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 .
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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Claim(s) 16-35 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 16-35 of copending Application No. 18/288,087 in view of U.S. Publication No. 2022/0409525 (“Imran”).
Regarding Claim 16, Claim 16 of the reference application claims:
An implantable device for providing a therapeutic agent, the implantable device comprising:
A container configured to contain a plurality of cells capable of producing the therapeutic agent within an interior region of the container, the container defining: first pores defined by an interior wall portion of the container, the first pores having a first average size that (i) allows passage of the therapeutic agent through the first pores and (ii) prevents passage of immune cells through the first pores, and second pores defined by an exterior wall portion of the container, the second pores having a second average size that is larger than the first average size, and the second pores being sized to promote vascularization along the exterior wall portion.
The instant claim 16 further requires:
A substance capable of reacting to generate oxygen for the plurality of cells within the interior region of the container.
However, the inclusion of such substances is well-known in the prior art. For example, Imran discloses a related implantable device (Fig. 1A) which has an interior region containing a plurality of cells for producing a therapeutic agent (Par. 137) which further includes within its interior a substance which is capable of reacting to generate oxygen to the cells (Par. 144, 108). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the claimed device of the reference patent to further incorporate an oxygen generating substance within the interior region for supplying oxygen to the cells, as disclosed by Imran, in order to supplement oxygen delivery to the cells thereby ensuring that the cells are sufficiently oxygenated in order to achieve optimal cell metabolism and therapeutic generation.
Regarding Claim 17, see Clm. 17.
Regarding Claim 8, see Clm. 19.
Regarding Claim 19, see Clm. 20.
Regarding Claims 20, see Clm. 22.
Regarding Claim 21, see Clm. 23.
Regarding Claim 23, see Clm. 24.
Regarding Claim 24, see Clm. 25.
Regarding Claim 25, this claim is understood to be the logical, obvious conclusion to Claim 25 of the reference patent where it would have been obvious to include the oxygen generating substance within the annular lumen – said annular lumen constituting a “core”.
Regarding Claim 26, Examiner submits that “coating” is merely one obvious manner which the ordinary artisan would have considered in resolving to practice the integration of an oxygen generating species into the reservoir of the claimed reference application in view of Imran.
Regarding Claim 27, see Clm. 26.
Regarding Claim 28, see Clm. 27.
Regarding Claim 29, see Clm. 28.
Regarding Claim 30, see Clm. 29.
Regarding Claim 31, see Imran.
Regarding Claim 32, see Clm. 30-31.
Regarding Claim 33, see Clm. 32.
Regarding Claim 34, see Clm. 33.
Regarding Claim 35, see the analysis of Clm. 16 above in consideration of Claim 34 of the reference application.
This is a provisional nonstatutory double patenting rejection.
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, 18-25, 28-31, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0126134 (“Cully”) in view of U.S. Publication No. 2022/0409525 (“Imran”).
Regarding Claim 16, Cully discloses an implantable (Abstract) device (e.g. 200) for providing a therapeutic agent (Abstract), the implantable device comprising:
A container (200) configured to contain a plurality of cells capable of producing the therapeutic agent (Par. 63) within an interior region of the container (Par. 60), the container defining:
first pores defined by an interior wall portion of the container (Par. 79), the first pores having a first average size (Par. 80) that
(i) allows passage of the therapeutic agent through the first pores and
(ii) prevents passage of immune cells through the first pores, and
second pores defined by an exterior wall portion of the container (Par. 79), the second pores having a second average size that is larger than the first average size, and the second pores being sized to promote vascularization along the exterior wall portion (Par. 81).
Cully discloses the invention substantially as claimed except that that the interior region of the container further comprises a substance capable of reacting to generate oxygen for the plurality of cells. While Cully is concerned with the delivery of oxygen to the cells (Par. 4, 139), Cully only explicitly considers permeation of oxygen from the exterior of the implant, not the interior. However, Imran discloses a related implant (Abstract), wherein the interior region of the implant container can be provided with an oxygen generating substance (Par. 14, 62, 72, 108, 130) which assists in maintaining the viability of the cells, particularly prior to and immediately following positioning of the implant prior to vascularization.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to include an oxygen generating substance within the container of the invention of Cully, as disclosed by Imran, in order to help support the viability of the cells through supplemental oxygen generation.
Regarding Claim 18, Cully discloses the second average size of the second pores locates vasculature along the second pores (Par. 81), and wherein the second average size of the second pores allows passage of the therapeutic agent through the exterior wall portion to the vasculature (Par. 81).
Regarding Claim, 19, Cully discloses the invention substantially as claimed except that that the first pores have first widths in a range of about 10nm to about 400nm. Rather Cully merely discloses that the pore width may be “less than about 0.5 microns [500nm]” (Par. 80), which establishes a range which contains Applicant’s claimed range. It has been held that in cases where ranges overlap or lie inside ranges disclosed by the prior art or when disclosed ranges are close to and approach a claimed range a prima facie case of obviousness exists, see In re Wertheim, 541 F.2d 257,191, USPQ 90 (CCPA 1976) and In re Becket, 88 F.2d 684 (CCP 1937). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the first pores of the invention of Cully to have a width within the range of 10nm to 400nm, a range which is encompassed by Cully’s disclosed range of less than 500nm where the endpoints are significantly close to one another, in order to arrive upon a specific range of pore sizes which are suitably constructed to resist cellular ingrowth but selectively pass macromolecules of interest.
Cully discloses that the outer porous layer/second pores may have a second width “greater than about 5.0 microns” a range which overlaps the instantly claimed range with an endpoint which lies within Applicant’s claimed range. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the second pores of the invention of Cully to have a width within the range of 2 microns to 60 microns, a range which substantially overlaps with Cully’s disclosed range of greater than 5 microns, in order to arrive upon a specific range of pore sizes which are suitable selected to optimize vascularization.
Regarding Claim 20-21, Cully discloses the inner diameter of the implant may range from 100 microns to 5mm (Par. 65), a range which encompasses Applicant’s claimed range, and therefore obviates said range as discussed in greater detail above with respect to obviousness of ranges, wherein said width is understood to be wide enough to accommodate multiple cells of the plurality of cells across a plane that is perpendicular to a central axis of the container.
Regarding Claim 22, Cully discloses wall thickness may be in the range of 2 microns to 1000 microns (Par. 75) – a range which encompasses Applicant’s claimed range, and therefore obviates said range as discussed in greater detail above.
Regarding Claim 23, Cully discloses that the container comprises a tube, and wherein the tube has a linear configuration (see Fig. 2).
Regarding Claim 24, Cully discloses that the tube is a first tube, wherein the implantable device further comprises a second tube disposed inside of the first tube, and wherein the first and second tubes together define an annular lumen for containing the plurality of cells (see Figs. 5-9 – wherein each layer can be considered to define a respective tube).
Regarding Claim 25, Cully discloses that the implantable device may comprise a core (105) which may be constructed to displace the cells within the implant. Cully discloses the invention substantially as claimed except that that the plurality of particles comprising the substance are disposed within this core. However, as discussed by Imran, it is known to provide a cell displacing core section (re: plug 110) with an oxygen suppling material, in order to affect delivery of oxygen to the retained cells, the core/plug being formed of “any suitable polymer” polyurethane, a species which overlaps with the materials for forming the core of Cully. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the polyurethane core of the invention of Cully to contain a plurality of particles comprising the substance, thereby only achieving the expected results of integrating the oxygen generating species of modified Cully using a well-known material known to be useful in the art for such a purpose.
Regarding Claim 28, Cully discloses comprising the plurality of cells contained within the interior region of the container (see generally Fig. 1A).
Regarding Claim 29, Cully discloses the invention substantially as claimed except that the cells may be beta cells, and wherein the therapeutic agent comprises insulin. However, Imran discloses that beta cells to produce insulin are one type of cell which are usefully implemented in such bioreactors (Par. 120). It would have been obvious for one having ordinary skill in the art at the time the invention was made to fill the device of Cully with beta cells to produce insulin, as disclosed by Imran, in order to help treat disorders of the endocrine system such as diabetes.
Regarding Claim 30, Cully discloses that the implant may be configured as a plurality of additional containers associated with one another, wherein each of the one or more additional containers contains an additional plurality of cells (see e.g. Fig. 12A).
Regarding Claim 31, Cully, as modified in view of Imran, discloses the substance is magnesium peroxide or calcium peroxide (Par. 108).
Regarding Claim 34, Cully discloses the interior wall portion comprises a tubular member and the exterior wall portion comprises a coating that surrounds the tubular member, and wherein the tubular member has a first material formulation and the coating has a second material formulation that is different from the first material formulation (Par. 68, 79).
Claim(s) 17, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0126134 (“Cully”) in view of U.S. Publication No. 2022/0409525 (“Imran”) as applied above, and further in view of U.S. Publication No. 2019/0240375 (“Hasilo”).
Regarding Claim 17, Cully discloses the invention substantially as claimed except for disclosing the external surface area to volume ratio. However, Hasilo discloses that the ratio of surface area to volume for such implants is a result effective variable (Par. 63). While Hasilo fails to disclose the optimal ratio it has been found that discovering the optimal or workable range for a result effective variable is obvious, requiring only routine and customary skill in the art, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the implant of the invention of Cully to have an external surface area to volume ratio of about 200 to about 5,000, thereby only achieving the obvious, expected, and predictable results of discovering the optimal or workable range for a variable that the prior art explicitly recognizes as being obvious and expected to optimize as a result effective variable.
Regarding Claim 27, Cully discloses the invention substantially as claimed except that that the exterior wall portion is coated with a growth factor to promote vascularization. However, Hasilo discloses that such implants can be provided with a growth factor coating on the exterior wall thereof, the coating comprising VEGF, PDGF, FGF, TGF…etc. It would have been obvious for one having ordinary skill in the art at the time the invention was made to coat the device of Hasilo with a growth factor such as VEGF, as disclosed by Hasilo, in order to help encourage vascular ingrowth through both mechanical and chemical means.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0126134 (“Cully”) in view of U.S. Publication No. 2022/0409525 (“Imran”) as applied above, and further in view of WO 2020/168327 (“Veiseh”)
Regarding Claim 26, Cully, as modified, that the plurality of particles comprising the substance are part of a coating applied to an inner surface of the interior wall portion. However, Veiseh discloses a related implant which is likewise concerned with generation of in situ oxygen to support cells (Pg. 4) wherein oxygen production can be affected by providing upon the device of layer of oxygen release compounds as an inner coating/layer (Pg. 5; Clm. 15). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner portion of the invention of Cully to have a layer/coating including the oxygen generating substance, as disclosed by Veiseh, in order to locate the oxygen geniting species in a suitable location adjacent to the cellular product to ensure that the cells are provided with sufficient oxygenation to maintain viability.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0126134 (“Cully”) in view of U.S. Publication No. 2022/0409525 (“Imran”) as applied above, and further in view of WO 2020/068852 (“Neuenfeldt”)
Regarding Claims 32-33, Cully discloses the invention substantially as claimed except that that the container comprises a third, intermediate section comprising 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. However, Neuenfeldt discloses a related implantable device which likewise comprises a first inner layer having a first smaller pore size and a second outer layer having a larger pore size with an intermediate region having a third, intermediate pore size disposed therebetween to define a transitional region (Pg. 10). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Cully with an intermediate, transitional region having a third pore size which lies between the first and second in order to create a gradual change in pore size, as disclosed by Neuenfeldt, in order to eliminate any abrupt changes in pore diameter which might lead to delamination between the layers.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0126134 (“Cully”) in view of U.S. Publication No. 2022/0409525 (“Imran”) and WO 2008/079997 (“Beck”).
Regarding Claim 35, Cully discloses an implantable (Abstract) device (e.g. 200) for providing a therapeutic agent (Abstract), the implantable device comprising:
A container (200) configured to contain a plurality of cells capable of producing the therapeutic agent (Par. 63) within an interior region of the container (Par. 60), the container defining:
first pores defined by an interior wall portion of the container (Par. 79), the first pores having a first average size (Par. 80) that
(i) allows passage of the therapeutic agent through the first pores and
(ii) prevents passage of immune cells through the first pores, and
second pores defined by an exterior wall portion of the container (Par. 79), the second pores having a second average size that is larger than the first average size, and the second pores being sized to promote vascularization along the exterior wall portion (Par. 81).
Cully discloses the invention substantially as claimed except that that the interior region of the container further comprises a substance capable of reacting to generate oxygen for the plurality of cells. While Cully is concerned with the delivery of oxygen to the cells (Par. 4, 139), Cully only explicitly considers permeation of oxygen from the exterior of the implant, not the interior. However, Imran discloses a related implant (Abstract), wherein the interior region of the implant container can be provided with an oxygen generating substance (Par. 14, 62, 72, 108, 130) which assists in maintaining the viability of the cells, particularly prior to and immediately following positioning of the implant prior to vascularization.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to include an oxygen generating substance within the container of the invention of Cully, as disclosed by Imran, in order to help support the viability of the cells through supplemental oxygen generation.
Cully, as modified, discloses the invention substantially as claimed except that that the system further comprises “an accessory device configured to cooperate with the implantable device for promoting delivery of oxygen to the plurality of cells”. However, such accessory devices are known to the prior art. For example, Beck discloses a related implantable cell container (22) which is provided in communication with an accessory device (pump 52) to promote the delivery of oxygen to the cells (Par. 224). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an accessory device to the system of Cully, as disclosed by Beck, in order to promote oxygen delivery to cells in addition to in situ generation of oxygen in order to supplement the oxygen or supplant oxygen generator after the oxygen generating species has been exhausted.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/24/2026