DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/29/2023, 07/28/2023, and 04/25/2023 (x2) have been considered by the examiner.
Status of the Claims
The response and amendment filed 08/26/2025 is acknowledged.
Claims 21-51 are pending.
Claims 21 and 37 are independent.
Applicant’s election of Group I, claims 21-36 in the reply filed on 08/26/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 37-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2025.
Claims 21-36 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 21-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bae, US 5262055 and Carvalho, US 7195774.
Bae teaches an implant formed of parallel semipermeable membrane walls having a seal around the perimeter 12, an additional perimeter seal, and also seals along generally parallel lines (12a) intermittently extending from the bottom or top of the pouch structure to form an internal reservoir. The pouch has two perimeter seals so that the reservoir contains two access ports acting as inlet and outlet (31 and 32) for the chamber within (Bae, e.g., Figs. 1-6, c5:31-53, and c11:20-49). The second seals interior to the perimeter (12a) are for the express purpose of limiting expansion (Bae, e.g., c11:20-49). The walls of the membrane are porous (Bae, e.g., c12:12-44), the membrane may be polytetrafluoroethylene (Bae, e.g., claims 1 and 12). The chamber is configured to contain islets comprising beta cells (Bae, e.g., c3:59-63). See Bae, e.g., Fig. 4:
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Bae therefore teaches a cell encapsulation device comprising: a first semi-permeable membrane; a second semi-permeable membrane disposed on the first semi-permeable membrane; a first seal formed between the first semi-permeable membrane and the second semi- permeable membrane and extending along at least a portion of a perimeter of a compartment formed between the first semi-permeable membrane and the second semi-permeable membrane, wherein the compartment is configured to hold a population of cells; a plurality of second seals formed between the first semi-permeable membrane and the second semi-permeable membrane and associated with the compartment.
Bae does not expressly teach the cell encapsulation device further comprising through holes formed in the plurality of second seals.
Carvalho teaches the technique of modifying similar implantable devices with through holes to enable the implant to be secured to tissue, e.g., by suturing (Carvalho, e.g., c17:4-10, Fig. 16, and c13:52-59 sealing base perforated with multiple holes (83) to allow a sewing suture).
It would have been obvious before the presently claimed invention was made to modify the seals of an implantable cell encapsulation device known from Bae by configuring the seals with through holes with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar implants in the same way. The skilled artisan would have been motivated to make this modification to allow for the implant to be secured to tissue at the implantation site while maintaining the semipermeable nature of the membranes for the cells encapsulated inside. The skilled artisan would have had a reasonable expectation of success since Bae suggests the pouch may be secured at the implant site and since Carvalho teaches sutures may be used to fix the device to target tissue when the device is configured with holes.
Accordingly, the subject matter of claims 21-36 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of US 8278106 in view of Bae, US 5262055 and Carvalho, US 7195774.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a method for producing insulin in vivo in a mammal, said method comprising: (a) providing an in vitro human pancreatic and duodenal homeobox gene 1 (PDX1)-positive pancreatic progenitor cell population into an implantable semi-permeable device, wherein the semi-permeable device comprises a first seal at a peripheral edge of the semi-permeable device, thereby forming at least one chamber for encapsulating living cells, and at least a second seal which effectively reduces the volume of the encapsulating chamber; (b) implanting the device containing the progenitor cell population into a mammalian host; and (c) maturing the progenitor cell population in said device in vivo such that there is no cell-to-cell contact between the progenitor cell within the device and the host cell in the mammal and the resulting cell population comprises endocrine and acinar cells, wherein at least some of the endocrine cells are insulin secreting cells that produce insulin in response to glucose stimulation in vivo, thereby producing insulin in vivo to the mammal. 2. The method of claim 1, further comprising maturing PDX1-positive pancreatic progenitor cells to acinar or duct cells. 3. The method of claim 1, wherein the device is first prevascularized by implanting in the mammal before introducing progenitor cells. 4. The method of claim 1, wherein the device comprises a plurality of welds for maximizing surface area to volume ratio of the human PDX1-positive pancreatic progenitor cell population in the device. 5. The method of claim 1, wherein the device comprises a plurality of welds to increase vascularization by the host. 6. The method of claim 1, wherein the device is refillable. 7. The method of claim 1, wherein the device is expandable. 8. The method of claim 1, wherein the in vivo cell population is monitored. 9. The method of claim 1, wherein greater than 25 pM of insulin is detectable in the serum of the mammal post glucose-stimulation. 10. The method of claim 1, wherein greater than 50 pM of human C-peptide is detectable in the serum of the mammal post glucose-stimulation. 11. The method of claim 1, wherein the mammal is immuno-suppressed. 12. The method of claim 1, wherein providing a human PDX1-positive pancreatic progenitor cell population comprises thawing a cell population. 13. The method of claim 1, wherein providing a human PDX 1-positive pancreatic progenitor cell population further comprises enriching the cell population for PDX1/NKX6.1 co-positive pancreatic progenitor cells. 14. The method of claim 1, wherein providing a human PDX1-positive pancreatic progenitor cell population further comprises enriching the cell population for PDX1/NKX6.1 co-positive pancreatic progenitor cell by contacting the cell population with an antibody that binds to CD142 antigen and enriching for said CD142 binding cells. 15. The semi-permeable device of claim 1, wherein the semi-permeable device comprises a semi-permeable membrane.
The reference claims teach the device comprising at least one second seal and a plurality of welds (seals) to increase the vascularization of the device (claim 5).
The reference patent claims do not expressly teach through holes formed in the plurality of second seals.
Carvalho teaches the technique of modifying similar implantable devices with through holes to enable the implant to be secured to tissue, e.g., by suturing (Carvalho, e.g., c17:4-10, Fig. 16, and c13:52-59 sealing base perforated with multiple holes (83) to allow a sewing suture).
It would have been obvious before the presently claimed invention was made to modify the seals of an implantable cell encapsulation device known from reference claims by configuring the seals with through holes with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar implants in the same way. The skilled artisan would have been motivated to make this modification to allow for the implant to be secured to tissue at the implantation site while maintaining the semipermeable nature of the membranes for the cells encapsulated inside. The skilled artisan would have had a reasonable expectation of success since Carvalho teaches sutures may be used to fix the device to target tissue when the device is configured with holes.
The reference patent claims do not expressly teach wherein the semipermeable membrane is porous PTFE. However, Bae teaches porous PTFE is an effective semipermeable material to enable insulin produced within as well as cell nutrients to be exchanged with the host. See Bae citations above.
It would have been obvious before the presently claimed invention was made to modify an implant useful in the method of the reference claims as modified by Carvalho to utilize first and second porous PTFE membranes as the semipermeable membrane material with a reasonable expectation of success. Bae provides a teaching which would have prompted the skilled artisan to select porous PTFE since the material is disclosed in Bae as biocompatible, may be sealed using known techniques, e.g., heat, is effective for maintaining immunoprotection of encapsulated cells, and enables insulin to pass through the membrane walls to the host. The skilled artisan would have had a reasonable expectation of success since the method of the reference claims is effective for delivering insulin to the mammalian host.
Accordingly, the subject matter of claims 21-36 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claim(s) 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-11 of US 8425928 in view of Carvalho, US 7195774.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach cell encapsulating assembly for implanting into a mammalian host, said assembly comprising at least one chamber for encapsulating living cells, wherein the assembly comprises a first seal at a peripheral edge of the assembly, thereby forming the encapsulating assembly, and at least a second seal, wherein said second seal is within said cell encapsulating chamber, and wherein said second seal within the cell encapsulating chamber does not increase the surface area of the chamber. 2. The assembly of claim 1, wherein the assembly comprises a semi-permeable membrane. 3. The assembly of claim 1, wherein the assembly has a third or fourth seal. 4. The assembly of claim 1 further comprising of at least one loading port. 5. The assembly of claim 1 comprising two loading ports. 6. The assembly of claim 1, wherein the assembly further comprises living cells. 7. The assembly of claim 6, wherein the living cells are human pancreatic and duodenal homeobox gene 1 (PDX1)-positive pancreatic progenitor cells. 8. The assembly of claim 1, wherein the second seal reduces the chamber volume. 9. The assembly of claim 1, wherein the second seal limits the lumen thickness. 10. A device comprising: a sealed edge; a cell encapsulating chamber; and a partition seal within the cell encapsulating chamber, wherein the partition seal within the cell encapsulating chamber does not increase the surface area of the chamber. 11. the device of claim 10, wherein said partition seal intersects with not more than one sealed edge of the device.
The reference patent claims do not expressly teach through holes formed in the plurality of second seals.
Carvalho teaches the technique of modifying similar implantable devices with through holes to enable the implant to be secured to tissue, e.g., by suturing (Carvalho, e.g., c17:4-10, Fig. 16, and c13:52-59 sealing base perforated with multiple holes (83) to allow a sewing suture).
It would have been obvious before the presently claimed invention was made to modify the seals of an implantable cell encapsulation device known from reference claims by configuring the seals with through holes with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar implants in the same way. The skilled artisan would have been motivated to make this modification to allow for the implant to be secured to tissue at the implantation site while maintaining the semipermeable nature of the membranes for the cells encapsulated inside. The skilled artisan would have had a reasonable expectation of success since Carvalho teaches sutures may be used to fix the device to target tissue when the device is configured with holes.
The reference patent claims do not expressly teach wherein the semipermeable membrane is porous PTFE. However, Bae teaches porous PTFE is an effective semipermeable material to enable insulin produced within as well as cell nutrients to be exchanged with the host. See Bae citations above.
It would have been obvious before the presently claimed invention was made to modify an implant of the reference claims as modified by Carvalho to utilize first and second porous PTFE membranes as the semipermeable membrane material with a reasonable expectation of success. Bae provides a teaching which would have prompted the skilled artisan to select porous PTFE since the material is disclosed in Bae as biocompatible, may be sealed using known techniques, e.g., heat, is effective for maintaining immunoprotection of encapsulated cells, and enables insulin to pass through the membrane walls to the host. The skilled artisan would have had a reasonable expectation of success since the implant of the reference claims is effective for encapsulating pancreatic cells.
Accordingly, the subject matter of claims 21-36 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Claim(s) 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of US 9132226 in view of Bae, US 5262055 and Carvalho, US 7195774.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a device comprising: a first cell encapsulation chamber having a lumen; and a second cell encapsulation chamber having a lumen, wherein said first and second cell encapsulation chambers are sealed at the peripheral edges, wherein said first and second cell encapsulation chambers are separated by at least one separation seal, and wherein the at least one separation seal does not cause an increase in the surface area of the device. 2. The device of claim 1, wherein each cell encapsulation chamber has at least one port. 3. The device of claim 1, wherein each cell encapsulation chamber has two ports. 4. The device of claim 1, wherein the separation seal intersects with the sealed edge. 5. The device of claim 1, wherein the first cell encapsulation chamber is completely sealed from the second cell encapsulation chamber. 6. The device of claim 1 further comprising living cells. 7. The device of claim 6, wherein the living cells comprise human pancreatic and duodenal homeobox gene 1 (PDX1)-positive pancreatic progenitor cells. 8. The device of claim 1, wherein the separation seal limits the lumen thickness of the cell encapsulation chambers. 9. The device of claim 1, wherein the first and second cell encapsulation chambers comprise a semi-permeable membrane. 10. A cell encapsulating assembly, said assembly comprising a plurality of chambers, each having a lumen comprising living cells, wherein the assembly comprises a first seal at a peripheral edge of the assembly, thereby forming the cell encapsulating assembly, and at least a second seal, wherein said second seal is within said cell encapsulating assembly, thereby sealing off the cell encapsulation chambers from one another, wherein the living cells comprise human pancreatic and duodenal homeobox gene 1 (PDX1)-positive pancreatic progenitor cells. 11. The assembly of claim 10, wherein each cell encapsulation chamber has at least one port. 12. The assembly of claim 10, wherein each cell encapsulation chamber has two ports. 13. The assembly of claim 10, wherein the second seal intersects with the first seal at the peripheral edge. 14. The assembly of claim 10, wherein each of the cell encapsulation chambers in the assembly is completely sealed off from one another. 15. The assembly of claim 10, wherein the second seal limits the lumen thickness of the cell encapsulation chambers. A plurality of second seals is encompassed by at least a second seal, as both phrases encompass more than one second seal.
The reference patent claims do not expressly teach through holes formed in the plurality of second seals.
Carvalho teaches the technique of modifying similar implantable devices with through holes to enable the implant to be secured to tissue, e.g., by suturing (Carvalho, e.g., c17:4-10, Fig. 16, and c13:52-59 sealing base perforated with multiple holes (83) to allow a sewing suture).
It would have been obvious before the presently claimed invention was made to modify the seals of an implantable cell encapsulation device known from reference claims by configuring the seals with through holes with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar implants in the same way. The skilled artisan would have been motivated to make this modification to allow for the implant to be secured to tissue at the implantation site while maintaining the semipermeable nature of the membranes for the cells encapsulated inside. The skilled artisan would have had a reasonable expectation of success since Carvalho teaches sutures may be used to fix the device to target tissue when the device is configured with holes.
The reference patent claims do not expressly teach wherein the semipermeable membrane is porous PTFE. However, Bae teaches porous PTFE is an effective semipermeable material to enable insulin produced within as well as cell nutrients to be exchanged with the host. See Bae citations above.
It would have been obvious before the presently claimed invention was made to modify an implant of the reference claims as modified by Carvalho to utilize first and second porous PTFE membranes as the semipermeable membrane material with a reasonable expectation of success. Bae provides a teaching which would have prompted the skilled artisan to select porous PTFE since the material is disclosed in Bae as biocompatible, may be sealed using known techniques, e.g., heat, is effective for maintaining immunoprotection of encapsulated cells, and enables insulin to pass through the membrane walls to the host. The skilled artisan would have had a reasonable expectation of success since the implant of the reference claims is effective for encapsulating pancreatic cells.
Accordingly, the subject matter of claims 21-36 would have been prima facie obvious before the presently claimed invention was made, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615