorbable (co)polymer having an elongation at break greater than or equal to 200%. However, Chhaya discloses a bioresorbable copolymer is a copolymer of ¢-caprolactone and L-, D- or DL-lactide (par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide which inherently has an elongation at break greater than or equal to 200%). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Chaaya to include wherein said main shell comprises at least one bioresorbable (co)polymer having an elongation at break greater than or equal to 200%, for using a biocompatible and bioresorbable material that allows sufficient tissue ingrowth and prevents scarring (par. 0143).
Regarding claim 2, Chhaya discloses a bioresorbable copolymer is a copolymer of ¢-caprolactone and L-, D- or DL-lactide (par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide which inherently has an elongation at break greater than or equal to 200%).
Regarding claims 3-5, Chhaya discloses the claimed invention of claims 1-2 including the required structure of a main shell comprising a set of through-openings (porous interconnected cells and channels 102/118) and being bioresorbable (par. 0106 discloses biodegradable implant), wherein said main shell comprises at least one bioresorbable (co)polymer having an elongation at break greater than or equal to 200% and bioresorbable copolymer is a copolymer of ¢-caprolactone and L-, D- or DL-lactide (par. 0106 discloses biodegradable copolymer of polycaprolactone and L-, D- or DL-lactide which inherently has an elongation at break greater than or equal to 200%). Chhaya fails to explicitly disclose the main shell has an outer surface and wherein the ratio of a total surface area (mm2) of the through-openings over a total surface area of the outer surface of the main shell is greater than or equal to 35%; the main shell has an outer surface and wherein a ratio of a surface area of a solid outer surface of the main shell over a total surface area of the outer surface of the main shell is greater than or equal to 40% and the main shell has a skeleton having a fill ratio greater than or equal to 70%.
However, Chhaya does disclose a main shell having an outer surface with a certain total surface area, a total surface area of the through-openings 102/118 and a surface area of a solid surface (Figs. 2A-2G). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the main shell has an outer surface and wherein the ratio of a total surface area (mm2) of the through-openings over a total surface area of the outer surface of the main shell is greater than or equal to 35%; the main shell has an outer surface and wherein a ratio of a surface area of a solid outer surface of the main shell over a total surface area of the outer surface of the main shell is greater than or equal to 40% and the main shell has a skeleton having a fill ratio greater than or equal to 70%, since these are result effective variables that contribute to the overall degradability and vascular ingrowth, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying Chhaya as suggested would allow for sufficient degradation of the implant post implantation allowing for implant to adopt surrounding tissue (par. 0143). In re Aller, 105 USPQ 233.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality that the main shell has an outer surface and wherein the ratio of a total surface area (mm2) of the through-openings over a total surface area of the outer surface of the main shell is greater than or equal to 35%; the main shell has an outer surface and wherein a ratio of a surface area of a solid outer surface of the main shell over a total surface area of the outer surface of the main shell is greater than or equal to 40% and the main shell has a skeleton having a fill ratio greater than or equal to 70%, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 16, Chhaya discloses wherein the main shell comprises at least two vertical arches 118 and transverse sections 102 extending between said vertical arches and connected thereto (Fig. 2F).
Claim 6 is rejected under 35 U.S.C. 103(a) as obvious over Chhaya et al. (2021/0186678) “Chhaya” in view of Schuessler (2012/0010706) “Schuessler”.
Chaaya discloses the claimed invention of claim 1; except for the implantable device comprises a main bottom having through-openings and forming a rear portion of a treatment chamber. However, Schuessler teaches a similar implant comprising a main bottom 2110 (Fig. 5C) having through-openings 2218 and forming a rear portion of a treatment chamber (space inside of rim 2220).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Chaaya to include a main bottom having through-openings and forming a rear portion of a treatment chamber, as taught and suggested by Shuessler, for providing a backing that prevents unintentional movement of the implant post implantation (par. 0006).
Claim 15 is rejected under 35 U.S.C. 103(a) as obvious over Chhaya et al. (2021/0186678) “Chhaya” in view of Limem et al. (2020/0375726) “Limem”.
Chaaya discloses the claimed invention of claim 1; except for at least one portion of the through-openings of the main shell are Voronoi polyhedra. However, Limem teaches a similar implant comprising at least one portion of the through-openings of the main shell are polyhedra (par. 0171 and Fig. 9B). It would have been an obvious matter of design choice to modify at least one portion of the through-openings of the main shell are Voronoi polyhedra, since such a modification would have involved a mere change in the form or shape of a component and such a shape modification would provide the implant with sufficient tissue ingrowth and compressibility (par. 0010). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04.
Allowable Subject Matter
Claims 7, 9, 10-14 and 17-21 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.
Claims 8 and 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record of Chhaya et al. and Schuessler fail to disclose an intermediate shell comprising through openings and an upper receiving partition subdividing a treatment chamber into an upper treatment chamber and a lower treatment chamber r of claim 7 and the main bottom comprising one or more recesses open towards the treatment chamber to receive a lower edge portion of the main shell or an intermediate she which has not been found anticipated by or obvious over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774