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 .
This action is written in response to the amendment filed 12/16/2025
Claims 1, 13 and 14 have been amended and claim 21 has been added
Claims 1-10 and 12-21 are presented for examination
This action is Final
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.
Claim(s) 1, 8-10, 12 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Provitera (US 9,346,571) in view of Voute et al. (US 2010/0072216) in view of Riley (US 5,573,741).
Claim 1. Provitera disclose a case for holding an implantable device, the case comprising:
inner and outer major surfaces of the cover body extend between two sidewalls of the cover body (col. 4, ll. 1-15);
wherein the hinge mechanism 300 is disposed at a first end of the case and allows the cover body to pivot away from the base body at an opposite, second end of the case (col. 4, ll. 3-8; fig. 2); and
a detachably connected cover body 115 and base body 117, wherein the cover body and base body are detachably connected at a hinge mechanism (fig. 2).
Provitera fails to disclose device port sealing areas coupled with the cover and body. Voute disclose a case for holding an implantable device 10, the case comprising:
wherein the cover body and the base body when secured comprise a volume 203/204 configured to receive the implantable device, and wherein the cover body has opposing inner and outer major surfaces and at least one opening 420 extending through the cover body from the outer major surface to the inner major surface to allow passage of one or more biologically active materials through the at least one opening [0022], [0039];
wherein the case further comprises an implantable device port sealing area including a cut-out arranged in the base body (fig. 1-2). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify the outer wall surfaces of Provitera to include the port sealing areas of Voute maintain control of the inserted products into the container.
Provitera fails to disclose a latch assembly used to connect the cover and base body. Riley teaches wherein the cover body has a first latch portion and the base body has a second latch portion configured to secure the cover body to the base body when the case is in a closed position (col. 1, ll. 55-65; fig. 1). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify the attachment mechanism of Provitera to include the latch assembly of Riley to assist in maintaining the cover and body portions in the closed position.
Claims 8-9: Provitera-Voute-Riley discloses the case of claim 1, wherein the base body has opposing inner and outer major surfaces that extend between two
sidewalls of the base body and at least one opening extending through the base
body from the outer major surface to the inner major surface to allow passage of
one or more biologically active materials through the at least one opening (Voute; fig. 1).
Claim 10: Provitera-Voute-Riley discloses the case of claim 1 wherein the case further comprises finger grips 300 (Voute; [0031]; fig. 1).
Claim 12: Provitera-Voute-Riley discloses the case of claim 1, wherein the case comprises a biocompatible polymer material or a metal, wherein the metal
consisting of stainless steel (Voute; [0004]).
Claim 21. Provitera-Voute-Riley discloses the case of claim 1, wherein the cut-out is arranged in the base body at the first end of the case (Voute; fig. 2, 4).
Claim(s) 2-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Provitera (US 9,346,571) in view of Voute et al. (US 2010/0072216) in view of Riley (US 5,573,741) in view of Green et al. (US 2014/0014226).
Claim 2: Provitera-Voute-Riley discloses the case of claim 1 but fails to disclose an implantable device within the tray recesses. Green teaches in combination with the implantable device within the case, wherein the implantable device is a semi- permeable macro-encapsulation device ([0069]; fig. 1-2, 4). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the invention to modify the tray recesses of Provitere-Voute to include the implantable device of Green to allow for safe keeping of the device when not in use.
Claim 3: Provitera-Voute-Riley-Green discloses the case of claim 2, wherein the implantable device further comprises therapeutic agents therein (Green, [0002-0003], [0009-0013], [0068]).
Claim 4: Provitera-Voute-Riley-Green discloses the case of claim 3, wherein the therapeutic agents are living cells (Green, [0002-0003], [0009-0013], [0068]).
Claim 5: Provitera-Voute-Riley-Green discloses the case of claim 4, wherein the living cells are progenitor cells differentiated from stem cells in vitro, endocrine cells, or immature beta cells (Green, [0002-0003], [0009-0013], [0068]).
Claim 6: Provitera-Voute-Riley-Green discloses the case of claim 5, wherein the progenitor cells are endoderm-lineage cells, pancreatic progenitor cells, or PDX1- positive pancreatic endoderm cells (Green, [0002-0003], [0009-0013], [0068]).
Claim 7: Provitera-Voute-Riley-Green discloses the case of claim 5, wherein the stem cells are selected from the group consisting of human embryonic stem cells, fetal stem cells, cord blood stem cell, induced pluripotent stem cells, reprogrammed cells, parthenote cells, and mesenchymal, or hematopoietic stem cells (Green, [0002-0003], [0009-0013], [0068]).
Allowable Subject Matter
Claims 13-20 are allowed.
Response to Arguments
Applicant's arguments with respect to the claims have been considered but in view of the amendment the search has been updated, new prior art has been identified and applied, and a new rejection has been made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAVEN COLLINS whose telephone number is (571)270-1672. The examiner can normally be reached Monday-Friday 8:30am to 5:00pm EST.
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/RAVEN COLLINS/ Examiner, Art Unit 3735
/Anthony D Stashick/ Supervisory Patent Examiner, Art Unit 3735