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 Amendment
The amendment filed December 04, 2025 has been entered. Claims 1-5, 8-13, 16-21 and 24-31 remain pending in the application. Claims 6-7, 14-15, and 22-23 were previously cancelled. Applicant’s amendments to the drawings, specification, and claims have overcome the objections and rejections under 35 USC 112 previously set forth in the Non-Final Office Action mailed September 04, 2025, except for those noted below.
Drawings
The drawings, specifically new Figures 15-25 were received on December 04, 2025. These drawings are unacceptable because they introduce new matter into the disclosure of the application:
Regarding Figures 15 and 16, the drawings introduce new matter because the disclosure as originally filed, specifically claims 5, 13, and 21 as originally filed, do not explicitly disclose how the “fixed sleeve or threaded connection” maintain the drug accommodating apparatus at the first opening of the oral delivery device. Figures 15 and 16 appear to each show that the fixed sleeve and threaded connection are part of the drug accommodating apparatus. However, the disclosure and claims as originally filed do not explicitly disclose this. One having ordinary skill in the art would recognize that based on the original disclosure, the “fixed sleeve or threaded connection” could be part of the drug accommodating apparatus, part of the oral delivery device, or a component separate from the drug accommodating apparatus and the oral delivery device.
Regarding Figure 17, the drawing introduces new matter because the disclosure as originally filed, specifically claims 5, 13, and 21 as originally filed, do not explicitly disclose the structure of the “top cover for sealing”. Figure 17 shows a top cover in the shape of a hollow cylinder with a covered end. However, based on the disclosure as originally filed, the “top cover for sealing” could have a material different structure, such as a peel-off cover.
Regarding Figure 18, the drawing introduces new matter because the disclosure as originally filed, specifically claims 5, 13, and 21 as originally filed, do not explicitly disclose the structure of “the fold structure has a pair of wings and a turning end”. Figure 18 appears to show a corrugated section of an oral delivery device and equates that structure to “a pair of wings and a turning end”. However, based on the disclosure as originally filed, the “the fold structure has a pair of wings and a turning end” could have a material different structure, such as a corrugated section having laterally extending wings to grip the oral delivery device.
Regarding Figures 19 and 21, the drawings introduce new matter because the disclosure as originally filed, specifically claims 5, 13, and 21, do not explicitly disclose the structures of the oral delivery devices shown in Figures 19 and 21. In Figures 19 and 21, the outer diameter of the first tube section is shown to be equal to the outer diameter of the third tube section. However, based on the disclosure as originally filed, the outer diameter of the first tube section could be smaller or larger than the outer diameter of the third tube section.
Regarding Figures 20 and 22, the drawings introduce new matter because the disclosure as originally filed, specifically claims 5, 13, and 21, do not explicitly disclose the structures of the oral delivery devices shown in Figures 20 and 22. In Figures 20 and 22, the inner and outer diameters of each tube section decrease sequentially. However, based on the disclosure as originally filed, the inner and outer diameters of each tube section could “gradually reduce” such that each tube section has a tapered, conical shape.
Regarding Figure 23, the drawing introduces new matter because the disclosure as originally filed, specifically claim 8 as originally filed, does not explicitly disclose that the water-soluble polymer material layer is a continuous layer of material as shown in Figure 23. Additionally, Figure 23 does not make clear how the water-soluble polymer material layer is integrated within the drug accommodating apparatus.
Regarding Figure 24, the drawing introduces new matter because the disclosure as originally filed, specifically claims 10, 16, and 18 as originally filed, does not explicitly disclose that the water-soluble polymer material layer is located directly on top of the filter membrane as shown in Figure 24.
Regarding Figure 25, the drawing introduces new matter because the disclosure as originally filed, specifically claim 8 as originally filed, does not explicitly disclose the structure of the “the drug accommodating apparatus is a cylindrical structure with a top end being an opening… and an inner cavity having the cylindrical structure” shown in Figure 25. Figure 25 shows a hollow cylinder having an open end with the same radius. However, based on the disclosure as originally filed, the “top end being an opening” could have a narrowed diameter as compared to the rest of the cylindrical structure, and the inner cavity could have intervening structures.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “1” and “2” have both been used to designate different structures in new Figure 18 and new Figure 24. Noted that the specification has not been amended to include either reference character. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1 and 2 in Figures 18 and 24. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities:
Applicant has provided new Figures 15-25; however, the specification has not been amended to include a brief description of these drawings. See MPEP § 608.01(f). No new matter should be included.
There appears to be typos regarding “The molecular weight of the polymer material is preferably 2000-200000, more preferably 2000-100000.” in paragraph [0068] and [0117] as opposed to “The molecular weight of the polymer material is preferably 2000-200000 Da, more preferably 2000-100000 Da.”
Appropriate correction is required.
Claim Objections
Claims 2, 9, and 17 are objected to because there is a lack of antecedent for “the active pharmaceutical ingredients”. Appropriate correction is required.
Claims 2, 5, 9, 10, 13, 17, 18, 21, and 24-28 are objected to because there appears to be a typos regarding “one or more of following conditions” in lines 2 or 3 of each of the claims. Appropriate correction is required.
Claims 3, 11, 19 are objected to because there appears to be a typos regarding “any one of following conditions” in line 3 of each of the claims. Appropriate correction is required.
Claims 5, 13, and 21 are objected to because there appears to be typos regarding “…are same” (3 instances in each claim). It is suggested to amend this to “…are equal”, or similar. Appropriate correction is required.
Claim 8 is objected to because there is a lack of antecedent for “the upper or lower surface of the filter membrane”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8-13, 16-21, 26-28, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwarz (US 20110174653).
Regarding claim 8, Schwarz discloses a drug accommodating apparatus (Figure 2) of a solid oral preparation, characterized by having a structure 1 or a structure 2:
structure 1: the drug accommodating apparatus comprises a filtering component (retaining element 240 and blocking element 220) and a supporting component (inlet part 202a and outlet part 202b) for supporting the filtering component (Figure 2), wherein the filtering component and the supporting components cooperate with each other to form space (passage 208) for bearing drug granules or multi-particulates (composition 230; [0069]. Noted that the “drug granules or multi-particulates” are not positively recited or claimed), and the filtering component has one or more pore channels (“the retainer is provided as a porous element” [0133]) allowing a liquid to pass (“The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]); and the filtering component is a filter membrane (retaining element 240; “The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]), a continuous water-soluble polymer material layer (dissolvable blocking element 220; “the blocking element comprises a water dissolvable compound, preferably a water dissolvable polymer” [0061]) is formed on the upper or lower surface of the filter membrane (Figure 2 showing blocking element 220 formed on the upper surface of inlet part 202a, and therefore formed on/attached to the upper surface of retaining element 240), so that the drug granules or multi- particulates cannot pass through (“a capsule is provided having a passage, in which a blocking element blocks the delivery of a composition stored in the passage.” [0026]; Figure 2); and
structure 2: the drug accommodating apparatus is a cylindrical structure with a top end being an opening and a bottom part being a screen mesh, and an inner surface of the screen mesh is provided with a water-soluble polymer material layer, and an inner cavity having the cylindrical structure above the water-soluble polymer material layer is used for accommodating drug granules or multi-particulates.
Regarding claim 9, modified Schwarz discloses the drug accommodating apparatus according to claim 8, wherein the drug accommodating apparatus satisfies one or more of the following conditions:
a pore diameter of the filter membrane is 1-500 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230.” [0133]); an effective diameter of the filter membrane is preferably 4-20 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 1-5000 µm (“the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.” [0051]. Noted that “the drug granules or multi-particulates” are not positively recited or claimed);
when particle sizes of the drug granules or multi-particulates are in the range of 50-1000 µm, the pore diameter of the filtering membrane in the structure 1 or the screen mesh in the structure 2 is 40-300 µm ([0032], [0051]);
the active pharmaceutical ingredients contained in the drug granules or multi- particulates (Noted that “the drug granules or multi-particulates” and “the active pharmaceutical ingredients” are not positively recited or claimed) comprise one or more of dabigatran etexilate or pharmaceutically acceptable salts thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudo ephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, sodium dimercaptosuccinate, amlodipine and esmolol (see all of [0068]).
Regarding claim 10, Schwarz discloses the drug accommodating apparatus according to claim 9, wherein the water-soluble polymer material layer satisfies one or more of the following conditions:
a polymer material (“the blocking element comprises a water dissolvable compound, preferably a water dissolvable polymer” [0061]) completely blocks the pore channels of the filter membrane and forms a complete and compact water-soluble polymer material layer (blocking element 220; Figure 2);
a dissolution time of the water-soluble polymer material layer is less than or equal to 10s (“the time needed between the first contact of a dissolvable element (e.g. the blocking element) and the release of a substantial amount (or all) of the composition can be in the range of 0.1-100 sec, preferably, 0.5-10 sec or 1 sec-3 sec.” [0053]);
a molecular weight of a polymer material in the water-soluble polymer material layer is 2000-200000 Da;
a type of the polymer material in the water-soluble polymer material layer is selected from one or more of hydroxypropyl methylcellulose, copolyvidone, hydroxypropyl cellulose, hydroxyethyl cellulose (HEC), povidone, polyethylene glycol (PEG), gelatin, poloxamer, xanthan gum and Eudragit (“The blocking element may for example comprise polyethylene glycol, polylactic acid, hydrolysed gelatine, mannite or water dissolvable cellulose, such as hydroxypropylmethyl cellulose and hydroxypropyl cellulose, or a mixture of two or more thereo” [0061]);
in a forming process of the water-soluble polymer material layer, a weight gain of the polymer material is 0.01-60 mg/cm2.
Regarding claim 11, Schwarz discloses the drug accommodating apparatus according to claim 8, wherein a structure of the supporting component satisfies any one of the following conditions:
the supporting component comprises an upper supporting component (inlet part 202a) and a lower supporting component (outlet part 202b), which can be closed with each other and hold the filtering component in a middle (Figure 2; [0134]), and a space (passage 208) above the upper supporting component and the filtering component is used for accommodating drug granules or multi-particulates (composition 230; Figure 2);
or the supporting component comprises a filter-component accommodating component (outlet part 202b) and a drug accommodating component (inlet part 202a), both of which have a pore-like structure end (at inlet 250 and outlet 210) and an open end, wherein the pore-like structure end has one or more holes allowing a liquid to pass through, and the open end of the filter-component accommodating component and the pore-like structure end of the drug accommodating component can be closed to form a cavity for accommodating the filtering component (Figure 2); and the open end of the drug accommodating component is an open tubular structure (forming passage 208) for accommodating drug granules or multi-particulates (composition 230; Figure 2).
Regarding claim 12, Schwarz discloses an oral delivery device (iii) or (iv) (“The invention can be realized by an oral delivery system formed of a capsule adapted to be at least partly fitted into an additional mouthpiece or a straw or another extension conduit” [0048]), which comprises the drug accommodating apparatus (Figure 2) according to claim 8,
the oral delivery device (iii) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; and the drug accommodating apparatus (Figure 2) is externally connected to a free end of the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is external to the first opening of the straw), and makes space for bearing drug granules or multi-particulates communicated with the inner cavity (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]; “The combination can further comprise information and direction for use describing the steps of plugging the capsule into the mouthpiece, immersing the capsule (fit into the mouthpiece) into a drink and to draw the drink through the capsule into the mouth.” [0070]);
the oral delivery device (iv) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; the drug accommodating apparatus is arranged in the inner cavity and close to the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the outlet part/outlet 210 is in the inner cavity), and space for bearing drug granules or multi- particulates is communicated with the second opening (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]); and a diameter of the first opening is smaller than a minimum diameter of the drug accommodating apparatus (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]).
Regarding claim 13, Schwarz discloses the oral delivery device according to claim 12, wherein the oral delivery device satisfies one or more of following conditions:
the drug accommodating apparatus of the oral delivery device (iii) is placed outside the tubular component (“In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is outside the tubular component), and is maintained at the first opening of the tubular component by a fixed sleeve (outer surface of the straw) or threaded connection (“the capsule or the part of the capsule for introduction of the mouthpiece has an outer diameter equal to the inner diameter of the mouthpiece, in addition of a small additional outer diameter equal to about 1%, 2%, 3%, 5% or 10% of the outer diameter. This ensures an adequate (releasable) press fit between straw and capsule.” [0047]);
a diameter of the second opening is smaller than the minimum diameter of the drug accommodating apparatus of the oral delivery device (iv) (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]);
the second opening is also provided with a top cover for sealing;
the tubular component is a straight straw; the straight straw is provided with at least one fold structure; the fold structure has a pair of wings and a turning end; and the fold structure can be stretched or contracted along an axial direction of the tubular component, and a turbulent flow is formed during stretching;
the tubular component has at least two tube sections which are hermetically connected and can be axially stretched or contracted along the tubular component; and when the tubular component is in a stretched state, a turbulent flow generating part with at least one step structure is formed, wherein, when a number of the tube sections is 3, inner diameters of a first tube section and a third tube section in the direction from the first opening to the second opening are same, a outer diameter of a second tube section is smaller than the inner diameter of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter of the first tube section, the outer diameter and a inner diameter of the second tube section, a outer diameter of the third tube section in the direction from the first opening to the second opening are gradually reduced, and each tube section can be axially stretched or contracted along other tube sections; wherein, when a number of the tube sections is 4, inner diameters of a first tube section and a third tube section in a direction from the first opening to the second opening are same, and inner diameters of a second tube section and a fourth tube section are same, wherein the inner diameter of the second tube section is smaller than that of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter thereof gradually decreases from the first tube section to the fourth tube section in the direction from the first opening to the second opening, and each tube section can be axially stretched or contracted along other tube sections.
Regarding claim 16, Schwarz discloses a drug accommodating apparatus (Figure 2) of a solid oral preparation, which comprises a filtering component (retaining element 240 and blocking element 220) and a supporting component (inlet part 202a and outlet part 202b) for supporting the filtering component (Figure 2), wherein the filtering component and the supporting components cooperate with each other to form space (passage 208) for bearing drug granules or multi-particulates (composition 230; [0069]. Noted that the “drug granules or multi-particulates” are not positively recited or claimed), and the filtering component has one or more pore channels (“the retainer is provided as a porous element” [0133]) allowing a liquid to pass (“The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]); and the pore channels are distributed in the filtering component in an up-down intricate intersection mode (“The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]) and a water-soluble polymer material layer (dissolvable blocking element 220; “the blocking element comprises a water dissolvable compound, preferably a water dissolvable polymer” [0061]) is also arranged on the filtering component (Figure 2), the filtering component is a filter membrane (retainer 240; “The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]), upper and lower surfaces and inner pore channels of the filter membrane are arranged in a fluffy structure formed by irregularly stacking and pressing layers of fibers (“The retaining element is provided as a porous sponge or filter.” [0127], wherein a sponge is considered to be a “fluffy structure”. The limitation “formed by irregularly stacking and pressing layers of fibers” is being treated as a as a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a produced appearing to be substantially the same or similar is found, the burden is shifted to the applicant to show an unobvious difference. In this case, the product, "a filter membrane" having a “fluffy structure”, could be produced via processes other than “by irregularly stacking and pressing layers of fibers”) so that the drug granules or multi- particulates cannot pass through (“a capsule is provided having a passage, in which a blocking element blocks the delivery of a composition stored in the passage.” [0026]; “the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition.” [0133]; Figure 2).
Regarding claim 17, Schwarz discloses the drug accommodating apparatus according to claim 16, wherein the drug accommodating apparatus satisfies one or more of following conditions:
a thickness of the filter membrane is 0.3-20 mm; a pore diameter of the filter membrane is 1-500 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]); an effective diameter of the filter membrane is 4-20 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 1-5000 µm (“the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.” [0051]. Noted that “the drug granules or multi-particulates” are not positively recited or claimed);
when particle sizes of the drug granules or multi-particulates are 50-1000 µm, the pore diameter of the filtering membrane is 40-300 µm ([0032], [0051]);
the active pharmaceutical ingredients contained in the drug granules or multi- particulates (Noted that “the drug granules or multi-particulates” and “the active pharmaceutical ingredients” are not positively recited or claimed) comprise one or more of dabigatran etexilate or pharmaceutically acceptable salts thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudo ephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, sodium dimercaptosuccinate, amlodipine and esmolol (see all of [0068]).
Regarding claim 18, Schwarz discloses the drug accommodating apparatus according to claim 17, wherein the water-soluble polymer material layer satisfies one or more of the following conditions:
a polymer material (“the blocking element comprises a water dissolvable compound, preferably a water dissolvable polymer” [0061]) completely blocks the pore channels of the filter membrane and forms a complete and compact water-soluble polymer material layer (blocking element 220; Figure 2);
a dissolution time of the water-soluble polymer material layer is less than or equal to 10s (“the time needed between the first contact of a dissolvable element (e.g. the blocking element) and the release of a substantial amount (or all) of the composition can be in the range of 0.1-100 sec, preferably, 0.5-10 sec or 1 sec-3 sec.” [0053]);
a molecular weight of a polymer material in the water-soluble polymer material layer is 2000-200000 Da;
a type of a polymer material in the water-soluble polymer material layer is selected from one or more of hydroxypropyl methylcellulose, copolyvidone, hydroxypropyl cellulose, hydroxyethyl cellulose (HEC), povidone, polyethylene glycol (PEG), gelatin, poloxamer, xanthan gum and Eudragit (“The blocking element may for example comprise polyethylene glycol, polylactic acid, hydrolysed gelatine, mannite or water dissolvable cellulose, such as hydroxypropylmethyl cellulose and hydroxypropyl cellulose, or a mixture of two or more thereo” [0061]);
in a forming process of the water-soluble polymer material layer, a weight gain of a polymer material is 0.01-60 mg/cm2.
Regarding claim 19, Schwarz discloses the drug accommodating apparatus according to claim 16, wherein a structure of the supporting component is any one of following conditions:
the supporting component comprises an upper supporting component (inlet part 202a) and a lower supporting component (outlet part 202b), which can be closed with each other and hold the filtering component in a middle (Figure 2; [0134]), and a space (passage 208) above the upper supporting component and the filtering component is used for accommodating drug granules or multi-particulates (composition 230; Figure 2);
or the supporting component comprises a filter-component accommodating component (outlet part 202b) and a drug accommodating component (inlet part 202a), both of which have a pore-like structure end (at inlet 250 and outlet 210) and an open end, wherein the pore-like structure end has one or more holes allowing a liquid to pass through, and the open end of the filter-component accommodating component and the pore-like structure end of the drug accommodating component can be closed to form a cavity for accommodating the filtering component (Figure 2); and the open end of the drug accommodating component is an open tubular structure (forming passage 208) for accommodating drug granules or multi-particulates (composition 230; Figure 2).
Regarding claim 20, modified Schwarz discloses an oral delivery device (v) or (vi) (“The invention can be realized by an oral delivery system formed of a capsule adapted to be at least partly fitted into an additional mouthpiece or a straw or another extension conduit” [0048]), which comprises the drug accommodating apparatus (Figure 2) according to claim 16,
the oral delivery device (v) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; and the drug accommodating apparatus (Figure 2) is externally connected to a free end of the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is external to the first opening of the straw), and makes space for bearing drug granules or multi-particulates communicated with the inner cavity (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]; “The combination can further comprise information and direction for use describing the steps of plugging the capsule into the mouthpiece, immersing the capsule (fit into the mouthpiece) into a drink and to draw the drink through the capsule into the mouth.” [0070]);.
the oral delivery device (vi) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; the drug accommodating apparatus is arranged in the inner cavity and close to the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the outlet part/outlet 210 is in the inner cavity), and space for bearing drug granules or multi- particulates is communicated with the second opening (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]); and a diameter of the first opening is smaller than a minimum diameter of the drug accommodating apparatus (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]).
Regarding claim 21, modified Schwarz discloses the oral delivery device according to claim 20, wherein the oral delivery device satisfies one or more of following conditions:
the drug accommodating apparatus of the oral delivery device (v) is placed outside the tubular component (“In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is outside the tubular component), and is maintained at the first opening of the tubular component by a fixed sleeve (outer surface of the straw) or threaded connection (“the capsule or the part of the capsule for introduction of the mouthpiece has an outer diameter equal to the inner diameter of the mouthpiece, in addition of a small additional outer diameter equal to about 1%, 2%, 3%, 5% or 10% of the outer diameter. This ensures an adequate (releasable) press fit between straw and capsule.” [0047]);
a diameter of the second opening is smaller than the minimum diameter of the drug accommodating apparatus of the oral delivery device (iv) (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]);
the second opening is also provided with a top cover for sealing;
the tubular component is a straight straw; the straight straw is provided with at least one fold structure; the fold structure has a pair of wings and a turning end; and the fold structure can be stretched or contracted along an axial direction of the tubular component, and a turbulent flow is formed during stretching; and/or, the tubular component has at least two tube sections which are hermetically connected and can be axially stretched or contracted along the tubular component; and when the tubular component is in a stretched state, a turbulent flow generating part with at least one step structure is formed, wherein, when a number of the tube sections is 3, inner diameters of a first tube section and a third tube section in a direction from the first opening to the second opening are same, an outer diameter of a second tube section is smaller than the inner diameter of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter of the first tube section, the outer diameter and a inner diameter of the second tube section, a outer diameter of the third tube section in the direction from the first opening to the second opening are gradually reduced, and each tube section can be axially stretched or contracted along other tube sections; wherein, when a number of the tube sections is 4, inner diameters of a first tube section and a third tube section in a direction from the first opening to the second opening are same, and inner diameters of a second tube section and a fourth tube section are same, wherein the inner diameter of the second tube section is smaller than that of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter thereof gradually decreases from the first tube section to the fourth tube section in the direction from the first opening to the second opening, and each tube section can be axially stretched or contracted along other tube sections.
Regarding claim 26, Schwarz discloses the drug accommodating apparatus according to claim 9, wherein the drug accommodating apparatus satisfies one or more of following conditions:
a shape of the filter membrane (retainer 240) is a wafer structure (Figure 2);
the thickness of the filter membrane is 0.5-15 mm;
a pore channel in the filter membrane connects and penetrates upper and lower surfaces of the filter membrane in a straight line way;
the pore diameter of the filter membrane is 20-400 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]);
the effective diameter of the filter membrane is 6-15 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
the particle sizes of the drug granules or multi-particulates are 25-2000 µm (“Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm” [0051]).
Regarding claim 27, Schwarz discloses the drug accommodating apparatus according to claim 17, wherein the drug accommodating apparatus satisfies one or more of following conditions:
a shape of the filter membrane (retainer 240) is a cylindrical structure (Figure 2);
the thickness of the filter membrane is 0.5-15 mm;
upper and lower surfaces and inner pore channels of the filter membrane are arranged in an irregular and intricately crossed structure;
the pore diameter of the filter membrane is 20-400 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]);
the effective diameter of the filter membrane is 6-15 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 25-2000 µm (“Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm” [0051]).
Regarding claim 28, modified Schwarz discloses the drug accommodating apparatus according to claim 27, wherein the drug accommodating apparatus satisfies one or more of following conditions:
the thickness of the filter membrane is 0.5-10 mm;
the pore diameter of the filter membrane is 40-300 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]);
the effective diameter of the filter membrane is 8-12 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 50-1000 µm (“Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm” [0051]).
Regarding claim 30, Schwarz discloses the drug accommodating apparatus according to claim 16, wherein the drug granules or multi-particulates have particle sizes that are smaller than or equal to a pore diameter of the filtering component (“The density, mesh size or pore size of the blocking element is not necessarily constant along the longitudinal axis of the passage. Rather, a longitudinal section with a dense mesh or pore size of the blocking element can be used to confine the active agent, and another section attached thereto or formed therewith can be used to mechanically stabilize the first section…In case of variable pore size, mesh size or density along the longitudinal axis of the capsule's passage, the particle size of the active agent, i.e. the respective minimum particle size, is adapted to the minimum mesh size, pore size or density of the blocking element.” [0054], wherein the claimed “filtering component” is the combination of the blocking element 220 and retaining element 240, and at granules/multi-particulates are smaller than at least some of the pores of the blocking element when the blocking element has a variable pore size), the particle sizes of the drug granules or multi- particulates are 1-5000 µm, the pore diameter of the filter membrane is 1-500 µm (“The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230.” [0133] Noted that “the drug granules or multi-particulates” are not positively recited or claimed).
Regarding claim 31, Schwarz discloses the drug accommodating apparatus according to claim 16, wherein a continuous water-soluble polymer material layer (dissolvable blocking element 220; “the blocking element comprises a water dissolvable compound, preferably a water dissolvable polymer” [0061]) is formed on the upper or lower surface of the filter membrane (Figure 2 showing blocking element 220 formed on the upper surface of inlet part 202a, and therefore formed on/attached to the upper surface of retaining element 240).
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.
Claims 1-5, 24-25, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US 20110174653) in view of Haldopoulos (USPN 6217545).
Regarding claim 1, Schwarz discloses a drug accommodating apparatus (Figure 2) of a solid oral preparation, which comprises a filtering component (retaining element 240 and blocking element 220) and a supporting component (inlet part 202a and outlet part 202b) for supporting the filtering component (Figure 2), wherein the filtering component and the supporting components cooperate with each other to form space (passage 208) for bearing drug granules or multi-particulates (composition 230; [0069]. Noted that the “drug granules or multi-particulates” are not positively recited or claimed), and the filtering component has one or more pore channels (“the retainer is provided as a porous element” [0133]) allowing a liquid to pass (“The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]); and the filtering component is a filter membrane (retainer 240; “The retainer can be provided as a grid filter, porous material or any liquid permeable plug, which allows a flow of liquid and forms a support of the active agent.” [0031]), upper and lower surfaces and inner pore channels of the filter membrane are arranged in a fluffy structure formed by irregularly stacking and pressing layers of fibers (“The retaining element is provided as a porous sponge or filter.” [0127], wherein a sponge is considered to be a “fluffy structure”. The limitation “formed by irregularly stacking and pressing layers of fibers” is being treated as a as a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a produced appearing to be substantially the same or similar is found, the burden is shifted to the applicant to show an unobvious difference. In this case, the product, "a filter membrane" having a “fluffy structure”, could be produced via processes other than “by irregularly stacking and pressing layers of fibers”), the pore channels are distributed in the filtering component in an up-down intricate intersection mode, so that the drug granules or multi-particulates cannot pass through (“the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition.” [0133]).
Schwarz fails to explicitly disclose a thickness of the filtering component is more than 0.5 mm.
Haldopoulos discloses a drug accommodating apparatus (filter 10) which comprises a filtering component (inner dense core region 16) and a supporting component (less dense annular region 18), wherein the thickness of the filtering component is more than 0.5 mm (“The filters were then cut to an axial length of approximately 0.31 inches.” [Col 5, line 30-32], wherein 0.31 inches is equivalent to 7.87 mm, which is greater than 0.5 mm as claimed).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the filtering component of Schwarz to have a thickness more than 0.5 mm based on the teachings of Haldopoulos to ensure the filtering component can be held within the supporting component and are able to support the drug granules or multi-particulates (Haldopoulos [Col 4, lines 16-21]).
Regarding claim 2, modified Schwarz discloses the drug accommodating apparatus according to claim 1, wherein the drug accommodating apparatus satisfies one or more of following conditions:
a thickness of the filter membrane is preferably 0.5-20 mm (As provided by Haldopoulos in claim 1: “The filters were then cut to an axial length of approximately 0.31 inches.” [Col 5, line 30-32], wherein 0.31 inches is equivalent to 7.87 mm); a pore diameter of the filter membrane is 1-500 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]); an effective diameter of the filter membrane is 4-20 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
a particle sizes of the drug granules or multi-particulates are 1-5000 µm, (“the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.” [0051]. Noted that “the drug granules or multi-particulates” are not positively recited or claimed);
when particle sizes of the drug granules or multi-particulates are 50-1000 µm, the pore diameter of the filtering membrane is 40-300 µm ([0032], [0051]);
the active pharmaceutical ingredients contained in the drug granules or multi- particulates (Noted that “the drug granules or multi-particulates” and “the active pharmaceutical ingredients” are not positively recited or claimed) comprise one or more of dabigatran etexilate or pharmaceutically acceptable salts thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudo ephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, sodium dimercaptosuccinate, amlodipine and esmolol (see all of [0068]).
Regarding claim 3, modified Schwarz discloses the drug accommodating apparatus according to claim 1, wherein a structure of the supporting component satisfies any one of the following conditions:
the supporting component (inlet part 202a and an outlet part 202b) is arranged on upper and lower surfaces of the filtering component (blocking element 220 and retaining element 240) and clamps the filtering component in a middle (Figure 2), or the filtering component (blocking element 220 and retaining element 240) is wrapped inside in a cage structure (formed by inlet part 202a and an outlet part 202b; Figure 2);
the supporting component comprises an upper supporting component (inlet part 202a) and a lower supporting component (outlet part 202b), which can be closed with each other and hold the filtering component in the middle (Figure 2; [0134]), and a space (passage 208) above the upper supporting component and the filtering component is used for accommodating drug granules or multi-particulates (composition 230; Figure 2);
the supporting component comprises a filter-component accommodating component (outlet part 202b) and a drug accommodating component (inlet part 202a), both of which have a pore-like structure end (at inlet 250 and outlet 210) and an open end, wherein the pore-like structure end has one or more holes allowing a liquid to pass through, and the open end of the filter-component accommodating component and the pore-like structure end of the drug accommodating component can be closed to form a cavity for accommodating the filtering component (Figure 2); and the open end of the drug accommodating component is an open tubular structure (forming passage 208) for accommodating drug granules or multi-particulates (composition 230; Figure 2);
the supporting component comprises a cage-like supporting component (outlet part 202b) with an upward opening (inlet 250) and an upper cover (inlet part 202a) matched with the cage-like supporting component (Figure 2), wherein the upper cover is provided with a pore channel (passage 208) for drug granules or multi- particulates and a liquid to circulate (Figure 2), and the cage-like supporting component and the upper cover can enclose to form a hollow space and limit the filtering component in the hollow space (Figure 2), a the space above the upper cover and the filtering component is used for accommodating the drug granules or multi-particulates (Figure 2).
Regarding claim 4, modified Schwarz discloses an oral delivery device (i) or (ii) (“The invention can be realized by an oral delivery system formed of a capsule adapted to be at least partly fitted into an additional mouthpiece or a straw or another extension conduit” [0048]), which comprises the drug accommodating apparatus (Figure 2) according to claim 1,
the oral delivery device (i) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; and the drug accommodating apparatus (Figure 2) is externally connected to a free end of the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is external to the first opening of the straw), and makes space for bearing drug granules or multi-particulates communicated with the inner cavity (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]; “The combination can further comprise information and direction for use describing the steps of plugging the capsule into the mouthpiece, immersing the capsule (fit into the mouthpiece) into a drink and to draw the drink through the capsule into the mouth.” [0070]);
the oral delivery device (ii) further comprises a tubular component with two end openings and an inner cavity (“As the straw, additional mouthpiece or extension conduit, a tube having a grip section with or without elevated gripping elements can be used. Any conventional straw could be used into which the outlet part of the capsule can be inserted.” [0048]), wherein one end opening is a first opening (one end of the conventional straw) and another end opening is a second opening (second end of the conventional straw forming a mouthpiece), and the inner cavity (internal space of the conventional straw) is communicated with the first opening and the second opening; the drug accommodating apparatus is arranged in the inner cavity and close to the first opening (“the inlet part of the capsule has a cross section larger than the inner cross section of a straw (or another extension conduit or additional mouthpiece) in order to allow to arrange or attach the outlet part and the outlet of the capsule into the straw and, at the same time, to ensure that the inlet part of the capsule can not enter the straw.” [0047]; “In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the outlet part/outlet 210 is in the inner cavity), and space for bearing drug granules or multi- particulates is communicated with the second opening (“Upon applying a vacuum at the outlet, a liquid located at the inlet and outside the capsule will enter the inlet, flow through the retainer as well as through the composition and will reach the blocking element. Then, the blocking element will be dissolved (completely or partly) and the composition flows, together with the liquid as well as parts of the dissolved blocking element, to the outlet towards the patient's mouth.” [0044]); and a diameter of the first opening is smaller than a minimum diameter of the drug accommodating apparatus (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]).
Regarding claim 5, modified Schwarz discloses the oral delivery device according to claim 4, wherein the oral delivery device satisfies one or more of the following conditions:
the drug accommodating apparatus of the oral delivery device (i) is placed outside the tubular component (“In a particular embodiment, the combination comprises a straw into which the outlet part (but not the inlet part) of the capsule can be plugged in” [0048], wherein at least the inlet part/inlet 250 is outside the tubular component), and is maintained at the first opening of the tubular component by a fixed sleeve (outer surface of the straw) or threaded connection (“the capsule or the part of the capsule for introduction of the mouthpiece has an outer diameter equal to the inner diameter of the mouthpiece, in addition of a small additional outer diameter equal to about 1%, 2%, 3%, 5% or 10% of the outer diameter. This ensures an adequate (releasable) press fit between straw and capsule.” [0047]);
a diameter of the second opening is smaller than the minimum diameter of the drug accommodating apparatus of the oral delivery device (ii) (“The inner diameter of the straw is slightly smaller than the outer diameter of the capsule, in particular of the end of the capsule comprising the outlet.” [0070]);
the second opening is also provided with a top cover for sealing;
the tubular component is a straight straw; the straight straw is provided with at least one fold structure; the fold structure has a pair of wings and a turning end; and the fold structure can be stretched or contracted along an axial direction of the tubular component, and a turbulent flow is formed during stretching;
the tubular component has at least two tube sections which are hermetically connected and can be axially stretched or contracted along the tubular component; and when the tubular component is in a stretched state, a turbulent flow generating part with at least one step structure is formed, wherein, when a number of the tube sections is 3, inner diameters of a first tube section and a third tube section in a direction from the first opening to the second opening are same, an outer diameter of a second tube section is smaller than the inner diameter of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter of the first tube section, the outer diameter and a inner diameter of the second tube section, an outer diameter of the third tube section in the direction from the first opening to the second opening are gradually reduced, and each tube section can be axially stretched or contracted along other tube sections; wherein, when a number of the tube sections is 4, inner diameters of a first tube section and a third tube section in a direction from the first opening to the second opening are same, and inner diameters of a second tube section and a fourth tube section are same, wherein the inner diameter of the second tube section is smaller than that of the first tube section, and each tube section can be axially stretched or contracted along other tube sections; or, the inner diameter thereof gradually decreases from the first tube section to the fourth tube section in the direction from the first opening to the second opening, and each tube section can be axially stretched or contracted along other tube sections.
Regarding claim 24, modified Schwarz discloses the drug accommodating apparatus according to claim 2, wherein the drug accommodating apparatus satisfies one or more of following conditions:
a shape of the filter membrane (retainer 240) is a cylindrical structure (Figure 2);
the thickness of the filter membrane is 0.5-15 mm (As provided by Haldopoulos in claim 1: “The filters were then cut to an axial length of approximately 0.31 inches.” [Col 5, line 30-32], wherein 0.31 inches is equivalent to 7.87 mm);
upper and lower surfaces and inner pore channels of the filter membrane are arranged in an irregular and intricately crossed structure;
the pore diameter of the filter membrane is 20-400 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]);
the effective diameter of the filter membrane is 6-15 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 25-2000 µm (“Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm” [0051]).
Regarding claim 25, modified Schwarz discloses the drug accommodating apparatus according to claim 24, wherein the drug accommodating apparatus satisfies one or more of following conditions:
the thickness of the filter membrane is 0.5-10 mm (As provided by Haldopoulos in claim 1: “The filters were then cut to an axial length of approximately 0.31 inches.” [Col 5, line 30-32], wherein 0.31 inches is equivalent to 7.87 mm);
the pore diameter of the filter membrane is 40-300 µm (“Thus, the size of the pores of the retainer and the blocking element can vary depending on the particle size of the pharmaceutical composition to be delivered.” [0032]; “The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230. ” [0133]);
the effective diameter of the filter membrane is 8-12 mm (“capsules with a diameter (at the capsule's center) in a range of 6 mm-10 mm, more preferably in the range of 7 mm-8 mm are used.” [0036]);
particle sizes of the drug granules or multi-particulates are 50-1000 µm (“Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm” [0051]).
Regarding claim 29, modified Schwarz discloses the drug accommodating apparatus according to claim 1, wherein the drug granules or multi-particulates have particle sizes that are smaller than or equal to a pore diameter of the filtering component (“The density, mesh size or pore size of the blocking element is not necessarily constant along the longitudinal axis of the passage. Rather, a longitudinal section with a dense mesh or pore size of the blocking element can be used to confine the active agent, and another section attached thereto or formed therewith can be used to mechanically stabilize the first section…In case of variable pore size, mesh size or density along the longitudinal axis of the capsule's passage, the particle size of the active agent, i.e. the respective minimum particle size, is adapted to the minimum mesh size, pore size or density of the blocking element.” [0054], wherein the claimed “filtering component” is the combination of the blocking element 220 and retaining element 240, and at granules/multi-particulates are smaller than at least some of the pores of the blocking element when the blocking element has a variable pore size), the particle sizes of the drug granules or multi- particulates are 1-5000 µm, the pore diameter of the filter membrane is 1-500 µm (“The composition is formed of solid particles, the solid particles having a minimum particle size, to which the micro-structure size channels, pores or density of the blocking element corresponds. Preferably, the minimum particle size is 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm, and the corresponding (maximum) pore or microstructure size of the blocking element is at least slightly smaller and is at most ca. 90%, 80%, 70%, 50%, 30%, 20% or 10% of the minimum or average particle size of the active agent.” [0051]; “The composition is provided in particles with a minimum particle size, whereas the retainer is provided as a porous element, having pores which are smaller than the particle size of the composition. In the same way, the porous size of the blocking element 220 is smaller than a minimum particle size of the composition 230.” [0133] Noted that “the drug granules or multi-particulates” are not positively recited or claimed).
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 8-13, 16-21 and 24-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that Schwarz fails to disclose the limitation “a continuous water-soluble polymer material layer is formed on the upper or lower surface of the filter membrane” as required by claim 8 (Remarks, page 27), the examiner respectfully disagrees. As detailed above with respect to the rejection of claim 8, Schwarz discloses a drug accommodating apparatus (Figure 2) comprising a filtering component (220 and 240), the filtering component is a filter membrane (240; [0031]), a continuous water-soluble polymer material layer (220; [0061]) is formed on the upper or lower surface of the filter membrane (Figure 2 showing blocking element 220 formed on the upper surface of inlet part 202a, and therefore formed on/attached to the upper surface of retaining element 240). It is noted that that the claim language as currently presented does not require that the a continuous water-soluble polymer material layer is formed directly on the upper or lower surface of the filter membrane (emphasis added).
Regarding the argument that Schwarz fails to explicitly disclose “upper and lower surfaces and inner pore channels of the filter membrane are arranged in a fluffy structure formed by irregularly stacking and pressing multiple layers of fibers” as required by amended claims 1 and 16 (Remarks, page 27-29), the examiner respectfully disagrees. As detailed above with respect to the rejections of claims 1 and 16, Schwarz discloses a drug accommodating apparatus (Figure 2) comprising a filtering component (220 and 240), the filtering component is a filter membrane (240; [0031]), upper and lower surfaces and inner pore channels of the filter membrane are arranged in a fluffy structure formed by irregularly stacking and pressing layers of fibers (“The retaining element is provided as a porous sponge or filter.” [0127], wherein a sponge is considered to be a “fluffy structure”) The limitation “formed by irregularly stacking and pressing layers of fibers” is being treated as a as a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a produced appearing to be substantially the same or similar is found, the burden is shifted to the applicant to show an unobvious difference. In this case, the product, "a filter membrane" having a “fluffy structure”, could be produced via processes other than “by irregularly stacking and pressing layers of fibers”.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783