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
The office acknowledges Applicants filing of the claim amendments and response to the restriction election requirement on 7/21/2025. Claims 1, 9-16,19 has been amended. Claims 17-18, 20-21 have been cancelled. Claims 1-16, 19, 22 are pending. Applicants have elected Group I, claims 1-16, 19 and 22. For species (i) Applicants have provisionally elected ulcerative colitis. Applicants arguments regarding this portion of the species election has been considered and withdrawn. Hence all species of inflammatory bowel disease will be examined. For species (ii), concerning Formula I, the applicant has elected DELAQ as diagrammed, e.g., in claim 5. Claims 1-16, 19, and 22 read on DELAQ. For species (iii), concerning Formula II, the applicant has elected laquinimod, which is shown in the specification as originally filed on page 13, lines 4-5. For species (iv), concerning further therapeutic agents, the applicant has elected aminosalicylate. The restriction election is made final. Claims 1-16, 19 and 22 are examined based on the merits herein.
Application Priority
This application filed 10/28/2022 is a National Stage entry of PCT/EP2021/ 061462, International Filing Date: 04/30/2021, claims foreign priority to 2006390.5, filed 04/30/2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/11/2025, 12/20/2024, 11/7/2024, 12/22/2022, 12/20/2022 and 10/28/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16, 19 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating inflammatory bowel disease (IBD) disease comprising administration of select compounds of formula I, e.g. DELAQ, does not reasonably provide enablement for prevention of IBD. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to practice for the prevention and/or delaying the onset of an infection or a disease caused by RNA virus as claimed.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
(1),(2),(3): The nature of the invention, state and relative skill level:
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The dependent claims are limited to specific compounds, diseases, administration regimen, release formulation, amount of additional compounds in the composition, the precursor compound, formula II, additional therapeutic agents in the method, composition is a pharmaceutical composition, and oral or rectal administration.
As to the state of the art, select compounds of formula I, N-desalkyl quinoline carboxylamide compounds e.g. DELAQ, DMTAS, DMROQ, and DEPAQ are derivatives and has been previously been reported to be active metabolites of N-alkyl quinoline-3-carboxanilides such as laquinimod and tasquinimod (See Specification, p 5).
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According to Cleveland Clinic, “Inflammatory bowel disease (IBD) includes Crohn’s disease and ulcerative colitis. IBD causes symptoms like belly pain and cramps, diarrhea and blood in your poop (stool). Inflammatory bowel disease is chronic and can’t be cured. There are treatments that can put the disease into remission but IBD often comes back” (See para 1, p 1, https://my.clevelandclinic.org/health/diseases/ 15587-inflammatory-bowel-disease, 2025).
According to Johns Hopkins Medicine, Inflammatory bowel disease is a term that refers to Crohn’s disease and ulcerative colitis, two inflammatory conditions that affect as many as 1.6 million Americans, most diagnosed before age 35 (See p 1). Although there is no curative treatment for IBD, it’s possible to reduce inflammation and address symptoms with a variety of therapies (Johns Hopkins Medicine, https://www.hopkins medicine.org/health/conditions-and-diseases/inflammatory-bowel-disease, 2025, p 6, IBD treatment).
Tarcic teach that there is no definitive treatment or cure for CD. The major therapeutic goals are the reduction of signs and symptoms, induction and maintenance of remission and most importantly, the prevention of disease progression and complications (See US 20110027219 A1, [0012]).
In summary, from the teachings of the prior art it is clear that IBD symptoms can be treated but there are not method of complete prevention as it can reoccur. The examiner maintains that absent demonstration from applicant demonstrating prevention of inflammatory bowel disease, e.g. ulcerative colitis and Crohn’s disease one would not be able to ascertain if indeed said prevention occurs.
The relative skill of those in the art is high, that of an MD or PHD.
(4) The breadth of the claims:
The claims are broad in regards to the compounds of formula I, II (claim 13) and additional therapeutic agent (claim 16).
(5) Predictability of the art:
Despite the advanced training of practitioners in the art, it is still impossible to predict from the specification and prior art that IBD can be prevented as claimed with the compounds of formula I.
Prevention requires the recited method to be completely effective in all patients at all times. It is respectfully pointed out that a method of preventing the diseases or disorders claimed means that the compounds or compositions are administered to subjects that do not have such diseases or disorders. The purpose is to prevent the condition before occurring but not to treat after it has occurred.
Furthermore, the definition of "to prevent" and the “act of preventing" embraces the complete 100% inhibition. Thus, the burden of enablement in the assertion of this claim is much higher than would be the case of enabling the treatment of the condition and is not achieved.
It is well established that "the scope of enablement various inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839 (1970).
Absent a mechanistic link between the method steps and the observed effect, the pharmaceutical and medical treatment arts are highly unpredictable. Most progress is established through empirical and anecdotal evidence as to the efficacy of certain treatments. Once a mechanistic link has been established between the method and the mechanism of action become more predictable. However, many uncertainties can still exist even when the mechanism of action is known. For example, factors such as the bioavailability, pharmacokinetic profile, and potency of a compound can still be uncertain even if it can be expected to be active in disease models. It is highly unpredictable to prevent IBD as claimed and the state of the art teach that treatment is possible but not prevention or complete cure.
(6)/(7) The amount of direction or guidance provided and the presence or absence of working examples:
The specification provides guidance and data for (i) synthesis of 5-chloro-4-hydroxy-1-methyl-2-oxo-N-phenyl-quinoline- 3-carboxamide free acid (Example compound 1); Synthesis of 5-chloro-4-hydroxy-1-methyl-2-oxo-N-phenyl-quinoline- 3-carboxamide potassium salt (Example compound 2); Biological activity of Example compound 1 in an Ulcerative Colitis mouse model; Activation of the aryl hydrocarbon receptor (AhR) in the colon of mice following administration of Example compound 2 in vivo pharmacokinetics of Example compound 2 (potassium salt of DELAQ).
There is no data or guidance towards prevention of inflammatory bowel disease, e.g. ulcerative colitis or Crohn’s disease in the instant specification or in the prior art using the composition comprising the compounds of formula I.
8) The quantity of experimentation necessary:
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that a composition comprising the compounds of formula I can be useful in the prevention of IBD as inferred by the claims and contemplated by the specification. To practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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.
Claim(s) 1-7, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over . Marom et al. (IDS: WO 2012070051 A1).
Marom teach a process for the preparation of compounds, including DELAQ and laquinimod. Marom teach the use of laquinimod in treating Crohn’s disease (See claims 1, 33-34). The reference teaches laquinimod has demonstrated potent therapeutic efficacy in preclinical and clinical models of other autoimmune diseases such as Crohn's disease (See p 1, lines 11-16). Marom further teach that laquinimod can be orally administered once daily (p 1, lines 10-12).
Marom is explicit in teaching the compounds of formula I, including DELAQ.
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If in the above formula, R1 is H, R2 is chloro, R3 is H then the compound is DELAQ.
Marom teaches purification of the compounds in each step, for e.g. compound 9A, if necessary, it can be further purified by any suitable technique, for example, by crystallization (e.g., from an alcohol such as methanol, ethanol, propanol or isopropanol), or by column chromatography (See p 14, para 2). Further teach that pure laquinimod is being prepared and used (See p 19, lines 23-25).
The reference is not explicit in teaching the use of DELAQ, a compound of formula I in the treatment of Crohn’s disease (IBD).
A person skilled in the art from the teachings of Marom before the effective filing date of the invention would have found it obvious that DELAQ is structurally related and similar to the compound, laquinimod. Hence a skilled artisan would have found it obvious to try using another compound of formula I, herein fore e.g. DELAQ in the treatment of Crohn’s disease is in expectation of achieving similar or better therapeutic benefits. As to the composition a person skilled in the art would have found it obvious to add a pharmaceutically acceptable carrier comprising DELAQ to formulate a pharmaceutical composition for administration and it is within the skill of an artisan. A person skilled in the art would have been motivated to administer the composition comprising DELAQ in treating Crohn’s disease is to provide therapeutic benefits in the IBD subject. Thus claims 1-7 are addressed. As to claims 11-14, it is noted that the compound prepared from the teachings of Marom, a compound of instant formula I, e.g. DELAQ, and the composition comprising the same will have no or minimal amounts of the precursor compound, e.g. formula II compound, laquinimod. Further Marom teach the compounds can be purified by any suitable technique, for example, by crystallization (e.g., from an alcohol such as methanol, ethanol, propanol or isopropanol), or by column chromatography and also pure laquinimod is being prepared and used. Hence from such teachings a person skilled in the art would have found it obvious to obtain pure compound of formula I of Marom, including DELAQ compound. Further it would have been obvious to a skilled artisan to use the composition comprising purified pharmaceutical active agents with little or no impurities in a treatment method to reduce side effects. Also one of ordinary skill in the art would have found it obvious to have less than 10% mole of the precursor compound or free of laquinimod in the composition comprising DELAQ to test the therapeutic effects of the compound by itself. As to claim 15, R1 and R2 are the same in precursor laquinimod and DELAQ (R1- Cl; R2=H).
Claims 8-10, 19, 22 are rejected under 35 U.S.C. 103 as being unpatentable over . Marom et al. (WO2012070051A1) as applied to claims 1-7 above, in view of Dixit (IDS: WO 2010001257) and Hua et al. (Frontiers in Pharmacology, 28 April 2020).
Marom as discussed above. The above rejection is incorporated herein.
Marom is not explicit in teaching the compound is administered locally to small/large intestine, the solid form adapted for release, composition comprises an enteric coating.
Dixit teach novel solid state forms of laquinimod, its pharmaceutical composition and its use in a method of treating inflammatory bowel disease (Abstract, claim 1, 86, 96). Further taught is that the capsule dosage forms containing laquinimod sodium may be coated with gelatin. Tablets and powders may also be coated with an enteric coating. Suitable enteric coating include phthalic acid cellulose acetate, hydroxypropylmethyl cellulose phthalate etc. and a coated capsule or tablet may have a coating on the surface thereof or may be a capsule or tablet comprising a powder or granules with an enteric-coating. Tableting compositions may have few or many components depending upon the tableting method used, the release rate desired and other factors (See p 23, lines 11-34, p 25, para 1). Dixit teach that the pharmaceutical composition can be administered orally or rectally (p 22, lines 30-34).
Hua is explicit in teaching that the oral route is by far the most common route of drug administration in the gastrointestinal tract and can be used for both systemic drug delivery and for treating local gastrointestinal diseases (see Abstract). The reference teach strategies to targe drug(s) to small intestine; enteric-coated solid dosage forms (e.g., tablets and capsules) are commonly used and are available clinically and large intestine (See p 7, col. 1 and col. 2). Further taught is that colon targeted drug delivery is an active area of research, particularly for the treatment of local diseases affecting the colon, such as IBD and colorectal cancer. Improving the delivery of drugs to the colon not only improves the local effectiveness of therapeutics, but it can also reduce the risk of systemic adverse effects; e.g. delayed release dosage forms that rely on gastrointestinal transit time (See p 7, col. 2, para 3).
From the teachings of the prior art a person skilled in the art before the effective filing date of the invention would have found it obvious to formulate the composition of a compound of formula I for local administration to small/large intestine, a solid form, e.g. tablets, capsules for release of the compound and with enteric coatings for release. A person skilled in the art would have been motivated to arrive at the composition for target delivery to colon for example is to improve the local effectiveness of therapeutics and reduce the risk of systemic adverse effects. Thus claims 8-10 would have been obvious over the combined prior art teachings. As to claims 19, 22, Dixit teach pharmaceutical composition comprising the active ingredient, laquinimod and the composition can be administered in oral or rectal dosage forms. Hence a skilled artisan would have found it obvious to administer Marom’s compound of formula I as a pharmaceutical composition and via oral administration in subjects with IBD.
Claim(s) 1-7, 11-16, 19, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mahiout et al. (IDS: Toxicology in Vitro 52 (2018) 178–188) and Pettersson (IDS: WO2012050500) in view of Tarcic (IDS: US 20110027219 A1).
Mahiout et al. teach that laquinimod N-dealkylation leads to the compound, IMA-06201 (see p 180). Further taught is that the compound is an AHR activator.
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In humans, laquinimod is metabolised by CYP3A4 to hydroxylated and dealkylated metabolites; C1, also called DELAQ (de-ethylated laquinimod), is one of these metabolites, and has already previously been identified as a very potent AHR-activator (See p 184, col. 2, last para). It is taught that while showing low to negligible in vitro toxicity, the novel SAHRMs, including IMA-06201 bind to the AHR qualitatively in a similar fashion to TCDD, and appear comparably powerful AHR agonists (See Abstract).The reference teaches that appropriate modulation of AHR activity has been shown as a potential target for novel therapeutics in the treatment of, for instance, Crohn's disease and inflammatory bowel disease. Therefore, the AHR appears a highly interesting target for novel therapies in several fields, and selective AHR modulators (SAHRMs) intriguing candidates for lead compounds (see p 179, col. 1, para 3).
Pettersson teach the N-hydrogen 3-carboxanilides ("N-H derivatives") and the N-alkyl 3-carboxanilides ("N-alkyl derivatives"), respectively, are described in the prior art documents relating to inflammation, immunomodulation, and cancer as a homogenous group of compounds in terms of biological effects. The prior art also teaches that the N-alkyl derivatives are the preferred compound derivatives.
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, R=alkyl : "N-alkyl derivatives", R=hydrogen: "N-H derivatives". It is taught that very few studies of N-hydrogen derivatives, especially in vivo studies, have been reported. Furthermore, no fundamental biological differences between the N-alkyl derivatives and the N-hydrogen derivatives, respectively, have been described.
The prior art is not explicit in teaching the use of IMA-06201 (DELAQ (de-ethylated laquinimod) composition, in treatment of the inflammatory bowel disease.
Tarcic is explicit in teaching the use of an effective amount of laquinimod in treating Crohn’s disease (IBD) (See abstract, claim 1, [0053]). This application also provides for a pharmaceutical composition comprising laquinimod for use in treating a subject suffering from Crohn's disease [0033], A dosage unit can be prepared for oral dosage forms, such as tablets, capsules [0036], claim 7. Tarcic teach administration of additional agents in the method e.g. aminosalicylic acid ([0031], claim 25).
A person skilled in the art from the teachings of Mahiout before the effective filing date of the invention would have found it obvious that DELAQ (IMA-06201) is a deethylated compound of laquinimod and its active metabolite. From Pettersson it is obvious that no fundamental biological differences between the N-alkyl derivatives and the N-hydrogen derivatives (e.g. DELAQ and laquinimod). Hence a skilled artisan would have found it obvious to use a composition of DELAQ in the treatment of Crohn’s disease for laquinimod in Tarcic method in expectation of achieving similar or better therapeutic benefits. A person skilled in the art would have been motivated to use the composition comprising DELAQ in treating Crohn’s disease is to provide therapeutic benefits in the IBD subject. Thus claims 1-7 are addressed. As to claims 11-14, it is noted that the compound DELAQ when purified, and the composition comprising the same will have no or minimal amounts of the precursor compound, e.g. formula II compound, laquinimod . Further it would have been obvious to a skilled artisan to use composition comprising purified pharmaceutical agents with little or no impurities in a treatment method to reduce side effects. Also one of ordinary skill in the art would have found it obvious to have less than 10% mole of the precursor compound or free of laquinimod in the composition comprising DELAQ to test the therapeutic effects of the compound by itself. As to claim 15, R1 and R2 are the same in precursor laquinimod and DELAQ (R1- Cl; R2=H). As to claims 16, 19, 22, Tarcic teach pharmaceutical composition, oral dosage form comprising laquinimod for Crohn’s disease treatment and the use of 5-aminosalicylic acid (additional agent) in the method. Hence a skilled artisan would have found it obvious to formulate a pharmaceutical composition comprising DELAQ, for oral administration, e.g. tablets or capsule and add aminosalicylate (salt of 5-aminosalicylic acid) in the method of treating Crohn’s disease for administration and to provide therapeutic benefits in the patient.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over . Mahiout et al. (IDS: Toxicology in Vitro 52 (2018) 178–188) and Pettersson (IDS: WO2012050500) in view of Tarcic (US 20110027219 A1) as applied to claims 1-7, 11-16. 19, 22 above, in view of Dixit (WO 2010001257) and Hua et al. (Frontiers in Pharmacology, 28 April 2020).
Mahiout, Pettersson and Tarcic as discussed above. The above rejection is incorporated herein.
The prior art is not explicit in teaching that the compound is administered locally to small/large intestine, the solid form adapted for release, composition comprises an enteric coating.
Dixit teach novel solid state forms of laquinimod, its pharmaceutical composition and its use in a method of treating inflammatory bowel disease (Abstract, claim 1, 86, 96). Further taught is that the capsule dosage forms containing laquinimod sodium may be coated with gelatin. Tablets and powders may also be coated with an enteric coating. Suitable enteric coating include phthalic acid cellulose acetate, hydroxypropylmethyl cellulose phthalate etc. and a coated capsule or tablet may have a coating on the surface thereof or may be a capsule or tablet comprising a powder or granules with an enteric-coating. Tableting compositions may have few or many components depending upon the tableting method used, the release rate desired and other factors (See p 23, lines 11-34, p 25, para 1). Dixit teach that the pharmaceutical composition can be administered orally or rectally (p 22, lines 30-34).
Hua is explicit in teaching that the oral route is by far the most common route of drug administration in the gastrointestinal tract and can be used for both systemic drug delivery and for treating local gastrointestinal diseases (see Abstract). The reference teach strategies to targe drug(s) to small intestine; enteric-coated solid dosage forms (e.g., tablets and capsules) are commonly used and are available clinically and large intestine (See p 7, col. 1 and col. 2). Further taught is that colon targeted drug delivery is an active area of research, particularly for the treatment of local diseases affecting the colon, such as IBD and colorectal cancer. Improving the delivery of drugs to the colon not only improves the local effectiveness of therapeutics, but it can also reduce the risk of systemic adverse effects; e.g. delayed release dosage forms that rely on gastrointestinal transit time (See p 7, col. 2, para 3).
From the teachings of the prior art a person skilled in the art before the effective filing date of the invention would have found it obvious to formulate the composition of DELAQ (IMA-06201) for local administration to small/large intestine, a solid form, e.g. tablets, capsules for release of the compound and with enteric coatings for release. A person skilled in the art would have been motivated to arrive at the composition for target delivery to colon for example is to improve the local effectiveness of therapeutics and reduce the risk of systemic adverse effects. Thus claims 8-10 would have been obvious over the combined prior art teachings.
Claim Objections
Claim 13 is objected to because of the following informalities: In page 6, line 4, recites a limitation of ‘and optionally substituted’, it is suggested that it is amended as
‘or optionally substituted’. Appropriate correction is required.
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.
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 12, 13 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 12 recites a limitation of ‘substantially free’ in line 3. ‘The term substantially is a relative term which renders the claims indefinite. The term, substantially, is not defined by the claims, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. Appropriate correction is required.
Claim 13 is directed to:
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It is not clear in regards to ‘the acyl residues of C5-C20 carboxylic acids optionally containing 1-3 multiple bonds’ and also in regards to ‘optionally substituted 1-3 times by substituents’. Also there is a limitation with ‘comprising methyl, ethyl’ etc., it should be ‘selected from’. Appropriate correction is required.
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 1-7, 11-14, 19, 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-13, 15-20 of co-pending Application No. 17922072 (reference application).
The instant claims are directed to:
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The dependent claims are limited to specific compounds, diseases, administration regimen, release formulation, amount of additional compounds in the composition, the precursor compound, formula II, additional therapeutic agents in the method, composition is a pharmaceutical composition, and oral or rectal administration.
‘072 reference claims are directed to:
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The dependent claims are limited to solid, crystalline, amorphous forms, pharmaceutical composition, comprises one or more further therapeutic agent(s), oral and/or rectal administration.
Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the use of the pharmaceutical composition comprising compound of formula I, which is DELAQ (5-chloro-4-hydroxy-1-methyl-2-oxo-N-phenyl-quinoline-3- carboxamide) in a method of treating inflammatory bowel disease, Crohn’s, ulcerative colitis by oral/rectal administration. Thus claims 1-7, 19, 22 are addressed. As to claims 11-14, it is noted that the reference claim teach compound 5-chloro-4-hydroxy-1-methyl-2-oxo-N-phenyl-quinoline-3- carboxamide (DELAQ) by itself, and in crystalline state. Hence the composition comprising the compound will have no or minimal amounts of the precursor compound, e.g. formula II compound, laquinimod. Further it would have been obvious to a skilled artisan to use composition comprising purified pharmaceutical agents with little or no impurities in a treatment method to reduce side effects. Also one of ordinary skill in the art would have found it obvious to have less than 10% mole of the precursor compound or free of laquinimod in the composition comprising DELAQ to test the therapeutic effects of the compound by itself. As to claim 15, R1 and R2 are the same in precursor laquinimod and DELAQ (R1- Cl; R2=H).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627