DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15/12/2026 has been entered.
Claim Objections
Claim 5, 7-8, 10, 12-14, 22-23, 29, and 32-36 objected to because of the following informalities:
Claims 5, 7-8, 10, 12-14, 22-23, limitation “An intra-ruminal device” on line 1 of each respective claim should read “The intra-ruminal device”.
Claims 29 limitation “A method of claim 24” on line 1 should read “The method of claim 24”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 15, 32 and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The following limitations include 96-100% extrusion which does not have support in the instant specification. Instant specification has support for extrusion range between 80%-95%, please see [0029]; [0158].
Claim 1 limitation "at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude".
Claim 15 limitation: " at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude”.
Claim 35 limitation: "at least 95% of each tablet at the outlet extrudes before a subsequent tablet in the stack of tablets begins to extrude".
Regarding claim 32, claim limitation: “extrusion of a subsequent tablet does not materially overlap with extrusion of a preceding tablet at the outlet.” necessitates complete extrusion of preceding tablet before extrusion of subsequent tablet, which is not supported by the instant specification. Instant specification has support for extrusion range between 80%-95%, please see [0029]; [0158].
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 33-34 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.
Claim 33 recites the limitation "substantially complete" and the limitation "minimal co-extrusion" in line 3. The boundaries for the claim limitation are not clear. Examiner is interpreting the claim limitations as: subsequent tablet to the tablet at the outlet exhibits co-extrusion.
Claim 34 recites the limitation "minimal co-extrusion" in line 2. The boundaries for the claim limitation are not clear. Examiner is interpreting the claim limitations as: tablet adjacent to the tablet at the outlet exhibits co-extrusion.
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.
Claims 1, 5, 7, 10, 12-13, 22-24, 28 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Laby et al. (US 4671789 A).
Regarding claim 1, Holmes discloses an intra-ruminal device (Fig 8-14), comprising: an elongate body or body assembly (1000, Annotated Fig 1) impervious to rumen fluids (elongated body is impervious to function as intended), the body defining a barrel (1001, Annotated Fig 1) having a first end (1002, Annotated Fig 1) and a second end (1003, Annotated Fig 1), a dose of one or more active agents (Fig 13; Page 1, lines 11-13) within the barrel (1001, Annotated Fig 1) at least one variable geometry device (wings 301, Fig 8) dependent from the body (1000, Annotated Fig 1) to assist rumen retention (Page 14, lines 30-31), a cap (end face 304, Fig 9) that encapsulates and seals against the first end (1002, Annotated Fig 1) of the barrel (1001, Annotated Fig 1) to retain a matrix of the one or more active agents (stack of tablets 330, Fig 13) within the barrel (1001, Annotated Fig 1), the cap (304) comprising a flat face (1004, Annotated Fig 1), a sidewall (1005, Annotated Fig 1) extending from the face (1004, Annotated Fig 1), an aperture (aperture 307, Fig 13) having a diameter (page 3, lines 15-16: “The diameter of the opening can be used to increase or restrict the speed of payout of the device.”; Fig 13) and located solely in the face (1004, Annotated Fig 1) to define an outlet (aperture 307, defines an outlet 1006, Annotated Fig 1), such that the one or more active agents (stack of tablets 330, Fig 13) are accessible to rumen fluid via only the outlet (1006, Annotated Fig 1), and a biasing arrangement (coil spring (not shown until Figures 15 and 16); Page 20, lines 13-14) within the body (1000, Annotated Fig 1) adapted to bias the one or more active agents (tablets 330, Fig 13) in the barrel (1001, Annotated Fig 1) towards the first end (1002, Annotated Fig 1) to maintain the one or more active agents (stack of tablets 330, Fig 13) at the outlet (1006, Annotated Fig 1) , and wherein the matrix is in a form of a tablet (330), and the one or more active agents are provided in a stack of tablets (stack of tablets 330, Fig 13) within the barrel (1001, Annotated Fig 1).
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Holmes is silent regarding the face having four to eight apertures wherein an average of the diameter of all the apertures of the cap defines an average aperture diameter, and wherein each of the apertures of the cap have a diameter that is within 2% to 20% of the average aperture diameter and wherein the device is configured so that at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude.
Laby teaches the face having four to eight apertures (6 holes round a central circular hole; Col 7, lines 27-31).
Holmes/Laby as modified teaches wherein the device is configured so that at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude (Device of Holmes is modified with the teaching of Laby to comprise 7 holes: a central hole and six additional holes around the central to eliminate cavitation (Col 7, lines 27-31); if cavitation is eliminated each tablet of device of Holmes is going to extrude completely before the next tablet begins to extrude)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with similar six additional holes spaced around the central circumferentially as taught by Laby for the purpose of eliminate cavitation (Col 7, lines 27-31).
Holmes/Laby are silent wherein an average of the diameter of all the apertures of the cap defines an average aperture diameter, and wherein each of the apertures of the cap have a diameter that is within 2% to 20% of the average aperture diameter.
The examiner notes that the diameter is a result effective variable, dependent on the desired dispensation rate. Further, the diameter range in the instant specification is lacking specific criticality ([0140]; [0145], in the instant specification).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the diameter of the apertures to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 5, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses that the diameter of the opening can be used to increase or restrict the speed of payout of the device (Page 3, lines 15-16).
Holmes/Laby are silent wherein the diameter of an aperture is about 1.0 to about 5.0 mm.
The examiner notes that the diameter of the apertures is a result effective variable, dependent on the desired dispensation rate. Further, the diameter range in the instant specification is lacking specific criticality ([0140], in the instant specification).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the diameter of the apertures to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 7, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes/Laby are silent wherein a total surface area of the apertures is about 10.0 to about 60.0 mm2.
The examiner notes that the total surface area of the apertures is a result effective variable, dependent on the desired dispensation rate. Further, the diameter range in the instant specification is lacking specific criticality ([0142], in the instant specification).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the diameter of the apertures to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 10, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein barrel and the cap are held together under heat and pressure (Page 16, lines 25-26; molding requires heat and pressure).
Regarding claim 12, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein the stack of tablets (stack of tablets, Fig 13) includes one or more controlled-release tablets (Page 21, lines 6-9; sustained release tablet dissolve at a slower rate and controlled manner).
Regarding claim 13, Holmes/Laby discloses an intra-ruminal device of claim1. Holms discloses wherein the stack of tablets (stack of tablets, Fig 13) includes one or more exit dose tablets (exit dose 331, (Page 21, lines 6-9).
Regarding claim 22, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein the stack of tablets (stack of tablets, Fig 13) comprises at least one tablet (330) comprising a first active agent (active agent inside 330) and least one tablet comprising an active agent that is different from the first active agent (exit dose 331; exit dose of a different medicament or mineral).
Regarding claim 23, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein the variable geometry device (301) is configured to separate from the body (Page 20, lines 5-7; Page 14, lines 26-30; wings are secured to by a dissolvable tape and are configured to separate from the body when in the extended configuration).
Regarding claim 24, Holmes/Laby discloses a method of delivering one or more active agents to a ruminant animal, the method comprising: administering the intra-ruminal device of claim 1 to the ruminant animal (Please see claim 1; active agents in tablet 330 of Holmes are delivered into the rumen of an animal). Holmes discloses wherein the variable geometry device (301) remains attached to the body (1000, Annotated Fig 1) of the device for at least the duration of an active agent payout period ensuring a continuous treatment period (payout period of tablets 330, Fig 30; whings 301 remain attached to body 1000 for the time of payout period).
Regarding claim 28, Holmes/Laby discloses the method of claim 24. Holmes/Laby are silent wherein at least about 80 to about 95% of each tablet extrudes before the next tablet in the stack of tablets begins to extrude.
The examiner notes that the percentage of extrusion of the tablet before it coextrudes with the next tablet is a result effective variable, dependent on the quantity and position of the holes. Further, the percentage of extrusion of the tablet before the next table in the stack begins to extrude in the instant specification is lacking specific criticality ([0158] from instant specification).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the number and position of the holes to achieve the claimed percentage of extrusion of the first tablet before the first and second tablet are co-extruded since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 31, Holmes/Laby discloses the method of claim 24. Holmes discloses wherein the stack of tablets (stack of tablets , Fig 13) comprises two or more zones of tablets in the stack (proximal and distal zones, Fig 13), wherein: each zone contains controlled-release tablets with similar or different release profiles/rates, and each zone contains similar or different individual active agents selected from the one or more active agents, or each zone contains similar or different combinations of the one or more active agents (each zone contains controlled-release tablets 330 with similar rates and similar agents; page 21, lines 6-9 ).
Regarding claim 32, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein the device is configured such that successive tablets in the stack of tablets are extruded in a sequential manner and sequentially presented to the rumen fluid (Page 7, lines 21-27)
Holmes is silent such that extrusion of a subsequent tablet does not materially overlap with extrusion of a preceding tablet at the outlet.
Laby teaches the face having four to eight apertures each having a diameter and located solely in the face to define an outlet (face at the end of device having 6 further holes round a central circular hole; Col 7, lines 27-31; the holes have a diameter) such that the one or more active agents are accessible to rumen fluid via only the outlet (7 holes at the face end; Col 7, lines 27-31).
Holmes/Laby disclose wherein extrusion of a subsequent tablet does not materially overlap with extrusion of a preceding tablet at the outlet (Device of Holmes is modified with the teaching of Laby to comprise 7 holes: a central hole and six additional holes around the central to eliminate cavitation (Col 7, lines 27-31); if cavitation is eliminated each tablet of device of Holmes is going to extrude completely before the next tablet begins to extrude).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with similar six additional circular holes spaced around the central circumferentially as taught by Laby for the purpose of eliminate cavitation (Col 7, lines 27-31).
Regarding claim 33, Holmes/Laby discloses the intra-ruminal device of claim 1. Holmes discloses wherein the device is configured such that a subsequent tablet in the stack of tablets begins to extrude only after extrusion of a preceding tablet at the outlet is substantially complete, such that there is minimal co-extrusion of the subsequent tablet with the tablet at the outlet (Page 7, lines 21-27; tablets extrude sequentially and substantially complete extrusion is achieved before the next tablet extrudes).
Regarding claim 34, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes discloses wherein a tablet adjacent to the tablet at the outlet exhibits minimal co-extrusion (Page 7, lines 21-27; tablets extrude sequentially, and substantially complete extrusion is achieved before the next tablet extrudes).
Regarding claim 35, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes is silent wherein the device is configured so that at least 95% of each tablet at the outlet extrudes before a subsequent tablet in the stack of tablets begins to extrude.
Laby teaches the face having four to eight apertures each having a diameter and located solely in the face to define an outlet (face at the end of device having 6 further holes round a central circular hole; Col 7, lines 27-31; the holes have a diameter) such that the one or more active agents are accessible to rumen fluid via only the outlet (7 holes at the face end; Col 7, lines 27-31).
Holmes/Laby disclose wherein extrusion of a subsequent tablet does not materially overlap with extrusion of a preceding tablet at the outlet (Device of Holmes is modified with the teaching of Laby to comprise 7 holes: a central hole and six additional holes around the central to eliminate cavitation (Col 7, lines 27-31); if cavitation is eliminated each tablet of device of Holmes is going to extrude completely before the next tablet begins to extrude).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with similar six additional circular holes spaced around the central circumferentially as taught by Laby for the purpose of eliminate cavitation (Col 7, lines 27-31).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of in view of Laby et al. (US 4671789 A) in further view of Higuchi et al. (US 3995631 A).
Regarding claim 8, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes/Laby are silent wherein the apertures of the caps are the same diameter.
Higuchi teaches an intra-ruminal device (Fig 5) wherein the apertures of the cap are the same diameter (Col 9, line 40: Diameter of orifices in cap 32: .0625 inch= 1.5875mm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the size of apertures of device of Holmes/Laby for the apertures to have the same diameter as taught by Higuchi for the purpose of providing reliable means for releasing effective concentrations of active agent contained therein at a controlled rate (abstract).
Claims 14, 25-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) view of Laby et al. (US 4671789 A) in further view of Lowe et al. (US 20050064032 A1).
Regarding claim 14, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes/Laby are silent wherein the stack of tablets includes one or more pulsatile release tablets.
Lowe teaches a stack of tablets (Fig 5A-B) includes one or more pulsatile release tablets (dual formulation tablets 130, Fig 5A-B; [0098]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes/Laby with similar pulsatile release tablets as taught by Lowe for the purpose of providing dual formulation tablets delivered at pre-determined times ([0098]).
Regarding claim 25, Holmes/Laby disclose the method of claim 24. Holmes is silent wherein the intra-ruminal device has a pay-out (release rate) linearity of at least 0.940.
Lowe teaches an intra-ruminal device having a pay-out (release rate) linearity of at least 0.940. (Fig 8 illustrates a constant release rate (linearity = 1) of Monensin 300mg/day from about day 5 to day 90).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Holmes/Laby with similar constant release rate as taught by Lowe for the purpose of improving accuracy of the dosage over ab extended period of time (Fig 8; [0015]).
Regarding claim 26, Holmes/Laby disclose the method of claim 24. Holmes is silent wherein the intra-ruminal device has a pay-out linearity measured over at least 80 to about 120 days.
Lowe teaches wherein the intra-ruminal device has a pay-out linearity measured over at least 80 to about 120 days (Fig 8 illustrates a release rate measured for approximately 110 days; from which active agent was constant = linearity of 1 for approximately 85 days).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Holmes/Laby with similar constant release rate and as taught by Lowe for the purpose of improving accuracy of the dosage over an extended period of time (Fig 8; [0015]).
Regarding claim 28, Holmes/Laby discloses the method of claim 24. Holmes/Laby are silent wherein at least about 80 to about 95% of each tablet extrudes before the next tablet in the stack of tablets begins to extrude.
Lowe embodiment of Fig 6A-C teaches a tablet (160) comprising a formulation (160, Fig 6B) and defines a discoid-shaped depression (FIG. 6B) or other conveniently shaped depression ([0100]). Lowe further discloses that a second formulation may also be provided in separately tableted (180, Fig 6B).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Holmes/Laby to include similar depressions as taught by embodiment of Fig 6 of Lowe to have co-extrusions of two tablets when the erosion of a tablet reach the depression portion allowing ruminal fluid to erode both the current tablet and the following one, the tablets might be arranged in the desired order to achieve a desired regime/timing of release of each formulation ([0100]; [0096])
However, Lowe is silent regarding wherein at least about 80 to about 95% of each tablet extrudes before the next capsule in the stack of capsule begins to extrude.
Lowe discloses that the depression can be conveniently shaped ([0100]).
The examiner notes that the percentage of extrusion of the tablet before it coextrudes with the next tablet is a result effective variable, dependent on the shape and volume of the depression which depends on the desired regime/timing. Further, the percentage of extrusion of the tablet before the next capsule in the stack of capsule begins to extrude in the instant specification is lacking specific criticality ([0158] from instant specification).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the volume of the recess to include the claimed percentage of extrusion of the first tablet before the first and second tablet are co-extruded since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05 (II)).
Regarding claim 29, Holmes/Laby discloses a method of claim 24. Holmes/Laby are silent wherein an adjacent tablet in the stack of tablets exhibits a reduction in co-extrusion.
Lowe embodiment of Fig 6A-C teaches a tablet 160 comprising a formulation (160, Fig 6B) and defines a discoid-shaped depression (FIG. 6B) or other conveniently shaped depression ([0100]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Holmes/Laby to include similar depressions conveniently shaped as taught by embodiment of Fig 6 of Lowe, the depression volume will decrease from each tablet to the next one in the rack, to have a reduction in co-extrusions of the and achieve a desired regime/timing of release of each formulation ([0100]; [0096]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Laby et al. (US 4671789 A) in further view of Scully et al. (US 5198222 A).
Regarding claim 15, Holmes discloses a method of assembling an intra-ruminal device (Fig 8-14), the method comprising: providing an intra-ruminal device (Fig 8-14), comprising: an elongate body or body assembly (1000, Annotated Fig 1) impervious to rumen fluids (elongated body is impervious to function as intended), the body defining a barrel (1001, Annotated Fig 1) having a first end (1002, Annotated Fig 1) and a second end (1003, Annotated Fig 1), and an opening (1007, Annotated Fig 1) at the first end (1002, Annotated Fig 1), at least one variable geometry device (wings 301, Fig 8) dependent from the body (1000, Annotated Fig 1) to assist rumen retention (Page 14, lines 30-31), a matrix (stack of tablets, including exit dose, Fig 13) comprising one or more active agent (Fig 13; Page 1, lines 11-13) within the body (1000, Annotated Fig 1) to be accessible to rumen fluid via the first end (1002, Annotated Fig 1), wherein the matrix (stack of tablets, including exit dose, Fig 13) is in a form of a tablet, and the one or more active agents are provided in a stack of tablets within the barrel, and a biasing arrangement (coil spring (not shown until Figures 15 and 16); Page 20, lines 13-14) within the body (1000, Annotated Fig 1) adapted to bias the matrix (stack of tablets, including exit dose, Fig 13) in the barrel (1001, Annotated Fig 1) towards the first end (1002, Annotated Fig 1), loading the matrix into the barrel (stack of tablets loaded, Fig 13), and attaching a cap (end face 304, Fig 9) located over the opening (1007, Annotated Fig 1) at the first end (1002, Annotated Fig 1), the cap (304) encapsulating and sealing against the first end (1002, Annotated Fig 1) of the barrel (1001, Annotated Fig 1) to retain the matrix (stack of tablets, including exit dose, Fig 13) within the barrel (1001, Annotated Fig 1), the cap (304) comprising a flat face (end face of 304 is flat, Fig 13), a sidewall extending from the face (side wall 308 containing threads extends from end face 304, Fig 13), and an aperture (central aperture 307, Fig 13) having a diameter (Fig 8 shows the diameter of the central aperture) in the face to define an outlet (outlet defined by aperture 307, Fig 13), such that the one or more active agents are accessible to rumen fluid via only the outlet (307).
Holmes is silent regarding four to eight apertures each having a diameter and located solely in the face to define an outlet, wherein the device is configured so that at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude, and wherein the variable geometry device is designed to separate from the device body after a payout period.
Laby teaches the face having four to eight apertures each having a diameter and located solely in the face to define an outlet (face at the end of device having 6 further holes round a central circular hole; Col 7, lines 27-31; the holes have a diameter) such that the one or more active agents are accessible to rumen fluid via only the outlet (7 holes at the face end; Col 7, lines 27-31).
Holmes/Laby as modified teaches wherein the device is configured so that at least 80% of each tablet at the outlet extrudes before the next tablet in the stack of tablets begins to extrude (Device of Holmes is modified with the teaching of Laby to comprise 7 holes: a central hole and six additional holes around the central to eliminate cavitation (Col 7, lines 27-31); if cavitation is eliminated each tablet of device of Holmes is going to extrude completely before the next tablet begins to extrude).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with similar six additional circular holes spaced around the central circumferentially as taught by Laby for the purpose of eliminate cavitation (Col 7, lines 27-31).
Holmes/Laby are silent wherein the variable geometry device is designed to separate from the device body after the payout period.
Scully teaches a method wherein the variable geometry device is designed to separate from the device body after the payout period (Col 8, lines 24-34; the arms break after payload).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the wings of method of Holmes/Laby with similar material that fatigues after the payload is released as taught by Scully for the purpose of regurgitating the medical device once the payload has been released (Col 8, lines 24-34).
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) view of Laby et al. (US 4671789 A) in further view of Leech et al. (US 20110280923 A1)
Regarding claim 27, Holmes/Laby disclose the method of claim 24. Holmes/Laby are silent wherein the intra-ruminal device has a pay-out (release rate) of about 0.30 to about 1.20 mm/day.
Leech teaches a method comprising a device from delivery of active agent to the rumen ([0029]) having a pay-out (release rate) of about 0.30 to about 1.20 mm/day ([0044]: “the erosion rate of the bolus housing the tablets is approximately 0.5 mm/day. However, persons skilled in the art will appreciate that this is not meant to be limiting, and the erosion rate of the bolus may be higher or lower depending on the construction of the bolus, and the desired dosage rate for the animal to be treated.”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the pay-out of method of Holmes/Laby to have similar rate 0.5mm/day as taught by Leech to adjust avoid drug resistant in the targeted parasites or bacteria ([0043]-[0044]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Laby et al. (US 4671789 A) in further view of Scully et al. (US 5198222 A).
Regarding claim 30, Holmes/Laby discloses the method of claim 24. Holmes/Laby are silent wherein the variable geometry device separates from the device body after the payout period.
Scully teaches a method wherein the variable geometry device is designed to separate from the device body after the payout period (Col 8, lines 24-34; the arms break after payload).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the wings of method of Holmes/Laby with similar material that fatigues after the payload is released as taught by Scully for the purpose of regurgitate the medical device once the payload has been released (Col 8, lines 24-34).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Laby et al. (US 4671789 A) in further view of Joshi et al. (US 5951538 A).
Regarding claim 36, Holmes/Laby discloses an intra-ruminal device of claim 1. Holmes/Laby are silent wherein the apertures are distributed equally around the cap for uniform hydration of the matrix at the outlet exposed to the rumen fluid to induce linear erosion and extrusion
Laby teaches the face having four to eight apertures each having a diameter and located solely in the face to define an outlet (face at the end of device having 6 further holes round a central circular hole; Col 7, lines 27-31; the holes have a diameter) such that the one or more active agents are accessible to rumen fluid via only the outlet (7 holes at the face end; Col 7, lines 27-31) wherein the apertures are distributed around the cap (end of device containing the holes; Col 7, lines 27-31) for uniform hydration of the matrix (Col 7, lines 27-31: the distribution of additional holes eliminate cavitation because they expose and hydrate the distal end of the matrix) at the outlet (7 holes ) exposed to the rumen fluid (Col.3,lines 33-44) to induce linear erosion and extrusion (Fig 3).
Holmes/Laby disclose wherein extrusion of a subsequent tablet does not materially overlap with extrusion of a preceding tablet at the outlet (Device of Holmes is modified with the teaching of Laby to comprise 7 holes: a central hole and six additional holes around the central to eliminate cavitation (Col 7, lines 27-31); if cavitation is eliminated each tablet of device of Holmes is going to extrude completely before the next tablet begins to extrude).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with similar six additional circular holes spaced around the central and similar formulation for linear extrusion, as taught by Laby for the purpose of eliminate cavitation (Col 7, lines 27-31).
Holmes/Laby does not explicitly disclose the apertures are distributed equally.
Joshi teaches the apertures are distributed equally (Fig 9, shows apertures 68 being equally distributed).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the distribution of holes of device of Holmes/Laby with to have equal separation between holes as taught by Joshi for the purpose of easy dispensation of the contents out of the delivery device 20 (Col 7, lines 39-40).
Response to Arguments
Applicant’s arguments with respect to claims 1, 5, 7-8, 10, 12-15, and 22-36 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.
Conclusion
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
