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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Nov. 24, 2023 and Aug. 24, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-10 are currently pending and subject to examination.
Claim Objections
Claims 8-10 are objected to because of the following informalities: Claims 8-10 do not have a period at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.”
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”
Claims 3-7 and 10 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.
Claims 3-7 are “use” claims (see MPEP § 2173.05(q)). For example, claim 3 recites: “Use of the compound according to claim 1 for preparing antibacterial drugs.” This claim is indefinite because it attempts to claim a process, “preparing antibacterial drugs,” without setting forth any active, positive steps involved in that process:
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: ‘[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon’ was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
MPEP§ 2173.05(q).
Claims 4-7 are also indefinite because they are dependent upon claim 3 and are also use claims that do not set forth any steps involved in the use of claim 3.
Claim 4 recites the limitation "the antibacterial agent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the preparation" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d):
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.
MPEP § 2173.05(d).
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
Claims 3-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they claim a “use” without setting forth any steps involved in a method or process. “Uses” are not one of the four categories of patent eligible subject matter:
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction."
MPEP 2173.05(q).
Claim Rejections - 35 USC § 102
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(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lam et al. (PLOS Pathogens, Vol. (8), No. 5, May 10, 2012, e1002691, p. 1-15) (of record, IDS filed Aug. 24, 2023, cite no. 1).
Claim 1 is directed towards a compound of formula (I),
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wherein R is selected from the group consisting of C3-16 straight or branched alkyls.
Lam discloses antibacterial compounds falling within the genus of formula (I), wherein R is a C3-4 branched alkyl (compounds 5-6):
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Lam, Figure 4, p. 6.
Therefore, claim 1 is anticipated.
Claim(s) 1-4 and 8-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Edagwa & Gendelman (US 2022/0288037 A1, Published Sept. 15, 2022, PCT filed Aug. 21, 2020, Effective filing date Aug. 22, 2019).
Claim 1 is directed towards a compound of formula (I),
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wherein R is selected from the group consisting of C3-16 straight or branched alkyls.
Claim 1 is anticipated by Edagwa because one of ordinary skill in the art would at once envisage a compound of formula (I) from the disclosure of Edagwa.
Edagwa teaches ester prodrugs of tizoxanide (TZ) having the same formula (I), wherein R is preferably a C15 straight alkyl (the alkyl chain of a C16 fatty acid), or a saturated liner aliphatic or hydrocarbon chain (alkyl) of 11-17 carbons in length or 12, 13, 14, 15, 16, 17, 18 or 19 carbons in length:
Herein, the preparation and characterization of long-acting prodrugs of thiazolide based drugs, particularly tizoxanide (TZ), are provided… The development was initiated by creating modified TZ prodrugs (MTZ) then packaging them into nanoformulations (NMTZ) to improve drug biodistribution and plasma half-life. In a particular embodiment, the prodrugs comprise the native drug linked to a hydrophobic moiety (e.g., a fatty acid, alkyl or aryl moiety) via a cleavable moiety, particularly a hydrophobic moiety linked through a cleavable ester bond. Ester bond linkages are susceptible to enzymatic or chemical cleavage.
Edagwa, Specification, p. 2, paragraph [0011];
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Edagwa, Specification, p. 13, paragraph [0098];
In a particular embodiment, the prodrug of the instant invention is…
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….wherein R is a hydrophobic and/or lipophilic moiety.
Edagwa, Specification, p. 4, paragraph [0026];
In a particular embodiment, R is a saturated linear aliphatic chain or a hydrocarbon chain of at least 9 carbons (e.g., 9 to 24 carbons in length in the chain, 9 to 21 carbons in length in the chain, 9 to 19 carbons in length in the chain, 11 to 17 carbons in length in the chain, 13 to 21 carbons in length in the chain, 13 to 19 carbons in length in the chain, 15 to 19 carbons in length in the chain, or 15 or 17 carbons in length in the chain). In a particular embodiment, R is a saturated linear aliphatic chain or a hydrocarbon chain of 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 carbons in length, particularly 12, 13, 14, 15, 16, 17, 18, or 19 carbons in length, 15, 16, 17, 18, or 19 carbons in length, or 17 carbons in length.
Edagwa, Specification, p. 5, paragraph [0031].
Edagwa teaches an exemplary species, wherein R is a C17 straight alkyl:
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(Edagwa, Specification, p. 5, paragraph [0032]).
One of ordinary skill in the art would readily envisage the compound wherein R is a straight alkyl of 11 to 17 carbons in length based on the above disclosure of the genus and preferred embodiments. As in In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962), paragraph [0031] of Edwaga discloses a preferred embodiment comprising a limited generic class of less than 20 compounds:
When a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of teachings within the reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to “at once envisage” the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be “at once envisaged.” One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
In In re Petering, the prior art disclosed a generic chemical formula “wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl radicals, R a side chain containing an OH group.” The court held that this formula, without more, could not anticipate a claim to 7-methyl-9-[d, l'-ribityl]-isoalloxazine because the generic formula encompassed a vast number and perhaps even an infinite number of compounds. However, the reference also disclosed preferred substituents for X, Y, Z, P, R, and R' as follows: where X, P, and R' are hydrogen, where Y and Z may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by the preferred formula in combination with the fact that the number of substituents was low at each site, the ring positions were limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described “each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name.” The claimed compound was 1 of these 20 compounds. Therefore, the reference “described” the claimed compound and the reference anticipated the claims.
In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a specific compound were anticipated because the prior art taught a generic formula embracing a limited number of compounds closely related to each other in structure and the properties possessed by the compound class of the prior art was that disclosed for the claimed compound. The broad generic formula seemed to describe an infinite number of compounds but claim 1 was limited to a structure with only one variable substituent R. This substituent was limited to low alkyl radicals. One of ordinary skill in the art would at once envisage the subject matter within claim 1 of the reference.
MPEP § 2131.02.III (emphasis added).
Therefore, claim 1 is anticipated.
Claim 2 is directed towards the compound according to claim 1, characterized in that the compound is selected from the group consisting of
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Claim 2 is anticipated because one of ordinary skill in the art would at one envisage the compounds I-3 and I-4, wherein R is a straight linear hydrocarbon chain of 11 or 13 carbons in length from the disclosure of Edagwa, as shown in the rejection of claim 1, incorporated herein by reference.
Therefore, claim 2 is anticipated.
Claim 3 is directed towards a use of the compound according to claim 1 for preparing antibacterial drugs.
Edagwa teaches drug preparations (prodrugs, compositions and nanoparticles) comprising the compounds of formula (I) for the treatment of bacterial infections including Clostridium infections:
The present invention also encompasses methods for preventing, inhibiting, and/or treating a disease or disorder. The methods comprise administering a prodrug and/or nanoparticle of the instant invention (optionally in a composition) to a subject in need thereof. The prodrugs and/or nanoformulations of the present invention can be used for the treatment and/or prevention of diseases including but not limited to viral infections, bacterial infections, and parasitic infections... Bacterial infections include, but are not limited to: Bacteroides based infections, Clostridium based infections, Helicobacter pylori infections, and other aerobic and anaerobic gram positive and gram negative based bacterial infections.
Edagwa, Specification, p. 9, paragraph [0060].
Therefore, claim 3 is anticipated.
Claim 4 is directed towards the use according to claim 3, characterized in that the antibacterial agent is a drug which inhibits the growth of Clostridium difficile.
The antibacterial agent is presumed to refer to the compound of formula (I) of claim 1. As shown above, Edagwa teaches that the prodrugs of the invention are effective against Clostridium based infections. While Edagwa does not explicitly teach that the infection is C. difficile, it is presumed that the compounds of the instant invention inherently have activity against C. difficile because they are identical or substantially identical to the claimed invention. The compounds of the instant invention and those disclosed by Edagwa are prodrugs of the active agent tizoxanide. As they are all metabolized to the same active agent, they are presumed to have the same activity.
Therefore, claim 4 is anticipated.
Claim 8 is directed towards: “A drug that inhibits the growth of Clostridium difficile, characterized in that it is a composition formed by a compound according to claim 1 as the active ingredient, with the addition of pharmaceutically acceptable excipients.”
The body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention: “a composition formed by a compound according to claim 1 as the active ingredient, with the addition of pharmaceutically acceptable excipients”. The preamble “A drug that inhibits the growth of Clostridium difficile” is an intended use of the claimed invention which is not a limitation and is of no significance to claim construction (see MPEP § 2112.02.II). As such, the claim reads solely on a composition comprising the compound according to claim 1 and pharmaceutically acceptable excipients.
Edagwa teaches a pharmaceutical composition comprising the compound according to claim 1 and one or more pharmaceutically acceptable carriers (excipients):
The instant invention encompasses compositions (e.g., pharmaceutical compositions) comprising at least one prodrug and/or nanoparticle of the instant invention and at least one pharmaceutically acceptable carrier.
Edagwa, Specification, p. 9, paragraph [0059].
Therefore, claim 8 is anticipated.
Claim 9 is directed towards the drug according to claim 8, characterized in that the pharmaceutically acceptable excipients are selected from one or more of diluents, bulking agents, colorants, glidants, lubricants, adhesives, stabilizers, suspending agents or buffering agents.
Edagwa teaches that a carrier is, for example, “a diluent, adjuvant, preservative (e.g., Thimersol, benzyl alcohol), anti-oxidant (e.g., ascorbic acid, sodium metabisulfite), solubilizer (e.g., polysorbate 80), emulsifier, buffer (e.g., Tris HCl, acetate, phosphate), antimicrobial, bulking substance (e.g., lactose, mannitol), excipient, auxiliary agent or vehicle with which an active agent of the present invention is administered.” (Edagwa, Specification, p. 11, paragraph [0078]).
Therefore, claim 9 is anticipated.
Claim 10 is directed towards a drug according to claim 8, characterized in that the preparation is oral; preferably, the oral preparation is selected from the group consisting of granules, capsules, tablets, pills, suspensions, and emulsions.
Edagwa teaches “dosages forms for oral administration” including “tablets (e.g., coated and uncoated, chewable), gelatin capsules (e.g., soft or hard), lozenges, troches, solutions, emulsions, suspensions, syrups, elixirs, powders/granules (e.g., reconstitutable or dispersible) gums, and effervescent tablets.” (Edagwa, Specification, p. 10, paragraph [0067]).
Therefore, claim 10 is anticipated.
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, 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 nonobviousness.
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edagwa & Gendelman (US 2022/0288037 A1, Published Sept. 15, 2022, PCT filed Aug. 21, 2020, Effective filing date Aug. 22, 2019), as applied to claims 1-4 and 8-10 above, and further in view of Musher et al. (Clinical Infectious Diseases, Volume 43, Issue 4, 15 August 2006, Pages 421–427).
The rejection of claims 1-4 and 8-10 above as anticipated by Edagwa is incorporated herein by reference. Given the teachings of Edagwa, claims 1-4 and 8-10 were prima facie obvious at the time of filing.
Claim 5 is directed towards the use according to claim 4, characterized in that the drug is those for preventing and/or treating C. difficile infectious diseases, and/or complications of C. difficile infectious diseases and/or relapse of C. difficile infectious diseases. Claim 6 is directed towards the use according to claim 5, characterized in that the drug for preventing and/or treating the complications of C. difficile infectious diseases is those for preventing and/or treating the digestive tract infection syndrome caused by C. difficile infection.
As shown in the rejection of claim 3, Edagwa teaches drug preparations (prodrugs, compositions and nanoparticles) comprising the compounds of formula (I) for the treatment of bacterial infections including Clostridium infections:
The present invention also encompasses methods for preventing, inhibiting, and/or treating a disease or disorder. The methods comprise administering a prodrug and/or nanoparticle of the instant invention (optionally in a composition) to a subject in need thereof. The prodrugs and/or nanoformulations of the present invention can be used for the treatment and/or prevention of diseases including but not limited to viral infections, bacterial infections, and parasitic infections... Bacterial infections include, but are not limited to: Bacteroides based infections, Clostridium based infections, Helicobacter pylori infections, and other aerobic and anaerobic gram positive and gram negative based bacterial infections.
Edagwa, Specification, p. 9, paragraph [0060].
While Edagwa does not specifically teach C. difficile infection, one of ordinary skill in the art would have a reasonable expectation of success to apply the compounds of the instant invention for preventing and/or treating C. difficile infectious diseases, and/or complications of C. difficile infectious diseases and/or relapse of C. difficile infectious diseases because similar drugs, such as nitazoxanide, are commonly known in the art for treating C. difficile infections.
For example, Musher teaches nitazoxanide, an ester prodrug of tizoxanide (TZ), like the compounds of the instant invention, for the treatment of C. difficle colitis (the digestive tract infection syndrome cause by C. difficile bacterial infection):
Background. Clostridium difficile colitis has increased in incidence and severity, and treatment failure with metronidazole therapy has increasingly been documented. It is uncertain whether treatment with vancomycin is more effective than treatment with metronidazole, but concern over the emergence of vancomycin resistance has motivated the search for alternative therapy. Nitazoxanide, a nitrothiazolide, blocks anaerobic metabolism of eukaryocyes and effectively treats intestinal infestation due to Cryptosporidium or Giardia species. At low concentrations, this compound inhibits C. difficile in vitro.
Methods. We designed a prospective, randomized, double-blind study to compare nitazoxanide to metronidazole in treating hospitalized patients with C. difficile colitis.
Results. Thirty-four patients received metronidazole at a dosage of 250 mg 4 times per day for 10 days, 40 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 7 days, and 36 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 10 days. After 7 days of treatment, 28 (82.4%) of 34 patients had responded to metronidazole therapy, compared with 68 (89.5%) of 76 who had received nitazoxanide therapy (difference, 7.1%; 95% confidence interval, -7.1% to 25.5%). Thirty-one days after beginning treatment, sustained responses were observed in 19 (57.6%) of 33 patients who had received metronidazole therapy for 10 days, compared with 25 (65.8%) of 38 who had received nitazoxanide for 7 days and 26 (74.3%) of 35 who had received nitazoxanide for 10 days (P = .34).
Conclusion. Nitazoxanide is at least as effective as metronidazole in treating C. difficile colitis.
Musher, Abstract.
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Edagwa, Specification, p. 13, paragraph [0098].
Therefore, claims 5-6 were prima facie obvious at the time of filing.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edagwa & Gendelman (US 2022/0288037 A1, Published Sept. 15, 2022, PCT filed Aug. 21, 2020, Effective filing date Aug. 22, 2019) and Musher et al. (Clinical Infectious Diseases, Volume 43, Issue 4, 15 August 2006, Pages 421–427), as applied to claims 1-6 and 8-10 above, and further in view of Posey et al. (American Journal of Gastroenterology, 103():p S176, September 2008).
The rejection of claims 1-6 and 8-10 above as unpatentable over Edagwa in view of Musher is incorporated herein by reference.
Claim 7 is directed towards the use according to claim 6, characterized in that the drug for preventing and/or treating the digestive tract infection syndrome is those for treating and/or preventing pseudomembranous enteritis, diverticulitis, antibiotic related diarrhea, and incomplete or complete intestinal obstruction.
While Edagwa does not teach that the drug is for treating and/or preventing pseudomembranous enteritis, diverticulitis, antibiotic related diarrhea, and incomplete or complete intestinal obstruction, one of ordinary skill in the art would have a reasonable expectation of success to apply the drug for the treatment of diverticulitis because similar drugs, such as nitazoxanide, are commonly known in the art for treating diverticulitis.
For example, Posey teaches nitazoxanide for the treatment of diverticulitis:
Purpose: In the United States, diverticulitis (DIV) is accountable for approximately 130,000 hospitalizations each year with a vast majority of these patients being over 50 years old. For less severe diverticular disease, a 7 to 10 day course of oral antibiotics with coverage against anaerobic organisms is often recommended. One of the more common antibiotic combinations used consists of a fluoroquinolone (FQ) and metronidazole (MTZ). While this combination is relatively efficacious, adverse drug reactions and the potential to induce Clostridium difficile disease is of considerable concern. Nitazoxanide (NTZ) is a first in class thiazolide antibiotic with excellent activity against anaerobic bacteria and an exceptional safety profile. Furthermore, NTZ has not been shown to induce Clostridium difficile disease and has a pharmacokinetic profile that is ideal for treating enteric diseases. This case series documents our practice experience utilizing NTZ for the treatment of DIV. To our knowledge, this is the first documentation of the use of NTZ in this manner.
Methods: We report our experience with three DIV patients treated with oral NTZ 500 mg BID for 5 to 10 days. Each patient had previously been treated with a FQ and MTZ prior to the initiation of NTZ therapy with little to no improvement. Resolution of symptoms was documented upon return visit to our clinic.
Results: Patient 1 –52 year old female with a history of recurrent DIV. In the past she had been treated with a combination of a FQ and MTZ with varying results. On this visit she had started her regular antibiotic regimen with mild improvement after 5 days. A course of NTZ 500 mg BID for 10 days was prescribed, at her follow-up visit 3 weeks later the patient was symptom free. Patient 2 –39 year old male with a history of at least three DIV flares in the previous 12 months, this was his fourth. The patient had started a FQ and MTZ regimen without resolution. At that time a 10 day course of NTZ 500 mg BID was given. The patient contacted our clinic reporting resolution of symptoms after completion of his course of NTZ. Patient 3 –52 year old male with a DIV flare. After 4 days of FQ and MTZ therapy the patient's symptoms had not resolved. He was then given a five day course of NTZ 500 mg BID which relieved him of his DIV symptoms.
Conclusion: NTZ is a well-tolerated, potent agent against anaerobic bacteria with a pharmacokinetic profile well suited to treat DIV. A regimen of NTZ 500 mg BID for 5 to 10 days appears to be a safe and effective therapy for the treatment of DIV. Additional studies are warranted to validate the efficacy of NTZ in patients with DIV.
Posey, Abstract.
Therefore, claim 7 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
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/HEATHER DAHLIN/Examiner, Art Unit 1629