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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/04/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 06/07/26 has been entered. Claims 1, 7, 17-18, 32, 35-36, 38, 42, 44, 50 have been amended. Claims 2-4, 8, 22-23, 27 are in the original/previously presented form. Claims 5-6, 9-16, 19-21, 24-26, 28-31, 33-34, 37, 39-41, 43, 45-49, and 51 are cancelled. Claim 52 is newly presented. Thus, claims 1-4, 7-8, 17-18, 22-23, 27, 32, 35-36, 38, 42, 44, 50, and 52 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 02/10/26, except for the claim objection and 112b rejection regarding claim 50 (see below).
Claim Objections
Claims 1 and 50 are objected to because of the following informalities:
Claim 1 lines 12-14 read “wherein the patch assembly is configured such that the gas-generating formulation are retained within a respective one of the auxiliary gas- generating reaction chambers during inflation” and should likely read “wherein the patch assembly is configured such that the gas-generating formulation [[are]] is retained within a respective one of the auxiliary gas- generating reaction chambers during inflation” for grammatical reasons
Claim 50, lines 13-16 read “the formulation generates an extended release of gas that flows towards the internal chamber of the inflatable patch while the water-sensitive gas-generating formulation is retained within its respective auxiliary gas-generating reaction chamber” and should likely read “the formulation generates an extended release of gas that flows towards the internal chamber of the inflatable patch while the water-sensitive gas-generating formulation is retained within [[its]] the one or more respective auxiliary gas-generating reaction chambers” to ensure that “its” is not accidentally interpreted as a different structure (i.e. the internal chamber instead of the reaction chamber) and to follow the language of “one or more” reaction chambers as previously set forth in the claim language
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 50 is 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.
Regarding claim 50, lines 13-16 read “the formulation generates an extended release of gas that flows towards the internal chamber of the inflatable patch while the water-sensitive gas-generating formulation is retained within its respective auxiliary gas-generating reaction chamber”. It remains unclear to the examiner how the gas “flows toward the internal chamber of the inflatable patch” and is also “retained” in the reaction chamber at the same time. Either there is flow of gas toward the patch, such that gas is leaving the reaction chamber OR there is no flow of gas such that the gas is completely “retained” in the reaction chamber. According to Applicant disclosure (see [0082] and Figs. 8A-C), it appears that gas flows from the reaction chamber toward the internal chamber of the patch in order to inflate the patch into the expanded configuration. It seems that some gas is retained in the reaction chamber during this gas flow process.
Therefore, for purposes of examination and to best align with Applicant disclosure, the examiner interprets lines 13-16 to read “the formulation generates an extended release of gas that flows towards the internal chamber of the inflatable patch [[while the water-sensitive gas-generating formulation is retained]] from within its respective auxiliary gas-generating reaction chamber”.
Claim Rejections - 35 USC § 103
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.
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 1-3, 7-8, 17-18, 22-23, 27, 32, 35-36, 38, 42, 50, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (WO2020/035857—provided with the Non-Final rejection mailed 02/10/26), hereinafter Gross.
Regarding claim 1, Gross discloses an auto-inflatable patch assembly (see page 42 lines 8-19: FIGs 10A-B is embodiment of device 624 as described with reference to other figures including features of Fig.1A-B, 2A-F, and FIG. 9A-B) for drug delivery within a lumen (lumen of intestine, see Fig. 1A where enteric coating 22 of pill is still intact, see page 32 lines 13-28. FIGs. 10A-B after coating 22 dissolves), comprising:
a pliable (see page 39 lines 7-12) and inflatable patch (830, see page 42 line 20) having walls (see page 42 lines 20-31 describing wall layers. Including perimeter 746), which define an internal chamber (873) and an array of penetrating needles (40) disposed on (see page 41 lines 30-32) a surface (766 as shown in FIG. 9B or 867 in FIG. 10B) thereof;
one or more auxiliary gas-generating reaction chambers (672/872) distinguished from (see ‘Modified FIG. 10B’ below and page 42 lines 20-28 and page 43 lines 6-22)
PNG
media_image1.png
523
971
media_image1.png
Greyscale
and fluidly connected (see page 43 lines 6-22: gas passes from chamber to chamber 873 via gas permeable layer 864==fluidly connected. See also page 43 lines 26-27: layer 864 can be liquid permeable for some applications) to the internal chamber (873) of the inflatable patch, the one or more auxiliary gas-generating reacting chambers (672/872) being positioned outwardly with respect to the internal chamber (873, see FIG. 10A-B with chambers 672/872 formed outwardly/ along edge of the chamber 873 and see positional description in page 42 lines 20-31), along a perimeter or outer circumference of the inflatable patch (see page 42 lines 20-31: chambers 672/872 are formed by layers 862/864 fixed at perimeter of patch 746, see FIG. 10A/B. Further, layer 862 is edge/perimeter of patch as shown in FIG. 10A/B); each of said one or more auxiliary gas-generating reacting chambers (672/872) defined by pliable reaction chamber walls (864 & 872, see page 42 lines 20-31 and page 43 lines 23-27) that house a water-sensitive gas- generating formulation (see page 43 lines 6-22: upon contact with liquid, gas in chambers 672/872 expands and see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate/ citric acid mixture); said reaction chamber walls (864 & 872) configured to constrain gas (see page 43 lines 6-22 and page 41 lines 12-20) and having at least a portion being a water-permeable outer surface (see page 43 lines 6-27 and page 41 lines 12-20), wherein the patch assembly is configured such that the gas-generating formulation are retained within a respective one of the auxiliary gas- generating reaction chambers during inflation (as seen in expansion from FIG. 10A to FIG. 10B and described on page 43 lines 6-27).
Gross (FIG. 10A-B) further discloses that the wall layers can be designed to achieve certain permeability characteristics to adjust the expansion and medication release timing (see page 43 line 6-27).
Gross (FIG. 10A-B) is silent to the patch having “water and gas-impermeable” walls.
However, in a separate embodiment (see FIG. 15), Gross teaches an auto-inflatable patch assembly for drug delivery within a lumen (see Fig. 14, page 46 lines 15-25, and page 48 line 28- page 49 line 11), comprising:
a pliable (see page 47 line 32- page 48 line 1) and inflatable patch (1230, see page 47 lines 13-26: patch 1230 has compressed shape 1242, such as when contained inside pill 22 as shown in FIG. 14, and expanded==inflatable shape 1244 as seen in ‘Modified FIG. 15’ below)
PNG
media_image2.png
880
1193
media_image2.png
Greyscale
having water and gas-impermeable walls (1274, see page 46 line 26- page 47 line 12 and page 48 lines 2-5), which define an internal chamber (see internal chamber in ‘Modified FIG. 15’ above defined by walls 1274 as described on page 47 lines 5-12 and page 48 lines 12-14) and an array of penetrating needles (1250, see page 47 lines 13-26) disposed on (see page 51 lines 4-10 and lines 15-16) a surface (1232) thereof; and ii. one or more auxiliary gas-generating reaction chambers (chamber 1270 housing gas-generating substance 1280, see ‘Modified FIG. 15’ above and page 47 line 13- page 48 line 5).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable patch disclosed in Gross (FIG. 10A-B) to include a water and gas impermeable layer to form water and gas impermeable walls as taught by Gross for the purpose of forming the patch with a desired permeability characteristic (see page 46 line 15- page 47 line 31and page 48 lines 6-27: 1274 has one or more windows 1276 with layer 1278 to allow amount of bodily fluids to pass into device to activate gas agent) and/or forming an impermeable structural layer that defines and maintains the shape of the inflated patch (see page 50 lines 9-17 & page 50 line 25-30: 1274 with integral foam 1292 prevents device from inflating too spherically shaped), thus achieving the patch having “water and gas-impermeable” walls.
Regarding claim 2, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the patch assembly is compressed (see FIG. 1A to FIG. 1B) and further housed within a swallowable enteric outer shell (22, see page 32 line 13-31: patch in enteric swallowable pill in compressed configuration and expands when shell dissolves and page 42 lines 8-17: FIGs. 10A-B is device after outer shell dissolves).
Regarding claim 3, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the water-sensitive gas-generating formulation is an extended-release gas-generating formulation (see page 41 lines 12-20: gas formed from liquid contacting sodium bicarbonate/ citric acid mixture. The mixture including citric acid aligns with Applicant’s disclosure for “extended release” in at least [0026]).
Regarding claim 7, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the one or more auxiliary gas-generating reaction chambers (672/872, see FIG. 10B) are fluidly connected (see page 43 lines 6-22: gas passes from chamber to chamber 873 via gas permeable layer 864==fluidly connected.) to the internal chamber (873) but separated from the internal chamber (873) of the inflatable patch by a formulation-retentive element (864, see page 41 lines 12-20: chambers such as 672 with walls==formulation-retentive element 864 retain substance for producing gas. See page 43 lines 6-27: 864 can have designed permeability characteristics and see page 42 lines 20-28: 864 forms chambers 672/872).
Regarding claim 8, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the patch assembly is configured so that a combination of the internal chamber of the patch (873, see FIG. 10B and page lines 6-27: chamber 873 expands with gas and thus is configured to constrain gas within) and respective interiors of the one or more auxiliary gas reaction chambers (interiors of 672/872) are configured to constrain gas within (see page 41 lines 12-20: chambers such as 672 with walls==formulation-retentive element 864 retain substance for producing gas. See page 43 lines 6-27: 864 can have designed permeability characteristics and see page 42 lines 20-28: 864 forms chambers 672/872).
Regarding claim 17, Gross discloses the auto-inflatable patch assembly of claim 7, and Gross further discloses wherein the formulation-retentive element (864, see FIG. 10B and page 41 lines 12-20: chambers such as 672 with walls==formulation-retentive element 864 retain substance for producing gas. See page 43 lines 6-27: 864 can have designed permeability characteristics and see page 42 lines 20-28: 864 forms chambers 672/872) is positioned along an outer circumference, perimeter, outer or side surface (864 forms top perimeter of the reaction chambers 872/672) of each of the one or more gas-generating reaction chambers (872/672).
Regarding claim 18, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein each of the one or more gas-generating reaction chambers (672/872, see FIG.10B) is configured to produce a consistent amount of gas over an extended period (see page 43 lines 6-22: layer 864 has designed gas permeability. see page 41 lines 12-20: gas generating agent/ mixture of sodium bicarbonate and citric acid is stored in reaction chamber. Therefore, the reaction chambers are “configured to” produce a consistent amount of gas over an extended period because the amount of the mixture in the chamber and the gas permeability of the chamber can be chosen to achieve a consistent release over a predetermined period of time).
Regarding claim 22, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the reaction chamber walls (for example, 864 in FIG. 10B) are directionally permeable (see page 43 lines 6-22).
Regarding claim 23, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the penetrating needles (40, see FIG. 10B) have a length of more than 6.0mm (see page 33 lines 9-16).
Regarding claim 27, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the array of penetrating needles (40, see FIG.10B) are positioned on a first surface (top surface, i.e.: 766/867) of the inflatable patch.
Regarding claim 32, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the internal chamber (873, see FIG. 10B) of the inflatable patch does not have a water permeable surface (The only surfaces of internal chamber 873 are either layer 864 or 866, see page 42 lines 25-26: 873 formed of layers 864 and 866:
In regard to layer 864, see page 43 lines 11-18: layer 864 is only gas permeable and therefore is not water permeable.
In regard to layer 866, 866 borders medication 52 as seen in FIG. 10B. On page 33 lines 22-25, Gross discloses that the medication 52 in the embodiment of FIG. 10B is liquid. On page lines 11-18, Gross discloses that medication only moves through fourth layer 867, Thus, 866 cannot be water permeable since it retains the liquid medicine and does not allow medication to move through during expansion of the chamber—see progression from FIG. 10A to FIG. 10B.)
Regarding claim 35, Gross discloses an auto-inflatable patch assembly (see page 42 lines 8-19: FIGs 10A-B is embodiment of device 624 as described with reference to other figures including features of Fig.1A-B, 2A-F, and FIG. 9A-B delivered to lumen of intestine, see Fig. 1A where enteric coating 22 of pill is still intact, see page 32 lines 13-28. FIGs. 10A-B after coating 22 dissolves) comprising:
a pliable (see page 39 lines 7-12) and inflatable patch (830, see page 42 line 20) having walls (see page 42 lines 20-31 describing different wall layers) which define an internal chamber (873);
one or more auxiliary gas- generating reaction chambers (672/872) distinguished from (see ‘Modified FIG. 10B’ below and page 42 lines 20-28 and page 43 lines 6-22)
PNG
media_image1.png
523
971
media_image1.png
Greyscale
and fluidly connected (see page 43 lines 6-22: gas passes from chamber to chamber 873 via gas permeable layer 864==fluidly connected. See also page 43 lines 26-27: layer 864 can be liquid permeable for some applications) to the internal chamber (873) of the inflatable patch, the one or more reaction chambers (672/872) being positioned outwardly with respect to the internal chamber (873, see FIG. 10A-B with chambers 672/872 formed outwardly/ along edge of the chamber 873 and see positional description in page 42 lines 20-31), along a perimeter or outer circumference of the inflatable patch (see page 42 lines 20-31: chambers 672/872 are formed by layers 862/864 fixed at perimeter of patch 746, see FIG. 10A/B. Further, layer 862 is edge/perimeter of patch as shown in FIG. 10A/B); each of said one or more reaction chambers (672/872) defined by pliable reaction chamber walls (864 & 872, see page 42 lines 20-31 and page 43 lines 23-27) that house a first and second reactant in a single compartment (such as in chamber 672, see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate==first reactant and citric acid==second reactant mixture), said first and second reactants configured to effervesce when exposed to water (see page 43 lines 6-22: upon contact with liquid, gas in chambers 672/872 expands and see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate/ citric acid mixture. Sodium bicarbonate/citric acid mixture aligns with Applicant’s disclosure regarding “ effervescent reaction” in at least the current Application’s [0006]);
said reaction chamber walls (864 & 872) configured to constrain gas (see page 43 lines 6-22 and page 41 lines 12-20) and having at least a portion being a water- permeable outer surface (see page 43 lines 6-27 and page 41 lines 12-20).
Gross (FIG. 10A-B) further discloses that the wall layers can be designed to achieve certain permeability characteristics to adjust the expansion and medication release timing (see page 43 line 6-27).
Gross (FIG. 10A-B) is silent to the patch having “water and gas-impermeable” walls.
However, in a separate embodiment (see FIG. 15), Gross teaches an auto-inflatable patch assembly (see Fig. 14, page 46 lines 15-25, and page 48 line 28- page 49 line 11), comprising a pliable (see page 47 line 32- page 48 line 1) and inflatable patch (1230, see page 47 lines 13-26: patch 1230 has compressed shape 1242, such as when contained inside pill 22 as shown in FIG. 14, and expanded==inflatable shape 1244 as seen in ‘Modified FIG. 15’ below)
PNG
media_image2.png
880
1193
media_image2.png
Greyscale
having water and gas-impermeable walls (1274, see page 46 line 26- page 47 line 12 and page 48 lines 2-5), which define an internal chamber (see internal chamber in ‘Modified FIG. 15’ above defined by walls 1274 as described on page 47 lines 5-12 and page 48 lines 12-14); and one or more auxiliary gas-generating reaction chambers (chamber 1270 housing gas-generating substance 1280, see ‘Modified FIG. 15’ above and page 47 line 13- page 48 line 5).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable patch disclosed in Gross (FIG. 10A-B) to include a water and gas impermeable layer to form water and gas impermeable walls as taught by Gross for the purpose of forming the patch with a desired permeability characteristic (see page 46 line 15- page 47 line 31and page 48 lines 6-27: 1274 has one or more windows 1276 with layer 1278 to allow amount of bodily fluids to pass into device to activate gas agent) and/or forming an impermeable structural layer that defines and maintains the shape of the inflated patch (see page 50 lines 9-17 & page 50 line 25-30: 1274 with integral foam 1292 prevent device from inflating too spherically shaped), thus achieving the patch having “water and gas-impermeable” walls.
Regarding claim 36, the modified system of Gross teaches the auto-inflatable patch assembly of claim 35, and Gross further discloses wherein the single compartment (chamber 672, see ‘Modified FIG. 10B’ above and page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate==first reactant and citric acid==second reactant mixture contained in the chambers as described on page 43 lines 6-22) is separated from the internal chamber (873) of the inflatable patch by a formulation-retentive element (864, see page 41 lines 12-20: chambers such as 672 with walls==formulation-retentive element 864 retain substance for producing gas. See page 43 lines 6-27: 864 can have designed permeability characteristics and see page 42 lines 20-28: 864 forms chambers 672/872).
Regarding claim 38, the modified system of Gross teaches the auto-inflatable patch assembly of claim 35, and Gross further discloses wherein each of said one or more reaction chambers (see page 43 lines 6-22: upon contact with liquid, gas in chambers 672/872 expands and see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate/ citric acid mixture.) comprises a water-sensitive gas-generating formulation (the combination of sodium bicarbonate & citric acid when contacted with liquid) which is configured for extended-release (see page 41 lines 12-20: gas formed from liquid contacting sodium bicarbonate/ citric acid mixture. The mixture including citric acid aligns with Applicant’s disclosure for “extended release” in at least [0026]).
Regarding claim 42, the modified system of Gross teaches the auto-inflatable patch assembly of claim 38, and Gross further discloses wherein the water-sensitive gas-generating formulation (the combination of sodium bicarbonate & citric acid when contacted with liquid) is a single unit (see page 41 lines 12-20: gas formed from liquid contacting sodium bicarbonate/ citric acid mixture. Thus, the “mixture” forms a single unit/ gas composition when contacted with liquid).
Regarding claim 50, Gross discloses a method for providing an auto-inflatable patch assembly (see page 42 lines 8-19: FIGs 10A-B is embodiment of device 624 as described with reference to other figures including features of Fig.1A-B, 2A-F, and FIG. 9A-B) for delivering a therapeutic agent into an intestinal wall of a subject (see page 32 line 13 -page 34 line 5) comprising:
orally administering to the subject a device comprising a swallowable enteric outer shell (22, see FIG. 1A and page 31 lines 13-25) and an auto-inflatable patch assembly (see FIG. 10B, page 32 lines 13-31, and page 32 lines 13-28. FIGs. 10A-B is the patch after coating 22 dissolves), said patch assembly (see FIG. 10B) comprising a pliable (see page 39 lines 7-12) and inflatable patch (830, see page 42 line 20) having walls (see page 42 lines 20-31 describing wall layers), which define an internal chamber (873) and an array of penetrating needles (40) disposed on (see page 41 lines 30-32) a surface (766 as shown in FIG. 9B or 867 in FIG. 10B) thereof (see ‘Modified FIG. 10B’ below);
PNG
media_image1.png
523
971
media_image1.png
Greyscale
And one or more auxiliary gas-generating reaction chambers (672/872) being positioned outwardly with respect to the internal chamber (873, see FIG. 10A-B with chambers 672/872 formed outwardly/ along edge of the chamber 873 and see positional description in page 42 lines 20-31), along a perimeter or outer circumference of the inflatable patch (see page 42 lines 20-31: chambers 672/872 are formed by layers 862/864 fixed at perimeter of patch 746, see FIG. 10A/B. Further, layer 862 is edge/perimeter of patch as shown in FIG. 10A/B); each of the reaction chambers defined by pliable reaction chamber walls (864 & 872, see page 42 lines 20-31 and page 43 lines 23-27) that house a water-sensitive gas-generating formulation (see page 43 lines 6-22: upon contact with liquid, gas in chambers 672/872 expands and see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate/ citric acid mixture); said reaction chamber walls (864 & 872) configured to constrain gas (see page 43 lines 6-22 and page 41 lines 12-20) and having at least a portion being a water- permeable outer surface (see page 43 lines 6-27 and page 41 lines 12-20);
exposing the water-sensitive gas-generating formulation to water (see page 33 lines 5-8: patch unfolds in response to contact with fluid in small intestine, which inherently includes water, page 41 lines 12-20: gas can be formed from bodily fluid contacting sodium bicarbonate/ citric acid mixture, and page 43 lines 6-22: upon contact with liquid, gas in chambers 672/872 expands) through the water-permeable outer surface (see page 43 lines 6-27 and page 41 lines 12-20) of the gas-generating reaction chamber (672/872) such that the formulation generates an extended release of gas (see page 41 lines 12-20: gas formed from liquid contacting sodium bicarbonate/ citric acid mixture. The mixture including citric acid aligns with Applicant’s disclosure for “extended release” in at least [0026]) that flows towards the internal chamber (873) of the inflatable patch [[while the water-sensitive gas-generating formulation is retained]] from within its respective auxiliary gas-generating reaction chamber (672/872, see page 43 lines 6-22: gas passes from chamber 872 toward chamber 873 via gas permeable layer 864, see ‘Modified FIG. 10B’ above).
Gross (FIG. 10A-B) further discloses that the wall layers can be designed to achieve certain permeability characteristics to adjust the expansion and medication release timing (see page 43 line 6-27).
Gross (FIG. 10A-B) is silent to the patch having “water and gas-impermeable” walls.
However, in a separate embodiment (see FIG. 15), Gross teaches an auto-inflatable patch assembly (see Fig. 14, page 46 lines 15-25, and page 48 line 28- page 49 line 11), comprising a pliable (see page 47 line 32- page 48 line 1) and inflatable patch (1230, see page 47 lines 13-26: patch 1230 has compressed shape 1242, such as when contained inside pill 22 as shown in FIG. 14, and expanded==inflatable shape 1244 as seen in ‘Modified FIG. 15’ below)
PNG
media_image2.png
880
1193
media_image2.png
Greyscale
having water and gas-impermeable walls (1274, see page 46 line 26- page 47 line 12 and page 48 lines 2-5), which define an internal chamber (see internal chamber in ‘Modified FIG. 15’ above defined by walls 1274 as described on page 47 lines 5-12 and page 48 lines 12-14); and one or more auxiliary gas-generating reaction chambers (chamber 1270 housing gas-generating substance 1280, see ‘Modified FIG. 15’ above and page 47 line 13- page 48 line 5).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable patch disclosed in the method of Gross (FIG. 10A-B) to include a water and gas impermeable layer to form water and gas impermeable walls as taught by Gross for the purpose of forming the patch with a desired permeability characteristic (see page 46 line 15- page 47 line 31and page 48 lines 6-27: 1274 has one or more windows 1276 with layer 1278 to allow amount of bodily fluids to pass into device to activate gas agent) and/or forming an impermeable structural layer that defines and maintains the shape of the inflated patch (see page 50 lines 9-17 & page 50 line 25-30: 1274 with integral foam 1292 prevents device from inflating too spherically shaped), thus achieving the patch having “water and gas-impermeable” walls.
Regarding claim 52, the modified system of Gross teaches the auto-inflatable patch assembly of claim 1, and Gross (FIG. 10A-B) further discloses wherein the reaction chambers (672/872) extend radially from the inflatable patch (chambers 672/872 extend radially from the patch with respect to radius of lumen wherein the patch is disposed, see FIG. 1B, and/or from a radial edge defined at surface where needles are disposed in FIG. 10A/B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gross as applied to claim 1 above, and further in view of Imran (U.S. PGPUB No. 2013/0164372).
Regarding claim 4, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the water-sensitive gas-generating formulation is configured to generate gas to provide a pressure of the inflatable patch (see page 41 lines 12-20: gas can be formed from liquid contacting sodium bicarbonate/ citric acid mixture. The gas is contained in the patch such as in chambers 672/872, see page 43 lines 6-22, and thus would inherently be “configured to” provide a pressure of the patch via the gas generation).
Gross is silent to the wherein the water-sensitive gas-generating formulation is configured to generate gas to provide a pressure of the inflatable patch “as measured at 37°C of more than 3psi.”
However, Imran teaches a swallowable device for delivering medication to the GI tract (see [0059]) via an inflatable/ expandable internal device (i.e.: expandable balloon, see [0060] and [0115]). Imran further teaches the inflatable device comprising a water-sensitive gas-generating formulation (see [0115] & [0117]: reactants such as citric acid and sodium bicarbonate that mix in liquid to produce a gas), wherein the water-sensitive gas-generating formulation (see [0115] & [0117]) is configured to generate gas to provide a pressure of the inflatable device as measured at 37°C of more than 3psi (see [0118]: citric acid & sodium bicarbonate can be provided in different ratios/ amounts in combination with other components such that pressure of the expandable device is in the range of 10 to 15 psi applied to the intestinal wall==at 37°C).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the water-sensitive gas-generating formulation comprising amounts of sodium bicarbonate and citric acid disclosed in Gross by modifying the amounts/ratios of sodium bicarbonate and citric acid in the formulation to achieve a pressure between 10 and 15psi using known stochiometric equations and the ideal gas law as taught by Imran for the purpose of achieving a certain penetration depth of the needles into the intestinal wall or to exert a selected amount of force against the intestinal wall (see [0118]), thus achieving wherein the water-sensitive gas-generating formulation is configured to generate gas to provide a pressure of the inflatable patch “as measured at 37°C of more than 3psi.”
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Gross as applied to claim 38 above, and further in view of Brister et al. (U.S. PGPUB No. 2010/0100117), hereinafter Brister.
Regarding claim 44, the modified system of Gross teaches the auto-inflatable patch assembly of claim 38, and Gross further discloses wherein the amount of the first and second reactants is a predetermined amount of the water-sensitive gas- generating formulation (see page 41 lines 12-20: sodium bicarbonate at 60-70% and citric acid at 30-40%).
Gross is silent to the amount of the first and second reactant “is less than 80%” of the water-sensitive gas-generating formulation.
However, Brister teaches a swallowable self-inflating device (see [0234] and see specifically a patch in [0238]) with a first and second reactant of a water-sensitive gas-generating formulation (see [0237]: combination of reactants such as sodium bicarbonate and citric acid). Brister further teaches that providing a disintegrant in the water-sensitive gas-generating formulation (see [0237]) will control degradation and other timing mechanisms for the device (see [0235-0238] and [0114]).Therefore, a person of ordinary skill in the art would consider the first and second reactant amounts of the water-sensitive gas-generating formulation to be a result effective variable that is optimized through routine experimentation of changing/modifying the amount of disintegrant added to the formulation to obtain a desired timing mechanism of the device.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first and second reactant amounts of the water-sensitive gas-generating formulation by modifying the formulation to include a disintegrant, such as 21% disintegrant, to optimize the timing mechanisms of the device and obtain the first and second reactant amounts “is less than 80%” of the water-sensitive gas-generating formulation as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 06/07/26 have been fully considered but they are not persuasive.
On page 14 of Applicant remarks, Applicant argues that Gross fails to disclose the reaction chambers positioned outwardly of the internal chamber and along a perimeter of the patch and therefore the 35 U.S.C. § 103 claim rejections under Gross should be withdrawn. The examiner disagrees and has maintained the claim rejections.
On page 14, Applicant argument suggests that the reaction chambers must be along “its” perimeter (“its” referring to the internal chamber of the patch). However, this argument does not align with the breadth of the claims as currently presented and is therefore not persuasive. Claim 1 requires “the one or more reaction chambers being positioned outwardly with respect to the internal chamber, along a perimeter or outer circumference of the inflatable patch;”. Therefore, the claim only requires that the reaction chambers be along a perimeter of the PATCH, not the internal chamber. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the auxiliary chambers positioned on the perimeter of the internal chamber of the inflatable patch) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the examiner was not persuaded by this argument and has maintained the claim rejections under Gross.
Next, on pages 14-15, Applicant argues that the combination of the different embodiments of Gross is improper hindsight reasoning and therefore the 35 U.S.C § 103 claim rejections under Gross should be withdrawn. The examiner disagrees and has maintained the claim rejections.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant application, the examiner has provided motivation for combining the embodiments (see pages 16-17 in the non-final rejection mailed 02/10/26) for the purpose of forming the patch with a desired permeability characteristic and/or forming an impermeable structural layer that defines and maintains the shape of the inflated patch. Thus, the examiner was not persuaded by this argument and has maintained the claim rejections under Gross.
To continue with the arguments on pages 14-15, Applicant also argues that the combination of the different embodiments of Gross would change the principle operation and therefore the 35 U.S.C § 103 claim rejections under Gross should be withdrawn. The examiner disagrees and has maintained the claim rejections.
Applicant suggests that the two Gross embodiments “are functionally distinct devices with incompatible architectures”. However, this argument is not persuasive because it appears to be a mischaracterization of the rejection. Applicant’s argument states that the inflatable chamber wall of the first embodiment of Gross cannot be modified to be water/gas impermeable because this modification would inhibit the gas flow across the boundary. However, the modification set forth by the examiner (see pages 16-17 in the non-final rejection mailed 02/10/26) is to modify the inflatable patch to include a water/gas impermeable layer to form impermeable walls. Therefore, the modification does not require the layer 864 of the inflatable chamber (see ‘Modified FIG. 10B’ on page 14 of the non-final rejection mailed 02/10/26) to be modified as argued by Applicant. Therefore, the examiner maintains that a person of ordinary skill in the art would have had enough suggestion from the embodiments of Gross to arrive at the claimed invention (see MPEP § 2145.III: Arguing that prior art devices are not physically combinable: "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art."). Thus, the examiner was not persuaded by this argument and has maintained the claim rejections under Gross.
No further arguments were presented. Therefore, all depending claim rejections were subsequently maintained by the examiner.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights