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 .
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.
Claims 39-43, 46-56, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20160015648, henceforth Gross et al.) in view of Kam et al. (US Pat. No. 11660436, henceforth Kam, previously made of record) and Ramtoola et al. (WO 2004032906, henceforth Ramtoola, previously made of record).
Regarding claim 39, Gross et al. discloses an ingestible pill (ingestible pill 120, fig. 10A) for delivery of medication to an intestine wall (see fig. 10B, unfolded element 130 acts on intestine wall 38 as shown) comprising: an enteric coating (coating 22, fig. 10A, which is enteric as in [0232]); and a medication-delivery device (core 124, fig. 10A) which comprises a medication (medication 26, fig. 10A and [0288]) and one or more medication-needles (plurality of protrusions of [0285]) coupled to a patch (in [0285], the protrusions are on surface 40 which is equivalent to first surface 140 of medication-delivery element 130 which is a patch as shown in the chosen embodiment), the medication being deliverable by way of said medication-needles (the protrusions are made up of medication 26 which is deliverable, see [0285]; since the protrusions are the way that medication is delivered in the chosen embodiment, the medication is deliverable through the protrusions as claimed as the medication is being delivered by way of, or through, these needles where it diffuses into and through the intestinal wall as in [0243]); wherein said patch comprises a gas-generating substance (sodium bicarbonate as in [0297]) and a chamber (chamber 160 in exemplary fig. 12B; being inflatable is an optional attribute as listed in [0303], and that optional attribute of the embodiment is integrated into the embodiment of fig. 10 as noted by the embodiment number of element 130 being the same across figs. 10-13), said chamber constructed to generate gas from said gas-generating substance (see [0346]), said gas causing said patch to expand (see [0202], [0303], and [0307]) from a compressed shape to an expanded shape (see states of figs. 10A, which includes the compressed shape, and fig. 10B, which includes the expanded shape).
Gross et al. does not explicitly disclose that the gas-generating substance is disposed within the chamber, or that the chamber is constructed to allow passage of a liquid from a gastrointestinal tract to flow into the chamber and contact said gas-generating substance to generate gas from said gas-generating substance. However, Gross et al. discloses that the embodiment of fig. 12A is inflatable ([0305]). Gross et al. teaches another embodiment of its invention which teaches use of a gas-generating substance contained within a chamber of a patch (see [0346], sodium bicarbonate is disposed in the chamber 360 of ring 330 of the embodiment of fig. 18) and a liquid is configured inside of the patch (acid or water can also be stored in patch 330 and folded to not come into contact with the sodium bicarbonate, see [0344] and [0346]) which is configured to contact said gas-generating substance (see [0346]) to generate gas from said gas-generating substance ([0346]) such as to cause said patch to expand ([0346]) similar to the elected embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the two embodiments of Gross et al. such that the gas-generating substance was disposed within the chamber as claimed and was configured to come into contact with liquid to cause expansion of the patch as Gross et al. teaches this to be an alternative and equivalent methodology of causing expansion of the foldable element and an acceptable location for the gas-generating substance to be placed (see at least [0344] and [0346]), and because configuring the patch such as to have the materials in the chamber would have yielded the same, predictable result of the patch being expandable after the enteric coating of pill 120 had dissolved, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Thus, Gross et al. as modified discloses that a reaction between a liquid in a chamber and a gas-generating substance disposed in the chamber are a method of causing expansion of the patch.
Gross et al. as modified does not explicitly disclose that the chamber is constructed to allow passage of a liquid from a gastrointestinal tract to flow into said chamber to cause the expansion of the patch. Gross et al. teaches another embodiment of its invention which uses flow of intestinal liquid into a patch to cause expansion of the patch (see [0315], the embodiment with pill 220 uses absorption of fluid from the intestinal tract to cause inflation and expansion of the patch). Additionally, Examiner notes that there are a limited number of ways for fluid to be configured to come into contact with and react with the gas-generating substance disposed in the chamber in the modified device, and Gross teaches both of these options where it teaches (1) fluid being disposed in the chamber in a way such that the fluid and gas-generating substance do not come into contact until coating 22 has dissolved (see [0346]) and (2) absorption of fluid into the patch causes expansion of the patch (see [0315]). There do not appear to be any other options for a fluid entry into the chamber or patch after coating 22 has dissolved (but not prior to the dissolving of coating 22 since this would cause unwanted premature expansion) other than the fluid already being present in the chamber or flowing into the patch from intestinal fluid, both of which options are contemplated by Gross et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the chamber and patch of Gross et al. as modified such that the chamber was constructed to allow passage of a liquid from a gastrointestinal tract to flow into said chamber to cause the expansion of the patch as Gross et al. teaches an alternative configuration of the patch where absorption of intestinal fluid into the patch causes expansion of the patch, because there were only a limited number of options to try to configure liquid to come into contact with the gas-generating substance after the dissolving of coating 22 which would present a reasonable expectation of success and where both of the options are contemplated by Gross, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Gross et al. as modified discloses a configuration for allowing a body fluid to pass into said chamber and contact said gas-generating substance (see above which details the relationship between the gas-generating substance and chamber, this is a configuration as it is the arrangement which allows for the proper functioning of the device), upon dissolving of said enteric coating ([0297]).
Gross et al. as modified does not disclose the chamber comprising a liquid-permeable and substantially gas-impermeable wetting layer for allowing passage of the liquid from the gastrointestinal tract to flow into said chamber and contact said gas-generating substance to generate gas from said gas generating substance. Ramtoola et al. teaches a liquid-permeable and substantially gas-impermeable wetting layer (water-permeable and substantially gas-impermeable membrane covers tablet, see Abstract), which entirely covers a tablet that it surrounds and is sealed to said tablet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gross et al. by adding the wetting layer of Ramtoola et al. to the exterior of the medication-delivery device to allow liquid to come inside of said wetting layer and react with the gas-generating substance of Gross et al., causing it to expand analogous to Ramtoola et al. to push the device into contact with the intestinal wall while maintaining the desired surface area of Gross et al. ([0255]). Such a modification would yield the same, predictable result of the gas generating substance being put into contact with bodily fluid and causing expansion of the chamber.
Gross et al. as modified does not disclose that the medication is deliverable by the medication flowing through said medication-needles as claimed. Kam teaches that medication (functionalized particles 100, fig. 11A) in a drug delivery system (device 10, fig. 11A) can be delivered by microneedles (tissue penetrating members 40, fig. 11A) where medication can flow through hollow microneedles (see figs. 11A and 11B, the functionalized particles 100 flow through tissue penetrating members 40 to escape the system and enter the patient’s body; see also Col. 23 lines 20-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the solid medicament microneedles of Gross et al. with an arrangement as in Kam with medicament flowable through microneedles as Kam teaches this to be an art effective equivalent method of administering drugs from a drug delivery system to a patient (see Col. 23 lines 20-28 and see Col. 4 lines 1-29, the embodiment of figs. 11A and 11B is listed as an equivalent embodiment of medication and microneedle arrangement to other known arrangements displayed in other figures), and because such a substitution would have yielded the same, predictable result of medication being delivered from the medication-needles and into the patient.
Regarding claim 40, Gross et al. as modified by Gross et al. and Kam (henceforth Gross et al. as modified) discloses that the patch is configured for rolling or folding (element 130 is rolled in fig. 10A).
Regarding claim 41, Gross et al. as modified discloses the one or more needles are coupled to at least one or more outer surfaces of the patch (protrusions are disposed on the top surface [0285]; this would also be true in the modified device since the protrusions on Kam are substituted for the protrusions of Gross et al., and thus they would be arranged the same as the protrusions of Gross et al.).
Regarding claim 42, Gross et al. as modified discloses that said wetting layer is configured to allow a body fluid to pass into said chamber and contact said gas-generating substance upon dissolving of said enteric coating (in the modified device, the wetting layer is disposed around the exterior of the medication delivery device, which is made accessible to fluid from the gastrointestinal tract when the enteric coating has dissolved as in [0232]).
Regarding claim 43, Gross et al. as modified by Gross et al., Kam, and Ramtoola et al. does not disclose that said wetting layer is coupled to a window in said ingestible pill. However, Gross et al. teaches the use of windows in a separate embodiment (openings 60, fig. 4) to maximize compression while folding the patch (element 130, fig. 10A) while maintaining the drug-coated surface area ([0255]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chosen embodiment of Gross et al. with the windows of the separate embodiment for the benefit of maximizing compression while folding the patch while maintaining the drug-coated surface and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Such a modification would then mean that the added wetting layer (see rejection of claim 39 above) would be coupled to said added windows as claimed as the added wetting layer of Ramtoola is added to the exterior of the medication-delivery device of Gross et al., and that addition represents a coupling as the windows and wetting layer would be physically attached, at least via the medication-delivery element.
Regarding claim 46, Gross et al. as modified discloses that the medication-needle is conical (see Kam figs. 11A and 11B, tissue penetrating member 40 is conical where it comes to a tapered point at the point furthest from reservoir 48 as shown).
Regarding claim 47, Gross et al. as modified discloses the chamber comprises: a substantially water-impermeable and substantially gas-impermeable, elastic layer (chamber further includes silicone, which at least partially coats the second surface, see [0291], silicone is understood by Examiner to be water impermeable and gas impermeable and to be elastic), and wherein said gas-generating substance is disposed within the chamber (see modification made in claim 39 above).
Gross et al. as modified does not disclose the chamber being shaped so as to define at least one window therethrough. Gross et al. teaches the use of windows in a separate embodiment (openings 60, fig. 4) to maximize compression while folding the patch (element 130, fig. 10A) while maintaining the drug-coated surface area ([0255]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chosen embodiment of Gross et al. with the windows of the separate embodiment for the benefit of maximizing compression while folding the patch while maintaining the drug-coated surface and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Gross et al. as modified thus discloses the device wherein the wetting layer (see rejection of claim 39 above) entirely covers the at least one window and is sealed to the elastic layer around the at least one window (in the modified device, the wetting layer covers the entire medication delivery device as in Ramtoola, see the modification made above in claim 39, and thus it entirely covers the at least one window as claimed; further, since the layer is disposed as a layer coated on the medication delivery device as in Ramtoola, it is sealed to the medication delivery device which it covers, and thus it is sealed to and around the at least one window of the modified device).
Regarding claim 48, Gross et al. as modified discloses the gas-generating substance is in an amount sufficient to generate a sufficient amount of gas to push the upper surface of the patch against an intestinal wall (chamber 160 is shown as expanding the ring in fig. 12B, and this is the state in which the upper surface 140 of the patch pushes against the intestinal wall, see fig. 10B).
Regarding claim 49, Gross et al. as modified discloses the gas-generating substance comprises any one or more of the following: sodium bicarbonate (sodium bicarbonate [0204]), citric acid, polymer and hydrogel.
Regarding claim 50, Gross et al. as modified discloses a gas-generating substance (sodium bicarbonate in [0204] is present in the chosen embodiment of fig. 10, see also the rejection of claim 39 above).
Gross et al. as modified does not disclose at least one window in the chosen embodiment (see fig. 10B; there is no window present). Gross et al. teaches the use of windows in a separate embodiment (openings 60, fig. 4) to maximize compression while folding the patch (element 130, fig. 10) while maintaining the drug-coated surface area ([0255]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chosen embodiment of Gross et al. with the windows of the separate embodiment for the benefit of maximizing compression while folding the patch while maintaining the drug-coated surface and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. In adding the windows of the separate embodiment, the gas-generating substance is disposed in a vicinity of at least one window as the chamber (chamber 160, depicted in fig. 12A and optionally included in the embodiment of fig. 10) comprises the gas-generating substance and the windows go through said chamber.
Regarding claim 51, Gross et al. as modified discloses the wetting layer comprises a material selected from the group consisting of: cellulose and biocellulose (see Ramtoola et al. [0055]).
Regarding claim 52, Gross et al. as modified discloses the patch is rolled, folded, or rolled and folded when disposed within the enteric coating in the compressed shape (element 130 is rolled when in coating 22 in a compressed shape, see fig. 10A).
Regarding claim 53, Gross et al. as modified discloses the patch has upper (upper surface 140, fig. 10A) and lower surfaces (lower surface 142, fig. 10B) that face in generally opposite directions (surfaces 140 and 142 oppose each other, see fig. 10B).
Regarding claim 54, Gross et al. as modified discloses the patch is arranged within the enteric coating in the compressed shape (compressed shape 134, fig. 10A), such that when the patch assumes the expanded shape after the enteric coating dissolves in a small intestine of a subject (expanded shape 136, fig. 10B), the upper surface of the patch (upper surface 140, fig. 10B) contacts an intestinal wall (wall 38, fig. 10B).
Regarding claim 55, Gross et al. as modified discloses the patch is configured to assume, after the enteric coating dissolves, an expanded shape (expanded shape 136, fig. 10B) in which the patch has an outer perimeter (outer perimeter, see Abstract).
Regarding claim 56, Gross et al. as modified discloses the patch is disposed within the enteric coating in a compressed shape (compressed shape 134, fig. 10A), in which two opposite perimeter portions of the outer perimeter are (b) folded toward each other over the lower surface of the patch (see fig. 10A and [0303]; opposite ends of embodiment of fig. 10 are folded together; it is understood that this folding would follow the pattern of figs. 5A-C), such that the two opposite perimeter portions touch the lower surface (see figs. 5A and 5B; opposite ends are folded together such that the lower surfaces 42 of each end are touching each other, these would be the lower surfaces 142 of chosen embodiment of fig. 10).
Regarding claim 59, Gross et al. discloses a method for delivery of medication to an intestine wall (see [0001] and [0008]) comprising: providing an ingestible pill (ingestible pill 120, fig. 10A) that comprises: an enteric coating (coating 22, fig. 10A, which is enteric as in [0232]); and a medication-delivery device (core 124, fig. 10A) which comprises a medication (medication 26, fig. 10A) and one or more medication-needles (plurality of protrusions of [0285]) coupled to a patch (in [0285], the protrusions are on surface 40 which is equivalent to first surface 140 of medication-delivery element 130 which is a patch as shown in the chosen embodiment), the medication being deliverable through said medication-needles (the protrusions are made up of medication 26 which is deliverable, see [0285]; since the protrusions are the way that medication is delivered in the chosen embodiment, the medication is deliverable through the protrusions as claimed as the medication is being delivered by way of, or through, these needles where it diffuses into and through the intestinal wall as in [0243]); and wherein said patch comprises a gas-generating substance (sodium bicarbonate as in [0297]) and a chamber (chamber 160 in exemplary fig. 12B; being inflatable is an optional attribute as listed in [0303], and that optional attribute of the embodiment is integrated into the embodiment of fig. 10 as noted by the embodiment number of element 130 being the same across figs. 10-13); and ingesting said ingestible pill (see [0212]) wherein the chamber is configured to generate gas from said gas-generating substance (see [0346]), said gas causing said patch to expand (see [0202], [0303], and [0307]) from a compressed shape to an expanded shape (see states of figs. 10A, which includes the compressed shape, and fig. 10B, which includes the expanded shape).
Gross et al. does not explicitly disclose that the gas-generating substance is disposed within the chamber, or that the chamber is constructed to allow passage of a liquid from a gastrointestinal tract to flow into the chamber and contact said gas-generating substance to generate gas from said gas-generating substance. However, Gross et al. discloses that the embodiment of fig. 12A is inflatable ([0305]). Gross et al. teaches another embodiment of its invention which teaches use of a gas-generating substance contained within a chamber of a patch (see [0346], sodium bicarbonate is disposed in the chamber 360 of ring 330 of the embodiment of fig. 18) and a liquid is configured inside of the patch (acid or water can also be stored in patch 330 and folded to not come into contact with the sodium bicarbonate, see [0344] and [0346]) which is configured to contact said gas-generating substance (see [0346]) to generate gas from said gas-generating substance ([0346]) such as to cause said patch to expand ([0346]) similar to the elected embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the two embodiments of Gross et al. such that the gas-generating substance was disposed within the chamber as claimed and was configured to come into contact with liquid to cause expansion of the patch as Gross et al. teaches this to be an alternative and equivalent methodology of causing expansion of the foldable element and an acceptable location for the gas-generating substance to be placed (see at least [0344] and [0346]), and because configuring the patch such as to have the materials in the chamber would have yielded the same, predictable result of the patch being expandable after the enteric coating of pill 120 had dissolved, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Thus, Gross et al. as modified discloses that a reaction between a liquid in a chamber and a gas-generating substance disposed in the chamber are a method of causing expansion of the patch.
Gross et al. as modified does not explicitly disclose that the chamber is constructed to allow passage of a liquid from a gastrointestinal tract to flow into said chamber to cause the expansion of the patch. Gross et al. teaches another embodiment of its invention which uses flow of intestinal liquid into a patch to cause expansion of the patch (see [0315], the embodiment with pill 220 uses absorption of fluid from the intestinal tract to cause inflation and expansion of the patch). Additionally, Examiner notes that there are a limited number of ways for fluid to be configured to come into contact with and react with the gas-generating substance disposed in the chamber in the modified device, and Gross teaches both of these options where it teaches (1) fluid being disposed in the chamber in a way such that the fluid and gas-generating substance do not come into contact until coating 22 has dissolved (see [0346]) and (2) absorption of fluid into the patch causes expansion of the patch (see [0315]). There do not appear to be any other options for a fluid entry into the chamber or patch after coating 22 has dissolved (but not prior to the dissolving of coating 22 since this would cause unwanted premature expansion) other than the fluid already being present in the chamber or flowing into the patch from intestinal fluid, both of which options are contemplated by Gross et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the chamber and patch of Gross et al. as modified such that the chamber was constructed to allow passage of a liquid from a gastrointestinal tract to flow into said chamber to cause the expansion of the patch as Gross et al. teaches an alternative configuration of the patch where absorption of intestinal fluid into the patch causes expansion of the patch, because there were only a limited number of options to try to configure liquid to come into contact with the gas-generating substance after the dissolving of coating 22 which would present a reasonable expectation of success and where both of the options are contemplated by Gross, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Gross et al. as modified discloses a configuration for allowing a body fluid to pass into said chamber and contact said gas-generating substance (see above which details the relationship between the gas-generating substance and chamber, this is a configuration as it is the arrangement which allows for the proper functioning of the device), upon dissolving of said enteric coating ([0297]).
Gross et al. as modified does not disclose the chamber comprising a liquid-permeable and substantially gas-impermeable wetting layer for allowing passage of the liquid from the gastrointestinal tract to flow into said chamber and contact said gas-generating substance to generate gas from said gas generating substance. Ramtoola et al. teaches a liquid-permeable and substantially gas-impermeable wetting layer (water-permeable and substantially gas-impermeable membrane covers tablet, see Abstract), which entirely covers a tablet that it surrounds and is sealed to said tablet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gross et al. by adding the wetting layer of Ramtoola et al. to the exterior of the medication-delivery device to allow liquid to come inside of said wetting layer and react with the gas-generating substance of Gross et al., causing it to expand analogous to Ramtoola et al. to push the device into contact with the intestinal wall while maintaining the desired surface area of Gross et al. ([0255]). Such a modification would yield the same, predictable result of the gas generating substance being put into contact with bodily fluid and causing expansion of the chamber.
Gross et al. as modified does not disclose that the medication is deliverable by the medication flowing through said medication-needles as claimed. Kam teaches that medication (functionalized particles 100, fig. 11A) in a drug delivery system (device 10, fig. 11A) can be delivered by microneedles (tissue penetrating members 40, fig. 11A) where medication can flow through hollow microneedles (see figs. 11A and 11B, the functionalized particles 100 flow through tissue penetrating members 40 to escape the system and enter the patient’s body; see also Col. 23 lines 20-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the solid medicament microneedles of Gross et al. with an arrangement as in Kam with medicament flowable through microneedles as Kam teaches this to be an art effective equivalent method of administering drugs from a drug delivery system to a patient (see Col. 23 lines 20-28 and see Col. 4 lines 1-29, the embodiment of figs. 11A and 11B is listed as an equivalent embodiment of medication and microneedle arrangement to other known arrangements displayed in other figures), and because such a substitution would have yielded the same, predictable result of medication being delivered from the medication-needles and into the patient.
Claim(s) 44-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20160015648, henceforth Gross et al.) in view of Kam et al. (US Pat. No. 11660436, henceforth Kam) and Ramtoola et al. (WO 2004032906, henceforth Ramtoola) as applied to claim 39 above, and further in view of Meyer et al. (US 20150306363, henceforth Meyer et al.).
Regarding claim 44, Gross et al. as modified does not explicitly disclose that the medication-needle has a length of between 20 and 600 microns. Meyer et al. discloses that microneedles for delivery of medicament can have a length of about 100-1000 microns ([0043]); this is sufficiently similar to the claimed range of 20-600 microns, and additionally, Applicant has not drawn any criticality to the length of the medication needles. Meyer et al. additionally teaches that microneedles can be resized by one of ordinary skill in the art as needed (see [0005]), and the microneedles of Gross et al. which were substituted with the microneedles of Kam in the modified device were in the claimed range for length at 50 to 400 microns as well ([0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the microneedles to have had a length between 20 and 600 microns as claimed as Meyer and Gross each teach sizes in this range to be known sizes of microneedles which can deliver medicament.
Regarding claim 45, Gross et al. as modified does not explicitly disclose that the greatest radius of a medication-needle is between 20 and 150 microns. Meyer et al. teaches that a width w of microneedles is equal to twice the greatest radius of the needles (fig. 3) and that the aspect ratios of these microneedles can be between 3:1 and 5:1 ([0054]); where heights of the microneedles can be 100-1000 microns, the greatest radius range would then be from 10-167 microns. This is sufficiently similar to the claimed range of 20-150 microns, especially since Applicant has not drawn any criticality to the greatest radius of the medication needles. The microneedles of Gross et al. which were substituted with the microneedles of Kam in the modified device were also in the claimed range where the greatest radius is between 20 and 100 microns ([0285]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sized the microneedles to have had a greatest radius between 20 and 150 microns as claimed as Meyer and Gross each teach sizes in this range to be known sizes of microneedles which can deliver medicament.
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20160015648, henceforth Gross et al.) in view of Kam et al. (US Pat. No. 11660436, henceforth Kam) and Ramtoola et al. (WO 2004032906, henceforth Ramtoola et al.) as applied to claim 47 above, and further, and further in view of Baigent et al. (US 20170326320).
Regarding claim 58, Gross et al. as modified discloses an elastic layer (silicone at least partially coats the second surface, see Gross et al. [0291]).
Gross et al. as modified does not disclose the elastic layer comprises a thermoplastic elastomer (TPE). Baigent et al. teaches an elastic layer comprising a thermoplastic elastomer (TPE) (silicone and TPE are taught as equivalents in [0069] and [0073] and both work to create a water impermeable and gas impermeable seal equivalent to Applicant).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thermoplastic elastomer for the elastic layer of Gross et al. as in Baigent et al. as it would yield the same, predictable result of a water impermeable and gas impermeable layer present in the device.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive.
Applicant has argued that Gross does not disclose the use of gastrointestinal fluid ingress to cause gas generation and thus that the combination is based on hindsight. Examiner respectfully disagrees. Gross et al. teaches another embodiment of its invention which uses flow of intestinal liquid into a patch to cause expansion of the patch (see [0315], the embodiment with pill 220 uses absorption of fluid from the intestinal tract to cause inflation and expansion of the patch). Thus, it is the Examiner’s position that the first embodiment (combining of separated fluid and sodium bicarbonate predisposed in the chamber) and second embodiment (embodiment of pill 220 using absorption of fluid from the gastrointestinal tract) are teaching alternative mechanisms for causing expansion, and that one of ordinary skill in the art would have been able to substitute predisposed fluid in a chamber with fluid flowing into the chamber from the gastrointestinal tract, especially since there are a limited number of sources of fluid in the gastrointestinal tract which could have caused such an expansion of the medication delivery device, and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Applicant has additionally argued against Ramtoola that Ramtoola is directed to a different structure and problem and does not teach the requirements of the claim since it is not incorporated as a structural component of the chamber. Examiner notes that the combination above relies on Ramtoola for covering the entire medication delivery device, and not being the sole structural wall on one side of the chamber, as this is not required by the claim. Further, Ramtoola is relevant prior art regarding the fact that it is prior art which teaches use of gas generation in a pill or tablet which goes into the gastrointestinal fluid and achieves the same functionality regarding delayed expansion due to its use of enteric coating combined with a wetting layer similar to that claimed by Applicant. The claim does not currently require that the wetting layer is one of the walls of the chamber, only that the chamber comprises the wetting layer, and thus a layer disposed around the entirety of the chamber meets the claim requirements.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects all pending claims as indicated above.
Terminal Disclaimer
The terminal disclaimer filed on 08/25/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,980,750 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783