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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim15 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 15 recites the limitation "the payout period" in in the ultimate line . There is insufficient antecedent basis for this limitation in the claim.
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, 23-24, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Joshi et al. (US 5951538 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).
PNG
media_image1.png
805
914
media_image1.png
Greyscale
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.
Joshi teaches a regarding the face having a plurality of apertures (Col 3, lines 48-51:“Although the outlet port 30 is shown here as a single, round aperture (see FIG. 2), it is understood that a variety of different shapes, configurations, and number of outlet port(s) can be used”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes with more than one aperture as taught by Joshi for the purpose of dispensing the medication at a desired rate accounting for the viscosity of the medication being extruded (abstract; Col 3, lines 55-60).
Holmes/Joshi are silent wherein 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.
The examiner notes that the diameter and exact quantity of the holes is a result effective variable, dependent on the desired dispensation rate. Further, the diameter range and the number of holes in the instant specification is lacking specific criticality ([0138]; [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/Joshi 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/Joshi 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/Joshi discloses an intra-ruminal device of claim 1,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/Joshi 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/Joshi discloses an intra-ruminal device of claim 1 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/Joshi 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 23, Holmes/Joshi 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/Joshi 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 31, Holmes/Joshi 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 ).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Joshi et al. (US 5951538 A) in further view of Higuchi et al. (US 3995631 A).
Regarding claim 8, Holmes/Joshi discloses an intra-ruminal device of claim 1. Holmes/Joshi 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/Joshi 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, 22, 25-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Joshi et al. (US 5951538 A) in further view of Lowe et al. (US 20050064032 A1).
Regarding claim 14, Holmes/Joshi discloses an intra-ruminal device of claim 1. Holmes/Joshi 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/Joshi 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 22, Holmes/Joshi 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)
Holmes/Joshi are silent regarding at least one tablet comprising an active agent that is different from the first active agent.
Lowe teaches a method comprising at least one tablet (first formulation tablets 90, Fig 4A-B) comprising a first active agent and at least one tablet (second formulation tablet 100; Fig 4A-B) comprising an active agent that is different from the first active agent ([0096]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Holmes/Joshi with similar separated tablet forms as taught by Lowe for the purpose of applying selected formulation over a certain desired period of time ([0096]).
Regarding claim 25, Holmes/Joshi disclose the method of claim 24 are 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/Joshi 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/Joshi disclose the method of claim 24. Holmes/Joshi are 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/Joshi 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/Joshi discloses the method of claim 24. Holmes/Joshi 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/Joshi 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 is a result effective variable, dependent on the shape/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 ([0156] 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/Joshi discloses a method of claim 24. Holmes/Joshi 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/Joshi 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]).
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Joshi et al. (US 5951538 A) in further view of Leech et al. (US 20110280923 A1)
Regarding claim 27, Holmes/Joshi disclose the method of claim 24. Holmes/Joshi 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 Holms/Joshi 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 Joshi et al. (US 5951538 A) in further view of Scully et al. (US 5198222 A)
Regarding claim 30, Holmes/Joshi discloses the method of claim 24, 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/Joshi 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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Holmes (AU 2016200312 A1) in view of Higuchi et al. (US 3995631 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 dose of an 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), 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 active agent (stack of tablets, Fig 13) in the barrel (1001, Annotated Fig 1) towards the first end (1002, Annotated Fig 1), loading the active agent 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) comprising an outlet (1006, Annotated Fig 1) in the top (flat face 1004, Annotated Fig 1).
Holmes is silent regarding the outlet comprising two or more apertures, and wherein the variable geometry device is designed to separate from the device body after the payout period.
Higuchi teaches a method comprising an intra-ruminal device (Fig 5) having an outlet further comprising two or more apertures (Col 9, line 40; cap 32 comprises an outlet defined by multiples apertures).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the cap of method of Holmes/Joshi with multiple apertures 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)
Holmes/Higuchi 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/Higuchi 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).
Response to Arguments
Applicant’s arguments with respect to claims 1, 5, 7-8, 10, 12-15, and 22-31 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.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783