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 .
Response to Amendment
Claim 31 was previously objected to and has been amended. The prior objection to claim 31 is withdrawn.
Claim 19 was previously rejected under 35 U.S.C. 112(b) and has been amended. The prior rejection under 35 U.S.C. 112(b) is thus withdrawn.
Claims 16, 19, 22, 31, and 34 have been amended. Claims 36-37 have been added. Claims 23 and 25 have been cancelled.
Claim Rejections - 35 USC § 103
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) 16-20, 22, 24, 26-27, 29-30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully, previously made of record).
Regarding claim 16, Cully discloses an implantable device (see Abstract) for providing a therapeutic agent (insulin as in [0063]), the implantable device comprising: a container (containment tube 200, fig. 2) configured to contain a plurality of cells ([0067]) capable of producing the therapeutic agent (see [0063]) within an interior region of the container (see at least [0066] and [0067]), the container defining: first pores ([0080], pores of inner porous polymeric layer) defined by an interior wall portion of the container (inner porous polymeric layer [0080]), the first pores having a first average size that (i) allows passage of the therapeutic agent through the first pores (this is the selective permeability to macromolecules as in [0004], [0080], and [0139]) and (ii) prevents passage of immune cells through the first pores (resists cellular ingrowth as in [0080], see also [0078] which discusses this resistance to be prevention of invasive cells from entering the container, and [0004] which discusses immune system attacks as being ideally prevented), and second pores (pores of the outer porous later as in [0081]) defined by an exterior wall portion of the container (outer porous layer of [0081]), the second pores having a second average size that is larger than the first average size (see [0081] and [0080], the second pores are on average much larger than the first pores), and the second pores being sized to promote vascularization along the exterior wall portion (see [0081], the vascularizing layer promotes vascularization where it causes ingrowth of vascular tissues and promotes oxygen transfer as claimed where it facilitates nutrient transfer where oxygen is one of the main required nutrients as in [0004] and [0139]), wherein the container has a generally tubular shape (see fig. 2, containment tube 200 has a tubular shape as claimed).
Cully as modified does not explicitly disclose the device wherein the interior region of the container has a width that is limited to accommodating a single cell of the plurality of cells along a central axis of the container such that at least a portion of a surface area of each cell of the plurality of cells has direct exposure to the first pores of the interior wall portion and such that the plurality of cells is arranged within the container to receive an amount of oxygen that is sufficient for the plurality of cells to survive from passive diffusion of the oxygen through the first pores without an additional energy source for providing supplemental oxygen to the plurality of cells.
While Cully as modified does not explicitly disclose that the interior region width is limited to accommodating a single cell of the plurality of cells as claimed, since Cully discloses the same range of widths as those claimed by Applicant ([0060], wherein a distance of 30 microns is a suitable small distance based upon Applicant’s Specification at [0179] which calls out a range "limited to accommodating a single cell of the multiple cells, and the width of the interior region is in a range of about 100 microns to about 2mm"), it is the Examiner’s position that Cully’s interior region is functionally configured as claimed since the arrangement of structures and sizes of structures are the same and the claim does not specify particularly how the sizing and/or shaping is configured to accommodate a single cell of the plurality of cells in such a manner as to exclude the disclosure of Cully such that at least a portion of a surface area of each cell of the plurality of cells has direct exposure to the first pores of the interior wall portion (see [0060], “A maximum distance between the outer surface of the core 105 and the inner surface of the permeable membrane 110 is sufficiently narrow to provide conditions suitable for the survival and function of the contained cells 115, whereby the viability of a large proportion of the contained cells 115 is maintained”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped and sized the container of Cully as claimed to have ensured that all cells in the container are directly exposed to the membrane as claimed to allow for sufficient oxygen to be delivered to the cells as claimed as the product of optimization of a result effective variable to obtain a predictable and expected outcome. It has been held that optimization of a result effective variable is obvious, requiring only routine and customary skill in the art to obtain a predictable and expected outcome, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It has been held that carrying forward a specific principle of invention is obvious, requiring only expected skill and knowledge to obtain a predictable and expected outcome, see In re Williams, 36 F.2d 436, 438 (CCPA 1929). It has been held that alterations to the size and proportion of an invention is obvious when it affects only expected and predictable results, see Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Cully does not explicitly disclose that the first pores are sized to allow passage of oxygen therethrough, or that the second pores are sized to promote oxygen transfer along the exterior wall portion. However, Cully teaches that the container should have pores which allow for the cells to get the required oxygen and nutrients ([0004]), and that high oxygen permeability could be favorable ([0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the first pores to allow oxygen passage therethrough as oxygen is a known nutrient which cells need to survive and is listed as an equivalent to a nutrient ([0004]) and because Cully teaches the pores being sized for nutrient transfer ([0080]). Since the second pores are disclosed by Cully as being larger than the first pores ([0080] and [0081]) and the first pores are sized as claimed, the second pores would also thus be sized as claimed since oxygen that can move through first, smaller pores can also move through second, larger pores.
Additionally, regarding the second pores, the promoting of vascularization could be considered to be a promoting of oxygen transfer since vascularization causes blood movement for delivery of nutrients such as oxygen.
Examiner additionally notes that the sizes of the pores provided (less than about 0.5-5 microns as in [0080] or larger) are much larger than the scale of oxygen atoms, as oxygen atoms are on the scale of being less than a nanometer and there are 1000 nanometers in a single micron.
Thus, in the modified device, Cully discloses the claimed arrangement such that the plurality of cells is arranged within the container to receive an amount of oxygen that is sufficient for the plurality of cells to survive from passive diffusion of the oxygen through the first pores (see [0060], the cells are arranged to allow for survival and viability which shows that they are arranged to receive vital nutrients, and see the modifications made above) without an additional energy source for providing supplemental oxygen to the plurality of cells (Cully does not disclose use of an additional energy source as claimed).
Regarding claim 17, Cully as modified discloses the device of claim 16 wherein the implantable device has an external surface area to volume ratio of about 200 to about 5,000.
{Cully discloses an approximate length for the cylinder as being about 1 cm at [0093], and discloses approximate diameters as being at about 100 microns to 5 mm. With a height of 1 cm and a diameter at 100 microns, the surface area of the cylinder would be 3.157 mm² and the volume of the volume would be 0.7854 mm³. The ratio of surface area to volume for this configuration would thus be ~1021, which anticipates the claimed range as it is within the claimed range. See also Cully [0056] which discloses that it is desirable to maximize surface area for increased vascularization and nutrient exchange relative to volume, which is referred to as device footprint in the body.}
Regarding claim 18, Cully as modified discloses the device of claim 16 wherein the implantable device has an aspect ratio of about 100 to about 2,000.
{An aspect ratio for a cylinder such as that of Cully is defined as the height (length) divided by the diameter of the cylinder. Cully discloses an approximate length for the cylinder as being about 1 cm at [0093], and discloses approximate diameters as being at about 100 microns to 5 mm at [0065]. With a height of 1 cm and a diameter at 100 microns, the aspect ratio would be 100; thus, Cully discloses the device with an aspect ratio as claimed. Additionally, Cully discloses that the size of the device is scalable as desired to ensure survival and function of the cells within, see [0067].}
Regarding claim 19, Cully as modified discloses the device of claim 16 wherein the second average size of the second pores allows passage of the therapeutic agent through the exterior wall portion to vasculature adjacent the implantable device (see [0081], the outer porous layer is configured for biomolecule transfer, with insulin being the chosen therapeutic agent and is a biomolecule where it is a cellular product as in [0063]).
Regarding claim 20, Cully as modified discloses the device of claim 16.
Cully as modified does not explicitly disclose the device wherein the first pores have first widths in a range of about 10 nm to about 400 nm, and wherein the second pores have second widths in a range of about 2 µm to about 60 µm. However, Cully teaches the first pores having first widths substantially similar to the range claimed by Applicant (see [0080], less than 500 nm is disclosed) and the second pores having second widths substantially similar to the range claimed by Applicant (see [0081], widths greater than 5 µm are disclosed). Cully additionally teaches pore size to be variable depending on desired permeability characteristics ([0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the first and second pores as claimed since Cully teaches sizes which are substantially the same as those closed by Applicant and since Applicant’s disclosure has not shown any unexpected or novel results as a result of the exact claimed size ranges which are not rendered obvious by Cully, and further since 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. In re Aller, 105 USPQ 233.
Regarding claim 22, Cully as modified discloses the device of claim 16 wherein the interior region has a width in a range of about 100 µm to about 2 mm (see [0065], the range substantially as claimed is disclosed).
Regarding claim 24, Cully as modified discloses the device of claim 16 wherein the container a linear configuration (see fig. 2, the tube has a linear configuration where it extends in a straight line).
Regarding claim 26, Cully as modified discloses the device of claim 16 wherein the exterior wall portion is coated with a growth factor that promotes vascularization (see [0069], the exterior may be coated with a material to promote vascularization), and: wherein the growth factor is covalently linked to the exterior wall portion, and/or wherein the growth factor is electrostatically bound to the exterior wall portion, and/or wherein the growth factor is site-specifically bound to the exterior wall portion (the coating of the wall is considered to be a site specific binding as it is a coating only on the exterior surface, [0069]), and/or wherein the growth factor is selected from the group consisting of: vascular endothelial growth factor (VEGF), placenta derived growth factor (PDGF), transforming growth factor beta (TGFP), and fibroblast growth factor (FGF), and/or wherein the growth factor is vascular endothelial growth factor (VEGF), placenta derived growth factor (PDGF), transforming growth factor beta (TGFP), fibroblast growth factor (FGF), or a combination thereof, and/or wherein the growth factor is vascular growth factor (VEGF).
Regarding claim 27, Cully as modified discloses the device of claim 16 further comprising the plurality of cells contained within the interior region of the container (see fig. 1A).
Regarding claim 29, Cully as modified discloses the device of claim 16 further comprising one or more additional containers associated with the container (see fig. 12C and interconnected containment tubes 1205), wherein each of the one or more additional containers contains an additional plurality of cells ([0100]).
Regarding claim 30, Cully as modified discloses the device of claim 16 wherein the container comprises a tubular wall (permeable membrane 205, fig. 2) that comprises the interior and exterior wall portions (see [0079]-[0081]).
Regarding claim 33, Cully as modified discloses the device of claim 16 wherein the interior wall portion comprises a tubular member (inner porous polymeric layer of [0079]) and the exterior wall portion comprises a coating (outer porous layer of [0079] with a coating as in [0069]) that surrounds the tubular member (see [0069] and [0117]), and wherein the tubular member has a first material formulation (see [0079]) and the coating has a second material formulation (see [0079] and [0069]) that is different from the first material formulation (see [0079]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully) as applied to claim 16 above, and further in view of Imran (US 20220409525, henceforth Imran, previously made of record in the IDS filed 03/11/2026).
Regarding claim 21, Cully as modified discloses the device of claim 16.
Cully is silent as to the thickness of the container wall (this is the exterior membranes of Cully) and thus does not disclose the device wherein the container has a wall thickness in a range of 1 µm to 100 µm. Imran teaches membrane walls with varying pore thicknesses of implantable devices made of polymers similar to the wall of Cully which can have thicknesses of 20-150 microns (pg. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the membrane walls to be thin and have a thickness in the claimed range as in Imran as Imran teaches membrane walls being desirably thin to allow for rapid diffusion of molecules out of the implantable device (pg. 7), and further because Applicant has not shown any unexpected results regarding the wall thickness in the claimed range and Imran teaches this wall thickness to be acceptable in the art to yield the desired results of diffusion across a membrane via pores and because 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. In re Aller, 105 USPQ 233.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully) as applied to claim 27 above, and further in view of Imran (US 20220409525, henceforth Imran).
Regarding claim 28, Cully as modified discloses the device of claim 27 wherein the therapeutic agent comprises insulin (see [0063]).
Cully as modified does not disclose the device wherein the plurality of cells are beta cells. Imran teaches that beta cells are a kind of cell used to produce insulin ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the plurality of cells be beta cells as Imran teaches that beta cells are used in the body for producing insulin ([0006]).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully) as applied to claim 30 above, and further in view of Neuenfeldt et al. (WO 2020068852, henceforth Neuenfeldt, previously made of record in the IDS filed 02/29/2024).
Regarding claim 31, Cully as modified discloses the device of claim 30.
Cully as modified does not disclose the device wherein the tubular wall further defines third pores arranged radially between the first and second pores, and wherein the third pores have a third average size that is greater than the first average size and less than the second average size. Neuenfeldt teaches an implantable device (implantable device of pg. 10 line 2) having a first inner layer (inner membrane region of pg. 10 lines 6) with first pores having smallest pore sizes (pg. 10 lines 6-7) and a second outer layer (outer membrane region of pg. 10 line 8) with second pores having largest pore sizes (pg. 10 lines 8-10) with a third layer (transitional gradient membrane region of pg. 10 lines 10-13) with third pores (gradient of pore sizes of pg. 10 lines 10-13) arranged radially between the first and second pores (between the inner and outer region, pg. 10 line 11), wherein the third pores have a third average size that is greater than the first average size and less than the second average size (see pg. 10 lines 10-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a gradient transitional layer comprising the pores as claimed between the inner and outer membrane layers of Cully as in Neuenfeldt for prevention of delamination between layers (see pgs. 1 and 2 of Neuenfeldt).
Regarding claim 32, Cully as modified discloses the device of claim 31 wherein pores defined by the tubular wall gradually increase in size from an interior surface of the tubular wall to an exterior surface of the tubular wall (see the modification made above with respect to Neuenfeldt, this is the purpose and structure of Neuenfeldt’s added transitional layer structure).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully) in view of Beck et al. (WO 2008079997, henceforth Beck, previously made of record).
Regarding claim 34, Cully discloses a therapeutic system (see Abstract) comprising: an implantable device (see Abstract) for providing a therapeutic agent (insulin as in [0063]), the implantable device configured to be implanted subcutaneously along a skin region (see fig. 22 and [0131]), and the implantable device comprising: a container (containment tube 200, fig. 2) configured to contain a plurality of cells ([0067]) capable of producing the therapeutic agent (see [0063]) within an interior region of the container (see at least [0066] and [0067]), the container defining: first pores ([0080], pores of inner porous polymeric layer) defined by an interior wall portion of the container (inner porous polymeric layer [0080]), the first pores having a first average size that (i) allows passage of the therapeutic agent through the first pores (this is the selective permeability to macromolecules as in [0004], [0080], and [0139]) and (ii) prevents passage of immune cells through the first pores (resists cellular ingrowth as in [0080], see also [0078] which discusses this resistance to be prevention of invasive cells from entering the container, and [0004] which discusses immune system attacks as being ideally prevented), and second pores (pores of the outer porous later as in [0081]) defined by an exterior wall portion of the container (outer porous layer of [0081]), the second pores having a second average size that is larger than the first average size (see [0081] and [0080], the second pores are on average much larger than the first pores), and the second pores being sized to promote vascularization along the exterior wall portion (see [0081], the vascularizing layer promotes vascularization where it causes ingrowth of vascular tissues and promotes oxygen transfer as claimed where it facilitates nutrient transfer where oxygen is one of the main required nutrients as in [0004] and [0139]), wherein the container has a generally tubular shape (see fig. 2, containment tube 200 has a tubular shape as claimed).
Cully as modified does not explicitly disclose the device wherein the interior region of the container has a width that is limited to accommodating a single cell of the plurality of cells along a central axis of the container such that at least a portion of a surface area of each cell of the plurality of cells has direct exposure to the first pores of the interior wall portion and such that the plurality of cells is arranged within the container to receive an amount of oxygen that is sufficient for the plurality of cells to survive from passive diffusion of the oxygen through the first pores without an additional energy source for providing supplemental oxygen to the plurality of cells.
While Cully as modified does not explicitly disclose that the interior region width is limited to accommodating a single cell of the plurality of cells as claimed, since Cully discloses the same range of widths as those claimed by Applicant ([0060], wherein a distance of 30 microns is a suitable small distance based upon Applicant’s Specification at [0179] which calls out a range "limited to accommodating a single cell of the multiple cells, and the width of the interior region is in a range of about 100 microns to about 2mm"), it is the Examiner’s position that Cully’s interior region is functionally configured as claimed since the arrangement of structures and sizes of structures are the same and the claim does not specify particularly how the sizing and/or shaping is configured to accommodate a single cell of the plurality of cells in such a manner as to exclude the disclosure of Cully such that at least a portion of a surface area of each cell of the plurality of cells has direct exposure to the first pores of the interior wall portion (see [0060], “A maximum distance between the outer surface of the core 105 and the inner surface of the permeable membrane 110 is sufficiently narrow to provide conditions suitable for the survival and function of the contained cells 115, whereby the viability of a large proportion of the contained cells 115 is maintained”).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped and sized the container of Cully as claimed to have ensured that all cells in the container are directly exposed to the membrane as claimed to allow for sufficient oxygen to be delivered to the cells as claimed as the product of optimization of a result effective variable to obtain a predictable and expected outcome. It has been held that optimization of a result effective variable is obvious, requiring only routine and customary skill in the art to obtain a predictable and expected outcome, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It has been held that carrying forward a specific principle of invention is obvious, requiring only expected skill and knowledge to obtain a predictable and expected outcome, see In re Williams, 36 F.2d 436, 438 (CCPA 1929). It has been held that alterations to the size and proportion of an invention is obvious when it affects only expected and predictable results, see Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Cully does not explicitly disclose that the first pores are sized to allow passage of oxygen therethrough, or that the second pores are sized to promote oxygen transfer along the exterior wall portion. However, Cully teaches that the container should have pores which allow for the cells to get the required oxygen and nutrients ([0004]), and that high oxygen permeability could be favorable ([0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the first pores to allow oxygen passage therethrough as oxygen is a known nutrient which cells need to survive and is listed as an equivalent to a nutrient ([0004] and Cully teaches the pores being sized for nutrient transfer ([0080]). Since the second pores are disclosed by Cully as being larger than the first pores ([0080] and [0081]) and the first pores are sized as claimed, the second pores would also thus be sized as claimed since oxygen that can move through first, smaller pores can also move through second, larger pores.
Additionally, regarding the second pores, the promoting of vascularization could be considered to be a promoting of oxygen transfer since vascularization causes blood movement for delivery of nutrients such as oxygen.
Examiner additionally notes that the sizes of the pores provided (less than about 0.5-5 microns as in [0080] or larger) are much larger than the scale of oxygen atoms, as oxygen atoms are on the scale of being less than a nanometer and there are 1000 nanometers in a single micron.
Thus, in the modified device, Cully discloses the claimed arrangement such that the plurality of cells is arranged within the container to receive an amount of oxygen that is sufficient for the plurality of cells to survive from passive diffusion of the oxygen through the first pores (see [0060], the cells are arranged to allow for survival and viability which shows that they are arranged to receive vital nutrients, and see the modifications made above) without an additional energy source for providing supplemental oxygen to the plurality of cells (Cully does not disclose use of an additional energy source as claimed).
Cully as modified does not disclose and an accessory device configured to cooperate with the implantable device for promoting delivery of oxygen to the plurality of cells. Beck teaches that implantable devices comprising a plurality of cells performs poorly due to lack of oxygen ([0008]) and that this can be avoided by using an accessory device (oxygen pump as in [0024]) configured to cooperate with the implantable device (see [0024]) for promoting delivery of oxygen to the plurality of cells (see [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an accessory device as in Beck to deliver oxygen to the plurality of cells as in Beck for preventing premature death after implantation of the implant as in Back (see at least [0008] and [0024]). Examiner notes that, in the modified device, the accessory device added from Beck is thus provided for additional benefit of oxygen delivery, however it is not required as the container is shaped and sized to allow for the cells to survive off of passive diffusion of oxygen across the membrane alone.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134, henceforth Cully) and Beck et al. (WO 2008079997, henceforth Beck) as applied to claim 34 above, and further in view of Rosati (US 20080021373, henceforth Rosati).
Regarding claim 35, Cully as modified discloses the system of claim 34.
Cully as modified does not disclose the system wherein the accessory device comprises: a transdermal patch that is configured to be secured to an exterior skin surface of the skin region, the transdermal patch comprising a plurality of needles that carry a substance capable of reacting to generate oxygen for the plurality of cells within the interior region of the container; a cuff that is configured to be secured to and apply pressure to the exterior skin surface of the skin region to direct a flow of blood towards the implantable device; or a sintered mesh that surrounds the implantable device and that carries a substance capable of reacting to generate oxygen. Rosati teaches an accessory device (system 100, fig. 1) comprising a transdermal patch (see [0008], [0014], [0071]) that is configured to be secured to an exterior skin surface of the skin region (see [0027]), the transdermal patch comprising a plurality of needles (micropenetrators as in [0012]) that carry a substance capable of reacting to generate oxygen for the plurality of cells within the interior region of the container (hydrogen peroxide as in [0062] which notes that it is used for oxygen generation; note that Beck [00219] additionally evidences that peroxides can be mixed for oxygen generation in bioreactor systems).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the accessory device of Rosati to deliver hydrogen peroxide to the container in the modified system of Cully as the device of Rosati is beneficial for controlled release of gas into a space (see [0047] and [0057]) and because the device of Rosati is better at dressing initial wounds, such as immediately after implantation of the implanted device of Cully, where it can last longer and allow the wound to breathe (Rosati [0090]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134) as applied to claim 16 above, and further in view of Slager et al. (US 20100303878, henceforth Slager).
Regarding claim 36, Cully as modified discloses the device of claim 16. Cully as modified additionally discloses that the container may be configured to assume “non-planar” arrangements ([0012]), and that shapes can vary to be circular, ovoid, or elliptical ([0065]), or that shapes can change to assist with implant anchoring ([0085]), and that anchoring can be improved through the use of curved or wavy shapes ([0086]).
Cully as modified does not disclose the device wherein the container has a spiral configuration or a helical configuration as claimed. Slager teaches a similar implant which has a spiral/helical configuration (see Slager fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the container of Cully to have had a spiral configuration as in Slager in order to select a specific shape species within the broader recited genus to affect improved retention of the implant in a known and predictable manner. It has been held that affecting a mere change in shape to obtain predictable and expected results is obvious, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 20180126134) as applied to claim 16 above, and further in view of Hasilo et al. (US 20190240375, henceforth Hasilo).
Regarding claim 37, Cully as modified discloses the device of claim 16.
Cully does not explicitly disclose the device wherein the interior region has a volume capacity of about 0.1 mL to about 1.5 mL. However, it is noted that the volume capacity of the implantable device of Cully is a mere product of the size of the device, the volume comprising the length of the implant multiplied by the cross-sectional area of the annular lumen as defined by the optimized spacing between the core and the first tube layer (see Fig. 1) and whereby it will be understood by one of ordinary skill in the art that the volume of the implant is a result effective variable based upon the desired quantity of therapeutic agent which can be suitably produced by a discrete population of cells, i.e. the volume of the container must support the inclusion of a sufficient number of cells needed to produce an efficacious amount of the therapeutic agent (see Hasilo [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized and shaped the device of Cully as modified to have had the necessary length to create a volume capacity in the claimed range in order to ensure that the device provides a sufficiently large population of cells to produce an effective volume of medicament thereby obtaining only expected and predicted outcomes associated with mere changes in size and proportion. See Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). It must be understood that there presents an optimal size for ensuring the volume is sufficiently large to ensure an adequate production of therapeutic agent, but no so large as to be unnecessarily intrusive, the device being an implantable device and therefore having necessary size limitations associated with implanting it within the patient's body.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 16-34 and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-37 of copending Application No. 18/288092 (reference application) in view of over Cully et al. (US 20180126134, henceforth Cully).
Regarding instant claim 16, claim 16 of the reference application claims everything except for the first pores having a first average size that allows passage of oxygen therethrough and the second pores being sized to promote oxygen transfer along the exterior wall portion.
Cully teaches a system similar to that claimed including the claimed first pores and second pores and their relative sizes (see Cully [0079]-[0081] and see the rejection of claim 16 below under 35 U.S.C. 103 for more details as needed).
Cully does not explicitly disclose that the first pores are sized to allow passage of oxygen therethrough, or that the second pores are sized to promote oxygen transfer along the exterior wall portion. However, Cully teaches that the container should have pores which allow for the cells to get the required oxygen and nutrients ([0004]), and that high oxygen permeability could be favorable ([0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the first pores to allow oxygen passage therethrough as oxygen is a known nutrient which cells need to survive and is listed as an equivalent to a nutrient ([0004]) and because Cully teaches the pores being sized for nutrient transfer ([0080]). Since the second pores are disclosed by Cully as being larger than the first pores ([0080] and [0081]) and the first pores are sized as claimed, the second pores would also thus be sized as claimed since oxygen that can move through first, smaller pores can also move through second, larger pores.
Additionally, regarding the second pores, the promoting of vascularization could be considered to be a promoting of oxygen transfer since vascularization causes blood movement for delivery of nutrients such as oxygen.
Examiner additionally notes that the sizes of the pores provided (less than about 0.5-5 microns as in [0080] or larger) are much larger than the scale of oxygen atoms, as oxygen atoms are on the scale of being less than a nanometer and there are 1000 nanometers in a single micron.
Regarding instant claim 17, see reference claim 17.
Regarding instant claim 18, see reference claim 16.
Reference claim 16 does not include that the implantable device has an aspect ratio of about 100 to about 2,000. Cully teaches such an aspect ratio (An aspect ratio for a cylinder such as that of Cully is defined as the height (length) divided by the diameter of the cylinder. Cully discloses an approximate length for the cylinder as being about 1 cm at [0093], and discloses approximate diameters as being at about 100 microns to 5 mm at [0065]. With a height of 1 cm and a diameter at 100 microns, the aspect ratio would be 100; thus, Cully discloses the device with an aspect ratio as claimed. Additionally, Cully discloses that the size of the device is scalable as desired to ensure survival and function of the cells within, see [0067].).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of reference claim 16 further in view of the teachings of Cully as Cully teaches such an aspect ratio to be an art effective sizing for such an implantable device, and further because Cully teaches that implantable devices can be resized for desired permeability and effectiveness characteristics (see at least Cully [0067] and [0068])
Regarding instant claim 19, see reference claim 18.
Reference claim 18 does not include that the second average size of the second pores allows passage of the therapeutic agent through the exterior wall portion to vasculature adjacent the implantable device. However, because claim 18 of the reference application claims that the second pores are sized larger than the first pores and that the first pores are sized to allow the therapeutic agent to pass through, it would have been obvious to one of ordinary skill in the art that the larger pores allow the same agent to pass through to the vasculature which the second pores promote vascularization along, and since the vasculature is vascularized along the device, it would also be considered to be adjacent to the device.
Regarding instant claim 20, see reference claim 19.
Regarding instant claim 21, see reference claim 22.
Regarding instant claim 22, see reference claim 20.
Reference claim 20 does not include that wherein the interior region has a width that is limited to accommodating a single cell of the plurality of cells. However, reference claim 20 includes the same range of widths as those claimed by Applicant, and thus it is the Examiner’s position that the reference claim’s interior region is functionally configured as claimed since the arrangement of structures and sizes of structures are the same and the claim does not specify particularly how the sizing and/or shaping is configured to accommodate a single cell of the plurality of cells in such a manner as to exclude the reference claim. Additionally, the pores of the reference claims are present for the same purposes of those as in the instant application. Further, Examiner notes that different cells can have different sizes, and the claim is not specific to a particular type of cell.
Regarding instant claim 24, see reference claim 23.
Regarding instant claim 26, see reference claim 27.
Regarding instant claim 27, see reference claim 28.
Regarding instant claim 28, see reference claim 29.
Regarding instant claim 29, see reference claim 30.
Regarding instant claim 30, see reference claim 32.
Regarding instant claim 31, see reference claim 32.
Regarding instant claim 32, see reference claim 33.
Regarding instant claim 33, see reference claim 34.
Regarding instant claim 34, claim 35 of the reference application claims everything except for the first pores having a first average size that allows passage of oxygen therethrough and the second pores being sized to promote oxygen transfer along the exterior wall portion.
See the modification made above with respect to claim 16 and Cully.
Regarding instant claim 36, see reference claim 37.
Regarding instant claim 37, see reference claim 20.
Claims 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 35 of copending Application No. 18/288092 (reference application) in view of over Cully et al. (US 20180126134, henceforth Cully) and Rosati (US 20080021373, henceforth Rosati).
Regarding instant claim 35, see reference claim 35.
Reference claim 35 does not include the further claimed specifics of the accessory device.
Rosati teaches an accessory device (system 100, fig. 1) comprising a transdermal patch (see [0008], [0014], [0071]) that is configured to be secured to an exterior skin surface of the skin region (see [0027]), the transdermal patch comprising a plurality of needles (micropenetrators as in [0012]) that carry a substance capable of reacting to generate oxygen for the plurality of cells within the interior region of the container (hydrogen peroxide as in [0062] which notes that it is used for oxygen generation; note that Beck [00219] additionally evidences that peroxides can be mixed for oxygen generation in bioreactor systems).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the accessory device of Rosati to deliver hydrogen peroxide to the container in the modified system of the reference claim and Cully as the device of Rosati is beneficial for controlled release of gas into a space (see [0047] and [0057]) and because the device of Rosati is better at dressing initial wounds, such as immediately after implantation of the modified implanted device of the reference claim, where it can last longer and allow the wound to breathe (Rosati [0090]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive.
Applicant has argued that Cully does not disclose the new claim limitations drawn to the arrangement of the claimed container. As indicated in the rejection above, Cully does not necessarily disclose explicitly the claimed arrangement, however the claimed arrangement is rendered obvious by the disclosure of Cully as one of ordinary skill in the art would have arranged the container as claimed such that all of the cells in the container would have received sufficient oxygen to have maintained their viability.
Thus, Applicant’s argument is respectfully found unpersuasive and the claims are respectfully rejected as indicated above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
