CTFR 17/342,978 CTFR 93294 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 The Amendment filed on 2/11/2026 has been entered. Claims 22-37 and 39 remain pending in the application. Claim 42-45 is new. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/1/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim 42 objected to because of the following informalities: Line 2 recites “the composition of the caps in a first population”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the composition” in line 2 with “a composition”. Line 2 recites “the caps in a first population”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the caps” in line 2 with “caps”. Line 2-3 recites “the composition of caps in a second population”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the composition” in line 2-3 with “a composition”. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 42-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In regard to claim 42, Line 3 recites “tailored to provide pulsatile release of the agent at two or more times”. It is unclear if “tailored to provide pulsatile release of the agent at two or more times” requires each microdevice in the combination of microdevices to be tailored to provide pulsatile release of the agent at two or more times or if “tailored to provide pulsatile release of the agent at two or more times” requires a first microdevice in the combination of microdevices to be tailored to provide pulsatile release of the agent at a first time and a second microdevice in the combination of microdevices to be tailored to provide pulsatile release of the agent at a second time different from the first time. Appropriate correction is required. For examination purposes Examiner construes “tailored to provide pulsatile release of the agent at two or more times” to require each microdevice in the combination of microdevices to be tailored to provide pulsatile release of the agent at two or more times. In regard to claim 43, Line 2 recites “a first population”. Line 1 recites “comprising at least two subpopulations of microdevices”. It is unclear if the first population is of the at least two subpopulations as line 2 states a first population, not a first subpopulation. For examination purposes Examiner construes “a first population” to be “a first subpopulation of the at least two subpopulations of microdevices”. Examiner suggests replacing “a first population” in line 2 of claim 43 with “a first subpopulation of the at least two subpopulations of microdevices”. Line 3 recites “a second population”. Line 1 recites “comprising at least two subpopulations of microdevices”. It is unclear if the second population is of the at least two subpopulations as line 3 states a second population, not a second subpopulation. For examination purposes Examiner construes “a second population” to be “a second subpopulation of the at least two subpopulations of microdevices”. Examiner suggests replacing “a second population” in line 3 of claim 43 with “a second subpopulation of the at least two subpopulations of microdevices”. In regard to claim 44, Line 2 recites “said microdevices”. It is unclear which microdevices said microdevices refer to. It is unclear if said microdevices refer to the microdevice in the population of microdevices introduced in line 1-2 of claim 44 or if said microdevices refer to the microdevices in the population of microdevices of claim 22, which claim 44 depends on. For examination purposes Examiner construes said microdevices to refer to the microdevices of line 1-2 of claim 44. Examiner suggests replacing “microdevices” in line 1 of claim 44 with “a combination of microdevices” AND replacing “said microdevices are” in line 2 of claim 44 with “said combination of microdevices is”. In regard to claim 45, Line 2 recites “said microdevices”. It is unclear which microdevices said microdevices refer to. It is unclear if said microdevices refer to the microdevice in the population of microdevices introduced in line 1-2 of claim 45 or if said microdevices refer to the microdevices in the population of microdevices of claim 39, which claim 45 depends on. For examination purposes Examiner construes said microdevices to refer to the microdevices of line 1-2 of claim 45. Examiner suggests replacing “microdevices” in line 1 of claim 45 with “a combination of microdevices” AND replacing “said microdevices are” in line 2 of claim 45 with “said combination of microdevices is”. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 22, 25-26, 29-30, 35-36, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over a first interpretation of Bonutti (U.S. PG publication 20070141106) further in view of Nazzaro (U.S. PG publication 20120238994) . In regard to claim 22, Bonutti discloses devices (see figure 24, item 130, figure 26, item 150, the device in figure 25 and the device in figure 27) comprising a population of devices (figure 24, item 130 and figure 26, item 150; Examiner notes the implant/device 150 is construed as not having lumen 168 which as supported by paragraph [0160] is optional; see also paragraph [0151] and [0158] which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade) each device in the population of devices having dimensions (paragraph [0008]; Examiner notes the medical implants/devices are sized to be positioned in the body), each device in the population of devices comprising: a base (figure 24, item 132 and figure 26, item 152) comprising a first biocompatible polymer (paragraph [0152] and [0159]: wherein the first biocompatible polymer is construed as a mixture of PLA, PGA, PLGA and collagen. Examiner notes paragraph [0152] and [0159] both support copolymers of PLA and PGA can be included, and PLGA is a copolymer of PLA and PGA), a cap (figure 24, item 134 and figure 26, item 154; paragraph [0149] and [0156]) sealed to the base to define a hollow core (figure 24, item 140 and figure 26, item 160; paragraph [0149] and [0156]), wherein the cap is a preformed cap (see figure 24 and 26; paragraph [0149] and [0156]), the cap comprising a second biocompatible polymer that is the same or different from the first biocompatible polymer (paragraph [0152] and [0159]: wherein the second biocompatible polymer is construed as a mixture of PLA, PGA, and PLGA. Examiner notes paragraph [0152] and [0159] both support copolymers of PLA and PGA can be included, and PLGA is a copolymer of PLA and PGA); and an agent (figure 24 and 26, item 12; paragraph [0053] and [0058]-[0059]) contained in the hollow core (see figure 24 and 26), wherein the base of each device in the population of devices and each preformed cap of each device in the population of devices are aligned, sealed, and bonded to form each device in the population of devices (paragraph [0149] and [0156]; Examiner notes the phrase “aligned, sealed, and bonded” is directed towards the process of making a device. The claimed phase “aligned, sealed, and bonded” is being treated as a product-by-process limitation. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language "aligned, sealed, and bonded" only requires the cap to be attached to the base, which does not distinguish the invention from Bonutti, which discloses the structure as claimed and that also discloses the base and cap are aligned, sealed, and bonded to form each device as supported by paragraph [0149] and [0156]. See MPEP 2113), wherein the base and the preformed cap have different thicknesses from one another (see figure 24 and 26; and paragraph [0149] and [0156]), and wherein (i) each device in the population of devices is singulated from another device in the population of devices (see figure 24 and 26) and (ii) each device in the population of devices has an external biodegradable surface (paragraph [0151] and [0158]; external surface of either each base or each cap which are made of a biodegradable material), wherein degradation of the external biodegradable surface is configured to control release of the agent (paragraph [0151] and [0158]: wherein the agent/pharmaceutical agent 12 is released as the device/implant degrades). Although a separate embodiment of Bonutti teaches an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071]), Bonutti is silent as to the specific size of the devices and therefore fails to disclose microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns. As a result, Bonutti is also silent as to each microdevice in the population of microdevices comprising the specifics of claim 22 and wherein the base of each microdevice in the population of microdevices and each preformed cap of each microdevice in the population of microdevices are aligned, sealed, and bonded to form each microdevice in the population of microdevices and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of the agent. Nazzaro teaches microdevices (figure 1, item 100 and figure 2A, item 200, figure 2, item 300; Examiner notes paragraph [0084] supports that each drug delivery device in figures 1-4C can be a microdevice as the dimensions can be less than about 4 mm long and less than about 0.5 mm in diameter. Examiner notes each device can therefore have a length less than 1 mm (as a length less than 1 mm is less than 4 mm) and a diameter less than .5 mm which would therefore result in each device being a microdevice in order to fit within a needle having a size from about 30 gauge to about 15 gauge as disclosed in paragraph [0084]) comprising a population of microdevices (figure 1, item 100 and figure 2A, item 200; see analysis above regarding the size of item 100 and 200; paragraph [0084]), each microdevice in the population of microdevices having dimensions of less than 1000 microns (see analysis above regarding the size of item 100 and 200; paragraph [0084]; Examiner notes the length is construed to be less than 1 mm and the diameter is less than .5 mm of each device which satisfies the limitations of “each microdevice in the population of microdevices having dimensions of less than 1000 microns”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of each device of the devices of Bonutti to include a length less than 1 mm and a diameter that is less than .5 mm, as taught by Nazzaro, therefore resulting in microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns, each microdevice in the population of microdevices comprising the specifics of claim 22, wherein the base of each microdevice in the population of microdevices and each preformed cap of each microdevice in the population of microdevices are aligned, sealed, and bonded to form each microdevice in the population of microdevices and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of the agent, for the purpose of enabling an implant to be delivered easily using a needle (paragraph [0084] of Nazzaro) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exits.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, as Bonutti supports any therapeutic/biologic agent can be delivered (paragraph [0053] and [0059] of Bonutti) and that an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071] of Bonutti), one of ordinary skill in the art would recognize that the device can be sized accordingly depending on the intended therapeutic/location of injection. Examiner notes the instant disclosure further supports that “The devices have microscale external dimensions, such as a length, width, height, or diameter, up to one centimeter in at least one dimension, more preferably having a maximum diameter between 1 micrometer (µm) and 1000 µm).” In regard to claim 25, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the second biocompatible polymer is different from the first biocompatible polymer (see analysis of claim 22 above; Examiner notes paragraph [0151]-[0152] and [0158]-[0159] of Bonutti further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in the second biocompatible polymer being different from the first biocompatible polymer), and the first biocompatible polymer and the second biocompatible polymer comprise different monomers, have different degrees of polymerization, have different co-polymer ratios, or comprise different blends (see analysis of claim 22 above wherein the first biocompatible polymer and the second biocompatible polymer comprise different blends). In regard to claim 26, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein at least one of the first biocompatible polymer and the second biocompatible polymer are selected from the group consisting of polyesters, polyanhydrides, poly glycolic acid (PGA), poly lactic acid (PLA), polycaprolactone (PCL), copolymers of lactic acid and glycolic acid (PLGA), polyacrylates, polyethylene glycol (PEG), and mixtures, blends and copolymers thereof (see analysis of claim 22 above; wherein the second biocompatible polymer consists of PGA, PLA and PLGA). In regard to claim 29, Bonutti in view of Nazzaro teaches the microdevices of claim 26 wherein at least one of the first biocompatible polymer or the second biocompatible polymer comprises PLGA (see analysis of claim 22 above). In regard to claim 30, Bonutti in view of Nazzaro teaches the microdevices of claim 26 wherein at least one of the first biocompatible polymer or the second biocompatible polymer comprises a mixture of two or more polymers (see analysis of claim 22 above). In regard to claim 35, Bonutti in view of Nazzaro fails to disclose wherein at least one microdevice in the population of microdevices comprises different encapsulated compounds located in different regions of a microstructure of the at least one microdevice. A second embodiment of Bonutti teaches wherein at least one device (figure 24, item 130) in the population of devices comprises different encapsulated compounds (paragraph [0154]) located in different regions of a microstructure of the at least one microdevice (paragraph [0154]; cavity 140 is subdivided into a plurality of cavities which each contain a different agent 12). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to item 130 of Bonutti in view of Nazzaro to include different encapsulated compounds located in different regions of a microstructure of the at least one microdevice, as taught by the second embodiment of Bonutti, therefore resulting in wherein at least one microdevice in the population of microdevices comprises different encapsulated compounds located in different regions of a microstructure of the at least one microdevice for the purpose of segregating two or more agents until implantation (paragraph [0154] of Bonutti). In regard to claim 36, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the agent comprises a therapeutic agent or a prophylactic agent (paragraph [0058]-[0059] and [0053]). In regard to claim 39, Bonutti discloses devices (see figure 24, item 130, figure 26, item 150, the device in figure 25 and the device in figure 27) comprising a population of devices (figure 24, item 130 and figure 26, item 150; Examiner notes the implant/device 150 is construed as not having lumen 168 which as supported by paragraph [0160] is optional; see also paragraph [0151] and [0158] which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade), each device in the population of devices having dimensions (paragraph [0008]; Examiner notes the medical implants/devices are sized to be positioned in the body), each device in the population of devices comprising: a fillable base (figure 24, item 132 and figure 26, item 152; Examiner notes the base can be filled with item 12) defining a hollow chamber (figure 24, item 140 and figure 26, item 160; paragraph [0149] and [0156]), the fillable base comprising a biocompatible polymer (paragraph [0152] and [0159]: wherein the biocompatible polymer is construed as a mixture of PLA and PGA); and a polymeric cap (figure 24, item 134 and figure 26, item 154; paragraph [0149] and [0156]) sealable to the fillable base (paragraph [0149] and [0156]), wherein a composition of the polymeric cap is different from a composition of the fillable base (paragraph [0152] and [0159]: wherein the composition of the polymeric cap is construed to be PLA, PGA, and collagen which is different than the composition of the fillable base; Examiner notes paragraph [0151]-[0152] and [0158]-[0159] further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in a composition of the polymeric cap being different from a composition of the fillable base), and wherein (i) each device in the population of devices is singulated from another device in the population of devices (see figure 24 and 26) and (ii) each device in the population of devices has an external biodegradable surface (paragraph [0151] and [0158]; external surface of either each base or each cap which are made of a biodegradable material), wherein degradation of the external biodegradable surface is configured to control release of an agent from the hollow chamber (paragraph [0058]-[0059], paragraph [0151] and [0158]: wherein an agent 12 is released from the hollow chamber as the device/implant degrades). Although a separate embodiment of Bonutti teaches an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071]), Bonutti is silent as to the specific size of the devices and therefore fails to disclose microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns. As a result, Bonutti is also silent as to each microdevice in the population of microdevices comprising the specifics of claim 39, and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of an agent from the hollow chamber. Nazzaro teaches microdevices (figure 1, item 100 and figure 2A, item 200, figure 2, item 300; Examiner notes paragraph [0084] supports that each drug delivery device in figures 1-4C can be a microdevice as the dimensions can be less than about 4 mm long and less than about 0.5 mm in diameter. Examiner notes each device can therefore have a length less than 1 mm (as a length less than 1 mm is less than 4 mm) and a diameter less than .5 mm which would therefore result in each device being a microdevice in order to fit within a needle having a size from about 30 gauge to about 15 gauge as disclosed in paragraph [0084]) comprising a population of microdevices (figure 1, item 100 and figure 2A, item 200; see analysis above regarding the size of item 100 and 200; paragraph [0084]), each microdevice in the population of microdevices having dimensions of less than 1000 microns (see analysis above regarding the size of item 100 and 200; paragraph [0084]; Examiner notes the length is construed to be less than 1 mm and the diameter is less than .5 mm of each device which satisfies the limitations of “each microdevice in the population of microdevices having dimensions of less than 1000 microns”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of each device of the devices of Bonutti to include a length less than 1 mm and a diameter that is less than .5 mm, as taught by Nazzaro, therefore resulting in microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns, each microdevice in the population of microdevices comprising the specifics of claim 39, and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of an angent from the hollow chamber, for the purpose of enabling an implant to be delivered easily using a needle (paragraph [0084] of Nazzaro) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exits.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, as Bonutti supports any therapeutic/biologic agent can be delivered (paragraph [0053] and [0059] of Bonutti) and that an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071] of Bonutti), one of ordinary skill in the art would recognize that the device can be sized accordingly depending on the intended therapeutic/location of injection. Examiner notes the instant disclosure further supports that “The devices have microscale external dimensions, such as a length, width, height, or diameter, up to one centimeter in at least one dimension, more preferably having a maximum diameter between 1 micrometer (µm) and 1000 µm).” 07-21-aia AIA Claim s 23-24, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Staas (U.S. Patent no 6312731) . In regard to claim 23, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the second biocompatible polymer is different from the first biocompatible polymer (see analysis of claim 22 above where the mixtures are different; Examiner notes paragraph [0151]-[0152] and [0158]-[0159] of Bonutti further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in the second biocompatible polymer being different from the first biocompatible polymer). Bonutti in view of Nazzaro is silent as to the second biocompatible polymer includes different end groups than end groups of the first biocompatible polymer. Staas teaches the second biocompatible polymer (component B which is a mixture of PGA, PLA, and PLGA which is blocked i.e. has an ester end group; column 17, line 41-60 and column 18, line 39-50) includes different end groups than end groups of the first biocompatible polymer (component A is construed as PLA, PGA, and PLGA which is unblocked; column 17, line 41-60; column 18, line 39-50). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second biocompatible polymer to include different end groups than end groups of the first biocompatible polymer, as taught by Staas, for the purpose of controlling/slowing down the degradation rate (column 18, line 39-48 of Staas). Bonutti further supports the degradation rate of the cap or base can be modified if desired (paragraph [0152] and [0159] of Bonutti). In regard to claim 24, Bonutti in view of Nazzaro in view of Staas teaches the microdevices of claim 23 wherein the end groups of the second biocompatible polymer comprise ester end groups (see analysis of claim 23 above; column 18, line 39-50 of Staas). In regard to claim 31, Bonutti in view of Nazzaro teaches a microdevice formulation comprising at least two microdevices in the population of microdevices of the microdevices of claim 22 (figure 24, item 130 of Bonutti and figure 26, item 150 of Bonutti; Examiner notes the implant/device 150 is construed as not having lumen 168 which as supported by paragraph [0160] of Bonutti is optional; see also paragraph [0151] and [0158] of Bonutti which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade; see analysis above of claim 22 wherein the devices are microdevices as modified by Nazzaro. The microdevice formulation is construed as item 130 and 150 of Bonutti which comprises at least two microdevices in the population of microdevices) wherein a first microdevice (figure 24, item 130 of Bonutti) of the at least two microdevices of the population of microdevices comprises a first PLGA (PLGA of base; see analysis of claim 22 above) and a second microdevice (figure 26, item 150 of Bonutti) of the at least two microdevices of the population of microdevices comprises a second PLGA (PLGA of cap). Although it appears the second PLGA would be different at least in shape/size than the first PLGA, Bonutti in view of Nazzaro is silent as to a second different PLGA. Staas teaches a first PLGA and a second different PLGA (column 17, line 41-60 and column 18, line 39-50: first PLGA with a carboxyl end group and second different PLGA with ester end group). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include a second PLGA that is different from the first PLGA, as taught by Staas, for the purpose of controlling/slowing down the degradation rate (column 18, line 39-48 of Staas). Bonutti further supports the degradation rate of the cap or base can be modified/controlled if desired (paragraph [0152] and [0159] of Bonutti). In regard to claim 32, Bonutti in view of Nazzaro in view of Staas teaches the microdevice formulation of claim 31 wherein the first microdevice and the second microdevice comprise the agent (see figure 24 and 26, item 12 of Bonutti; paragraph [0059] of Bonutti), wherein the agent is the same in the first microdevice and in the second microdevice (see figure 24 and 26, item 12 of Bonutti; paragraph [0059] of Bonutti). In regard to claim 33, Bonutti in view of Nazzaro in view of Staas teaches the microdevice formulation of claim 31 wherein the first microdevice and the second microdevice exhibit different release kinetics (see analysis of claim 31 above and figure 24 and 26 of Bonutti wherein the first microdevice and the second microdevice exhibit different release kinetics due to their composition. Additionally due to the second microdevice being shaped differently than the first microdevice and having varying thicknesses, the first microdevice and the second microdevice would also exhibit different release kinetics; see also paragraph [0152] and [0159] of Bonutti) . 07-21-aia AIA Claim s 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Wang (U.S. PG publication 20140336487) . In regard to claim 27, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the preformed cap of each microdevice in the population of microdevices is aligned and sealed to the base of each microdevice in the population of microdevices (see figure 24 and 26 of Bonutti and paragraph [0156] and [0149] of Bonutti). Bonutti in view of Nazzaro is silent as to wherein the preformed cap of each microdevice in the population of microdevices is microscopically aligned and sealed to the base of each microdevice in the population of microdevices. Wang teaches aligning two components microscopically (paragraph [0097]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the two components which are aligned i.e. the preformed cap of each microdevice in the population of microdevices and the base of each microdevice in the population of microdevices of Bonutti in view of Nazzaro to be aligned microscopically, as taught by Wang, therefore resulting in wherein the preformed cap of each microdevice in the population of microdevices is microscopically aligned and sealed to the base of each microdevice in the population of microdevices for the purpose of facilitating alignment (paragraph [0097] of Wang). Additionally, the language, term, or phrase "microscopically aligned and sealed ", is directed towards the process of making the microdevices. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. In re Hirao, 190 USPQ 15 at 17 (footnote 3). See also, In re Brown, 173 USPQ 685; In re Luck, 177 USPQ 523; In re Fessmann, 180 USPQ 324; In re Avery, 186 USPQ 161; In re Wethheim, 191 USPQ 90 (209 USPQ 554 does not deal with this issue); In re Marosi et al., 218 USPQ 289; and particularly In re Thorpe, 227 USPQ 964, all of which make it clear that it is the patentability of the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or otherwise. As such, the language "microscopically aligned and sealed" only requires the preformed cap of each microdevice in the population of microdevices to be sealed to the base of each microdevice in the population of microdevices which does not distinguish the invention from Bonutti in view of Nazzaro, which teaches the structure as claimed. See also MPEP 2113. In regard to claim 28, Bonutti in view of Nazzaro in view of Wang teaches the microdevices of claim 27 wherein the preformed cap of each microdevice of the population of microdevices is sealed to the base of each microdevice in the population of microdevices by heating at a temperature between 40°C and 60°C (The language, term, or phrase "sealed to the base by heating at a temperature between 40°C and 60°C", is directed towards the process of making the microdevices. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. In re Hirao, 190 USPQ 15 at 17 (footnote 3). See also, In re Brown, 173 USPQ 685; In re Luck, 177 USPQ 523; In re Fessmann, 180 USPQ 324; In re Avery, 186 USPQ 161; In re Wethheim, 191 USPQ 90 (209 USPQ 554 does not deal with this issue); In re Marosi et al., 218 USPQ 289; and particularly In re Thorpe, 227 USPQ 964, all of which make it clear that it is the patentability of the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or otherwise. As such, the language "sealed to the base by heating at a temperature between 40°C and 60°C" only requires the preformed cap of each microdevice of the population of microdevices to be sealed to the base of each microdevice of the population of microdevices, which does not distinguish the invention from Bonutti in view of Nazzaro in view of Wang, which teaches the structure as claimed; See also MPEP 2113) . 07-21-aia AIA Claim s 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Jaklenec (U.S. PG publication 20150165020) . In regard to claim 34, Bonutti in view of Nazzaro teaches the microdevices of claim 22. Bonutti in view of Nazzaro fails wherein each microdevice in the population of microdevices is sterilized. Jaklenec teaches wherein each microdevice in the population of microdevices is sterilized (paragraph [0091]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include wherein each microdevice in the population of microdevices is sterilized, as taught by Jaklenec, for the purpose of maintaining antigen stability and producing a sterile microdevice which would not introduce unwanted contaminates to the body (paragraph [0091] and [0053] of Jaklenec). In regard to claim 37, Bonutti in view of Nazzaro teaches the microdevices of claim 22. Bonutti in view of Nazzaro is silent as to wherein the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm. Jaklenec teaches wherein the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm (paragraph [0213]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm, as taught by Jaklenec, for the purpose of ensuring the microdevice can be delivered with a 21 gauge needle or 23 gauge needle (paragraph [0213] of Jaklenec). Examiner notes as detailed above, Nazzaro supports modifying the size of the device of Bonutti to enable use with a needle, but is silent as to the specific size of the hollow core. Jaklenec teaches an appropriately sized hollow core to enable use with a specific size needle . 07-21-aia AIA Claim s 22, 25-26, 29-30, 35-36, 39, and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over a second interpretation of Bonutti (U.S. PG publication 20070141106) further in view of Nazzaro (U.S. PG publication 20120238994). The second interpretation differs from the first interpretation in regard to the population of microdevices . In regard to claim 22, Bonutti discloses devices (see figure 24, item 130, figure 26, item 150, the device in figure 25 and the device in figure 27) comprising a population of devices (figure 24, item 130 and the device shown in figure 25; see paragraph [0151] which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade. Examiner notes the device shown in figure 25 also would have a cap 134, as the device shown in figure 25 is the implant of figure 24 having a plurality of coverable cavities a supported by paragraph [0036]) each device in the population of devices having dimensions (paragraph [0008]; Examiner notes the medical implants/devices are sized to be positioned in the body), each device in the population of devices comprising: a base (figure 24 and 25, item 132) comprising a first biocompatible polymer (paragraph [0152]: wherein the first biocompatible polymer is construed as a mixture of PLA, PGA, PLGA and collagen. Examiner notes paragraph [0152] supports copolymers of PLA and PGA can be included, and PLGA is a copolymer of PLA and PGA), a cap (figure 24, item 134; Examiner notes the device of figure 25 would also have a cap 134 as paragraph [0036] supports figure 25 is the implant of figure 24 having a plurality of coverable cavities; paragraph [0149]) sealed to the base to define a hollow core (figure 24, item 140 and figure 25, item 144), wherein the cap is a preformed cap (see figure 24; paragraph [0149]), the cap comprising a second biocompatible polymer that is the same or different from the first biocompatible polymer (paragraph [0152]: wherein the second biocompatible polymer is construed as a mixture of PLA, PGA, and PLGA. Examiner notes paragraph [0152] supports copolymers of PLA and PGA can be included, and PLGA is a copolymer of PLA and PGA); and an agent (figure 24 and 25, item 12; paragraph [0053] and [0058]-[0059]) contained in the hollow core (see figure 24 and 25), wherein the base of each device in the population of devices and each preformed cap of each device in the population of devices are aligned, sealed, and bonded to form each device in the population of devices (paragraph [0149]; Examiner notes the phrase “aligned, sealed, and bonded” is directed towards the process of making a device. The claimed phase “aligned, sealed, and bonded” is being treated as a product-by-process limitation. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language "aligned, sealed, and bonded" only requires the cap to be attached to the base, which does not distinguish the invention from Bonutti, which discloses the structure as claimed and that also discloses the base and cap are aligned, sealed, and bonded to form each device as supported by paragraph [0149]. See MPEP 2113), wherein the base and the preformed cap have different thicknesses from one another (see figure 24; and paragraph [0149]), and wherein (i) each device in the population of devices is singulated from another device in the population of devices (see figure 24 and 25) and (ii) each device in the population of devices has an external biodegradable surface (paragraph [0151]; external surface of either each base or each cap which are made of a biodegradable material), wherein degradation of the external biodegradable surface is configured to control release of the agent (paragraph [0151]: wherein the agent/pharmaceutical agent 12 is released as the device/implant degrades). Although a separate embodiment of Bonutti teaches an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071]), Bonutti is silent as to the specific size of the devices and therefore fails to disclose microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns. As a result, Bonutti is also silent as to each microdevice in the population of microdevices comprising the specifics of claim 22 and wherein the base of each microdevice in the population of microdevices and each preformed cap of each microdevice in the population of microdevices are aligned, sealed, and bonded to form each microdevice in the population of microdevices and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of the agent. Nazzaro teaches microdevices (figure 1, item 100 and figure 2A, item 200, figure 2, item 300; Examiner notes paragraph [0084] supports that each drug delivery device in figures 1-4C can be a microdevice as the dimensions can be less than about 4 mm long and less than about 0.5 mm in diameter. Examiner notes each device can therefore have a length less than 1 mm (as a length less than 1 mm is less than 4 mm) and a diameter less than .5 mm which would therefore result in each device being a microdevice in order to fit within a needle having a size from about 30 gauge to about 15 gauge as disclosed in paragraph [0084]) comprising a population of microdevices (figure 1, item 100 and figure 2A, item 200; see analysis above regarding the size of item 100 and 200; paragraph [0084]), each microdevice in the population of microdevices having dimensions of less than 1000 microns (see analysis above regarding the size of item 100 and 200; paragraph [0084]; Examiner notes the length is construed to be less than 1 mm and the diameter is less than .5 mm of each device which satisfies the limitations of “each microdevice in the population of microdevices having dimensions of less than 1000 microns”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of each device of the devices of Bonutti to include a length less than 1 mm and a diameter that is less than .5 mm, as taught by Nazzaro, therefore resulting in microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns, each microdevice in the population of microdevices comprising the specifics of claim 22, wherein the base of each microdevice in the population of microdevices and each preformed cap of each microdevice in the population of microdevices are aligned, sealed, and bonded to form each microdevice in the population of microdevices and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of the agent, for the purpose of enabling an implant to be delivered easily using a needle (paragraph [0084] of Nazzaro) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exits.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, as Bonutti supports any therapeutic/biologic agent can be delivered (paragraph [0053] and [0059] of Bonutti) and that an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071] of Bonutti), one of ordinary skill in the art would recognize that the device can be sized accordingly depending on the intended therapeutic/location of injection. Examiner notes the instant disclosure further supports that “The devices have microscale external dimensions, such as a length, width, height, or diameter, up to one centimeter in at least one dimension, more preferably having a maximum diameter between 1 micrometer (µm) and 1000 µm).” In regard to claim 25, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the second biocompatible polymer is different from the first biocompatible polymer (see analysis of claim 22 above; Examiner notes paragraph [0151]-[0152] of Bonutti further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in the second biocompatible polymer being different from the first biocompatible polymer), and the first biocompatible polymer and the second biocompatible polymer comprise different monomers, have different degrees of polymerization, have different co-polymer ratios, or comprise different blends (see analysis of claim 22 above wherein the first biocompatible polymer and the second biocompatible polymer comprise different blends). In regard to claim 26, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein at least one of the first biocompatible polymer and the second biocompatible polymer are selected from the group consisting of polyesters, polyanhydrides, poly glycolic acid (PGA), poly lactic acid (PLA), polycaprolactone (PCL), copolymers of lactic acid and glycolic acid (PLGA), polyacrylates, polyethylene glycol (PEG), and mixtures, blends and copolymers thereof (see analysis of claim 22 above; wherein the second biocompatible polymer consists of PGA, PLA and PLGA). In regard to claim 29, Bonutti in view of Nazzaro teaches the microdevices of claim 26 wherein at least one of the first biocompatible polymer or the second biocompatible polymer comprises PLGA (see analysis of claim 22 above). In regard to claim 30, Bonutti in view of Nazzaro teaches the microdevices of claim 26 wherein at least one of the first biocompatible polymer or the second biocompatible polymer comprises a mixture of two or more polymers (see analysis of claim 22 above). In regard to claim 35, Bonutti in view of Nazzaro fails to disclose wherein at least one microdevice (device shown in figure 25) in the population of microdevices comprises different encapsulated compounds located in different regions of a microstructure of the at least one microdevice (paragraph [0154]). In regard to claim 36, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the agent comprises a therapeutic agent or a prophylactic agent (paragraph [0058]-[0059] and [0053]). In regard to claim 39, Bonutti discloses devices (see figure 24, item 130, figure 26, item 150, the device in figure 25 and the device in figure 27) comprising a population of devices (figure 24, item 130 and the device shown in figure 25; see paragraph [0151] which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade. Examiner notes the device shown in figure 25 also would have a cap 134, as the device shown in figure 25 is the implant of figure 24 having a plurality of coverable cavities a supported by paragraph [0036]), each device in the population of devices having dimensions (paragraph [0008]; Examiner notes the medical implants/devices are sized to be positioned in the body), each device in the population of devices comprising: a fillable base (figure 24 and 25, item 132; Examiner notes the base can be filled with item 12) defining a hollow chamber (figure 24, item 140 and figure 25, item 144; paragraph [0149]), the fillable base comprising a biocompatible polymer (paragraph [0152]: wherein the biocompatible polymer is construed as a mixture of PLA and PGA); and a polymeric cap (figure 24, item 134; paragraph [0149]; Examiner notes the device of figure 25 would also have a cap 134 as paragraph [0036] supports figure 25 is the implant of figure 24 having a plurality of coverable cavities; paragraph [0149]) sealable to the fillable base (paragraph [0149]), wherein a composition of the polymeric cap is different from a composition of the fillable base (paragraph [0152]: wherein the composition of the polymeric cap is construed to be PLA, PGA, and collagen which is different than the composition of the fillable base; Examiner notes paragraph [0151]-[0152] further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in a composition of the polymeric cap being different from a composition of the fillable base), and wherein (i) each device in the population of devices is singulated from another device in the population of devices (see figure 24 and 25) and (ii) each device in the population of devices has an external biodegradable surface (paragraph [0151]; external surface of either each base or each cap which are made of a biodegradable material), wherein degradation of the external biodegradable surface is configured to control release of an agent from the hollow chamber (paragraph [0058]-[0059], and paragraph [0151]: wherein an agent 12 is released from the hollow chamber as the device/implant degrades). Although a separate embodiment of Bonutti teaches an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071]), Bonutti is silent as to the specific size of the devices and therefore fails to disclose microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns. As a result, Bonutti is also silent as to each microdevice in the population of microdevices comprising the specifics of claim 39, and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of an agent from the hollow chamber. Nazzaro teaches microdevices (figure 1, item 100 and figure 2A, item 200, figure 2, item 300; Examiner notes paragraph [0084] supports that each drug delivery device in figures 1-4C can be a microdevice as the dimensions can be less than about 4 mm long and less than about 0.5 mm in diameter. Examiner notes each device can therefore have a length less than 1 mm (as a length less than 1 mm is less than 4 mm) and a diameter less than .5 mm which would therefore result in each device being a microdevice in order to fit within a needle having a size from about 30 gauge to about 15 gauge as disclosed in paragraph [0084]) comprising a population of microdevices (figure 1, item 100 and figure 2A, item 200; see analysis above regarding the size of item 100 and 200; paragraph [0084]), each microdevice in the population of microdevices having dimensions of less than 1000 microns (see analysis above regarding the size of item 100 and 200; paragraph [0084]; Examiner notes the length is construed to be less than 1 mm and the diameter is less than .5 mm of each device which satisfies the limitations of “each microdevice in the population of microdevices having dimensions of less than 1000 microns”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of each device of the devices of Bonutti to include a length less than 1 mm and a diameter that is less than .5 mm, as taught by Nazzaro, therefore resulting in microdevices comprising a population of microdevices, each microdevice in the population of microdevices having dimensions of less than 1000 microns, each microdevice in the population of microdevices comprising the specifics of claim 39, and wherein (i) each microdevice in the population of microdevices is singulated from another microdevice in the population of microdevices and (ii) each microdevice in the population of microdevices has an external biodegradable surface, wherein degradation of the external biodegradable surface is configured to control release of an angent from the hollow chamber, for the purpose of enabling an implant to be delivered easily using a needle (paragraph [0084] of Nazzaro) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exits.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, as Bonutti supports any therapeutic/biologic agent can be delivered (paragraph [0053] and [0059] of Bonutti) and that an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071] of Bonutti), one of ordinary skill in the art would recognize that the device can be sized accordingly depending on the intended therapeutic/location of injection. Examiner notes the instant disclosure further supports that “The devices have microscale external dimensions, such as a length, width, height, or diameter, up to one centimeter in at least one dimension, more preferably having a maximum diameter between 1 micrometer (µm) and 1000 µm).” In regard to claim 44, Bonutti in view of Nazzaro teaches the microdevices of claim 22, wherein microdevices in the population of microdevices have substantially the same dimensions (see figure 24 and 25 of Bonutti; Examiner notes the term “substantially” allows for some variation) and said microdevices are configured for release of the agent with substantially the same release kinetics in vitro or in vivo (Examiner notes “configured for release of the agent with substantially the same release kinetics in vitro or in vivo” is a functional limitation. The microdevices are fully capable of the recited function due to their structure. Examiner notes the term “substantially” allows for some variation). In regard to claim 45, Bonutti in view of Nazzaro teaches the microdevices of claim 39, wherein microdevices in the population of microdevices have substantially the same polymer composition (see figure 24 and 25 of Bonutti and analysis of claim 39 above; Examiner notes the term “substantially” allows for some variation) and said microdevices are configured for release of the agent with substantially the same release kinetics in vitro or in vivo (Examiner notes “configured for release of the agent with substantially the same release kinetics in vitro or in vivo” is a functional limitation. The microdevices are fully capable of the recited function due to their structure. Examiner notes the term “substantially” allows for some variation) . 07-21-aia AIA Claim s 23-24 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Staas (U.S. Patent no 6312731) . In regard to claim 23, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the second biocompatible polymer is different from the first biocompatible polymer (see analysis of claim 22 above where the mixtures are different; Examiner notes paragraph [0151]-[0152] and [0158]-[0159] of Bonutti further supports that the cap and base can have varying rates of release by modifying the ratio of PLA to PGA which would also result in the second biocompatible polymer being different from the first biocompatible polymer). Bonutti in view of Nazzaro is silent as to the second biocompatible polymer includes different end groups than end groups of the first biocompatible polymer. Staas teaches the second biocompatible polymer (component B which is a mixture of PGA, PLA, and PLGA which is blocked i.e. has an ester end group; column 17, line 41-60 and column 18, line 39-50) includes different end groups than end groups of the first biocompatible polymer (component A is construed as PLA, PGA, and PLGA which is unblocked; column 17, line 41-60; column 18, line 39-50). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the second biocompatible polymer to include different end groups than end groups of the first biocompatible polymer, as taught by Staas, for the purpose of controlling/slowing down the degradation rate (column 18, line 39-48 of Staas). Bonutti further supports the degradation rate of the cap or base can be modified if desired (paragraph [0152] and [0159] of Bonutti). In regard to claim 24, Bonutti in view of Nazzaro in view of Staas teaches the microdevices of claim 23 wherein the end groups of the second biocompatible polymer comprise ester end groups (see analysis of claim 23 above; column 18, line 39-50 of Staas). In regard to claim 31, Bonutti in view of Nazzaro teaches a microdevice formulation comprising at least two microdevices in the population of microdevices of the microdevices of claim 22 (figure 24, item 130 of Bonutti and the device shown in figure 25 of Bonutti; see also paragraph [0151] of Bonutti which described the implants/devices as being made from a degradable material in which the pharmaceutical agent 12 is released from as the implants/devices degrade; see analysis above of claim 22 wherein the devices are microdevices as modified by Nazzaro. The microdevice formulation is construed as item 130 and the device of figure 25 of Bonutti which comprises at least two microdevices in the population of microdevices) wherein a first microdevice (device shown in figure 25 of Bonutti) of the at least two microdevices of the population of microdevices comprises a first PLGA (PLGA of base 132 in figure 25; see analysis of claim 22 above) and a second microdevice (figure 24, item 130 of Bonutti) of the at least two microdevices of the population of microdevices comprises a second PLGA (PLGA of cap 134). Although it appears the second PLGA would be different at least in shape/size than the first PLGA, Bonutti in view of Nazzaro is silent as to a second different PLGA. Staas teaches a first PLGA and a second different PLGA (column 17, line 41-60 and column 18, line 39-50: first PLGA with a carboxyl end group and second different PLGA with ester end group). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include a second PLGA that is different from the first PLGA, as taught by Staas, for the purpose of controlling/slowing down the degradation rate (column 18, line 39-48 of Staas). Bonutti further supports the degradation rate of the cap or base can be modified/controlled if desired (paragraph [0152] and [0159] of Bonutti). In regard to claim 32, Bonutti in view of Nazzaro in view of Staas teaches the microdevice formulation of claim 31 wherein the first microdevice and the second microdevice comprise the agent (see figure 24 and 25, item 12 of Bonutti; paragraph [0059] of Bonutti and paragraph [0154]: wherein the same pharmaceutical agents 12 can be present in each cavity), wherein the agent is the same in the first microdevice and in the second microdevice (see figure 24 and 25, item 12 of Bonutti; paragraph [0059] and [0154] of Bonutti: wherein the same pharmaceutical agents 12 can be present in each cavity) . 07-21-aia AIA Claim s 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Wang (U.S. PG publication 20140336487) . In regard to claim 27, Bonutti in view of Nazzaro teaches the microdevices of claim 22 wherein the preformed cap of each microdevice in the population of microdevices is aligned and sealed to the base of each microdevice in the population of microdevices (see figure 24 of Bonutti and paragraph [0149] of Bonutti). Bonutti in view of Nazzaro is silent as to wherein the preformed cap of each microdevice in the population of microdevices is microscopically aligned and sealed to the base of each microdevice in the population of microdevices. Wang teaches aligning two components microscopically (paragraph [0097]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the two components which are aligned i.e. the preformed cap of each microdevice in the population of microdevices and the base of each microdevice in the population of microdevices of Bonutti in view of Nazzaro to be aligned microscopically, as taught by Wang, therefore resulting in wherein the preformed cap of each microdevice in the population of microdevices is microscopically aligned and sealed to the base of each microdevice in the population of microdevices for the purpose of facilitating alignment (paragraph [0097] of Wang). Additionally, the language, term, or phrase "microscopically aligned and sealed ", is directed towards the process of making the microdevices. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. In re Hirao, 190 USPQ 15 at 17 (footnote 3). See also, In re Brown, 173 USPQ 685; In re Luck, 177 USPQ 523; In re Fessmann, 180 USPQ 324; In re Avery, 186 USPQ 161; In re Wethheim, 191 USPQ 90 (209 USPQ 554 does not deal with this issue); In re Marosi et al., 218 USPQ 289; and particularly In re Thorpe, 227 USPQ 964, all of which make it clear that it is the patentability of the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or otherwise. As such, the language "microscopically aligned and sealed" only requires the preformed cap of each microdevice in the population of microdevices to be sealed to the base of each microdevice in the population of microdevices which does not distinguish the invention from Bonutti in view of Nazzaro, which teaches the structure as claimed. See also MPEP 2113. In regard to claim 28, Bonutti in view of Nazzaro in view of Wang teaches the microdevices of claim 27 wherein the preformed cap of each microdevice of the population of microdevices is sealed to the base of each microdevice in the population of microdevices by heating at a temperature between 40°C and 60°C (The language, term, or phrase "sealed to the base by heating at a temperature between 40°C and 60°C", is directed towards the process of making the microdevices. It is well settled that "product by process" limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. In re Hirao, 190 USPQ 15 at 17 (footnote 3). See also, In re Brown, 173 USPQ 685; In re Luck, 177 USPQ 523; In re Fessmann, 180 USPQ 324; In re Avery, 186 USPQ 161; In re Wethheim, 191 USPQ 90 (209 USPQ 554 does not deal with this issue); In re Marosi et al., 218 USPQ 289; and particularly In re Thorpe, 227 USPQ 964, all of which make it clear that it is the patentability of the final product per se which must be determined in a "product by process" claim, and not the patentability of the process, and that an old or obvious product produced by a new method is not patentable as a product, whether claimed in "product by process" claims or otherwise. As such, the language "sealed to the base by heating at a temperature between 40°C and 60°C" only requires the preformed cap of each microdevice of the population of microdevices to be sealed to the base of each microdevice of the population of microdevices, which does not distinguish the invention from Bonutti in view of Nazzaro in view of Wang, which teaches the structure as claimed; See also MPEP 2113) . 07-21-aia AIA Claim s 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Bonutti (U.S. PG publication 20070141106) in view of Nazzaro (U.S. PG publication 20120238994) further in view of Jaklenec (U.S. PG publication 20150165020) . In regard to claim 34, Bonutti in view of Nazzaro teaches the microdevices of claim 22. Bonutti in view of Nazzaro fails wherein each microdevice in the population of microdevices is sterilized. Jaklenec teaches wherein each microdevice in the population of microdevices is sterilized (paragraph [0091]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include wherein each microdevice in the population of microdevices is sterilized, as taught by Jaklenec, for the purpose of maintaining antigen stability and producing a sterile microdevice which would not introduce unwanted contaminates to the body (paragraph [0091] and [0053] of Jaklenec). In regard to claim 37, Bonutti in view of Nazzaro teaches the microdevices of claim 22. Bonutti in view of Nazzaro is silent as to wherein the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm. Jaklenec teaches wherein the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm (paragraph [0213]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Bonutti in view of Nazzaro to include the hollow core of each microdevice in the population of microdevices has dimensions less than 800 µm, as taught by Jaklenec, for the purpose of ensuring the microdevice can be delivered with a 21 gauge needle or 23 gauge needle (paragraph [0213] of Jaklenec). Examiner notes as detailed above, Nazzaro supports modifying the size of the device of Bonutti to enable use with a needle, but is silent as to the specific size of the hollow core. Jaklenec teaches an appropriately sized hollow core to enable use with a specific size needle . Allowable Subject Matter Claims 42-43 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Examiner notes the indication of allowability is on the condition that the claims are amended in such a way as to be in line with the interpretation that has been applied in view of the rejections under 35 U.S.C. 112(b) and any other amendments to the claims may affect their allowability. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: In regard to claim 42, The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the microdevices of claim 22, wherein the population of microdevices comprises a combination of microdevices differing from one another in polymer composition, core-shell geometry, or size, tailored to provide pulsatile release of the agent at two or more times. Bonutti (U.S. PG publication 20070141106) discloses the population of devices comprises a combination of devices differing from one another in polymer composition, core-shell geometry, or size (see core-shell geometry of figure 24 compared to figure 26) but fails to disclose the population of microdevices comprises a combination of microdevices differing from one another in polymer composition, core-shell geometry, or size, tailored to provide pulsatile release of the agent at two or more times. Herman (U.S. PG publication 20070275035) teaches a combination of reservoirs tailored to provide pulsatile release of the agent at two or more times (paragraph [0042]). Herman however also fails to disclose the population of microdevices comprises a combination of microdevices differing from one another in polymer composition, core-shell geometry, or size tailored to provide pulsatile release of the agent at two or more times, tailored to provide pulsatile release of the agent at two or more times. The subject matter of the microdevices of claim 22, wherein the population of microdevices comprises a combination of microdevices differing from one another in polymer composition, core-shell geometry, or size, tailored to provide pulsatile release of the agent at two or more times could not be found nor was suggested elsewhere in the prior art of record. In regard to claim 43, The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the microdevices of claim 22, comprising at least two subpopulations of microdevices in which the composition of the caps in a first population differs from the composition of caps in a second population. Bonutti (U.S. PG publication 20070141106) discloses at least two subpopulations of devices (the device of figure 24 and figure 25 form the first subpopulation and the device of figure 26 and figure 27 form the second subpopulation) in which the shape of the caps in a first population differs from the shape of caps in a second population (see cap of figure 24 and 25 vs. cap of figure 26 and 27). Bonutti however fails to disclose comprising at least two subpopulations of microdevices in which the composition of the caps in a first population differs from the composition of caps in a second population. The subject matter of the microdevices of claim 22, comprising at least two subpopulations of microdevices in which the composition of the caps in a first population differs from the composition of caps in a second population could not be found nor was suggested elsewhere in the prior art of record . Response to Arguments 07-37 AIA Applicant's arguments filed 2/11/2026 have been fully considered but they are not persuasive. Applicant argues that “the Examiner cobbled together separate figures in Bonutti” and each of figures 24, 25, 26, and 27 are isolated from each other and not as a plurality of devices in a given formulation. Claims 22 and 39 specifically require each microdevice in the population of microdevices to be singulated from another microdevice in the population of microdevices. The fact that the devices in figure 24, 25, 26, and 27 are shown in separate figures, does not preclude the devices from being construed as a plurality of devices. The figures and disclosure of Bonutti clearly support that a plurality of devices exist. The claims for example do not require the microdevices in the population of microdevices to be manufactured together or used together in any way . Applicant argues that new claims 42-45 are not taught by Bonutti in view of Nazzaro. No specific reasons why Applicant believes new claims 42-45 are not taught by Bonutti in view of Nazzaro have been included. As detailed above, claims 44-45 are taught by Bonutti in view of Nazzaro. Applicant argues that Nazzaro teaches away from the claims. Applicant argues that the Examiner cannot pick and choose only one aspect of a prior art reference and exclude other aspects of the reference or ignore the central teaching of the reference. Applicant additionally argues that Nazzaro focuses on drug-eluting implants where release occurs substantially via zero-order kinetics. Applicant further argues that the Examiner fails to explain why a person of ordinary skill in the art would simply extract the dimensions from Nazzaro and overlook Nazzaro’s central teaching that involves a release mechanism that focuses on drug-elution with ideal release kinetics. These arguments are not found to be persuasive as both Nazzaro and Bonutti disclose devices which deliver an agent. Although Nazzaro may disclose embodiments which use a different mechanism for delivery, the teaching of the size of the devices of Nazzaro is still pertinent to Bonutti, as both disclosures are concerned with agent delivery. Nazzaro further also discloses an embodiment with a mechanism for delivery similar to Bonutti as paragraph [0084] of Nazzaro specifically states “Optionally, the materials may be chosen to be biodegradable at rates that control, or contribute to control of, the release rate of latanoprost or latanoprost acid”. As clearly cited in the rejections above, the purpose for modifying Bonutti in view of Nazzaro was for the purpose of enabling an implant to be delivered easily using a needle (paragraph [0084] of Nazzaro). Bonutti does not disclose a size of the devices. Enabling implants to be delivered easily using a needle as taught by Nazzaro would be beneficial to the devices of Bonutti. Bonutti further supports that an implant/device can be appropriately shaped and sized depending on the intended area of use (paragraph [0071] of Bonutti) i.e. the size and shape of the devices can be modified. One of ordinary skill in the art would therefore recognize that the device can be sized accordingly depending on the intended therapeutic/location of injection while Nazzaro provides specific beneficial dimensions which enable an implant to be delivered easily using a needle. Applicant provides arguments referencing Ashton410, previously cited in the Final Office Action mailed 2/20/2025, but not cited in the most recent Non-final Office Action mailed 10/29/2025. Applicant states that “In sum, to arrive at the instant claims, a person of ordinary skill in the art must overlook teachings in references that the Examiner has made of Record about achieving a linear zero order release of an agent and example disclosing devices containing rate-controlling permeable membranes”. Applicant further argues that “a person of ordinary skill in the art, reading references of Record, would be led away from the instant claims for at least the reasons articulated above”. Ashton410 is not cited in the current rejections above. Bonutti, the current cited art of record, discloses degradation of the external biodegradable surface is configured to control release of the agent. Nazzaro is used solely to modify the size of the devices of Bonutti. As noted above, paragraph [0084] of Nazzaro supports an embodiment similar to Bonutti in which the release rate is controlled via degradation. Applicant’s arguments are therefore not found to be persuasive. Applicant argues in regard to claims 23-24 and 31-33 that Staas is silent on microdevices with the features specified by the claims. Applicant specifically argues that the combination of Nazzaro and Staas is improper, because Nazzaro as whole teaches away from Staas. See response to arguments above in regard to Nazzaro. Paragraph [0084] of Nazzaro supports an embodiment similar to Staas in which the release rate is controlled via degradation. Applicant argues in regard to claims 27-28 that Wang is also silent on microdevices with the features specified by the claims. No specific arguments have been provided in regard to Wang. See response to arguments above in regard to Nazzaro. Applicant argues in regard to claims 33 and 37 that the combination of Nazzaro and Jaklenec is improper, because Nazzaro as whole teaches away from Jaklenec. See response to arguments above in regard to Nazzaro. Paragraph [0084] of Nazzaro supports an embodiment similar to Jaklenec in which the release rate is controlled via degradation. Conclusion 07-40 AIA 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST. 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. /ALEXANDRA LALONDE/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 17/342,978 Page 2 Art Unit: 3783 Application/Control Number: 17/342,978 Page 3 Art Unit: 3783 Application/Control Number: 17/342,978 Page 4 Art Unit: 3783 Application/Control Number: 17/342,978 Page 5 Art Unit: 3783 Application/Control Number: 17/342,978 Page 6 Art Unit: 3783 Application/Control Number: 17/342,978 Page 7 Art Unit: 3783 Application/Control Number: 17/342,978 Page 8 Art Unit: 3783 Application/Control Number: 17/342,978 Page 9 Art Unit: 3783 Application/Control Number: 17/342,978 Page 10 Art Unit: 3783 Application/Control Number: 17/342,978 Page 11 Art Unit: 3783 Application/Control Number: 17/342,978 Page 12 Art Unit: 3783 Application/Control Number: 17/342,978 Page 13 Art Unit: 3783 Application/Control Number: 17/342,978 Page 14 Art Unit: 3783 Application/Control Number: 17/342,978 Page 15 Art Unit: 3783 Application/Control Number: 17/342,978 Page 16 Art Unit: 3783 Application/Control Number: 17/342,978 Page 17 Art Unit: 3783 Application/Control Number: 17/342,978 Page 18 Art Unit: 3783 Application/Control Number: 17/342,978 Page 19 Art Unit: 3783 Application/Control Number: 17/342,978 Page 20 Art Unit: 3783 Application/Control Number: 17/342,978 Page 21 Art Unit: 3783 Application/Control Number: 17/342,978 Page 22 Art Unit: 3783 Application/Control Number: 17/342,978 Page 23 Art Unit: 3783 Application/Control Number: 17/342,978 Page 24 Art Unit: 3783 Application/Control Number: 17/342,978 Page 25 Art Unit: 3783 Application/Control Number: 17/342,978 Page 26 Art Unit: 3783 Application/Control Number: 17/342,978 Page 27 Art Unit: 3783 Application/Control Number: 17/342,978 Page 28 Art Unit: 3783 Application/Control Number: 17/342,978 Page 29 Art Unit: 3783 Application/Control Number: 17/342,978 Page 30 Art Unit: 3783 Application/Control Number: 17/342,978 Page 31 Art Unit: 3783 Application/Control Number: 17/342,978 Page 32 Art Unit: 3783 Application/Control Number: 17/342,978 Page 33 Art Unit: 3783 Application/Control Number: 17/342,978 Page 34 Art Unit: 3783 Application/Control Number: 17/342,978 Page 35 Art Unit: 3783 Application/Control Number: 17/342,978 Page 36 Art Unit: 3783 Application/Control Number: 17/342,978 Page 37 Art Unit: 3783 Application/Control Number: 17/342,978 Page 38 Art Unit: 3783
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