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
Election/Restriction
Applicant’s election without traverse of Group I invention, and of the species: i) polyoxyl 40 hydrogenated castor oil; and ii) a combination of castor oil, glyceryl caprylate, and polysorbate 80 as the solubilizing excipient, in the reply filed on 10/10/2025 is acknowledged.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 read on the elected invention and species.
Claims 3 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 32-33 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Status of Claims
Claims 1, 3-5, 7, 11, 15, 17, 25, 26, 28, 30, 32, 33, 35, 39, 43, 50, 55, and 67 are pending.
Claims 3, 4, 32-33 and 35 are withdrawn.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 are currently under examination.
Priority
This application 18/034,411 filed on 04/28/2023 is 371 of PCT/EP2021/080168 filed on 10/29/2021, which claims benefit of priority to US provisional application No. 63/107,406 filed on 10/29/2020.
Information Disclosure Statement
The information disclosure statements filed 07/28/2023 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Claim Objections
Claims 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 are objected to because of the following informalities: “Claim 1” and/or “Claim 25” within the claims should be in lower case.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Instant claim 15 recites limitation wherein the at least one additional solubilizing agent allows for a rifaximin saturation solubility of greater than about 14% w/w. Instant specification (See [0059], Table 6A and [0182], Table 8) discloses percent of drug soluble(%w/w), e.g. 0.0131 for 5256-27C, 0.0503 for 5394-58A, etc. The percent of drug soluble disclosed by instant specification does not support instant claimed saturation solubility of rifaximin “greater than about 14% w/w”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 15, 25, 26, 28 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites limitation “wherein the at least one additional solubilizing excipient is one which allows for a rifaximin saturation solubility of greater than about 14% w/w”. The saturation solubility of rifaximin is result of multiple factors, e.g. excipient type and amount of solubilizing excipient(s) or combination thereof, temperature, pH, etc. An ordinary skilled in the art would not know what type of solubilizing agent or combination thereof in what amount would allow rifaximin achieve saturation solubility of greater than about 14% w/w.
Claim 25 recites: “The method of Claim 1, wherein the at least one additional solubilizing excipient is a combination of castor oil, glyceryl caprylate, and polysorbate 80”. Claim 1 recites: “A pharmaceutically acceptable composition comprising rifaximin, a hydrogenated castor oil, and at least one additional solubilizing excipient.” As seen from claim 1, “at least one additional solubilizing excipient” is defined to be separate from a hydrogenated castor oil, but castor oil is defined to be a part of “at least one additional solubilizing excipient” in claim 25. The contradictory definition of “at least one additional solubilizing excipient” in claim 25 is confusing. It’s not clear if the “castor oil” in the combination of “at least one additional solubilizing excipient” is the same as “hydrogenated castor oil”. Claims 26, 28 and 30 are rejected due to dependency on claim 25.
Claim Interpretation
Instant claims are directed to a method of treating sickle cell disease (SCD) in a patient in need thereof comprising administering to the patient a pharmaceutically acceptable composition comprising rifaximin. Instant specification disclosed clinical study wherein “ 550 mg dose of rifaximin (i.e., XIFAXAN® 550 mg), delivered BID, was capable of reducing CANs in SCD patients (Clinical Trial Identifier: NCT03719729). Furthermore, when SCD patients received a 550 mg dose of rifaximin (i.e., XIFAXAN® 550 mg) BID for 6 months, the result was a decrease in the number of VOCs, and thus an
increased quality of life” (See [0006]). Instant specification further discloses clinical study design to evaluate safety, efficacy, and pharmacokinetics of rifaximin oral administration in sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) (See [0172]-). Although instant specification does not disclose result of the clinical study, rifaximin is designated as orphan drug for treatment of sickle cell disease (SCD) for further development by FDA as of 10/28/2020 (retrieved from https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=778520). As such , rifaximin is considered as enabled for treating sickle cell disease (SCD) to the extent of ameliorating the symptoms of sickle cell disease SCD (reducing circulating aged neutrophils CANs and vaso-occlusive crises VOCs) in a subject in need thereof based on the prior art (NCT03719729) and FDA designation.
Please note the efficacy of treating sickle cell disease (SCD) is considered as the function/property of active compound rifaximin. Instant claims recite limitation directed to inactive ingredients as solubilizing excipient. It is commonly known to the skilled person that rifaximin has a low solubility in water and basic organic solvents. Therefore, incorporating solubilizing excipient (e.g. hydrogenated/ethoxylated castor oil and other solubilizing excipient ) is considered within common knowledge of the skilled person.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1, 11 , 39 and 67 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lim (WO 2020/198136 A1, Applicant’s IDS dated 07/28/2023).
Lim teaches a method of treating or ameliorating the symptoms of sickle cell disease SCD in a subject in need thereof comprising administering to the subject a therapeutically effective amount of composition comprising antibiotic rifaximin (See abstract, [0002],[0005], [0035] -[0038], [0046], Figures 1-7, claims 1-14).
Lim teaches rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta subunit of bacterial DNA-dependent RNA polymerase blocking transcription which results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria. Rifaximin, sold under the trade name Xifaxan, is typically used to treat traveler's diarrhea, irritable bowel syndrome, and hepatic encephalopathy (See [0018]). Lim teaches variety of assay to evaluate rifaximin therapy (550 mg twice a day for six months) in SCD patient in clinical trial (NCT03719729)(See [0053], Example 1 and 2). Lim teaches SCD subjects who were treated with rifaximin showed reduced baseline activated neutrophils(See [0055]). Lim teaches reduction in CANs (circulating aged neutrophils) after 2-4 weeks of rifaximin therapy indicating rifaximin's ability to reduce CANs in humans and support the concept that local effects on intestinal microbiota contribute to the beneficial effects of the ANMV cocktail(See [0054], Figure 2). Lim also teaches rifaximin can benefit patients, as measured by a decrease in the number of VOCs (vaso-occlusive crises) and days needing IOA, in patients with SCD (See [0053]). Lim teaches rationale for rifaximin therapy in SCD patient: “being a minimally absorbed antibiotic, rifaximin provided the opportunity to dissect the effect of reducing intestinal microbial load in SCD from systemic effect of any antibiotic”, and concludes rifaximin therapy support the local effects of an antibiotics in the intestine in modifying the course in SCD (See [0063]).
Lim teaches variety of dosing regimen of rifaximin about 200mg to 800mg per 12 hour (See [0043]-0045], claims 5-10).
Regarding the pharmaceutical excipients, Lim teaches the rifaximin may be formulated by methods known to those of skill in the art, and may include, for example, but not limited to solubilizing, diluting, or dispersing substances (See [0020]).
Lim teaches the rifaximin composition in solid or liquid preparation, e.g. capsules, suspensions, solutions, elixirs or emulsions, sustained release preparation, etc. Lim teaches rifaximin composition in liquid form comprising liquid carrier such as water, petroleum, oils of animal or plant origin such as peanut oil, mineral oil, soybean oil, or sesame oil, or synthetic oils, and the liquid form of the rifaximin co mposition(s) may further contain glycols such as ethylene glycol, propylene glycol, or polyethylene glycol(See [0035]). Lim teaches liquid preparations are prepared by dissolving the composition(s) in an aqueous or non-aqueous pharmaceutically acceptable solvent (ethanol, or oils, etc.) , or suspension comprising fatty oils, sesame oil, or synthetic fatty acid esters, e.g. ethyl oleate or triglycerides, or liposomes (See [0036]-[0038]).
Regarding claim 39, Lim teaches embodiments comprising antioxidants (e.g. BHT) and buffers (citrate, phosphate and other organic acid) (See [0030]).
A skilled artisan would have known hydrogenated castor oil is a synthetic oil. Glycols such as ethylene glycol, propylene glycol, or polyethylene glycol are considered as one additional solubilizing excipient. As such, Lim collectively teaches a method of treating sickle cell disease SCD in a subject in need thereof comprising administering to the subject a therapeutically effective amount of composition comprising rifaximin, hydrogenated castor oil and at least one additional solubilizing excipient (e.g. glycol).
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.
The factual inquiries 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 non-obviousness.
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 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.
Claims 1, 5, 7, 11, 15, 17, 39, 43, 50 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (WO 2020/198136 A1, Applicant’s IDS dated 07/28/2023), in view of Purandare et al. (WO2012076832A1, Applicant’s IDS dated 07/28/2023).
The collective teachings of Lim is elaborated in preceding 102 rejection and applied as before.
Lim is silent about the amount of hydrogenated castor oil.
Purandare teaches pharmaceutical composition comprising rifaximin and a variety of excipients, e.g. sorbitan fatty acid esters, glycerol fatty acid, esters, glycerol, decaglycerin fatty acid esters, polyglycerin fatty acid esters, propylene glycol fatty, acid esters, pentaerythritol fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitol fatty acid esters, polyoxyethylene glycerin fatty acid esters, polyethylene glycol fatty acid esters, sucrose fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene phytosterols, polyoxyethylene phytostanols, polyoxyethylene, polyoxypropylene glycol, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, etc. page 12, lines 10-18). Purandare teaches embodiments comprising rifaximin, hydrogenated castor oil and soybean oil (See page 10, lines 22, Example 6). The soybean oil is considered as additional solubilizing agent. The percentage of rifaximin, hydrogenated castor oil, soybean oil in Example 6 is calculated to be 6.6%, 3.3%, 90% by weight, respectively. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
It is commonly known to the skilled person that rifaximin has a low solubility in water and basic organic solvents. In order to increase the solubility and permeability of rifaximin for use in treating disease, it would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore/optimize different excipients and combination thereof based on the combined teaching of prior art, together with experimentation/ optimization based on the general knowledge of pharmaceutical compositions and rifaximin. Hydrogenated castor oil is commonly used surfactant as taught by Purandare. A skilled artisan would reasonably expect the composition comprising rifaximin and hydrogenated castor oil as taught by Purandare and other excipients exhibit similar efficacy as Lim taught.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (WO 2020/198136 A1, Applicant’s IDS dated 07/28/2023), in view of Kulkarni et al. (US20120214833A1, Cite# 13, Applicant’s IDS dated 07/28/2023).
The collective teachings of Lim is elaborated in preceding 102 and 103 rejection and applied as before.
Lim is silent about polysorbate 80 and glyceryl caprylate and weight percentage thereof.
Kulkani teaches a solid dispersion of rifaximin comprising rifaximin and variety of pharmaceutically acceptable carrier, wherein the solubility and gastrointestinal availability of rifaximin is increased by 30%(See abstract, [0008], [0039]-[0047], [0090], Examples 1-8, claims 1-7). Kulkani teaches rifaximin is practically insoluble in water and is virtually undissolved in the gastro intestinal tract (GIT). The relative insolubility of rifaximin also leads to its negligible systemic absorption wherein less than 0.5% of rifaximin is absorbed into the blood stream when taken orally (See [0005]).
Regarding the limitation of hydrogenated castor oil and one additional solubilizing excipient, Kulkani teaches variety of carrier/solvent selected from organic acids, polyethylene glycol, povidone, copovidone, polymethacrylates, polyvinyl acetate, cellulose derivatives, self-emulsifying carriers, poloxamer, glyceryl behenate (Compritol), gelucire (polyethyleneglycol derivative of a mono-glyceride, i.e. a PEGylated monoglyceride), Vitamin E such as tocophersol, tocotrienols; polyethylene or polyoxyethylene ester of hydroxyl stearic acid such as solutol HS, polyoxylglycerides such as labrafil, gelucire 44/14, labrasol; polyethoxylated castor oil such as cremophor or any combinations thereof (See [0041]-[0044], claim 2).
Regarding the limitation of additional solubilizing excipient, Kulkani further teaches dipolar aprotic solvent, polyethylene glycol, polyethyleneglycol ether, polyethyleneglycol derivative of a mono- or di-glyceride, buffers, water soluble organic solvent or combination thereof (See [0042])( which also reads on instant claim 11).
Regarding claim 5 and 25, Kulkani teaches carrier/surfactant selected from polyethoxylated castor oil such as Cremophor RH40, Cremophor ELP, Polysorbate 80 HP or combination thereof (See [0043] ). Kulkani also teaches oils include a medium chain triglyceride, castor oil, a medium chain mono-glyceride, a medium chain di-glyceride, or combination thereof (See [0044]). The medium chain mono-glyceride taught by Kulkani is considered as read on instantly claimed glyceryl caprylate.
Kulkani teaches embodiments comprising rifaximin and variety of excipients and combination thereof (See [0048], Example 1-8), e.g. polysorbate 80 (Tween 80) and povidone. In Example 6, the amount of polysorbate 80 (Tween 80) is calculated to be 5% by weight (50/1000g), the povidone amount is calculated to be 35% by weight (350/1000g) (which reads on instant claim 17).
Kulkani collectively teaches pharmaceutical composition comprising rifaximin. polyethoxylated castor oil (e.g. Cremophore RH40), polysorbate 80 ( See [0043]) and medium chain glyceride (e.g. glyceryl caprylate).
It’s common practice in the pharmaceutical industry to explore different excipients and combination thereof for improving solubility and permeability of active ingredients as demonstrated in Kulkani. Kulkani teaches the solubility of rifaximin is increased by 30%. In order to further increase the solubility and permeability of rifaximin for use in treating disease, it would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to further explore/optimize different excipients and combination thereof based on the beneficial teaching of combined prior art, together with experimentation/ optimization based on the general knowledge of pharmaceutical compositions and rifaximin.
Lim teaches a method of treating or ameliorating the symptoms of sickle cell disease SCD in a subject in need thereof comprising administering a therapeutically effective amount of composition comprising antibiotic rifaximin, wherein the rifaximin may be formulated with solubilizing, agents. Kulkani collectively teaches pharmaceutical composition comprising rifaximin. polyethoxylated castor oil (e.g. Cremophore RH40), polysorbate 80 ( See [0043]) and medium chain glyceride with enhanced solubility. The normal desire of artisans to improve upon what is already generally known provide the motivation to further optimize the inactive ingredients of rifaximin for enhanced solubility and permeability. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of rifaximin and treatment of sickle cell disease. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (WO 2020/198136 A1, Applicant’s IDS dated 07/28/2023), in view of Michaelis et al. (US 20040034021 A1).
The collective teachings of Lim is elaborated in preceding 102 and 103 rejection and applied as before. Lim collectively teaches a method of treating sickle cell disease SCD in a subject in need thereof comprising administering to the subject a therapeutically effective amount of composition comprising rifaximin, oil and at least one additional solubilizing excipient (e.g. glycol).
Lim is silent about polysorbate 80 and glyceryl caprylate and weight percentage thereof.
Michaelis teaches pharmaceutical compositions comprising variety of pharmaceutical excipients and combination thereof for improved delivery of antibiotic rifamycin derivative (e.g. rifalazil) for treating immune and autoimmune disease associated with bacterial infection (See abstract, [0137], Examples 1-2, claims 1, 4 and 5).
Michaelis teaches rifalazil is insoluble in water at physiological pH(See [0085]) and a variety of solubilizers/ micelle-forming excipient are used to enhance the solubility of rifalazil for preparation of liquid formulation(solution), e.g. polyethoxylated fatty acids, PEG-fatty acid diesters, PEG-fatty acid mono-ester and di-ester mixtures, polyethylene glycol glycerol fatty acid esters, alcohol-oil transesterification products, polyglycerized fatty acids, propylene glycol fatty acid esters, mixtures of propylene glycol ester, S-glycerol esters, mono and diglycerides, polyethylene glycol sorbitan fatty acid esters, polyethylene glycol alkyl ethers, sugar esters, polyethylene glycol alkyl phenols, polyoxyethylene-polyoxypropylene block copolymers, Sorbitan fatty acid esters, lower alcohol fatty acid esters, and ionic surfactants, etc. ( See claims 1, 4 and 5, [0007], [0089]-[0110]).
Michaelis teaches examples of hydrogenated castor oils include PEG-40 hydrogenated castor oil Cremophor RH 40) (See [0094]-[0095], claims 5-6 ). Michaelis teaches mono- and diglycerides (e.g. glyceryl caprylate) may be used as excipients for the formulation of rifalazil. Michaelis teaches polyethylene glycol sorbitan fatty acid esters (e.g. polysorbate 80, Tween80) may also be used as excipients (See [0100]). Michaelis explicitly teaches solubility study of rifalazil in PEG-35 castor oil, Twee-80, etc. wherein the percentage of surfactant is about 1-10%(See [0148], Fig. 6. Example 1). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
It is commonly known to the skilled person that rifaximin has a low solubility in water and basic organic solvents. In order to increase the solubility and permeability of rifaximin for use in treating disease, it would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore/optimize different excipients and combination thereof based on the combined teaching of prior art, together with experimentation/ optimization based on the general knowledge of pharmaceutical compositions and rifaximin/ rifamycin derivative.
Lim teaches a method of treating or ameliorating the symptoms of sickle cell disease SCD in a subject in need thereof comprising administering a therapeutically effective amount of composition comprising antibiotic rifaximin, wherein the rifaximin may be formulated with solubilizing, agents. Michaelis collectively teaches pharmaceutical composition/solution comprising rifamycin derivative (e.g. rifalazil) and solubilizing excipients, polyethoxylated castor oil (e.g. Cremophor RH40), polysorbate 80 and glyceryl caprylate with enhanced solubility/stability. Since both rifaximin and rifalazil are rifamycin derivatives with poor solubility, a skilled artisan would have been motivated to solve low solubility issues of rifaximin with the solubility enhancing agents for the poorly soluble drug rifalazil taught by Michaelis, and reasonably expect composition of rifaximin comprising polyethoxylated castor oil and other solubilizing excipient would exhibit similar efficacy of ameliorating SCD symptoms as taught by Lim.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of rifaximin/ rifamycin derivatives and treatment of sickle cell disease. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43 and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 17/918,374 (reference application), in view of Kulkarni et al. (US 20120214833A1).
Reference claims are directed to a method of treating sickle cell disease (SCD) in a patient in need thereof comprising administering at least one rifaximin SSD composition to the patient.
Reference claim 4 recites rifaximin SSD composition comprises an immediate release (IR) tablet, a sustained extended release (SER) tablet, or a combination thereof.
Reference claims are silent about the limitation directed to the pharmaceutical composition.
As elaborated in preceding 103 rejection, Kulkani collectively teaches pharmaceutical composition comprising rifaximin. polyethoxylated castor oil (e.g. Cremophore RH40), polysorbate 80 and medium chain glyceride with improved solubility and permeability of rifaximin. It’s known rifaximin has poor solubility as taught by Kulkani. It would be prima facie obvious for a skilled artisan in the art to incorporate the pharmaceutical composition comprising rifaximin with improved solubility and permeability of rifaximin taught by Kulkani for the method of treating sickle cell disease (SCD) as taught by reference claims.
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Claims 1, 5, 7, 11, 15, 17, 25, 26, 28, 30, 39, 43, 50, 55, and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 11, 14, 21-22, 24, 26, 36, 39, 44-45, 48, 51, 53 and 62 of copending Application No. 17/763,615 (reference application), in view of Lim (WO 2020/198136 A1, Applicant’s IDS dated 07/28/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a pharmaceutical composition comprising rifaximin, a hydrogenated castor oil, and at least one additional solubilizing excipient.
Reference claim 21 reciting “the at least one additional solubilizing excipient is a combination of castor oil, glyceryl caprylate, and polysorbate 80” read on instant claim 25. Reference claims 22, 24 and 26 further recite concentration/amount of castor oil, glyceryl caprylate, and polysorbate 80 that read on instant claims. Reference claims 39, 44-45, 48 recite the concentration and amount of rifaximin that read on instant claims 43 and 45. Reference claim 62 reciting liquid formulation that read on instant claim 67. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
Reference claims are silent about treating sickle cell disease SCD with the reference composition comprising antibiotic rifaximin.
As elaborated in previous 102 and 103 rejections and applied as before, Lim teaches a method of treating sickle cell disease SCD in a subject in need thereof comprising administering to the subject a therapeutically effective amount of composition comprising rifaximin and lipid carrier .
It would have been prima facie obvious and logical to one of the ordinary skill in the art to explore rifaximin composition taught by reference claims for treating sickle cell disease SCD as taught by Lim with reasonable expectation of success. A skilled artisan would reasonably expect composition taught by reference claims would exhibit equivalent efficacy for reducing SCD symptoms as taught by Lim.
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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, Amy L Clark can be reached on (571)272-1310. 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.
/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628