`
`Appl. No. (cid:9)
`Applicant (cid:9)
`Filed (cid:9)
`TC/A.U. (cid:9)
`Examiner (cid:9)
`
`: 13/617,138
`: Roberto VILLA et al.
`: 14 September 2012
`: 1615
`: Susan T. Tran
`
`Docket No. (cid:9)
`Customer No. (cid:9)
`Confirmation No. (cid:9)
`
`: 3850-125
`: 06449
`: 7811
`
`AMENDMENT AND RESPONSE TO ADVISORY ACTION
`
`MAIL STOP AF
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Dear Sir:
`
`In further response to the Final Office Action dated 22 August 2013 and in response to
`
`the Advisory Action dated 18 October 2013, please further amend this application as follows.
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`Amendments to the Claims begin on page 2 of this paper. The amendments to the
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`claims include those made in the Amendment and Response filed on 26 September 2013.
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`Remarks begin on page 4 of this paper immediately after the Amendments to the Claims.
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`Exhibit 1013
`ARGENTUM
`IPR2018-00080
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`000001
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`
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`AMENDMENTS TO THE CLAIMS
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`This listing of claims will replace all prior versions and listings of claims in the
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`application.
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`Listing of Claims
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`1. (Currently Amended) (cid:9)
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`A controlled release oral pharmaceutical composition consisting
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`essentially of:
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`(1) a tablet core comprising consisting essentially of:
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`a) budesonide in an amount effective to treat intestinal inflammatory disease; and
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`b) a macroscopically homogeneous composition comprising at least one
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`lipophilic excipient, at least one amphiphilic excipient, and at least one hydrogel-forming
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`hydrophilic excipient other than a gum, wherein said budesonide is dispersed in said
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`macroscopically homogeneous composition; and
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`(2) a coating on said tablet core, said coating comprising consisting essentially of a
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`gastro-resistant film.
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`2. (Canceled)
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`3. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`4. (Canceled)
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`5. (Currently Amended) A controlled release oral pharmaceutical composition according to
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`claim 1, wherein said gastro-resistant film c (cid:9)
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`• - consists essentially of at least one
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`methacrylic acid polymer.
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`2
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`Application No.: 13/617,138
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`6. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 5, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`7-8. (Canceled)
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`9. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1, wherein said at least one lipophilic excipient comprises stearic acid or magnesium
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`stearate.
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`10. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 9, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`11. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 1, wherein said at least one amphiphilic excipient comprises lecithin.
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`12. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 11, wherein said at least one hydrogel-forming hydrophilic excipient comprises at least one
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`hydroxyalkyl cellulose.
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`13. (Previously Presented) A controlled release oral pharmaceutical composition according to
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`claim 11, wherein said at least one lipophilic excipient comprises stearic acid or magnesium
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`stearate.
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`REMARKS
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`Status of Claims
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`Claims 1, 3, 5, 6, and 9-13, as amended, are currently pending and under examination.
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`Claims 2, 4, 7 and 8 were previously canceled. Claims 1 and 5 are currently amended. Support
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`for the amendments can be found throughout the specification, for example, at paragraphs
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`[0047], [0051], [0052], [0080], and [0082] in the substitute Specification. Applicants note that
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`the amendment to claim 5 and the amendment to the tablet core language in claim 1 are newly
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`made in the paper. Applicants submit that these amendments do not constitute new matter, raise
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`new issues, or require further searching. Thus, their entry and allowance are requested.
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`Examiner Interview
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`The undersigned thanks the Examiner for the courtesies shown during the telephone
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`interview held on 18 October 2013. During the interview, the undersigned discussed the
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`possibility of amending claim 5 to change the language to "consisting essentially of in order to
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`overcome the continued rejection of the claims. The Examiner indicated that this amendment
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`might overcome the rejection as made with respect to the coating, but she would need to review
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`the references. The Examiner then raised a further issue with the claims in the context of the
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`outstanding rejections. This issue concerned the language "comprising" as used with respect to
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`the tablet core. The Examiner said that she believes that this language does not exclude a
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`coating. As a basis for this belief, the Examiner explained that there are many types of tablet
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`cores including those made by coating a particle, such as with a drug layer and with further
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`layers. Thus, she believes that this comprising language for the tablet core allows other layers,
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`such as a coating layer of Lerner.
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`Rejection under 35 U.S.C. § 102(a) over Lerner
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`The Examiner has rejected claims 1, 5 and 6, as allegedly anticipated by U.S. Patent No.
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`5,840,332 to Lerner et al. ("Lerner"). Final Office Action at 2-3.
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`Claim 1 as amended is patentable over Lerner. Claim 1 specifies a controlled release oral
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`pharmaceutical composition that consists essentially of a table core and a coating. The table core
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`Application No.: 13/617,138
`Attorney Docket No. 3850-125
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`consists essentially of budesonide and a macroscopically homogeneous composition. This
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`macroscopically homogeneous composition comprises (i) at least one lipophilic excipient, (ii) at
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`least one amphiphilic excipient and (iii) at least one hydrogel-forming hydrophilic excipient
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`other than a gum. The budesonide is dispersed in the macroscopically homogeneous
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`composition.
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`According to the Examiner,
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`Lerner teaches a gastrointestinal drug delivery system comprising an active
`core surround by a coating. See abstract. Core in a form of a matrix tablet
`comprises drug and combinations of pectin, calcium pectinate,
`hydroxypropylmethyl cellulose, microcrystalline cellulose, lactose, starch,
`calcium phosphate, and polyvinylpyrrolidone (column 6, lines 9-10; and
`column 8, lines 35-64). Coating comprises methacrylic acid. See column 9,
`lines 28-65. Drug includes budesonide suitable for irritable bowel syndrome
`and the like (column 6, lines 44-57; and column 12, line 43).
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`Final Office Action at 3.
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`Applicant submits that Lerner does not teach a tablet core that consists essentially of a
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`macroscopically homogeneous composition comprising "(i) at least one lipophilic excipient,
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`(ii) at least one amphiphilic excipient and (iii) at least one hydrogel-forming hydrophilic
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`excipient other than a gum." Thus, Lerner does not describe all of the elements of the
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`macroscopically homogeneous composition and hence does not describe all of the elements of
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`the tablet core. Therefore, Lerner does not anticipate the subject matter of amended claim 1. For
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`these reasons alone, the rejection under 35 U.S.C. § 102(a) in view of Lerner should be
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`withdrawn.
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`Furthermore, Applicants have amended claim 1 to recite the transitional phrase
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`"consisting essentially of in part (2) with respect to the coating. That is, part (2) now recites "a
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`coating on said tablet core, said coating consisting essentially of a gastro-resistant film." In
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`addition, Applicants have amended claim 5 to recite the transitional phrase "consisting
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`essentially of with respect to the gastro-resistant film in order to make the language consistent
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`with the language of amended claim 1. It will not be in dispute that "consisting essentially of is
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`used to exclude from the claim that which affects the basic and novel characteristics of the
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`claimed invention. See MPEP 2163(II)(A)(1). The amendment to claim 5 makes it clear that the
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`"consisting essentially of language used in part (2) is used to exclude from the claim that which
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`affects the basic and novel characteristics of the claimed invention.
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`By reciting "consisting essentially of for the coating, Applicants wish to clarify that a
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`basic and novel characteristic of amended claim 1 is a coating consisting essentially of a gastric
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`resistant film, in which the coating is on a tablet core. See, e.g., substitute Specification,
`
`paragraph [0053].
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`In addition, by reciting "consisting essentially of for the tablet core, Applicants wish to
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`clarify that a basic and novel characteristic of amended claim 1 is a tablet core consisting
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`essentially of budesonide and a macroscopically homogeneous composition comprising at least
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`one lipophilic excipient, at least one amphiphilic excipient and at least one hydrogel-forming
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`hydrophilic excipient other than a gum in which the budesonide is dispersed in the
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`macroscopically homogeneous composition. See, e.g., substitute Specification, paragraph
`
`[0052].
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`Lerner is directed to a gastrointestinal delivery system in which a core is "surrounded by
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`a water-insoluble or relatively water-insoluble coating material in which a particulate water-
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`insoluble material is embedded." Lerner, Abstract, 11. 1-4; see also col. 6, 11. 11-16; col 10, 11. 2-
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`11 and 63-67. In the gastrointestinal tract, that particulate matter "takes up liquid, thus forming
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`channels interconnecting the drug containing core with the outside of the delivery device."
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`Lerner, Abstract, 11. 5-8; see also col. 6, 11. 11-25. More specifically, the particulates embedded
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`in the coating swell, thereby creating channels through which fluid can pass into the core and
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`dissolve the active ingredient contained in the core. The solubilized active ingredient then passes
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`through the channels, thereby controlling the release of the active ingredient. See e.g., Lerner at
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`col. 6, 11. 11-14; col. 8, 11. 66-67; col. 6, 11. 11-14. Therefore, the Lerner coating is not a coating
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`that is meant to dissolve in the gastrointestinal tract, but instead remains intact to control the
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`release of the active ingredient in the core. Lerner, col. 10,11. 6-11.
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`In contrast, the claimed controlled release oral pharmaceutical compositions consist
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`essentially of a tablet core and a coating on the tablet core, the coating consisting essentially of a
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`gastro-resistant film. See, e.g., substitute Specification, paragraph [0053] and Example 1 at
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`paragraphs [0078]-[0079]. One of ordinary skill in the art reading the specification would
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`understand that a gastro-resistant coating is designed to prevent early release of the drug in the
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`stomach but dissolves when the dosage form reaches the desired target region of the
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`gastrointestinal tract, such as the colon. As such, one of ordinary skill in the art would
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`understand that the dosage forms disclosed in Lerner are very different than the presently
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`claimed controlled release oral pharmaceutical compositions in which a core is coated with a
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`gastro-resistant film that is designed to dissolve when the dosage form reaches the target region
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`of the gastrointestinal tract. Therefore, Lerner does not anticipate the subject matter of amended
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`claim 1. For these additional reasons, the rejection under 35 U.S.C. § 102(a) in view of Lerner
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`should be withdrawn.
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`In the Advisory Action, the Examiner argued that the language "comprising" in claim 5
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`which depends from claim 1 requires the interpretation of claim 1 to include other components
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`that which affect the basic and novel characteristics of the claimed invention. Applicants submit
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`that the amendment of claim 5 to use the language "consisting essentially of does not support
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`such an interpretation of claim 1. That is, it is now that the language of claim 1 excludes the
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`presence of particulates in the coating as taught and required by Lerner. Therefore, Lerner does
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`not anticipate the subject matter of amended claim 1. For these additional reasons, the rejection
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`under 35 U.S.C. § 102(a) in view of Lerner should be withdrawn.
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`In addition, one of ordinary skill in the art reading the specification would also
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`understand that the tablet core is designed to be a macroscopically homogeneous composition of
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`the recited excipients in which the budesonide is dispersed. See, e.g., substitute Specification,
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`paragraph [0052]. This macroscopically homogeneous composition is different than a core made
`
`of layers or that includes a layer. Therefore, Lerner does not anticipate the subject matter of
`
`amended claim 1. For these additional reasons, the rejection under 35 U.S.C. § 102(a) in view of
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`Lerner should be withdrawn.
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`Rejection under 35 U.S.C. § 103(a) over Lerner in view of Savastano
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`The Examiner has rejected claims 1, 3, 5, 6, and 9-13 as allegedly unpatentable over U.S.
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`Patent No. 5,840,332 to Lerner et al. ("Lerner") in view of U.S. Patent No. 5,681,584 to
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`Savastano ("Savastano"). Final Office Action at 3-4.
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`Claim 1 as amended is patentable over Lerner in view of Savastano. As discussed in
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`detail above, Applicants have amended claim 1 to recite the transitional phrase "consisting
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`essentially of in part (2) with respect to the coating. That is, part (2) now recites "a coating on
`
`said tablet core, said coating consisting essentially of a gastro-resistant film." The presently
`
`claimed controlled release oral dosage forms are very different than those disclosed in the Lerner
`
`and Savastano references.
`
`As discussed earlier, Lerner is directed to a gastrointestinal delivery system in which a
`
`core is "surrounded by a water-insoluble or relatively water-insoluble coating material in which a
`
`particulate water-insoluble material is embedded." Lerner, Abstract, 11. 1-4; see also col. 6, 11.
`
`11-16, col 10, 11. 2-11 and 63-67. In the gastrointestinal tract, that particulate matter "takes up
`
`liquid, thus forming channels interconnecting the drug containing core with the outside of the
`
`delivery device." Lerner, Abstract, 11. 5-8, see also col. 6, 11. 11-25. More specifically. the
`
`particulates embedded in the coating swell, thereby creating channels through which fluid can
`
`pass into the core and dissolve the active ingredient contained in the core. The solubilized active
`
`ingredient then passes through the channels, thereby controlling the release of the active
`
`ingredient. See e.g., Lerner at col. 6, 11. 11-14; col. 8,11. 66-67; col. 6, 11. 11-14. Therefore, the
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`Lerner coating is not a coating meant to dissolve in the gastrointestinal tract, but instead remains
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`intact to control the release of the active ingredient in the core. Lerner, col. 10, 11. 6-11.
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`Therefore, one of ordinary skill in the art would not seek to modify the teachings of the Lerner
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`reference in order to arrive at the presently claimed controlled release oral pharmaceutical
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`compositions.
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`Further, the addition of the Savastano reference does not cure the deficiencies of Lerner.
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`In particular, the dosage forms taught by Savastano require both a delay jacket and a semi-
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`permeable membrane surrounding the tablet core to control the release of the active ingredient
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`and so are very different than the presently claimed controlled release oral pharmaceutical
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`compositions. See e.g., Savastano, abstract, and col. 5, lines 31-42.
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`Hence, the "consisting essentially of language used in amended claim 1 and in claim 5,
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`completely distinguishes over the very different teachings of Lerner and Savastano. Therefore,
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`the combination of Lerner and Savastano would not have rendered obvious the subject matter of
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`amended claim 1. For these reasons, the rejection under 35 U.S.C. § 103(a) over Lerner in view
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`of Savastano should be withdrawn.
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`In addition, one of ordinary skill in the art reading the specification would also
`
`understand that the tablet core is designed to be a macroscopically homogeneous composition of
`
`the recited excipients in which the budesonide is dispersed. See, e.g., substitute Specification,
`
`paragraph [0052]. This macroscopically homogeneous composition is different than a core made
`
`of layers or that includes a layer. Therefore, the combination of Lerner and Savastano would not
`
`have rendered obvious the subject matter of amended claim 1. For these additional reasons, the
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`rejection under 35 U.S.C. § 103(a) over Lerner in view of Savastano should be withdrawn.
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`Conclusion
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`Although principally directed to amended claim 1, the remarks above apply with equal
`
`force to all the dependent claims. Consequently, in view of the above amendments and remarks,
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`it is submitted that the claims satisfy the requirements of the patent statutes and are patentable
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`over the prior art of record. Reconsideration of this application and early notice of allowance is
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`requested. The Examiner is invited to telephone the undersigned if it will assist in expediting the
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`prosecution and allowance of the instant application.
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`In the event that any additional fee is required in connection with the filing of this
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`Amendment and Response, the Commissioner for Patents is authorized to charge the amount of
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`such fee to Rothwell, Figg, Ernst and Manbeck P.C. Deposit Account No. 02-2135.
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`Respectfully submitted,
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`Dated: 21 February 2014 (cid:9)
`
`By (cid:9)
`
`/Jeffrey L. Ihnen/
`Jeffrey L. Ihnen
`Registration No. 28,957
`Attorney for Applicants
`607 14th Street, N.W., Suite 800
`Washington, D.C. 20005
`Phone: 202-783-6040
`Fax: 202-783-6031
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