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 .
DETAILED ACTION
Status of Claims
Claims 58-75 are pending.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 58-60 and 64-67 are rejected under 35 U.S.C. 103 as being unpatentable over WO2015/120133 (hereafter, Li) in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Li discloses a crystalline free base ansolvate forms of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (Compound 1):
PNG
media_image1.png
174
170
media_image1.png
Greyscale
and a pharmaceutical composition thereof (abstract, [0027], claims 1 and 20).
Li discloses that suitable dosage forms include tablets and capsules ([0088]). Li teaches that the compositions is used in conjunction with any of the vehicles and excipients commonly employed in pharmaceutical preparations and coloring and flavoring agents may also be added to preparations, particularly to those for oral administration ([0090] and [0091]). Li further teaches that solid pharmaceutical excipients include starch, cellulose, hydroxypropyl cellulose, talc, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, magnesium stearate, sodium stearate, glycerol monostearate, sodium chloride, dried skim milk and the like ([0091]).
Li discloses a method for treating oxygen deficiency associated with sickle cell anemia (sickle cell disease), the method comprising administering to a subject in need thereof a therapeutically effective amount of the crystalline solvate forms of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde ([0029] and claim 11).
While Li teaches and suggest a tablet comprising the claimed compound with excipients commonly employed in pharmaceutical preparations including celluloses, silica and magnesium stearate (lubricant), and coloring and flavoring agents, Li dose not disclose a specific embodiment of a dispersible tablet comprising a filler such as microcrystalline cellulose, a disintegrant such as croscarmellose sodium, a glidant such as colloidal silicone dioxide, and the specific concentration of the Compound 1 and the excipients. Also, Li dose not specifically discloses iron oxide pigment as coloring agent.
Battung teaches the use of a dispersible tablet for the treatment of iron overload in transfusion dependent anemias including sickle cell diseases wherein the table comprises 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid (Compound I) in an amount of from 42% to 65% by weight based on the total weight of the tablet and at least one pharmaceutically acceptable excipient suitable for the preparation of dispersible tablets and a process for making said dispersible tablet (abstract and ([0069]).
Battung further discloses thar the dispersible tablet comprises the following pharmaceutically acceptable excipients: one or more fillers such as microcrystalline cellulose in a total amount of about 30% to 50% by weight, one or more binders such as polyvinylpyridone, hydroxypropylmethyl cellulose in a total amount of about 1.5% to 5% by weight, one or more disintegrants such as CMC-Na (croscarmellose sodium) and Crospovidone in a total amount of about 2% to 8% by weight, one or more surfactant such as sodium lauryl sulfate in a total amount of about 0.01% to 1.5% by weight, one or more glidants such as colloidal silicon dioxide in a total amount of about 0.1% to 5% by weight, and one or more lubricants such as magnesium stearate in a total amount of about 0.45% to 0.85% by weight, based on the total weight of the dispersible tablet ([0019], [0021]-[0026]) and [0036]). Also, Battung discloses the dispersible tablets may be colored and/or marked so as to impart an individual appearance and to make them instantly recognizable and dyes suitable for use in pharmacy typically include carotinoids, iron oxides or chlorophyll ([0068]).
Battung also teaches that the dispersible tablets are, despite the high drug loading, dispersible in aqueous media (e.g., water) in less than 5 minutes, preferably less than 3 minutes, and, therefore, convenient to administer to patients and this leads to a better patient compliance ([0043]). Battung further teaches this invention provides a dispersible tablet comprising more than 800 mg of Compound I as active ingredient, e.g., of from 900 mg to about 1100 mg, e.g., 1000 mg and most preferably, dispersible tablets according to the invention are dispersible tablets containing 1000 mg of Compound I as active ingredient ([0044]).
Battung further teaches that the dispersible tablet comprises an inner phase (intragranular) and outer phase (extragranular) wherein the inner phase is granulated with the granulation liquid comprising one or more surfactant and/or one or more binder, e.g. an aqueous solution of sodium lauryl sulfate and PVP K.30 and the outer phase comprises one or more fillers, one or more glidants, one or more disintegrant and one or more lubricant ([0046]-[0048], [0058], and [0059]). Battung further teaches that the filler is preferably microcrystalline cellulose and preferably the amount of one or more fillers in the outer phase is ranging from about 5 to 50% by weight based on the total weight of the dispersible tablet, more preferably from about 10 to 45% by weight ([0021] and [0048]). Battung further teaches that the amount of disintegrant present in the inner phase is preferably ranging from 2 to 8% based on the total weight of the dispersible tablet ([0022] and [0048]). Battung further teaches that the outer phase may also contain one or more glidants, most preferably colloidal silicon dioxide and the amount of glidant in the outer phase is ranging from about 0.1 to 5%, preferably from about 0.1 to 2.5%, most preferably from about 0.1 to 1%, e.g. 0.5%, in weight based on the total weight of the tablet ([[0048]). Battung further teaches that the outer phase may also contain one or more lubricant in an amount of from about 0.45 to 0.85%, preferably 0.5 to 0.8%, e.g. 0.5 to 0.7%, e.g. 0.5% in weight based on the total weight of the tablet ([0026] and [0048]). The concentration ranges fall within overlap those claimed. In addition, Battung teaches that one or more of these pharmaceutically acceptable excipients may be selected and used having regard to the particular desired properties of the dispersible tablet by routine experimentation ([0027]). Battung teaches that the dispersible tablet of the present invention is dispersible in an aqueous phase, preferably water ([0067]).
Also, it was known in the art that fast disintegrating drug delivery systems have started gaining popularity and acceptance as new drug delivery systems because they are easy to administer and lead to better patient compliance and various drugs can be prepared in fast disintegrating tablets (FDT) as evidenced by Deepak et al. (p74, col 1, para 1 and p77, Table 1). Deepak et al. teach that one important drawback of conventional tablets and hard gelatin capsules is “Dysphagia‟ or difficulty in swallowing for many patients and US FDA defined fast-dissolving/disintegrating tablets (FDDTs) are “A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue” (p74, col 2, para 1). Fast disintegrating tablets (FDT) are also known as “fast-dissolving”, “orodispersible”, or “quick dissolving” tablets (p74, col 2, para 1). Deepak et al. further disclose that excipients used in FDTs contain at least one superdisintegrant (1-15%), a diluent (filler, 0-85%), an antistatic agent (glidant and lubricant, 0-10%) and optionally a swelling agent, a permeabilizing agent, sweeteners and flavorings (p78, 6. 6. EXCIPIENTS COMMONLY USED FOR FDTs PREPARATION and Table 2). Common superdisintegrants used in formulation are croscarmellose sodium (p78, 6.1. Superdisintegrants and Table 3). The most common antistatic agents (glidant) used are colloidal silica, magnesium stearate is used as lubricant, and diluents are most commonly selected from cellulose derivatives and preferably microcrystalline cellulose (p80, 6.3).
It would have been prima facie obvious to one of ordinary skill in the art to prepare the compound of Li in a dispersible tablet because of the following reasons. Li discloses a base product (a tablet comprising the claimed compound 1 or its crystalline form) and excipients commonly employed in pharmaceutical preparations) upon which the claimed invention can be seen as an "improvement”. The claimed invention is an improvement on the base product because dispersible tablets provide advantages over conventional tablets. Dispersible tablets are taught to facilitate ease of medication and are thus more suitable for those having difficulty in swallowing, thereby improving patient compliance as evidenced by Battung and Deepak et al. Also, Battung teaches and suggests the use of a dispersible tablet for the treatment of sickle cell diseases. Thus, one of ordinary skill in the art would have been motivated to apply the technique disclosed in Battung and Deepak et al., the method of preparing a dispersible tablet comprising an active compound, a filler such as microcrystalline cellulose, a disintegrant such as croscarmellose sodium, a glidant such as colloidal silicone dioxide, a known coloring agent such as iron oxide pigment as, and sweetening and flavoring agents to the base product of Li in order to provide an alternative oral dosage form, which is easily swallowed by patients in the treatment of sickle cell disease.
One of ordinary skill in the art would have recognized that applying the known technique to the base product would have yielded the predictable result of getting a dispersible tablet of the Compound 1 and resulted in an improved product. Fast disintegration and easier administration would have been expected to increase patient compliance with the product for recommended treatment regimens.
As to the specific percentages of ingredients, Battung and Deepak et al. teach the range overlapping those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 Obviousness of Ranges. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Claims 61-63 and 68-75 are rejected under 35 U.S.C. 103 as being unpatentable over WO2015/120133 (hereafter, Li) in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86) as evidenced by US 2009/0087485.
Li, Battung, and Deepak et as applied supra are herein applied for the same teachings in their entirety.
They do not specifically disclose specific excipients for intragranular and extragranular components, sucralose as sweetener, and grape flavor as flavoring agent.
However, Battung already discloses dispersible tablets comprises an inner phase (intragranular component) and outer phase (extragranular component), which include similar excipients as stated above. Also, sucralose and grape flavor were well-known sweetening and flavoring agent, which are commonly used for orally disintegrating tablets as evidenced by US 2009/0087485 (abstract, [0047], and [0051]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare dispersible tablets comprises an intragranular component and extragranular component using known excipients disclosed in Battung and to use sucralose and grape flavor as sweetening and flavoring agents for the tablet for improving taste and flavor of the tablet. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07.
As to the specific percentages of excipients in intragranular and extragranular components, Battung and Deepak et al. teach the ranges of overlapping those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 Obviousness of Ranges. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US 10,493,035 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘035 patent are drawn to tablets comprising the same compound and the same excipients such as microcrystalline cellulose (filler), croscarmellose sodium (disintegrant), magnesium stearate (lubricant); sodium lauryl sulfate (surfactant) and colloidal silicon dioxide (glidant) in the concentration ranges, which fall within or overlap those claimed. The claims of the patent are silent about the tablet being dispersible. However, the tablets of the patent comprise the same compound and the same excipients in the same amounts as claimed, the tablet necessarily has the same property as claimed. It is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In the alternative, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets using the same excipients for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the crystalline ansolvate of Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the crystalline ansolvate of Compound 1, thereby increasing patient compliance for recommended treatment regimens.
Also, the claims of the patent do not specifically recite a sweetener, a flavoring agent and a coloring agent. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to use known sweetener, flavoring and coloring agents for the dispersible tablet for improving taste, flavor, and appearance of the tablet. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of US 9,447,071 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘071 patent are drawn to crystalline ansolvate of claimed Compound 1 and a pharmaceutical composition thereof. The claims of the patent do not specifically recite a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the crystalline ansolvate of Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the crystalline ansolvate of Compound 1, thereby increasing patient compliance for recommended treatment regimens.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US 10,137,118 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘118 patent are drawn to the claimed Compound 1 and a pharmaceutical composition thereof. The claims of the patent do not specifically recite a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the Compound 1, thereby increasing patient compliance for recommended treatment regimens.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of US 10,722,502 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘502 patent are drawn to a composition comprising a crystalline ansolvate of claimed Compound 1. The claims of the patent do not specifically recite a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the crystalline ansolvate of Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the crystalline ansolvate of Compound 1, thereby increasing patient compliance for recommended treatment regimens.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of US 10,017,491 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claim of ‘491 patent are drawn to a pharmaceutical composition comprising the claimed Compound 1 and a pharmaceutically acceptable excipient. The claims of the patent do not specifically recite a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the Compound 1, thereby increasing patient compliance for recommended treatment regimens.
As such, the instant claims would have been obvious over by the claim of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of US 10,034,879 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘879 patent are drawn to the claimed Compound 1 and a solid dosage form comprising the Compound 1 and a pharmaceutically acceptable excipient. The claims of the patent do not specifically recite a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the Compound 1, thereby increasing patient compliance for recommended treatment regimens.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of US 11,020,382 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘382 patent are drawn to a method for treating a sickle cell disease by administering the claimed Compound 1 or a crystalline ansolvate of claimed Compound 1. The claims of the patent do not specifically recite the use of the compound in a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the crystalline ansolvate of Compound 1. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the Compound 1, thereby increasing patient compliance for treating a sickle cell disease.
As such, the instant claims would have been obvious over by the claims of the patent.
Claims 58-75 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US patent 11944612 in view of US 2008/0311194 (hereafter, Battung) and Deepak et al. (Journal of Drug Delivery & Therapeutics; 2012, 2(3):74-86).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘612 patent are drawn to a method for treating a sickle cell disease by administering the claimed Compound 1 in a crystalline ansolvate and a capsule dosage form comprising the crystalline ansolvate. The claims of the patent do not specifically recite the use of the compound in a dispersible tablet comprising the claimed excipients. However, those excipients were commonly used for preparing dispersible tablets, which improve patient compliance due to easy medication as evidenced by Battung and Deepak et al. (see the detailed teachings in 103 rejection). It would have been obvious to one of ordinary skill in the art to apply the known technique of preparing dispersible tablets for the compound of the patent on the reasonable expectation of getting a dispersible tablet comprising the Compound 1 as alternative oral dosage form. The skilled artisan would have been motivated to do so for getting a pharmaceutical composition which would facilitate fast disintegration and easier administration of the Compound 1, thereby increasing patient compliance for treating a sickle cell disease.
As such, the instant claims would have been obvious over by the claims of the patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
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 an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
Prosecution Insights