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 .
Response to Preliminary Amendment
The preliminary amendment filed 12/18/25 has been entered. Claims 3-4, 7-8, 11-12, 17-18, 22-23, 27, 32, 38, 42, 44 have been amended. Claims 1-2, 35-36, and 50 are in the original form. Claims 5-6, 9-10, 13-16, 19-21, 24-26, 28-31, 33-34, 37, 39-41, 43, 45-49, and 51 are cancelled. Thus, claims 1-4, 7-8, 11-12, 17-18, 22-23, 27, 32, 35-36, 38, 42, 44, and 50 remain pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “internal chamber” such as in at least claim 1 must be shown or the feature(s) canceled from the claim(s). To overcome this objection, Applicant could amend the specification to include a reference numeral (for illustrative purposes, numeral 50) for “internal chamber” and then label the internal chamber using the numeral on the figures, such as shown in the example of ‘Modified FIG. 2C’ below. The examiner has provided numeral 50 at the position that is seems that the internal chamber likely exists.
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No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “12” has been used to designate both the patch and an internal portion of the patch (see Modified FIG. 7A’ below).
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Applicant is encouraged to check the correctness of at least FIGs. 7B-C and 8A-C because it appears that numeral “12” is also placed in a way that labels an internal portion of the patch on those figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 7, 11, 17, 18, 35, 38, 44, and 50 are objected to because of the following informalities:
Claim 1 lines 5-6 read “a water-sensitive gas- generating formulations” and should likely read “a water-sensitive gas- generating formulation[[s]]” for grammatical reasons
Claim 1 lines 7-9 read “wherein the patch assembly is configured such that each gas-generating formulation or a set thereof, is retained within its respective auxiliary gas- generating reaction chamber during inflation.” And should likely read “wherein the patch assembly is configured such that each gas-generating formulation or a set thereof, is retained within [[its]] a respective chamber of the one or more said auxiliary gas- generating reaction chambers during inflation.” 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
Claim 7 line 2 reads “wherein one or more auxiliary gas-generating reaction chamber are fluidly connected…” and should likely read “wherein the one or more auxiliary gas-generating reaction chamber are fluidly connected…”” because antecedent basis of the one or more auxiliary reaction chambers was already introduced for the structure in claim 1, from which claim 7 depends
Claim 11 line 2 reads “wherein the gas-generating reaction chamber is positioned” and should likely read “wherein the one or more gas-generating reaction chambers [[is]] are positioned” to align with the language as previously set forth for the structure of the reaction chambers in claim 1, from which claim 11 depends
Claim 17 line 2 reads “wherein the gas-generating reaction chamber is surrounded” and should likely read “wherein the one or more gas-generating reaction chambers [[is]] are surrounded” to align with the language as previously set forth for the structure of the reaction chambers in claim 1, from which claim 17 depends
Claim 17 lines 2-3 read “the formulation-retentive element” but should likely read “[[the]] a formulation-retentive element” to provide antecedent basis for “formulation-retentive element” which is a structure that has not yet been introduced in claim 17 or claim 1 from which claim 17 depends
Claim 18 line 2 reads “wherein the gas-generating reaction chamber” and should likely read “wherein the one or more gas-generating reaction chambers” to align with the language as previously set forth in claim 1 from which claim 18 depends
Claim 35 lines 3-4 read “said reaction chamber” and should likely read “said one or more reaction chambers” to align with the language as previously set forth in the claim
Claim 38 line 2 reads “wherein the water-sensitive gas-generating formulation is configured for extended-release.” And should likely read “wherein [[the]] a water-sensitive gas-generating formulation is configured for extended-release” to provide antecedent basis for water-sensitive gas-generating formulation that has not yet been introduced in claim 38 or claim 35 from which claim 38 depends
Claim 44 lines 2-3 read “wherein the amount of first and second reactant amount is less than 80% of the water-sensitive gas- generating formulation.” And should likely read “wherein the amount of first and second reactants [[amount]] is less than 80% of the water-sensitive gas- generating formulation” because the word “amount” seems to be accidentally repeated in the claim language
Claim 50 lines 6-7 read “auxiliary gas-generating reaction chambers defined by pliable reaction chamber walls” and should likely read “one or more auxiliary gas-generating reaction chambers defined by pliable reaction chamber walls” for antecedent basis to reaction chambers and for grammatical reasons
Claim 50 line 10 reads “exposing a water-sensitive gas-generating formulation to water” and should likely read “exposing [[a]] the water-sensitive gas-generating formulation to water” because a “water-sensitive gas-generating formulation” has already been introduced as antecedent basis in the claim and there seems to be only one water-sensitive gas-generating formulation in the reaction chamber of the invention
Claim 50, lines 11-13 read “the formulation generates an extended release of gas that flows towards the inflatable patch while being 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 inflatable patch while being 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.
Claims 1-4, 7-8, 11-12, 17-18, 22-23, 27, 32, 35-36, 38, 42, 44, and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, lines 3-5 read “one or more auxiliary gas-generating reaction chambers distinguished from and fluidly connected to the inflatable patch said reaction chamber defined by pliable reaction chamber walls”. It is unclear to the examiner how the one or more auxiliary gas-generating reaction chambers are “fluidly connected” to the said reaction chamber because this language seems to recite that the reaction chamber is fluidly connected to itself. According to Applicant disclosure, the reaction chambers are fluidly connected to the internal chamber of the patch such that the gas can move from the gas reaction chambers and into the inflatable patch internal chamber (see at least FIGs. 8A-C and [0082]).
Therefore, for purposes of examination, the examiner interprets lines 3-5 to read “one or more auxiliary gas-generating reaction chambers distinguished from and fluidly connected to the inflatable patch said [[reaction]] internal chamber, said one or more auxiliary gas-generating reaction chambers defined by pliable reaction chamber walls…”” to best align with Applicant disclosure of the fluidly connected chambers.
Due to claim dependency from claim 1, claims 2-4, 7-8, 11-12, 17-18, 22-23, 27, and 32 are subsequently rejected under 112b.
Regarding claim 7, lines 2-3 read “wherein one or more auxiliary gas-generating reaction chambers are fluidly connected to the internal chamber but separated from the inflation patch by a formulation-retentive element.” It is unclear to the examiner how the reaction chambers are fluidly connected to the inflatable patch when the reaction chambers form a portion of the patch. Similar to claim 1, according to Applicant disclosure, the reaction chambers are fluidly connected to the internal chamber of the patch such that the gas can move from the gas reaction chambers and into the inflatable patch internal chamber (see FIGs. 8A-C and [0082]).
Therefore, for purposes of examination, the examiner interprets claim 7 lines 2-3 to read “wherein one or more auxiliary gas-generating reaction chambers are fluidly connected to the internal chamber but separated from the inflation patch said internal chamber by a formulation-retentive element”.
Regarding claim 32, line 2 reads “wherein the inflatable patch does not have a water permeable surface.” However, in view of Applicant disclosure, it is unclear how the patch does not have a water permeable surface when the reaction chambers only work to release the gas-generating agent when activated by water. The gas reaction chambers are part of the patch and therefore the patch MUST have a water permeable surface at least on the gas reaction chambers (see at least FIGs. 8A-C, [0082], and claim 1 from which claim 32 depends).
In alignment with Applicant disclosure, the examiner interprets claim 32 line 2 to read “wherein the inflatable patch said internal chamber does not have a water permeable surface.”
Regarding claim 35, lines 2-3 read “one or more auxiliary gas- generating reaction chambers distinguished from and fluidly connected to the inflatable patch”. In view of Applicant disclosure (see at least [0082] and FIGs. 8A-C), it is unclear how the reaction chambers are fluidly connected to the patch when the reaction chambers seem to be a part of the patch. Similar to claim 1 above, in alignment with Applicant disclosure, the examiner interprets claim 35 lines 2-3 to read “one or more auxiliary gas- generating reaction chambers distinguished from and fluidly connected to the inflatable patch said internal chamber”.
Due to claim dependency from claim 35, claims 36, 38, 42, and 44 are subsequently rejected under 112b.
Regarding claim 36, lines 2-3 read “wherein a single compartment is separated from the inflatable patch by a formulation-retentive element.”. However, it is unclear to the examiner if the “a single compartment” as recited in claim 36 is meant to be the same “a single compartment” as recited in claim 35 form which claim 36 depends or if “a single compartment” in claim 36 is directed to a separate “single compartment” structure. According to Applicant disclosure, the reaction chamber compartments containing the first and second reactants are separated from the internal chamber of the patch by the formulation-retentive element (see FIG. 2B and [0063]). Thus, the single compartment seems to be the same single compartment as recited in claim 35.
Therefore, for purposes of examination, the examiner interprets claim 36 lines 2-3 to read “wherein [[a]] the single compartment is separated from the inflatable patch said internal chamber by a formulation-retentive element”.
Regarding claim 50, lines 11-13 read “the formulation generates an extended release of gas that flows towards the inflatable patch while being retained within its respective auxiliary gas-generating reaction chamber”. It is unclear to the examiner how the gas “flows toward 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 11-13 to read “the formulation generates an extended release of gas that flows towards the inflatable patch said internal chamber [[while being 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, 11-12, 17-18, 22-23, 27, 32, 35-36, 38, 42, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (WO2020/035857), 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), 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)
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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 inflatable patch said [[reaction]] internal chamber (873), 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 formulations (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 each gas-generating formulation or a set thereof, is retained within its respective auxiliary gas- generating reaction chamber 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)
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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 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 inflation patch said internal chamber (873) 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 11, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the gas-generating reaction chamber (672/872, see FIG. 10B) is positioned along an outer circumference, perimeter, or side surface of the inflatable patch (see FIG. 10B with chambers 672/872 positioned at side/ bottom surface. See also page 42 lines 20-31).
Regarding claim 12, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein three or more (see 5 chambers in FIG.10B) gas-generating reaction chambers (such as 672/872) are positioned along an outer circumference, perimeter, or side surface of the inflatable patch (see FIG. 10B with chambers 672/872/ and others positioned at side/ bottom surface. See also page 42 lines 20-31).
Regarding claim 17, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses 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 one or more gas-generating reaction chambers (872/672).
Gross (FIG. 10A-B) is silent to “wherein the gas-generating reaction chamber is surrounded by the inflatable patch.”
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’ above) 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), wherein the gas-generating reaction chamber (1270) is surrounded by the inflatable patch (see perimeter of patch 1230 surrounding reaction chamber 1270 in FIG. 15) and a formulation-retentive element (1278, see page 46 line 26- page 47 line 31: 1278 allows bodily fluids into chamber and thus retains the formulation until the permeable layer allows bodily fluids therethrough to initiate reaction) is positioned along an outer circumference, perimeter, outer or side surface (see 1278 at top side surface of 1270 in FIG. 15) of one or more gas-generating reaction chambers (1270).
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 formulation-retentive element positioned along a perimeter of the gas-generating reaction chamber disclosed in Gross (FIG. 10B) to be surrounded by the inflatable patch as taught by Gross (FIG.15) for the purpose of forming the reaction chamber with a controlled permeability surface with increased wetting efficiency (see page 47 lines 5-26 and page 48 lines 15-27) that is placed to allow for a desired flow of bodily fluid therethrough (see page lines 12-29), thus achieving “wherein the gas-generating reaction chamber is surrounded by the inflatable patch.”
Regarding claim 18, Gross discloses the auto-inflatable patch assembly of claim 1, and Gross further discloses wherein the gas-generating reaction chamber (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 inflatable patch said internal chamber (873, see FIG. 10B) 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)
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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 inflatable patch said internal chamber (873), said reaction chamber (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)
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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 [[a]] 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 inflatable patch said internal chamber (873) 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 the water-sensitive gas-generating formulation (the combination of sodium bicarbonate & citric acid when contacted with liquid) 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 35, and Gross further discloses wherein a 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),
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auxiliary gas-generating 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 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 a 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 a 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 inflatable patch said internal chamber (873) [[while being 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)
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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.
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 35 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 35, and Gross further discloses wherein the amount of first and second reactant amount 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 first and second reactant amounts “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 effect 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783