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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 6, 2026 has been entered.
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.
Claim(s) 1-8, 10-14, 17-19, 21, and 48-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2009/0259246 A1) in view of Williams et al. (US 2019/0030311 A1), Park et al. (US 6,271,278 B1) as evidenced by and in view of Gaur et al. (US 2014/0188151 A1), Sun et al. (US 2016/0354520 A1), and McCarthy et al. (US 2017/0367863 A1).
With regard to claims 1-8, 10-13, 17-19, 48, and 49, Eskaros et al. teach an expandable hydrogel structure comprising: a housing fabricated of a membrane, the housing having a cavity therein (Fig. 5B swallowable member 2, cavity where 3 is indicated, [0019]); a superabsorbent material disposed and sealed within the housing cavity, the superabsorbent material having an initial superabsorbent size ([0028], Fig. 5B member 3 sealed within 2); and a plurality of pores in the membrane (abstract), wherein the superabsorbent material contains a plurality of particles ([0052]), wherein the housing has a compressed initial housing size, and wherein the housing has an expanded housing size upon exposure of the superabsorbent material to an expansion trigger, the expanded housing size being at least about 50 times to at least about 100 times the initial housing size ([0018], initial state is unexpanded and thus compressed), wherein the superabsorbent material is in a solid state and the plurality of particles are aggregate within the membrane upon compression of the housing (at the least when the material is placed within the housing if the housing is compressed the particles would be aggregated within the housing, compression may occur by someone holding the device or when the housing it brought around the particles to enclose the particles). Eskaros et al. do not teach the membrane is a macroporous hydrogel. However, Williams et al. teach a porous hydrogel membrane within the body for controlled release and delivery ([0050]). Further, Park et al. teach effective pore sizes for an expandable gastric device can be microporous or microporous, with pore size between 10nm-10 micrometers (Col. 1 lines 40-55, Figs. 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a porous hydrogel material for the membrane in Eskaros et al. as Williams et al. teach such is one of several suitable materials for placement in the body and controlled release which would still yield the same predictable result and further to use macropores and Park et al. teach micropores and macropores are suitable for allowing the intake of gastric fluid for expansion while retaining the superabsorbent material and would yield the same predictable result of swelling the device of Eskaros et al. Eskaros et al. does not disclose the material of the superabsorbent material as recited in the claims such that it would deflate upon exposure to a deflation trigger. However, Park et al. teach an effective superabsorbent material for gastric expansion includes PAA (Col. 15 lines 15-35). Additionally, Guar et al. teach superabsorbent PAA hydrogels are provided by granules distributed in a size of 1-100 microns ([0146], [0197]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use PAA in Eskaros et al. as Park et al. and of a size as in Guar et al. as they teach such to be an art effective superabsorbent material which would yield the same predictable result. Based on the size ranges given for the pores and the particles, particles may be smaller than the pores, further as the particles in Guar et al. are distributed in a range of sizes at least several would be smaller. Further, it would have been obvious to a person having ordinary skill in the art to select values for the pores and particles as claimed as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Applicant has not disclosed that the particles sizes claimed are used for a particular purpose or advantage. The specification refers to a large range of size options. As Park et al. teach the material to be PAA, Col. 15 lines 15-35, which is the same as used by Applicant it would be expected to deflate upon exposure to a deflation trigger. Further, Gaur et al. evidences that PAA deswells in response to triggers like calcium ions ([0222], [0225], [0227]). Eskaros et al. do not disclose an anti-fatigue polymer network. However, Sun et al. teach an anti-fatigue polymer network infiltrated with water, which resists a crack propagation ([0005], [0007], [0008], [0028], [0083]). Sun et al. teach a composition comprising a self-healing IPN hydrogel comprising between 30% to 90% water which recovers after cyclical loading (see at least [0007], [0055], [0073], [0098]). The network may comprise methacrylated PEG ([0008]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an anti-fatigue polymer network in Eskaros et al. as Sun et al. teach this is beneficial to aid in the recovery of the material. Eskaros et al. do not disclose an electronic sensor. Eskaros et al. teach the location may be tracked via radiopaque markers ([0022], cl. 22). However, McCarthy et al. teach an ingestible device for the treatment of obesity in which the location may be determined using various imaging techniques ([0107]) or that an electronic package may be used to communicate with an external device to transmit information including location based on sensed data ([0185], [0187]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use an electronic sensor in Eskaros et al. as in McCarthy et al. to determine and transmit location data as this is beneficial for ensuring the ingested device is in the correct location for treatment.
With regard to claims 14 and 21, Eskaros et al. teach the device may have drug elution properties but does not explicitly disclose one or more agents in the cavity ([0027]). However, Park et al. teach a gastric device which expands and may contain drugs for controlled release which is beneficial in that it provides great convenience to patients and improves therapeutic efficacy by maintaining a consistent and uniform blood level of medication over an extended period of time (Col. 30 lines 10-19 and 39-50). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide a drug for controlled release in Eskaros et al. as Park et al. teach this is convenient for patients and improves efficacy.
With regard to claim 50, Eskaros et al. teach an expandable hydrogel structure comprising: a housing fabricated of a membrane, the housing having a cavity therein (Fig. 5B swallowable member 2, cavity where 3 is indicated, [0019]); a superabsorbent material disposed and sealed within the housing cavity, the superabsorbent material having an initial superabsorbent size ([0028], Fig. 5B member 3 sealed within 2); and a plurality of pores in the membrane (abstract), wherein the superabsorbent material contains a plurality of particles ([0052]), wherein the housing has a compressed initial housing size, and wherein the housing has an expanded housing size upon exposure of the superabsorbent material to an expansion trigger, the expanded housing size being at least about 50 times to at least about 100 times the initial housing size ([0018], initial state is unexpanded and thus compressed), wherein the superabsorbent material is in a solid state and the plurality of particles are aggregate within the membrane upon compression of the housing (at the least when the material is placed within the housing if the housing is compressed the particles would be aggregated within the housing, compression may occur by someone holding the device or when the housing it brought around the particles to enclose the particles). Eskaros et al. do not teach the membrane is a macroporous hydrogel. However, Williams et al. teach a porous hydrogel membrane within the body for controlled release and delivery ([0050]). Further, Park et al. teach effective pore sizes for an expandable gastric device can be microporous or microporous, with pore size between 10nm-10 micrometers (Col. 1 lines 40-55, Figs. 5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a porous hydrogel material for the membrane in Eskaros et al. as Williams et al. teach such is one of several suitable materials for placement in the body and controlled release which would still yield the same predictable result and further to use macropores and Park et al. teach micropores and macropores are suitable for allowing the intake of gastric fluid for expansion while retaining the superabsorbent material and would yield the same predictable result of swelling the device of Eskaros et al. Eskaros et al. does not disclose the material of the superabsorbent material as recited in the claims such that it would deflate upon exposure to a deflation trigger. However, Park et al. teach an effective superabsorbent material for gastric expansion includes PAA (Col. 15 lines 15-35). Additionally, Guar et al. teach superabsorbent PAA hydrogels are provided by granules distributed in a size of 1-100 microns ([0146], [0197]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use PAA in Eskaros et al. as Park et al. and of a size as in Guar et al. as they teach such to be an art effective superabsorbent material which would yield the same predictable result. Based on the size ranges given for the pores and the particles, particles may be larger than the pores. Further, it would have been obvious to a person having ordinary skill in the art to select values for the pores and particles as claimed as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Applicant has not disclosed that the particles sizes claimed are used for a particular purpose or advantage. The specification refers to a large range of size options. As Park et al. teach the material to be PAA, Col. 15 lines 15-35, which is the same as used by Applicant it would be expected to deflate upon exposure to a deflation trigger. Further, Gaur et al. evidences that PAA deswells in response to triggers like calcium ions ([0222], [0225], [0227]). Eskaros et al. do not disclose an anti-fatigue polymer network. However, Sun et al. teach an anti-fatigue polymer network infiltrated with water, which resists a crack propagation ([0005], [0007], [0008], [0028], [0083]). Sun et al. teach a composition comprising a self-healing IPN hydrogel comprising between 30% to 90% water which recovers after cyclical loading (see at least [0007], [0055], [0073], [0098]). The network may comprise methacrylated PEG ([0008]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an anti-fatigue polymer network in Eskaros et al. as Sun et al. teach this is beneficial to aid in the recovery of the material. Eskaros et al. do not disclose an electronic sensor. Eskaros et al. teach the location may be tracked via radiopaque markers ([0022], cl. 22). However, McCarthy et al. teach an ingestible device for the treatment of obesity in which the location may be determined using various imaging techniques ([0107]) or that an electronic package may be used to communicate with an external device to transmit information including location based on sensed data ([0185], [0187]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use an electronic sensor in Eskaros et al. as in McCarthy et al. to determine and transmit location data as this is beneficial for ensuring the ingested device is in the correct location for treatment.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over E Eskaros et al. (US 2009/0259246 A1), Williams et al. (US 2019/0030311 A1), Park et al. (US 6,271,278 B1) as evidenced by and in view of Gaur et al. (US 2014/0188151 A1), Sun et al. (US 2016/0354520 A1), and McCarthy et al. (US 2017/0367863 A1) as applied to claim 7 above, and further in view of Vidlund (US 2019/0175339 A1).
With regard to claim 9, Eskaros et al. and Sun et al. teach an anti-fatigue polymer but do not specifically disclose one or more nanostructures. However, Vidlund teaches high-cycle fatigue tolerant expandable polymer may include nanofibers ([0105]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use nanofibers in Eskaros et al. and Sun et al. as Vidlund teaches this is a suitable material additive to fatigue resistant polymers and would still yield the same predictable result of an expandable fatigue resistant polymer.
Claim(s) 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eskaros et al. (US 2009/0259246 A1), Williams et al. (US 2019/0030311 A1), Park et al. (US 6,271,278 B1) as evidenced by and in view of Gaur et al. (US 2014/0188151 A1), Sun et al. (US 2016/0354520 A1), and McCarthy et al. (US 2017/0367863 A1) as applied to claims 14 and 21 above, and further in view of Kasic (US 2009/0192535 A1).
With regard to claims 22-28, Eskaros et al. and Park et al. teach a device substantially as claimed and teach controlled release of an agent through the membrane (see Park et al. at least Col. 30 lines 10-24 and 39-54) but do not the number of days the housing is configured to remain expanded. However, Kasic teaches that a device which expands for gastric treatment may be designed to last a variety of time frames depending on treatment including at least two weeks to allow for prolonged and maintained treatment ([0015]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device remain expanded for at least fourteen days to deliver treatment during the time frame in Eskaros et al. and Park et al. as Kasic teaches the time frame may be varied depending on treatment and is beneficial for providing prolonged and maintained treatment.
Response to Arguments
Applicant's arguments filed April 6, 2026 have been fully considered but they are not persuasive. At the outset, the Examiner notes Applicant’s arguments focus on some particles having a smaller diameter than the macropores. However, claim 50 recites the opposite, there do not seem to be specific arguments to the different scenario claimed in claim 50. Regarding the new limitation “wherein the superabsorbent material is in a solid state and the plurality of particles are aggregate within the membrane upon compression of the housing” there are no specific remarks to this limitation or how it is intended to differentiate over the current art. Applicant argues that as combined the particles would leave the housing in an expanded state as they are smaller than the macropores. As claimed only several particles are required to have a smaller diameter. Guar teaches the particles are provided with a range of sizes ([0146]). If only several are smaller while the rest are larger this would not affect the overall operation. It is also noted that the particles swell from their initial size. The Examiner maintains one of ordinary skill would be able to select the particles and pore sizes as effective for treatment and the references teach various sizes for both.
The amendments are sufficient to overcome the previous rejections under 35 U.S.C. 112.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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