Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/7/25 has been entered.
Receipt of amendment and response dated 8/7/25 is acknowledged.
Claims 1-10 and 15 have been canceled. Claims 17-20 have been withdrawn.
New claim 22 has been added.
Claims 11-14 and 16-22 are pending.
Claims 11-14, 16 and 21-22 are considered for examination.
Instant claims 11-14 and 16 have been amended to limit the carbon dioxide absorbent to “calcium hydroxide”. Claims 21 and 22, dependent on claim 11, further require “alkali metal hydroxide”.
In of the amendment, the previous rejections of record have been replaced the following new rejections:
Claim Objections
Claim 22 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 21. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
1. Claim(s) 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 5817340 to Roche et al., in view of US 4786505 to Lovegren et al.
Roche teaches a solid oral dosage form comprising an antacid and guanidinothiazole compound wherein the antacid and guanidinothiazole compound are separated by a barrier (abstract), and the composition in the form of a multilayer solid dosage form with one layer containing at least one antacid and one layer containing a guanidinothiazole compound (col. 1, l 57-col. 2, l 8).
For the antacid, Roche teaches selected from the group consisting of aluminum hydroxide, magnesium carbonate, calcium carbonate, magnesium hydroxide and mixtures of two or more thereof (col. 4, l 3-10 and col.5, l 3-10). Roche teaches 35-70% of antacid in the composition (col. 7, l 39-56). The tablet composition (col.13, l 1- 20) includes 250.0 mg of magnesium hydroxide (reads on alkaline earth metal hydroxide) that amounts to 15% of the composition. Roche particularly teaches preferred coatings such as cellulose acetate, cellulose triacetate and cellulose acetate butyrate. The amount of coating applied on as a weight percentage of the coated granules weight will vary with the coating process coating granulation and granules used. The appropriate amount of coating can be determined by determining dissolution of the active pharmaceutical suitable for the treatment of gastric disorders with various coating thicknesses (col. 8, l 28-60). Further, Roche teaches various amounts cellulose coating (in col.7-8), which falls within the range of claim 12.
Roche further teaches that the coated granules are prepared in the form of tablets (col. 9, l 6-19). The granules size is in the range of 125 microns to 500 microns (col. 7, l 34-43), and hence meets claim 13.
Roche further teaches additional excipients such as a sweetener, a binder, a lubricant, and a filler (col. 5, l 56-col. 6, 19). Roche teaches binder in an amount of 0% to 10% (col. 6, 40-45), and therefore the composition does not require any binder in the composition.
Roche reference does not teach the carbon dioxide absorbent of claim 11, however teaches magnesium hydroxide, an alkaline earth metal hydroxide.
Lovegren teaches oral composition comprising omeprazole for treating gastrointestinal disorders i.e., gastric ulcers, by inhibiting gastric acid secretion, wherein the composition is enteric coated to prevent the drug from interacting with acidic gastric juice(abstract, col. 1, l 1-55). The core further contains alkaline compounds (col. 3, l 14-33). For the cores, Lovegren teaches omeprazole mixed with alkaline reacting substances such as calcium hydroxide, magnesium hydroxide etc (col. 3, l 35-53). Lovegren further teaches a separating layer between the core and an enteric coating, and teaches including magnesium hydroxide, calcium hydroxide etc., with pH-buffering properties (col. 4, l 4-27), and hydroxypropyl cellulose, methylcellulose, hydroxypropyl methylcellulose (col. 4, l 31-45). Table 1 of Lovegren exemplifies compositions comprising omeprazole, magnesium hydroxide, and Table 2 exemplifies cellulose polymeric coating.
Therefore, it would have been obvious for one of an ordinary skill in the art to prepare the composition of Roche and further include calcium hydroxide in the core, to arrive at the instant claimed composition comprising calcium hydroxide coated with a polymeric coating made of cellulose ester. One of an ordinary skill in the art would have been motivated to do so because both Roche and Lovegren references are directed to compositions for treating acidity and thus constitute analogous teachings, and further Lovegren teaches equivalence of magnesium and calcium hydroxide in providing effective for creating a “micro pH” around the drug cores, as well as providing antacid effect. Therefore, one of an ordinary skill in the art would have expected that calcium hydroxide to be equally effective as that of magnesium hydroxide in the composition of Roche.
Roche does not clearly envisage the claimed alkaline earth metal hydroxide embedded in the claimed cellulose derivative. However, in one embodiment (Fig.3), Roche teaches the first portion containing the antacid is in the form of an inner core 20, and the second portion comprising the guanidinothiazole compound in the form of an outer layer 21 encompassing inner core 20. Barrier 22 is disposed between inner core 20 and outer layer 21 and encompasses inner core 20. Outer layer 21 encompasses barrier 22. Barrier 22 may be in the form of a thin plastic film or sheet surrounding and enclosing inner core 20, or barrier 22 may be in the form of a thin plastic film applied as a coating on the outer surface 24 of inner core 20 before outer layer 21 is formed (col. 3, l 35-50). The barrier layer 22 comprises a film forming polymer which includes ethyl celluloses, cellulose acetate butyrate, hydroxypropyl cellulose phthalate or combinations thereof (col.4, l 15-44). In this regard, Lovegren also teaches a coating of the core comprising cellulose ester, also desired by Roche and claimed in the instant claims.
Therefore, one of an ordinary skill in the art would have been able to prepare a core containing antacid including calcium hydroxide coated with cellulose ester coating, with amounts of calcium hydroxide and cellulose coating in the claimed ranges, with an expectation to provide the desired antacid effect along with an effective treatment of gastric disorders. One of an ordinary skill in the art would be able to employ optimum amounts of calcium hydroxides because Lovegren exemplifies (Table 1, examples 7-8) compositions with varying amounts of hydroxide and still achieve an antacid effect as well as protect omeprazole for gastric acids.
With respect to “carbon dioxide absorbent”, even though Roche does not teach magnesium hydroxide as a carbon dioxide absorbent, a product and its properties are inseparable. In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
Instant “comprising” language allows for the presence of guanidinothiazole compound of Roche. Instant limitation “for in vivo prophylaxis or treatment of an acute or chronic respiratory disease in mammals” refers to an intended use Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).
3. Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 5817340 to Roche et al. in view of US 4786505 to Lovegren et al, as applied to claims 11-13 above, and further in view of Stewart et al (Stewart).
Roche and Lovegren, discussed above, fail to teach the instant claimed silicone coating.
Stewart teaches polymeric materials for drug delivery and suggests several types of polymers. Stewart teaches polysiloxanes (page 9/24) and cellulose (11/24) as suitable drug release. Among the polysiloxanes, Stewart teaches vulcanized silicones using a two-component poly(dimethylsiloxanes) (PDMS) in the presence of platinum-based catalyst (4.2.1). Further, Stewart suggests that PDMS forms a rate controlling membrane to control the diffusivity of the drug. Stewart further teaches cellulose esters/ethers as being suitable for providing drug delivery (p 11/24), including oral tablets (p 16/24).
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the pharmaceutical composition of Roche modified by Lovegren, and further employ a drug delivery coating polymer comprising a vulcanized silicone such as that suggested by Stewart, over the said formulation with an expectation to provide a controlled release of guanidinothiazole compound and magnesium hydroxide. One of an ordinary skill in the art would have been motivated to do so because Stewart suggests the claimed silicone coating (vulcanized silicones using a two-component poly(dimethylsiloxanes) (PDMS) in the presence of platinum-based catalyst) for forming a rate controlling membrane that controls the diffusivity of the drug that is being coated, and further teaches the coating for a tablet composition, thus constituting analogous art. Hence, one of an ordinary skill in the art would have been able to choose to appropriately fill the granules in to a capsule or compress to for a solid formulation such as a tablet, and still provide a controlled release of the composition of Roche. Thus, one of an ordinary skill in the art would have expected to control the release of the composition of Roche (modified by Lovegren) with the coating of Stewart.
3. Claim(s) 11-13 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 5817340 to Roche et al., in view of US 4786505 to Lovegren et al., as applied to claims 11-13 and further in view of US 20020039597 to Ukai et al.
Roche and Lovegren, discussed above, fail to teach the instant claimed alkali metal hydroxides.
Ukai teaches an oral composition comprising benzimidazole type compound and at least one “substance” selected from sodium carbonate, potassium carbonate, sodium hydroxide, potassium hydroxide, aminoalkyl methacrylate copolymer E, arginine aspartate, hydroxypropyl cellulose and crospovidone incorporated into a benzimidazole type compound or an alkali metal salt thereof (abstract). Ukai teaches a core comprising sodium hydroxide and coated with an intermediate coating and further an enteric coating [0008], and further with a moisture resistant coating [0009]. Ukai teaches sodium hydroxide is effective and further teaches 0.01 to 20 parts by 1 part of weight of the benzimidazole type compound [0018]. For the coating materials, Ukai teaches polymers such as hydroxypropyl cellulose, ethyl cellulose etc [0026, 0029] and table 3, which meets instant claimed cellulose coating. Thus, Ukai teaches the instant claimed alkali metal hydroxide coated or encapsulated with a cellulose ether, and further suggests amounts that meet the instant claimed components and further suggests the claimed amounts (of claim 11).
Hence it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare the pharmaceutical composition of Roche modified by Lovegren, and further add sodium hydroxide or potassium hydroxide of Ukai, because Ukai also teaches compositions for treating gastric acidity (analogous to Roche and Lovegren references) and suggests sodium hydroxide or potassium hydroxide for providing stability to the composition. One of an ordinary skill in the art would have expected to provide further stability to the composition of Roche (modified by Lovegren).
Response to Arguments
Upon further consideration, the following rejection has been withdrawn:
Claim(s) 11-13, 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20020039597 to Ukai et al., in view of US 5817340 to Roche et al.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 20020039597 to Ukai et al., in view of US 5817340 to Roche et al., as applied to claims 11-13, 16 and 21 above, and further in view of Stewart et al (Stewart).
Applicant's arguments filed 8/7/25 have been fully considered but not found persuasive.
Applicants argue that Roche et al is silent with respect to the claimed calcium hydroxide and instead teaches magnesium hydroxide. It is argued that the formulation of Roche differ in three aspects: 1. Calcium hydroxide as a strong base cannot be used as antacid. 2. The claimed encapsulation prevents the release of the strongly basic and thus caustic substance calcium hydroxide into the GI tract, whereas Roche et al. require the release of the antacid to have a therapeutic effect. 3. The encapsulated calcium hydroxide allows a carbon dioxide absorption within the capsule/coating and keeping it encapsulated leads to a reduction of the carbon dioxide within the treated patient, allowing its therapeutic use for the treatment of acute or chronic respiratory disease in mammals, and therefore teach away from the instant claims.
Applicants’ arguments have been considered but not found persuasive because the present rejection does not rely on Roche et al reference alone. Instead, in light of the amendment, the present rejection relied additionally on the teachings of US 4786505 to Lovegren et al. Lovegren teaches equivalence of calcium and magnesium hydroxides for creating a “micro pH” around the drug cores, as well as providing antacid effect. With respect to the argument that encapsulated calcium hydroxide allows a carbon dioxide absorption within the capsule/coating and keeping it encapsulated leads to a reduction of the carbon dioxide within the treated patient, allowing its therapeutic use for the treatment of acute or chronic respiratory disease in mammals, instant claims are directed to a product and not a method of treatment, and hence the argument is not persuasive.
Applicants’ argument that Ukai does not teach the claimed calcium hydroxide is not found persuasive because the present rejection relies on Ukai only for sodium hydroxide or potassium hydroxide for providing stability to the composition of Roche (modified by Lovegren).
Applicants’ argument that Stewart adds nothing to the teachings of Roche et al and Ukai et al. The argument is not persuasive because the arguments regarding Roche and Ukai have been addressed above. Since Applicants have not provided any specific arguments regarding the teachings of Stewart and hence the rejection has been maintained.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKSHMI SARADA CHANNAVAJJALA whose telephone number is (571)272-0591. The examiner can normally be reached Generally M- F 9 AM to 6 PM.
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, Bethany Barham can be reached on 571-272-6175. 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.
/LAKSHMI S CHANNAVAJJALA/ Primary Examiner, Art Unit 1611