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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 7, 2025 has been entered.
Response to Amendment
By Applicant’s amendment filed on November 7, 2025, claims 19 and 29 have been amended, claims 26-28 and 30-33 have been canceled, and new claims 40-41 have been added. Claims 1-18 were previously canceled. Claims 19-25, 29 and 34-41 are currently presented for examination.
Response to Arguments
Applicant's arguments filed November 7, 2025 with respect to the rejection under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that none of the cited references teach an enema composition that is produced by combining an active agent in a dry non-aqueous form with water, a thermo-active polymer, and one or more lipids, wherein the active agent is not suspended in water prior to the combining step, to produce a lipidic suspension in which the active agent is dispersed in the suspension.
Applicant argues that Lichtenberger discloses three methods of preparation of 5-ASA formulations. The first method comprises mixing 5-ASA with lecithin oil containing PC, which created an oil-based formulation, to which a pH-sensitive polymer was added to form polymer encapsulated microspheres of 5ASA. Lichtenberger, paragraph [0042]. The second method disclosed in Lichtenberger discloses suspending 5-ASA in water or an appropriate aqueous solution, and aqueous solution is then added to a second container coated with a dried lipid film of PC paragraphs [0037] and [0043]. The third method teaches mixing phospholipids and 5-ASA to a temperature where 5-ASA melts in the phospholipid to form covalent bonds and/or molecular complexes of lipid and 5-ASA paragraphs [0037], [0038].
Applicant argues that unlike the methods taught in Lichtenberger, the method recited in the currently pending claims do not involve the use of an oil-based lipid formulation, or addition of a suspension of active agent in water, which is then added to a lipid film, or formation of molecular complexes of phospholipids and the active agent by heating to a high temperature. In contrast, the pending independent claim 19 recites a process of producing an enema composition by combining mesalazine in a dry, non-aqueous form, with water, a thermo-active polymer, and one or more lipids to produce a lipidic suspension, wherein the active agent is not suspended in water prior to combining with water, a thermo-active polymer, and one or more lipids.
Applicant argues that the enema compositions produced by the process recited in the instant claims are advantageous over the methods described in Lichtenberger. Specifically, the claimed method does not involve the use of oil-based lipid formulation and does not involve the exposure of the active agent in water for an extended duration before the active agent is mixed with a dried lipid film. Because the active agent is not dissolved or suspended in water prior to being mixed with lipids, the enema compositions of the invention demonstrate lower degradation of the active agent as compared to the formulations prepared by methods disclosed in Lichtenberger. This is unexpected and surprising. Because there is lower degradation of the active ingredients in the enema composition produced by the process recited in independent claim 1, they will provide a benefit over the enema compositions produced by processes provided in Lichtenberger. Applicant further argues that the instability of mesalamine in water is known as taught in the provided reference Palsmeier et al. and not just merely an argument by counsel.
These arguments are found not persuasive since as previously argued the cited claims of the instant application claim a method of treating inflammatory bowel disease (IBD), comprising treating IBD in a patient in need of such treatment with an enema composition that exhibits a gel transition temperature between 32°C and 38°C, wherein: the enema composition is produced by combining an active agent in a dry, non- aqueous form with water, a thermo-active polymer, and one or more lipids to produce a lipidic suspension into which the active agent is dispersed, wherein the active agent is not suspended in water prior to the combining step; and the enema composition is at a temperature of less than 30°C when administered. Thus the claims of the instant application require combining mesalazine (also known as mesalamine or 5-aminosalicylic acid, 5-ASA) with water at some point in the method. Applicant should demonstrate that the order of their method provides improved results as compared to the order of the method demonstrated in the prior art.
Lichtenberger specifically teaches a method of treating IBD comprising the administration of a formulation comprising 5-ASA which may be administered in the form of an enema wherein the composition is produced by suspending 5ASA or a 5ASA containing pharmaceutical in water or an appropriate aqueous solution, the aqueous solution is then added to a second container coated with a dried lipid film of PC, the resulting mixture is then subjected to vigorous mixing, vortexing, sonication or other means of agitation to form an aqueous lipidic suspension for oral, enteral or rectal (enema) administration (abstract and [0043]). Lichtenberger further teaches including components in the formulation that facilitate release of the 5ASA-containing component in the distal gut such as polymers [0010]. Thus, Lichtenberger teaches preparing the formulation by combining an active agent in the dry form with water and the lipid to produce a lipidic suspension with the active agent dispersed therein. Although, Lichtenberger does not teach adding the thermo-active polymer, the teachings of Charrueau et al. cures this deficiency by providing motivation to add poloxamer 407 to the enema formulation with a reasonable expectation of improving the properties of the enema formulation of Lichtenberger. Thus, by adding the poloxamer 407 to the enema composition of Lichtenberger, which contains the active agent, water and the lipid, the method of producing the product as claimed in claim 20 of the instant application is rendered obvious.
Thus the prior art teaches a similar method of preparing the 5-ASA formulation as claimed. Furthermore, Applicant has not demonstrated criticality for how the product is produced. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). With respect to Applicant’s argument that their method does not involve the exposure of the active agent in water for an extended duration before the active agent is mixed with a dried lipid film, the prior does not teach or suggest exposing the active agent to only water for any extended duration of time. Lichtenberger specifically teaches the composition is produced by suspending 5ASA or a 5ASA containing pharmaceutical in water or an appropriate aqueous solution, the aqueous solution is then added to a second container coated with a dried lipid film of PC, the resulting mixture is then subjected to vigorous mixing, vortexing, sonication or other means of agitation to form an aqueous lipidic suspension for oral, enteral or rectal (enema) administration [0043]. Thus the prior art does not teach or suggest that the active agent must be exposed to only water for an extended period of time to risk any degradation of the active agent as argued by Applicant. Furthermore Applicant has not demonstrated that there would be any advantage for the active agent not being suspended in water prior to the combining step as claimed, over adding water to the active agent followed by the lipid as taught in the prior art. Applicant argues that mesalazine is instable in water, however, the claims of the instant application require water and Applicant does not show that their method of producing the composition protects mesalazine from the water in the method of the instant claims vs. the method of Lichentenberger.
It has been held that merely changing the order of steps in a multi-step process is not a patentable modification absent a showing of unexpected results. Ex parte Rubin 128 USPQ 440 (POBA 1959).
All Applicant presents is attorney argument, but “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Moreover, it is maintained that the claims of the instant application recite the use of a product produced by a certain process. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. In the instant case, the prior art renders obvious, preparing an enema composition comprising the same components as claimed in a similar method of producing the composition which is combining a dry active agent (Mesalazine, mesalamine or 5-aminosalicylic acid (5-ASA)) with water, the lipid, and a thermo-active polymer to form a lipidic suspension for rectal (enema) administration. Thus, in the absence of a demonstration of improved or unexpected results for the use of the claimed product produced by the claimed process of preparing the composition, the claims of the instant application are rendered obvious for reasons of record.
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Applicant further argues that the other references cited in the Office Action do not cure this deficiency of Lichtenberger since Charrueau discloses compositions of short-chain fatty acid solutions and does not disclose a method of producing an enema composition by combining an active agent in a dry, non-aqueous form with water, a thermo-active polymer, and one or more lipids to produce a lipidic suspension, wherein the active agent is dispersed in the lipidic suspension, as claimed. Similarly, Devi also does not provide a method of producing enemas by mixing an active agent in a non-aqueous dry state, with water, thermo-active polymer and a non-ionic polymer. Devi teaches properties of poloxamers as gelling agents at physiological temperatures (Devi, page 159). Applicant further argues that the disclosures of Lichtenberger, Charrueau, and/or Devi would not provide a reasonable expectation of success to a person of ordinary skill in the art to administer an enema composition produced by combining an active agent in a dry, non-aqueous form with water, a thermo-active polymer, and one or more lipids to produce a lipidic suspension to treat patients with IBD as claimed.
These argument are found not persuasive for the reasons as detailed above. The teachings of Charrueau and Devi were provided for reasons of record to cure the deficiencies of the inclusion of a triblock copolymer such as Poloxamer 407 and poloxamer 188 as the thermo-active polymer.
Accordingly, the previous rejections under 35 USC 103 are hereby maintained and reproduced below. The new claims are also being rejected on the same grounds. With respect to claim 40 the rejection of record renders obvious combining the polymer to the formulation which contains water, and thus in the absence of a demonstration of criticality for mixing the polymer with water prior to the adding step, claim 40 is rendered obvious. Claim 41 is rendered obvious since Charrueau specifically teaches adding the polymer (poloxamer 407) to the active agent using the cold method which is in an ice bath at 5° C (page 353). Thus new claims 40 and 41 do not add any limitations to the claims that overcome the rejections of record. Accordingly, this action is FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 19-23, 25, 29 and 34-41 are rejected under 35 U.S.C. 103 as being unpatentable over Lichtenberger U.S. Publication No. 2008/0020056 A1 (Provided on IDS) in view of Charrueau et al. (2001, Drug Development and Industrial Pharmacy, 27(4), pages 351-357) (Provided on IDS).
Claims 19-23, 25, 29 and 34-41 of the instant application claim a method of treating inflammatory bowel disease (IBD) comprising treating a patient in need thereof with an enema composition that has a gel transition temperature between 32° and 38°C, wherein the enema composition is produced by combining an active agent such as the salicylic acid derivative mesalazine or mesalamine in a dry, non-aqueous form with water, a thermo-active polymer such as a triblock copolymer such as Poloxamer 407, one or more lipids such as a mixture of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and dipalmitoylphosphatidylcholine (DPPC), to produce a lipidic suspension into which the active agent is dispersed, wherein the active agent is not suspended in water prior to the combining step, and the enema composition is at a temperature of less than 30° C when administered.
Lichtenberger teaches a composition comprising a 5-amino salicylic acid (5ASA) and a phospholipid for treating inflammatory bowel disease (IBD) (abstract). Inflammatory bowel disease represents a family of ulcerative diseases including ulcerative colitis and Crohn’s disease that affect the colon and distal small bowel [0007]. Lichtenberger teaches unique formulations for treating inflammatory bowel disease (IBD), such as ulcerative colitis, including 5-amino salicylic acid (5ASA) and a phospholipid such as phosphatidylcholine (PC) in a bio-compatible carrier and/or resin, wherein the unique compositions of matter including 5ASA and phospholipid are adapted to release 5ASA in a distal small intestine and/or colon, where lesions due to colitis or Inflammatory Bowel Disease (IBD) are present in order to enhance the anti-inflammatory efficacy of 5ASA [0003] [0004]. The compositions may be administered orally, enterally and/or rectally [0004]. The 5-amino salicylic acid containing component may be mesalamine [0010] [0011].
Lichtenberger teaches that compositions of 5-amino salicylic acid (5ASA) and 5ASA based pharmaceuticals and phospholipids such as phosphatidylcholine have improved activity to reduce colitis [0035] [0039]. Lichtenberger teaches that the phospholipids are phospholipids enriched in phosphatidylcholine (PC) or a derivative of phosphatidylcholine [0035]. These 5ASA/PC formulations are capable of being administered orally, enterally, or rectally (enema) for treatment or amelioration of GI inflammation, ulceration, bleeding and other symptoms associated with inflammatory bowel disease (IBD), and its associated sequelae of diarrhea, fever and pain [0035]. Lichtenberger teaches that the compositions comprising 5ASA and a phospholipid enhance anti-inflammatory benefits of the 5ASA and fortify hydrophobic barrier properties of affected mucosa, which are attenuated in IBD [0035].
Lichtenberger teaches a method for preparing a composition including a phospholipid and 5ASA such as mesalamine, generally, in a weight ratio of 5ASA to phospholipid between about 1:10 and about 10:1, or between about 1:5 and about 5:1, or ratio 2:1 and about 1:2 such as about 1:1 [0036]. These formulations can be prepared by taking a powder containing 5ASA (e.g., Mesalamine, Sulfsalazine, Olsalazine, Balsalazide, or mixtures thereof) and simply mixing it with a phospholipid [0036].
Suitable phospholipids include mixtures and combinations of zwitterionic phospholipids including phosphatidylcholines such as dipalmitoylphosphatidylcholine (DPPC), distearoylphosphatidylcholine, etc. [0040] [0041]. Lichtenberger teaches the preparation of a composition comprising 5ASA in a soy lecithin oil and further teaches an alternative method to the oil-based formulation is to suspend 5ASA or a 5ASA containing pharmaceutical in water or an appropriate aqueous solution, wherein the aqueous solution is then added to a second container coated with a dried lipid film of PC, and then the resulting mixture is then subjected to vigorous mixing, vortexing, sonication or other means of agitation to form an aqueous lipidic enema suspension for rectal administration [0043].
Lichtenberger teaches preparing the formulation by first making an aqueous solution comprising 5ASA, wherein the aqueous solution is then added to a second container coated with a dried lipid film of PC, and then the resulting mixture is then subjected to vigorous mixing, vortexing, sonication or other means of agitation to form an aqueous lipidic enema suspension for rectal administration [0043].
Thus Lichtenberger discloses a method of treating inflammatory bowel disease (IBD) comprising treating a patient in need thereof with an enema composition wherein the enema composition is produced by combining mesalazine or mesalamine in a dry, non-aqueous form with water, and one or more lipids such as a mixture of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), to produce a lipidic suspension into which the active agent is dispersed and the enema composition is at room temperature which is less than 30° C when administered.
Lichtenberger does not specifically exemplify the combination of DSPC and DPPC as the phospholipid component. Lichtenberger does not teach the inclusion of Poloxamer 407. Lichtenberg does not teach the specific amounts of each component as claimed. Lichtenberg does not teach that the active agent is not suspended in water prior to the combining step.
Although Lichtenberger does not specifically exemplify the combination of DSPC and DPPC as the phospholipid component, Lichtenberger teaches that dipalmitoyl phosphatidylcholine (DPPC) is a preferred zwitterionic phospholipid and furthermore teaches that mixtures and combinations of zwitterionic phospholipids including phosphatidylcholines such as dipalmitoylphosphatidylcholine (DPPC) and distearoylphosphatidylcholine (DSPC). [0040] [0041]. Accordingly, prior to the effective filing date of the instant application, it would have been obvious to a person of ordinary skill in the art to use mixtures of zwitterionic phospholipids including the preferred DPPC in combination with any other phospholipid disclosed therein including DSPC with a reasonable expectation of similar success. Thus, although Lichtenberger includes DPPC and DSPC on a list that includes other suitable phospholipids, a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Thus, selecting a mixture of DPPC and DSPC would have been seen as selecting an obvious alternative to yield predictable results.
Although Lichtenberger does not teach the inclusion of a triblock copolymer such as Poloxamer 407 as a thermo-active polymer, Lichtenberger teaches that IBD represents a family of ulcerative diseases that affect the colon and distal small bowel and thus treatment involves administration of active agents in the distal gut [0007]. Lichtenberger teaches that the release of 5 ASA can cause its intended therapeutic effect, while the release of the phospholipid helps maintain or restore the hydrophobic barrier of the affected mucosa of the distal gut, inhibits inflammation and promotes healing [0038]. Thus, Lichtenberger teaches that components can be included in the formulation such that the active ingredients are released in the distal gut.
Charrueau et al. teaches that studies have clearly demonstrated that enemas can deliver drugs up to the splenic flexure and that local application of drugs has several advantages over oral therapy, including delivery of high concentrations to the mucosa and better response rates (page 352). Charrueau et al. teaches a major disadvantage of an enema is the inconvenience of handling the enema or the incapability of retaining it due to disease (page 352). Charrueau et al. further teaches that the liquid form requires bed rest after introduction and these problems may be overcome in part by the use of mucoadhesive gel preparations which could result in longer persistence in the colon and less interference with daily life activities (page 352). Charrueau et al. teaches the preparation of a gel rectal solution to make the formulation bioadhesive to decrease the loss of drug in the colonic lumen to thereby optimize drug absorption, reduce the number of administrations per day, and improve the patient comfort (page 352). Charrueau et al. teaches that gelling of the rectal solution should remain compatible with easy administration of the preparation which should be fluid at room temperature (page 352).
Charrueau et al. teaches the use of poloxamer 407 for the rectal solution which forms micelles at low concentration and clear, thermoreversible gels at high concentrations (page 352). Charrueau et al. teaches that poloxamer 407 is chemically inert and have very low toxicity and the gel formation process is characterized by a sol-gel transition temperature wherein below this temperature the sample is fluid allowing comfortable and precise delivery and above this temperature, the solution gels (page 352). Charrueau et al. teaches optimizing the solution such that a suitable gelling temperature is reached and the release of the drug is suitable (pages 353-354). Charrueau et al. teaches that poloxamer 407 solutions are fluid at room temperature (20-25° C) and at 37°C the behavior of poloxamer 407 solutions changed depending on the polymer concentration (page 354). Charrueau et al. teaches the sol-gel transition temperature of poloxamer 407 solutions is dependent on the polymer concentration and the ionic content of the solution (page 355). Charrueau et al. teaches that poloxamer 407 should be assessed to determine compatibility with the components of the solution and to determine the range of concentrations that could provide solutions that are liquid at room temperature and that gel at physiological temperature (page 355). Thus Charrueau et al. teaches that poloxamer 407 is a suitable additive for enema preparations which improves the properties of the enema composition by causing gelling of the enema at physiological temperatures and thus improve administration.
Accordingly, prior to the effective filing date of the instant invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Lichtenberger which teaches an aqueous solution comprising 5ASA and a phospholipid for rectal administration in the form of an enema for the treatment of IBD which represents a family of ulcerative diseases that affect the colon and distal small bowel and thus treatment involves administration of active agents in the distal gut and moreover teaches that components can be included in the formulation such that the active ingredients are released in the distal gut, with the teachings of Charrueau et al. which teaches that poloxamer 407 is a suitable additive for enema preparations which improves the properties of the enema composition by causing gelling of the enema at physiological temperatures and thus improve administration. Thus, since Charrueau et al. teaches the advantages of an enema preparation and furthermore teaches the benefits of using poloxamer 407 in the enema formulation, an ordinary skilled artisan would have been motivated to add poloxamer 407 to the formulation of Lichtenberger and optimize the amount added such that the formulation is liquid at room temperature and gels at physiological temperatures. Thus, adding poloxamer 407 to the enema formulation taught in Lichtenberger which comprising water, 5ASA and a phospholipid, at the amounts as claimed such that the composition exhibits a gel transition temperature between 32° and 38°C as claimed is rendered obvious in view of the cited prior art teachings.
With respect to the amounts if each component as claimed, said amounts are rendered obvious since the prior art teaches the same use as claimed in the instant claims which is for the treatment of inflammatory bowel disease including ulcerative colitis and Crohn’s disease. Thus, an ordinary skilled artisan would necessarily arrive at the same amounts as claimed since the formulation contains the same components for treating the same conditions as claimed. Please note that it is obvious to vary and/or optimize the amounts of components provided in a composition such that optimal treatment results are achieved.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Furthermore, it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Although Lichtenberg does not teach that the active agent is not suspended in water prior to the combining step, Lichtenberg does teach that the enema composition is produced by combining mesalazine or mesalamine in a dry, non-aqueous form with water, and then combining the aqueous solution to the one or more lipids such as a mixture of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), to produce a lipidic suspension into which the active agent is dispersed. Thus Lichtenberg teaches combining the water in the first step whereas the claims recite combining all components with water during the final step. It has been held that merely changing the order of steps in a multi-step process is not a patentable modification absent a showing of unexpected results. Ex parte Rubin 128 USPQ 440 (POBA 1959).
Moreover, the claims of the instant application recite the use of a product produced by a certain process. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. In the instant case, the prior art renders obvious, preparing an enema composition comprising the same components as claimed in a similar method of producing the composition which is combining a dry active agent with water, the lipid, and a thermo-active polymer to form a lipidic suspension for rectal (enema) administration. Thus, in the absence of a demonstration of improved or unexpected results for the use of the claimed product produced by the claimed process of preparing the composition, the claims of the instant application are rendered obvious.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Lichtenberger U.S. Publication No. 2008/0020056 A1 (Provided on IDS) in view of Charrueau et al. (2001, Drug Development and Industrial Pharmacy, 27(4), pages 351-357) (Provided on IDS) as applied to claims 19-23, 25, 29 and 34-41 above and further in view of Devi et al. (2013, J Pharm Sci and Res. Vol 5(8), pages 159-165).
Claim 24 of the instant application claims the triblock copolymer is poloxamer 188.
Lichtenberger in view of Charrueau et al. is as set forth above.
Lichtenberger in view of Charrueau et al. does not teach poloxamer 188.
Devi et al. teaches that prior to the effective filing date of the instant application poloxamers other than poloxamer 407 were known in the art to be useful for drug delivery. Devi et al. teaches that block copolymer poloxamer in aqueous media exhibits micellar structures which can convert into gel like structures based on their length, concentrations and temperature (page 159). Devi et al. teaches that a thermo-sensitive gel was developed using poloxamer 188 (page 159). Thus Devi et al. teaches that poloxamer 188 serves the same purpose as poloxamer 407 in drug delivery as they are both useful for thermogelling activity wherein the aqueous solution is liquid at room temperature and gel at higher physiological temperature.
Accordingly, prior to the effective filing date of the instant application, it would have been obvious to a person of ordinary skill in the art to utilize poloxamer 188 in the formulation of Lichtenberger since as detailed in Devi et al. poloxamer 188 would have been expected to have the same purpose as poloxamer 407 which Charrueau et al. teaches would improve the properties of the formulation of Lichtenberger by allowing the enema formulation to be liquid at room temperature for ease of application, and gel upon entry in the body to improve retention of the active agent, resulting in improved treatment of inflammatory bowel disease including ulcerative colitis and Crohn’s disease.
Conclusion
Claims 1-18, 26-28, 30-33 are canceled. Claims 19-25, 29 and 34-41 are rejected. No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM