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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 16-23, 25, 27-37 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 25 of copending Application No. 18/288,087 in view of U.S. Publication No. 2022/0409525 (“Imran”) and U.S. Publication No. 2018/0126134 (“Cully”).
Regarding Claims 16, Claims 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.
Claim 25 further recites that the tube is a first tube, with the implantable device further comprising a second tube disposed inside the first tube, the tubes collectively defining an annular lumen which defines a radially disposed interior region having width/radial length which accommodates the cells.
The reference patent, at Claim 25, fails to recite that the radial length/width is “limited to accommodate a single cell… such that at least a portion of a surface area of each cell of the plurality of cells has direct access to the first pores”. However, such a size construction would have been obvious for the ordinary artisan in view of Cully (see Par. 60, 66, 67) which discloses a dual tube construction wherein the radial space is limited in size to “ensure cell survival” with widths as low as 30 microns to ensure that the cells are exposed to the device membrane to receive nutrients and other biomolecules, 30 microns being a size limited to accommodate a single cell.
Claim 25 of the reference patent fails to explicitly disclose a substance capable of reacting to generate oxygen for the plurality of cells within the interior region of the container at a core region of the second tube.
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. Locating the oxygenating substance in a core portion of the second tube is an obvious, predictable and expected location pursuant to rearrangement of the working parts/plug of Imran, with Cully disclosing configurations of such implantable devices having core sections (105) and the reference patent conspicuously claiming the second tube.
Regarding Claim 35, the instant claims further recite an “accessory device”, wherein such an accessory device is recited in reference patent Claim 34 and obvious in view of Cully (see Par. 68 and 79).’
With respect to the dependent claims, these particular limitations are not found to make a non-obvious contribution over the claims of the reference patent for at least the reasons recited below with respect to the prior art of Cully and Imran which would have been obvious to include in the claims of the reference patent to perfect operation of the implantable device as disclosed. Examiner notes that the dependent claims of the reference patent substantially correspond to the limitations of the instant claims, further echoing this subject matter known to the claims of the reference patent and the prior art (see Cully and Imran).
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, 19, 21, 22, 23, 25, 28, 29, 30, 31, 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 (100) for providing a therapeutic agent (Abstract), the implantable device comprising:
A container (100 – see Fig. 1A) formed as a first tube (110) configured to contain a plurality of cells (115) capable of producing the therapeutic agent (Par. 63) within an interior region of the container (see Fig. 1), 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 and oxygen 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 and oxygen transfer along the exterior wall portion (Par. 81);
A second tube (105) disposed inside of the first tube (see Fig. 1A), wherein the first and second tubes together define the interior region for accommodating the plurality of cells such that the interior region is provided as an annular lumen (see Fig. 1A – note the radial space between 110 and 105), and wherein the annular lumen has a radial length that is limited to accommodating a single cell of the plurality of cells along the radial length (Par. 60 – wherein a distance of “30 microns” is understood to be such a suitably small distance based upon Applicant’s instant disclosure (see e.g. Par. 179 of the instant specification which defines the range that is “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”), such that at least a portion of a surface area of each cell of the plurality of cells has direct access to the first pores (re: “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… suitable distances to ensure cell survival may include from about 30 microns…”) and 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 annular space to be suitably small, as disclosed by Cully, in order to ensure that ALL cells are directly exposed to the permeable membrane 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). Here Cully recognizes a range of radial widths that lie within the range which Applicant notes as useful for ensuring a single cell width and Cully recognizes the reason why such a limited width is beneficial by ensuring that the cells are sufficiently exposed to the permeable membrane to ensure nutrient transfer.
Cully discloses the invention substantially as claimed except that that the interior region of the second tube further comprises a substance capable of reacting to generate oxygen for the plurality of cells thereby forming a “core region” within that second tube. 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.
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. It has been found that rearranging the location of the parts of an invention is obvious where it provides only expected and predictable results, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Here the core section (105) of Cully constitutes simply an obvious, suitable location where an oxygen generating species might be provided in order to permit the device to provide oxygen to the cells to ensure their optimal metabolism and viability.
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 21, modified Cully is constructed such that the interior region is wide enough to accommodate multiple cells of the plurality of cells across a plane that is perpendicular to a central axis of the container, i.e. in an annular space having a width limited to accommodate a single cell (e.g. 30 microns) the side of the annular space, diametrically opposed thereto and located on the other side of the core will likewise be configured to accommodate only a single cell, whereby the plane which is perpendicular to a central axis of the container will be wide enough to accommodate multiple cells, i.e. a single cell on one side of the core and another single cell on the side of the core diametrically opposed thereto.
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 25, Cully, as modified by Imran, discloses the substance is encapsulated within a plurality of particles (i.e. the oxygen generating species is encapsulated within the polymeric matrix of the plug – see Imran, Par. 106, 107).
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 - Imran).
Regarding Claim 34, Cully discloses the exterior wall portion comprises a coating that surrounds the interior wall portion of the first tube, and wherein the interior wall portion comprises 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) 36 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 ”Sintering Technique for the Preparation of Polymer Matrices for the Controlled Release of Macromolecules” (“Cohen”).
Regarding Claim 36, Cully, as modified, discloses the invention substantially as claimed except that that the core region comprises a “sintered matrix” in which the substance is loaded. Rather Imran only suggests a generic polymeric matrix (Par. 106 – Imran). However, Cohen discloses that such polymeric matrix configured for controlled release of an agent can be produced as a “sintered” matrix to provide for a porous matrix for affecting controllable, sustained release whereby producing the matrix via sintering allows for improved control on release rate (Abstract; Pg. 1037). It would have been obvious for one having ordinary skill in the art at the time the invention was made to product the matrix of modified Cully via sintering, as disclosed by Cohen, in order to provide a polymeric matrix with well-controlled pore size and distribution to allow for improved rate and sustained release control.
Claim(s) 17, 20, 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 20, Cully discloses the invention substantially as claimed except for explicitly disclosing the volume capacity range for the implantable device. 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 the ordinary artisan 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 – Par. 63; see also Imran, Par. 73). 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 modified Cully to have the necessary length to create a volume capacity of about 0.1mL to about 1.1mL, in order to ensure that the implant can accommodate a sufficiently efficacious population of cells to produce an efficacious volume of medicament thereby obtaining only expected and predicted outcomes associated with mere changes in size/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.
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) 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) 37 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. 2010/0303878 (“Slager”).
Regarding Claim 37, Cully discloses the invention substantially as claimed except that the container has a spiral configuration or a helical configuration. Cully does recite that the device may be configured to assume “non-planar” arrangements (Par. 12) and that shapes can vary from the linear configuration shown including “circular, ovoid, or elliptical” arrangements (Par. 65) with shape memory changes envisaged to assist in anchoring (Par 85) with “curved or wavy shapes” (Par. 86). Although a “spiral” or “helical” curve or wave is not explicitly resolved. However, Slager discloses a related implant which comprises a helical/spiral/coiled shape (see Figs. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the device of modified Cully as a non-planar, curved/wavy explicitly in the form of a coil/helix/spiral, a shape known to the prior art as demonstrated by 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) 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 (100) for providing a therapeutic agent (Abstract), the implantable device comprising:
A container (100 – see Fig. 1A) formed as a first tube (110) configured to contain a plurality of cells (115) capable of producing the therapeutic agent (Par. 63) within an interior region of the container (see Fig. 1), 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 and oxygen 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 and oxygen transfer along the exterior wall portion (Par. 81);
A second tube (105) disposed inside of the first tube (see Fig. 1A), wherein the first and second tubes together define the interior region for accommodating the plurality of cells such that the interior region is provided as an annular lumen (see Fig. 1A – note the radial space between 110 and 105), and wherein the annular lumen has a radial length that is limited to accommodating a single cell of the plurality of cells along the radial length (Par. 60 – wherein a distance of “30 microns” is understood to be such a suitably small distance based upon Applicant’s instant disclosure (see e.g. Par. 179 of the instant specification which defines the range that is “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”), such that at least a portion of a surface area of each cell of the plurality of cells has direct access to the first pores (re: “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… suitable distances to ensure cell survival may include from about 30 microns…”) and 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 annular space to be suitably small, as disclosed by Cully, in order to ensure that ALL cells are directly exposed to the permeable membrane 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). Here Cully recognizes a range of radial widths that lie within the range which Applicant notes as useful for ensuring a single cell width and Cully recognizes the reason why such a limited width is beneficial by ensuring that the cells are sufficiently exposed to the permeable membrane to ensure nutrient transfer.
Cully discloses the invention substantially as claimed except that that the interior region of the second tube further comprises a substance capable of reacting to generate oxygen for the plurality of cells thereby forming a “core region” within that second tube. 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.
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. It has been found that rearranging the location of the parts of an invention is obvious where it provides only expected and predictable results, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Here the core section (105) of Cully constitutes simply an obvious, suitable location where an oxygen generating species might be provided in order to permit the device to provide oxygen to the cells to ensure their optimal metabolism and viability.
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.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 10) that “a radial length of the boundary zone [of Cully] accommodates two or more cells along the radial length such that not all cells 115 within the boundary zone have direct access to openings within the permeable membrane”. However, this is not persuasive. Cully explicitly recognizes that the width/radial length of the boundary zone/annular space is a result effective variable which should be sufficiently minimized in order to provide sufficient exposure of the retained cells to the permeable membrane to maintain viability (Par. 60) with distances as small as “30 microns” resolved, wherein the instant specification recognizes substantially larger dimensions (re: 100 microns to about 2mm) as being useful for resolving a width that is “limited to accommodating a single cell”. As such, Examiner submits that it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the boundary zone of the invention of Cully of substantially small distances including those effectively within the range disclosed by Applicant as accommodating a single cell in order to affect the explicitly recognized and expected benefits of ensuring cell viability by reducing the maximum distance between the retained cells and the permeable membrane.
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 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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/18/2026
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