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
Applicants' arguments, filed 03/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
New by Amendment
1) Claims 2-3, 5-7, 9-13, 15 and 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann (GB 2436537) and Kashimura et al. (US 5,968,906) and further in view of Hansen et al., (US 5,955,502) and Herh et al., (American Laboratory, 1998).
Hoffmann teaches “nozzle arrangements for dispensing a flowable material, and to devices and methods for dispensing a flowable material” (p. 1, lines 2-3). Here the nozzle arrangements suffice as a site specific applicator.
The nozzle arrangement has a proximal end and distal end, as illustrated by Fig. 1(c)(d):
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Note the proximal and distal ends of the applicator are connected by a continuous wall extending between proximal and distal end, thereby defining an inner margin.
Regarding the width of the inner margin ranging from 0.5 mm to 2mm, the reference further teaches, “Thus, by screwing the outer nozzle in and out with respect to the inner nozzle, a user can set the diameter of the outlet of the outer nozzle between a maximum and minimum size, and thereby control the bead size of the dispensed flowable material between predetermined maximum and minimum valves” (p. 9, lines 14-17).
Accordingly, the artisan would have been reasonably expected to adjust the width of the inner margin, defining an opening at the distal end, such that the bead size of the flowable material can be controlled. This is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize the flow of material out of the device.
The device comprises a “nozzle” that is taught to be “substantial conical or frusto-conical” (p. 3, lines 2-5), as per claim 6, “having an inlet and an outlet” (p. 3, line 14) and “a reservoir of flowable material in flowable material conducting connection with the inner nozzle” (p. 3, liens 16-17), which would have provided “fluid communication with the reservoir”, as per claim 2.
The “reservoir may be squeezable so as to conduct flowable material from the reservoir to the inner nozzle” (p. 3, lines 24 to p. 4, line 1). “The reservoir may be a tube, bottle or canister” (p. 4, line 19), as per claim 3.
The nozzle or “site-specific applicator” is removably fixed, as per claim 10, insofar as Hoffmann teaches “at least one of the inner and outer nozzles is moveable with respect to the other nozzle by user control so as to vary a region of contact between the inner and outer nozzles, thereby causing the size of the outlet of the outer nozzle to vary in a user controllable manner” (p. 3, lines 18-21).
The device has a removable closure arranged at the distal end of the site-specific applicator, as per claim 11, insofar as Hoffmann teaches, “Figure 1 shows a first embodiment of a nozzle arrangement in which (a) is a view with the outer nozzle removed (b) is a view of a closed nozzle arrangement (c) is a view of a partially opened nozzle arrangement and (d) is a view of a fully opened nozzle arrangement” (p. 5, lines 15-18).
Since the nozzle is taught to be “formed of a rigid material, most preferably a plastic” (p. 3, lines 6-7), it would have been obvious for it to be formed of a copolymer, as per claim 16
“Typical application areas include the application of mastics, sealants, glues, medicinal and therapeutic ointments and gels, foodstuffs, and hair and cosmetic ointments and gels” (p. 1, lines 7-9).
Ointments and gels are expected to have Bingham plastic rheology insofar as they behave as viscoplastics, which, according to the instant specification, “behaves as a rigid body at low stresses but flows as a viscous fluid at high stress” (Spec. at p. 3, para. [0009]).
The reference to Herh et al. shows that pharmaceuticals, e.g. ointments and gels, are semisolid products subject to “rheological measurements”, which is important “to revealing the flow and deformation behaviors of materials” (p. 1, 1st and 2nd paragraphs). The products are subject to yield stress, which is “the minimum shear stress required to initiate flow” (Id. last paragraph). Since pharmaceutical gels and ointments are semisolid products, subject to shear stress in order to initiate flow, gels and ointments would have reasonably been expected to behave has Bingham plastics insofar as they behave as a solid until a force, i.e. yield stress, is applied, at which point flow is initiated.
Hoffman does not teach that the medicinal and therapeutic ointments and gels comprise sucralfate.
Kashimura et al. teaches “sucralfate preparations” comprising “an organic acid having at least two carboxyl groups” (Abstract), wherein “Malic acid is more preferred” [malic acid is API stabilizer as per claims 12 and 22] (col. 2, lines 18-22). The compositions may be used to treat “ulcerative colitis, as well as to dermal ulcers such as bedsores, stomatitis and the like” (Abstract).
The reference further teaches, “To treat proctitis, ulcerative colitis and other diseases in the lower digestive tract, suspensions, solutions and the like may preferably be put into enemic containers to formulate enemas or suppositories may be formulated for administration by the enteral route” (col. 3, lines 30-34)
The sucralfate preparations may be used in many forms including “solutions, emulsions, suspensions, lotions, ointments, cataplasms and elixirs”, where “[p]harmaceutical formulations” include “excipients, dispersants, fillers, bulking agents, solvents, emulsifiers, additives, lubricants, antiseptics, flavoring agents, wetting agents, flavor correctives, dyes and buffers” (col. 2, lines 51-61).
The prior art teaches adding “propylene glycol” (col. 3, lines 19-22), which suffices as humectant, as per claim 12 and 22.
The prior art teaches a specific embodiment of a sulcralfate preparation “formulated by adding malic acid to a 10% sucralfate suspension containing 2.5% hydroxypropyl starch gel” (col. 5, Example 3, lines 6-9). Table 2 shows the ratios of Sucralfate to malic acid (Id.). At the 4:1 ratio the amount of malic acid is 2.5%, which leaves a water concentration of 85%, as per claim 13. The hydroxypropyl starch suffices as rheology modifier, as per claim 22. Note: this type of starch is taught therein as a “[h]yrophilic polymner . . . to impart viscosity such that the retention in the ulcer site and the mucosal affinity are enhanced” (col. 3, lines 47-48).
Since the prior art teaches a gel formulation of sucralfate in a concentration ranging from 3% w/w to about 15% w/w, the composition would have been capable of being packaged in a squeezable reservoir for a period of time of 1-year . . ., as per claim 2, 5, 22.
The prior art concentration ratio of malic acid to sucralfate “ranges typically from 1:1 to 1:20” (col. 2, lines 23-27).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use the container of Hoffmann for the gels and ointments of Kashimura et al. since the container of Hoffmann is suitable for medicinal and therapeutic ointments and gels.
The combination of Hoffmann and Kashimura et al., which is taught above, does not teach a “crosslinking agent” or “consistency improver”.
Hansen et al. teaches compositions for treating “undamaged or damaged skin or mucosa of an animal such as a human”, wherein the “mucosa may be the oral, aural, nasal lung, gastrointestinal, vaginal, or rectal mucosa” (Abstract). The compositions may be in the form of “a spray, a solution, a dispersion, a suspension, an emulsion, tablets, capsules, pills, powders, granulates, gels including hydrogels, pastes, ointments, creams, drenches, delivery devices, suppositories, enemas . . . “ (col. 13, lines 36-42).
The formulations include pharmaceutically acceptable excipients, “for example, inert diluents for fillers, such as sucrose, sorbitol, sugar, mannitol . . . calcium carbonate . . . calcium sulfate . . . “ (Id. lines 48-57). Other excipients include “xanthan gum” and “propylene glycol” (col. 15, lines 26-30).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
Accordingly, in this instance, it would have been obvious to have used calcium carbonate (cross-linking agent), calcium sulfate dehydrate (consistency improver), and xanthan gum (rheology modifier), as excipients in the primary reference compositions, since the primary reference include excipients and the compounds discussed above are recognized to be suitable for that intended purpose, as taught by Hansen et al.
It is noted that the prior art is silent as to the amounts calcium carbonate, calcium sulfate, xanthan gum, propylene glycol present in the compositions; however, because the presence calcium carbonate, calcium sulfate, xanthan gum, propylene glycol is taught it would have been obvious to optimize the range for each excipient.
Accordingly, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
2) Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann (GB 2436537), Kashimura et al. (US 5,968,906, cited in IDS), and Hansen et al., (US 5,955,502) and Herh et al., (American Laboratory, 1998) as applied to claims 2 above, and further in view of Weinstock-Rosin (US 2014/0349927).
The combination of Kashimura et al., Hoffman, Hansen et al., and Herh, which is taught above differs from claims 14 insofar as it does not teach sucralose as sweetener.
Weinstock-Rosin teaches compositions for treating ulcerative colitis (see abstract and p. 4, para. [0050]). The compositions include excipients such as “sucralose” (p. 15, para. [0175]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add sucralose as excipient to the compositions of Kashimura et al. based on its suitability for its intended use in compositions suitable for treating ulcerative colitis, as taught aby Weinstock-Rosin.
4) Claim(s) 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann (GB 2436537), Kashimura et al. (US 5,968,906), and Hansen et al., (US 5,955,502) and Herh et al., (American Laboratory, 1998)as applied to claim 2 above, and further in view of Rivers et al., (US 2009/0208685).
The combination of Hoffmann, Kashimura et al., Hansen et al., Herh et al., which is taught above, differs from claims 16-20 insofar as it does not teach a reservoir comprising an inner and outer layer, aluminum alloy, polyethylene, a tie-layer, nor ethylene acrylic acid copolymer.
Rivers et al. teaches packaging films that “exhibits decreased scalping of essential oils, flavor compounds, anti-bacterial additives, antifungal additives, and the like from products packaged using the disclosed films” (Abstract).
The packaging films “can be used in packaging a wide variety of articles or objects, such as for example, food, beverages, medications, biocides, and personal care items. To form the packaged article, the disclosed film can be heat sealed to another film, to itself (for example, by a fin seal and/or a lap seal arrangement), or to a substrate (such as, for example, metal foil) to form an open package such as a bag, pouch (e.g. vertical or horizontal form-fill-sealed pouch), tube, or other containment configuration into which an article is placed before the package is sealed” (p. 8, para. [0101]). Other applications include “gels”, (p. 9, para. [0111]).
The films are taught to “have any number of layers desired, so long as the film provides the desired properties for the particular packaging operation in which the film is used. The outer layer can function as a sealing layer, while the core layer, or at least one of a plurality of inner layers, can provide the film with one or more desired properties” (p. 8, para. [0095]), as per claim 16.
“In some embodiments, various metal foils can be used as one or more barrier layers or outside layers in the presently disclosed films”, wherein light metal foils include “aluminum alloy” (p. 7, para. [0088]), as per claim 17.
The layers “sealant” or “a layer adjacent to a sealant layer” can comprise “preferably medium density polyethylene”, (p. 1, para. [0009]), as per claim 18.
The layers also include a “tie-layer” “to adhere two film layers, to adhere a film to another material, or to enhance the adhesion between tow layers in a co-extruded substrate” (p. 7, para. [0091]), as per claim 19. The tie layer may be made of “ethylene/methacrylic acid copolymer” (ethylene acrylic acid copolymer) (Id. at para. [0092]), as per claim 20.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add to the reservoir of Hoffmann an inner and outer layer, aluminum alloy, polyethylene, a tie-layer, nor ethylene acrylic acid copolymer, as claimed, for the advantage of providing packaging that minimally scalp polar cyclic compounds from the packaged product, as taught by Rivers et al.
The artisan would have reasonably expected success with the combination insofar as the films of Rivers et al. may be provided in a tube for storing medication, including gels.
Technological Background
1) The prior art made of record and not relied upon is considered pertinent to applicant's disclosure McGrath (US 2012/0064139). McGrath is pertinent for teaching, “The sucralfate paste is packaged in any suitable container, e.g., 1.5 g of sucralfate paste can be placed in a 5 mL syringe, 4g of sucralfate paste can be placed in a 15mL ointment jar, 4 grams of sucralfate paste can be placed in a 5 to 10 gram ointment tube” (p. 2, para. [0019]).
2) The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Rania Gollakner (Sucralfate, VCA Animal Hospitals). Rania Gollakner is pertinent for teaching, Sucralfate should be stored in a tightly sealed container, protected from light, and at room temperature” (2nd page last paragraph).
3) The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Herh et al., (American Laboratory, 1998). Herh et a. is pertinent for teaching the rheology of pharmaceutical and cosmetic semisolids. The reference recognizes, “The application and acceptance of pharmaceuticals and cosmetics are also dependent on the flow properties of the final product” and “rheological measurements” are “an important route to revealing the flow and deformation behaviors of materials” and “cannot only improve efficiency in processing but can also help formulators and end users find pharmaceutical and cosmetic products that are optimal for their individual needs” (p. 1, 1st paragraph).
4) The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Iverson et al. (US 2011/0275736). Iverson et al. is pertinent for teaching, “wherein the gum exhibits viscoplastic behavior” (p. 8, claim 6), “wherein the gum comprises . . . xanthan gum” (p. 8, claim 7).
Response to Arguments
Applicant argues that the amendment, i.e., the recitation of a Bingham plastic rheology, is sufficient to overcome the art of record.
The Examiner disagrees.
Having a Bingham plastic rheology, according to the instant specification, “means the inventive formulation behave as viscoplastics (i.e., behaves as a rigid body at low stresses but flows as a viscous fluid at high stress)” (Spec. at p. 3, para. [0009]).
The prior art formulations are taught to be in the form of gel and ointments, which are non-Newtonian fluids. These gels and ointments would have reasonably been expected to behave as Bingham plastics insofar as they are semi-solid fluids subject to rheological measurements which is important to determining flow properties of the products for affecting things like efficacy and intended use (see Herh et al. above). Measurements include yield stress used to initiate flow (Id.). Furthermore, Xanthan gum, shown in Hansen et al., is a type of gum known for its viscoplastic behavior (see Iverson et al.). Accordingly, these types of fluids have been reasonably expected possess a Bingham plastic rheology.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612 .
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