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 .
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 10 September 2025 are acknowledged and have been fully considered. Claims 1-4, 7-11, and 14-15 are pending. Claims 1-4, 7-8, 10-11, and 14-15 are under consideration in the instant office action. Claim 9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 5-6 and 12-13 are canceled. Applicant’s claim amendments and arguments necessitated a new ground of rejections under 35 USC 103 as set forth below. Accordingly, this office action is made final.
Moot Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-8, 10-11, and 14-15 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.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 15 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.
The recitation of paracetamol-acetaminophen in claims 8 and 15 renders the claim unclear. As it is conventionally known the other name of acetaminophen is paracetamol. It is not clear if Applicant is intending to indicate in the claim the other name of paracetamol is acetaminophen or Applicant is intending to recite two different drugs.
Note: For prior art rejection purpose the examiner interpreted paracetamol-acetaminophen as acetaminophen or paracetamol.
Response to Arguments
Applicant in their response to the rejections section under 35 USC 112 failed to address the above rejection. Therefore, the rejection of claims 8 and 15 is maintained.
New Rejections-Necessitated by Amendments
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 10-11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cimiluca (US Patent No. 5,641,512, previously cited) in view of Schurig et al. (WO 94/04118, previously cited) and Greiner-Perth et al. (US 2015/0166224, newly cited).
Applicants’ claims
Applicants claim a device for the delivery of liquid formulation.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Cimiluca teaches improved pharmaceutical compositions containing an analgesic encapsulated within a soft gelatin shell wherein said shell contains a xanthine derivative, such as caffeine (see abstract). A pharmaceutical composition in the form of a soft gelatin capsule of a size suitable for easy swallowing and typically containing from about 100 mg to about 2000 mg of a solubilized pharmaceutical active composition, comprising:
a) an outer gelatin shell containing a xanthine derivative incorporated into the soft gelatin of the outer shell; and
b) a concentrated liquid core composition, which is encapsulated by said outer gelatin shell, comprising a solvent solution of a safe and effective mount of at least one solubilized analgesic pharmaceutical active; said soft gelatin capsule upon swallowing dissolves or ruptures in the gastrointestinal tract thereby introducing the xanthine derivatives from the outer gelatin shell and the pharmaceutical actives from the liquid core composition into the physiological system (see claim 1). A pharmaceutical composition according to claim 1 wherein said concentrated liquid core composition comprises a solvent selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, propylene glycol and monohydric alcohols having from one to four carbon atoms and mixtures thereof (see claim 2). A process according to claim 3 wherein said analgesic active is selected from the group consisting of acetaminophen, acetylsalicylic acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indomethacin, naproxen, pharmaceutically-acceptable salts thereof and mixtures thereof (see claim 4). The solubilized pharmaceutical compositions of the present invention can be encapsulated within any conventional soft gelatin shell that is capable of substantially containing the composition for a reasonable period of time. The soft gelatin shells of the instant invention can be prepared by combining appropriate amounts of gelatin, water, plasticizer, xanthine derivative and any optional components in a suitable vessel and agitating and/or stirring while heating to about 65° C. until a uniform solution is obtained. This soft gelatin shell preparation can then be used for encapsulating the desired quantity of the solubilized fill composition employing standard encapsulation methodology to produce one-piece, hermetically-sealed, soft gelatin capsules. The gelatin capsules are formed into the desired shape and size so that they can be readily swallowed. The soft gelatin capsules of the instant invention are of a suitable size for easy swallowing and typically contain from about 100 mg to about 2000 mg of the solubilized pharmaceutical active composition (column 7, lines 15-60).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Cimiluca do not specifically teach the inclusion of a tab that has a cross section area lower than the soft gelatin capsule. These deficiencies are cured by the teachings of Schurig et al.
Schurig et al. teach Knurled surfaces such as raised ribs (24, 30) are provided on the shell (12) of a soft gelatin capsule (10) in order to enhance gripping and manipulation of the capsule (10). The capsule (10) has a removable tab (14) at one end thereof which may also be provided with a knurled surface (30). One embodiment of the invention is a capsule (10) used for delivery of medicaments to an external body surface. An alternative embodiment of the capsule (10) is disclosed for insertion into a body orifice (see abstract).
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A capsule is provided which comprises a hollow shell suitable for encapsulating a medicament. The shell has an exterior surface which is provided with a knurled texture region of sufficient area so as to enhance manipulation of the said capsule. The capsule further includes a removable tab integrally formed with the shell to seal the capsule. The medicament is expelled from the shell upon removal of the said tab and application of pressure to the shell. Since the shell, and preferably also the tab, have knurled surfaces, the difficulties of use associated with prior art capsules is largely eliminated. In one embodiment of the invention, the shell is formed as an elongated body having top and bottom flattened portions, with the knurled texture region applied to both the top and bottom flattened portions. In an alternative embodiment of the invention, a capsule is provided which is suitable for insertion into an orifice, such as the rectum. In this alternative embodiment, the shell comprises an elongated neck portion and a bulb portion, with the knurled texture region applied to the bulb portion. In both embodiments, the removable tab may be provided with a knurled texture surface (see page 2). It is clear from the Figures above the tab has lower cross-sectional area than the soft gelatin capsule. As noted previously, the exterior surface of gelatin capsules tends to be very smooth and slippery. However, the addition of a starch or starch derivative to the gelatin base during manufacture of the capsule has been found to produce drier, more tactile, and less slippery characteristics to the capsule surface. Capsules made with 0.1% to 30% by weight starch or starch derivatives, and preferably 5% to 20% by weight starch or starch derivatives, are suitable for this purpose. Suitable starch derivatives include high amylose starch, oxidized starch, esterified starch, acid-thinned starch, etherified starch, hydrolyzed starch, hydrolyzed and hydrogenated starch, and enzyme-treated starch. Other polysaccharide thickening agents in the range of 0.1% to 15% and preferably in the range of 2% to 10% by weight, may be incorporated into the capsule composition to modify the surface of the capsule. Suitable thickeners include agar, acacia, alginates, carrageenans, gellan, guar, karaya, locust bean gum, pectin, pullulan, tragacanth, and xanthan (see pages 6-7).
Cimiluca and Schurig et al. do not specifically teach a weakening line serving as a connection between the removable cap and the reservoir; and a tab arranged on an opposite side of the reservoir relative to the removable cap. These deficiencies are cured by the teachings of Greiner-Perth et al.
Greiner-Perth et al. a protective cap for a dispenser for discharging liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid is discharged into a surrounding atmosphere. The protective cap has an inner cap and an outer cap, the inner cap having a ventilation opening for communication between an interior of the protective cap and an external environment. Before use, the outer cap is mounted on the inner cap in a first position with the inner cap and the outer cap in sealing contact with each other and the ventilation opening is separated in an airtight and germproof manner from the environment, and the outer cap is movable relative to the inner cap from the first position to a second position in which the inner and outer caps are out of sealing contact with each other and the ventilation opening communicates with the environment (see abstract). In an advantageous embodiment, the at least one blocking element is designed as a radially outwardly protruding tab. Tabs of this kind can be formed inexpensively on an outer cap designed as an injection-molded part and/or in an inner cap designed as an injection-molded part (the examiner noted that the tab is in the opposite side of the reservoir) (see paragraph 0017). In another embodiment, at least one protection element is assigned to at least one of the blocking elements in order to avoid a manual operation of said blocking element. Before a first use, the outer cap is removed. The tabs are elastically deformable for allowing a removal of the outer cap by the user. After removal of the outer cap, the blocking elements are forced into the blocking position on account of elastic restoring forces and hinder a reassembly of the outer cap onto the inner cap. The protection elements hinder a user from manually forcing the blocking elements in the release position. In one embodiment, several U-shaped protection elements are provided, each assigned to one blocking element for covering the blocking element at least partially. In other embodiments, an outer ring is provided covering all blocking elements. In a preferred embodiment, two L-shaped protection ribs are assigned to each blocking element. The inner cap 4 is produced as an injection-molded part and has a tamper-evident safety device 45, which has to be removed at the time of a first use. The tamper-evident safety device 45 has a first segment 450, a second segment 451 arranged between the first segment 450 and the shoulder portion 44 of the inner cap 4, and also a tear-open tab 452. Predetermined breaking points 453, 454 are provided between the first segment 450 and the second segment 451 and also between the second segment 451 and the shoulder portion 44. On an inner wall of the first segment 450, latch elements 455 are provided for latching onto the dispenser 2 according to FIG. 1, and also slits 456 into which detent springs of the dispenser 2 are inserted. The latch elements 455 are designed in such a way that they prevent detachment of the inner cap 4 and/or pulling-off of the outlet assembly 22 from the container body 20 without removal or destruction of the tamper-evident safety device 45. A manipulation or unauthorized access to the liquid reservoir 21 is discernible from a destruction of the tamper-evident safety device 45 of parts thereof. Before a first use, the tamper-evident safety device 45 is separated at the predetermined breaking points 453, 454 by application of a force on the tear-open tab 452, and the second segment 451 is irreversibly removed. The tabs are elastically deformable for allowing a removal of the outer cap by the user. After removal of the outer cap, the blocking elements are forced into the blocking position on account of elastic restoring forces and hinder a reassembly of the outer cap onto the inner cap. The protection elements hinder a user from manually forcing the blocking elements in the release position. In one embodiment, several U-shaped protection elements are provided, each assigned to one blocking element for covering the blocking element at least partially. In other embodiments, an outer ring is provided covering all blocking elements. In a preferred embodiment, two L-shaped protection ribs are assigned to each blocking element (paragraph 0018).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Cimiluca by incorporating a tab that has a cross section lower than the soft gelatin capsule because Schurig et al. teach Knurled surfaces such as raised ribs (24, 30) are provided on the shell (12) of a soft gelatin capsule (10) in order to enhance gripping and manipulation of the capsule (10). The capsule (10) has a removable tab (14) at one end thereof which may also be provided with a knurled surface (30). One embodiment of the invention is a capsule (10) used for delivery of medicaments to an external body surface. An alternative embodiment of the capsule (10) is disclosed for insertion into a body orifice (see abstract).
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One of ordinary skill in the art would have been motivated to do so because Schurig et al. teach a capsule is provided which comprises a hollow shell suitable for encapsulating a medicament. The shell has an exterior surface which is provided with a knurled texture region of sufficient area so as to enhance manipulation of the said capsule. The capsule further includes a removable tab integrally formed with the shell to seal the capsule. The medicament is expelled from the shell upon removal of the said tab and application of pressure to the shell. Since the shell, and preferably also the tab, have knurled surfaces, the difficulties of use associated with prior art capsules is largely eliminated. In one embodiment of the invention, the shell is formed as an elongated body having top and bottom flattened portions, with the knurled texture region applied to both the top and bottom flattened portions. In an alternative embodiment of the invention, a capsule is provided which is suitable for insertion into an orifice, such as the rectum. In this alternative embodiment, the shell comprises an elongated neck portion and a bulb portion, with the knurled texture region applied to the bulb portion. In both embodiments, the removable tab may be provided with a knurled texture surface (see page 2). It is clear from the Figures above the tab has lower cross-sectional area than the soft gelatin capsule. As noted previously, the exterior surface of gelatin capsules tends to be very smooth and slippery. However, the addition of a starch or starch derivative to the gelatin base during manufacture of the capsule has been found to produce drier, more tactile, and less slippery characteristics to the capsule surface. Capsules made with 0.1% to 30% by weight starch or starch derivatives, and preferably 5% to 20% by weight starch or starch derivatives, are suitable for this purpose. Suitable starch derivatives include high amylose starch, oxidized starch, esterified starch, acid-thinned starch, etherified starch, hydrolyzed starch, hydrolyzed and hydrogenated starch, and enzyme-treated starch. Other polysaccharide thickening agents in the range of 0.1% to 15% and preferably in the range of 2% to 10% by weight, may be incorporated into the capsule composition to modify the surface of the capsule. Suitable thickeners include agar, acacia, alginates, carrageenans, gellan, guar, karaya, locust bean gum, pectin, pullulan, tragacanth, and xanthan (see pages 6-7). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Cimiluca and Schurig et al. because both references are drawn to soft gelatin capsules for the delivery of liquid formulations.
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Cimiluca and Schurig et al. by incorporating a tab that has a cross section lower than the soft gelatin capsule because a weakening line serving as a connection between the removable cap and the reservoir; and a tab arranged on an opposite side of the reservoir relative to the removable cap because Greiner-Perth et al. teach a protective cap for a dispenser for discharging liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid is discharged into a surrounding atmosphere. The protective cap has an inner cap and an outer cap, the inner cap having a ventilation opening for communication between an interior of the protective cap and an external environment. Before use, the outer cap is mounted on the inner cap in a first position with the inner cap and the outer cap in sealing contact with each other and the ventilation opening is separated in an airtight and germproof manner from the environment, and the outer cap is movable relative to the inner cap from the first position to a second position in which the inner and outer caps are out of sealing contact with each other and the ventilation opening communicates with the environment (see abstract). One of ordinary skill in the art would have been motivated to do so because Greiner-Perth et al. teach in an advantageous embodiment, the at least one blocking element is designed as a radially outwardly protruding tab. Tabs of this kind can be formed inexpensively on an outer cap designed as an injection-molded part and/or in an inner cap designed as an injection-molded part (the examiner noted that the tab is in the opposite side of the reservoir) (see paragraph 0017). In another embodiment, at least one protection element is assigned to at least one of the blocking elements in order to avoid a manual operation of said blocking element. Before a first use, the outer cap is removed. The tabs are elastically deformable for allowing a removal of the outer cap by the user. After removal of the outer cap, the blocking elements are forced into the blocking position on account of elastic restoring forces and hinder a reassembly of the outer cap onto the inner cap. The protection elements hinder a user from manually forcing the blocking elements in the release position. In one embodiment, several U-shaped protection elements are provided, each assigned to one blocking element for covering the blocking element at least partially. In other embodiments, an outer ring is provided covering all blocking elements. In a preferred embodiment, two L-shaped protection ribs are assigned to each blocking element. The inner cap 4 is produced as an injection-molded part and has a tamper-evident safety device 45, which has to be removed at the time of a first use. The tamper-evident safety device 45 has a first segment 450, a second segment 451 arranged between the first segment 450 and the shoulder portion 44 of the inner cap 4, and also a tear-open tab 452. Predetermined breaking points 453, 454 are provided between the first segment 450 and the second segment 451 and also between the second segment 451 and the shoulder portion 44. On an inner wall of the first segment 450, latch elements 455 are provided for latching onto the dispenser 2 according to FIG. 1, and also slits 456 into which detent springs of the dispenser 2 are inserted. The latch elements 455 are designed in such a way that they prevent detachment of the inner cap 4 and/or pulling-off of the outlet assembly 22 from the container body 20 without removal or destruction of the tamper-evident safety device 45. A manipulation or unauthorized access to the liquid reservoir 21 is discernible from a destruction of the tamper-evident safety device 45 of parts thereof. Before a first use, the tamper-evident safety device 45 is separated at the predetermined breaking points 453, 454 by application of a force on the tear-open tab 452, and the second segment 451 is irreversibly removed. The tabs are elastically deformable for allowing a removal of the outer cap by the user. After removal of the outer cap, the blocking elements are forced into the blocking position on account of elastic restoring forces and hinder a reassembly of the outer cap onto the inner cap. The protection elements hinder a user from manually forcing the blocking elements in the release position. In one embodiment, several U-shaped protection elements are provided, each assigned to one blocking element for covering the blocking element at least partially. In other embodiments, an outer ring is provided covering all blocking elements. In a preferred embodiment, two L-shaped protection ribs are assigned to each blocking element (paragraph 0018). The inner cap 4 is produced as an injection-molded part and has a tamper-evident safety device 45, which has to be removed at the time of a first use. The tamper-evident safety device 45 has a first segment 450, a second segment 451 arranged between the first segment 450 and the shoulder portion 44 of the inner cap 4, and also a tear-open tab 452. Predetermined breaking points 453, 454 are provided between the first segment 450 and the second segment 451 and also between the second segment 451 and the shoulder portion 44. On an inner wall of the first segment 450, latch elements 455 are provided for latching onto the dispenser 2 according to FIG. 1, and also slits 456 into which detent springs of the dispenser 2 are inserted. The latch elements 455 are designed in such a way that they prevent detachment of the inner cap 4 and/or pulling-off of the outlet assembly 22 from the container body 20 without removal or destruction of the tamper-evident safety device 45. A manipulation or unauthorized access to the liquid reservoir 21 is discernible from a destruction of the tamper-evident safety device 45 of parts thereof. Before a first use, the tamper-evident safety device 45 is separated at the predetermined breaking points 453, 454 by application of a force on the tear-open tab 452, and the second segment 451 is irreversibly removed (paragraph 0044). The outer cap 5 is described below with reference to FIG. 3. The outer cap 5 comprises a substantially sleeve-shaped portion 52, a cover portion connected to the latter, and, lying opposite the cover portion 53, a shoulder portion 54 adjoining the sleeve-shaped portion 52. The portions are chosen such that the outer cap 5 can be fitted onto the inner cap 4, wherein a sealing area 55 on an inner jacket surface of the outer cap 5 bears sealingly on the inner cap 4, more precisely on the sealing area 422 of the inner cap 4, such that an area of the ventilation openings 40 is separated from the environment. The outer cap 5 has a plurality of blocking elements 56, which are distributed about the circumference, are designed as tabs and, starting from the sleeve-shaped portion 52, extend in the direction of the shoulder portion 54 and, through recesses 540 in the transition area to the shoulder portion 54, into an interior of the shoulder portion 54. When the outer cap 5 is fitted onto the inner cap 4, the blocking elements 56 engage in the recesses 46. In the illustrative embodiment shown, four blocking elements 56 are distributed uniformly about the circumference. In other embodiments, a greater number or blocking elements or fewer blocking elements are provided for this purpose. The blocking elements 56 are pretensioned radially outwards and have a projection 560. On the shoulder portion 54, recesses 57 are provided through which the tear-open tab 452 of the inner cap 4 projects, in order to permit access to the tear-open tabs 452 when the outer cap 5 is fitted in place. To increase a stability of the outer cap 5, webs 58 extending in the longitudinal direction of the outer cap 5 are provided on an inner jacket surface of the shoulder portion 54. The examiner notes that Greiner-Perth et al. teach weakened lines to remove the inner cap in several embodiments. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Cimiluca, Schurig et al., and Greiner-Perth et al. because all of the references deal with devices for the delivery of liquid formulations.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 7-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cimiluca (US Patent No. 5,641,512, previously cited) in view of Schurig et al. (WO 94/04118, previously cited) and Greiner-Perth et al. (US 2015/0166224, newly cited) as applied to claims 1-4, 10-11, and 15 above, and further in view of Salazar et al. (US Patent No. 8,739,698).
Applicant Claims
Applicants claim a device for the delivery of liquid formulation. Instant claims 7 and 14 recite that the tab bears variable information.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Cimmiluca, Schurig et al., and Greiner-Perth et al. are described in detail above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Cimmiluca , Schurig et al., and Greiner-Perth et al. do not specifically teach that the tab bears variable information. These deficiencies are cured by the teachings of Salazar et al.
Salazar et al. teach a method and apparatus for printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while a product is being encapsulated, including means for transporting the gelatin ribbon, inking means and means for shaping the soft capsule, including an injection, molding and die-cutting station and additional printing means (see abstract). The present invention relates to printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while the product is being encapsulated, including means for transporting the gelatin ribbon; inking means; and means for shaping the soft capsule, including an injection, casting, and die-cutting station, and additional printing means. The present invention meets these needs and provides for some other related advantages (column 1, lines 11-20).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Cimmiluca , Schurig et al., and Greiner-Perth et al. by including variable information on the tab because Salazar et al. teach a method and apparatus for printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while a product is being encapsulated, including means for transporting the gelatin ribbon, inking means and means for shaping the soft capsule, including an injection, molding and die-cutting station and additional printing means (see abstract). One of ordinary skill in the art would have been motivated to do so because Salazar et al. teach that the present invention relates to printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while the product is being encapsulated, including means for transporting the gelatin ribbon; inking means; and means for shaping the soft capsule, including an injection, casting, and die-cutting station, and additional printing means. The present invention meets these needs and provides for some other related advantages (column 1, lines 11-20). The printed matter on the capsule help patients understand on doses and other compliance information. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Cimmiluca , Schurig et al., and Greiner-Perth et al., and Salazar et al. because all of the references are drawn devices for the delivery of liquids.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached on 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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