DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is a Final Office Action.
Claims 1-4, 11, 13, 15, 19, 23-25 and 27-31 are pending and under examination.
Specification
The objection to the title of the invention is withdrawn based on the amendments.
The objection to the abstract of the disclosure is withdrawn based on the amendments.
Claim Objections
The objection to claim 30 because of the phrase, “an effective amount” is withdrawn based on the amendments.
Claim Rejections - 35 USC § 112
The rejection of claims 1-4, 11, 13, 15, 19, 23-25 and 29-30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “one or more hydrogen(s) is(are) substituted with…” is withdrawn based on the amendments.
The rejection of claims 1-4, 11, 13, 15, 19, 23-25 and 29-30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “Y combines directly with A or with R6” is withdrawn based on Applicant’s remarks.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “R5, R6” is withdrawn based on the amendments.
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.
Claim 30 is 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 pre-AIA the applicant regards as the invention.
In claim 30, the phrase “diseases associated with” is indefinite because it is not clear what Applicant is claiming. The diseases disclosed in the specification include vastly different inflammatory diseases and the specification on page 1 and uses open- ended language. Is this the entire scope of the therapeutic claims or are there other diseases? It must be noted that diseases such as cancer are not considered to be inflammatory related. Thus, claims 30 and 31 are indefinite.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 30 and 31 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 the treatment of inflammation by the inhibition of TNF-alpha and IL-1B production, does not reasonably provide enablement for the treatment of all inflammatory diseases, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement for the scope of "treating inflammatory diseases" generally is not present. For a compound or genus to be effective against inflammation generally is contrary to medical science. Inflammation is a process, which can take place individually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. There is no common mechanism by which all, or even most, inflammations arise. Mediators include bradykinin, serotonin, C3a, C5a, histamine, assorted leukotrienes and cytokines, and many, many others. Accordingly, treatments for inflammation are normally tailored to the particular type of inflammation present, as there is no, and there can be no "magic bullet" against inflammation generally. Inflammation is the reaction of vascularized tissue to local injury; it is the name given to the stereotyped ways tissues respond to noxious stimuli. These occur in two fundamentally different types. Acute inflammation is the response to recent or continuing injury. The principal features are dilatation and leaking of vessels, and recruitment of circulating neurophils. Chronic inflammation or "late-phase inflammation" is a response to prolonged problems, orchestrated by T-helper lymphocytes. It may feature recruitment and activation of T- and B-lymphocytes, macrophages, eosinophils, and/or fibroblasts. The hallmark of chronic inflammation is infiltration of tissue with mononuclear inflammatory cells. Granulomas are seen in certain chronic inflammation situations. They are clusters ofmacrophages, which have stuck tightly together, typically to wall something off. Granulomas can form with foreign bodies such as aspirated food, toxocara, silicone injections, and splinters. Otitis media is an inflammation of the lining of the middle ear and is commonly caused by Streptococcus pneumoniae and Haemophilus influenzae. Cystitis is an inflammation of the bladder, usually caused by bacteria. Blepharitis is a chronic inflammation of the eyelids that is caused by a staphylococcus. Dacryocystitis is inflammation of the tear sac, and usually occurs after a long-term obstruction of the nasolacrimal duct and is caused by staphylococci or streptococci. Preseptal cellulitis is inflammation of the tissues around the eye, and Orbital cellulitis is an inflammatory process involving the layer of tissue that separates the eye itself from the eyelid. These life-threatening infections usually arise from staphylococcus. Hence, these types of inflammations are treated with antibiotics. Certain types of anti- inflammatory agents, such as non-steroidal anti-inflammatory medications (Ibuprofen and naproxen) along with muscle relaxants can be used in the non-bacterial cases. The above list is / by no means complete, but demonstrates the extraordinary breadth of causes, mechanisms and treatment (or lack thereof) for inflammatory disorders. It establishes that it is not reasonable to any agent to be able to treat inflammatory disorders generally.
Further, Hyperplasia (or "hypergenesis") is a general term for an abnormal increase in the number of the cells of an organ or tissue causing it to increase in size. It may be due by any number of causes including (but not limited to) chronic inflammatory response, hormonal dysfunctions, or neoplasia. Restenosis literally means the reoccurrence of stenosis. This is usually restenosis of an artery, or other blood vessel, but possibly any hollow organ that has been "unblocked". This term is common in vascular surgery, cardiac surgery, interventional radiology, or interventional cardiology following angioplasty, all branches of medicine that frequently treat stenofic lesions.
Applicants have not provided sufficient support or disclosed assays that are highly predictive for the pharmaceutical use of the instant compounds. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved". See In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24 (CCPA 1970).
(Only a few of the claimed diseases are discussed here to make the point of an insufficient disclosure, it does not definitely mean that the other diseases meet the enablement requirements).
Thus, factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the use of the invention. In view of the breadth of the claim, the chemical nature of the invention, the unpredictability of ligand-receptor interactions in general, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Thus, claims 30 and 31 are rejected for scope of enablement.
The rejection is maintained as the amendments have not overcome the rejection. See also the 112(b) rejection above.
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.
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.
Claims 1-2, 4, 11, 13, 15, 19, 25 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pellicciari et al. (WO 2004007521).
The reference teaches the following species:
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, see page 17. The ethyl compound is removed by proviso.
With regards to R2 of the presently claimed compounds, when the compound is not specifically named, but instead it is necessary to select portions of teachings within a 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). Thus, a generic chemical formula will anticipate a claimed species covered by the formula when the species can be “at once envisaged’ from the formula.
Therefore, said claims are anticipated.
Applicant should review the reference for more species that may anticipate or render obvious the present claims.
Claims 1-3, 11, 13, 15, 19, 23, 25 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bellini et al. (European Journal of Medicinal Chemistry, 1983, 18(2), 185-190).
The reference teaches the following species:
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see page 186, and all compounds, except the two removed by proviso, read on at least claim 1.
Therefore, said claims are anticipated.
Claims 1-3, 11, 13, 15, 19, 25 and 27-29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sipos, T. (US 5234697).
The reference teaches the following species:
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see column 4, line 39. This compound is found in the present claim 27, page 8, compound NC 10006 and claim 28, page 22.
Therefore, said claims are anticipated.
Applicant should review the reference for more species that may anticipate or render obvious the present claims.
Claims 1-3, 11, 13, 23-25 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fieser et al. (Journal of the American Chemical Society, 1953, 75, 6306-6307).
The reference teaches the following species:
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, see page 6306, compound II.
Therefore, said claims are anticipated.
Applicant should review the reference for more species that may anticipate or render obvious the present claims.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9272047 in view of Broadhead and Gibson (Drugs and the Pharmaceutical Sciences, 2nd edition, Pharmaceutical Preformulation and Formulation, 2009, Volume 199, Chapter on Parenteral Dosage Forms, 325-347). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘047 patent are drawn to a method of treating sepsis comprising administering sodium taurodeoxcholic acid, the sodium salt of compound of formula 2, see above right, in the form of a liquid solution (claim 3).
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Broadband and Gibson teach pharmaceutical formulations for parenteral formulations, see pages 325-347).
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 1-4, 11, 13, 15, 19, 23-25 and 27-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9629854. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘854 patent are drawn to a method of treating an allergic skin disease comprising administering sodium taurodeoxcholic acid, the sodium salt of compound of formula 2, see above right, in the form of an external preparation.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10342807. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘807 patent are drawn to a method of treating Alzheimer’s-related disease or dementia-related disease comprising administering a GPCR19 agonist, wherein the GPCR19 agonist is sodium taurodeoxcholic acid, the sodium salt of compound of formula 2, see above right.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10071107. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘107 patent are drawn to a method of treating Alzheimer’s Disease or dementia comprising administering a GPCR19 agonist, wherein the GPCR19 agonist is sodium taurodeoxcholic acid, the sodium salt of compound of formula 2, see above right.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
Applicant traverses the above NSDP rejections by stating:
There Is No Homologous Relationship Between the Compounds Specified in the Claims of the Cited Patents and the Presently Claimed Compounds;
Aspects of Three-Dimensional Structure and Steric Hindrance Bile acid-based compounds, such as taurodeoxycholic acid (Formula 2), possess a steric three-dimensional structure formed by a rigid steroidal scaffold; and
(3) Lack of Motivation for Structural Modification.
Applicant states, “The Office asserts that adding a methyl group to R1 or R2 of the instantly claimed compounds results in a homologue, and thus it would be expected that the compounds possess similar properties in accordance with MPEP § 2144.09. However, Applicant submits that a "homologue," as defined in MPEP § 2144.09, refers to the case where a -CH2- group is sequentially added to a linear alkyl chain (e.g., methane -- ethane -- propane). The presently claimed compounds, in contrast, are based on a rigid, polycyclic bile acid scaffold. The introduction of a substituent at a specific position in such a structure does not correspond to a simple "chain extension," but rather to the synthesis of a new derivative or analog. Accordingly, the presently claimed compounds are not homologues of the compounds disclosed in the cited patents.”
This is not persuasive. The claims encompass homologues of compounds of, e.g. taurodeoxycholic acid, wherein e.g. R1, R2, X, A and Y, among other variables have various lengths of carbon chains. A homologue is the replacement of a hydrogen with a methyl substituent. Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548; In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 247; Ex parte Henkel, 130 USPQ 474; In re Jones, 74 USPQ 152, 154; In re Herr, 134 USPQ 176; Ex parte Dibella, 157 USPQ 59; In re Zickendraht, 138 USPQ 22; Ex Parte Fischer, 96 USPQ 345; In re Fauque, 121 USPQ 425; In re Druey, 138 USPQ 39; In re Bowers and Orr, 149 USPQ 570. In all of these cases, the close structural similarity between two compounds differing by one or two methyl groups was itself sufficient show obviousness.
Applicant further states, “Bile acid-based compounds, such as taurodeoxycholic acid (Formula 2), possess a steric three-dimensional structure formed by a rigid steroidal scaffold. The spatial arrangement of the entire molecule and its receptor binding mode can be significantly altered depending on variations in the length of the side-chain, the types of substituents, and the linker structure. For example, when various substituents are introduced into the side-chain, as in the present compounds, the orientation, steric effects, and electrostatic distribution of the side-chain within the receptor binding pocket may change, resulting in the formation of a different interaction network compared to conventional compounds. Accordingly, it is unreasonable for the Office to conclude that the presently claimed compounds and the compounds of the cited patents would be expected to possess similar properties or efficacies based solely on the two-dimensional structural similarity of the bile acid scaffold.”
This is also not persuasive. Methyl and ethyl are different is size and have different steric effects, and without a secondary teaching, are considered obvious. Note also In re Jones, 21 USPQ2d 1942, which states at 1943 “Particular types or categories of structural similarity without more, have, in past cases, given rise to prima facie obviousness”; one of those listed is “adjacent homologues and structural isomers”. Similar is In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.”
Applicant notes, “Moreover, the determination of obviousness-type double patenting is based on the standard of obviousness. Applicant further submits that neither the cited patents nor the Office provides any teaching or suggestion that would have motivated a person of ordinary skill in the art to methylate or otherwise substitute and modify the R1 and R2 positions of taurodeoxycholic acid to arrive at the instantly claimed compounds. In view of the foregoing, reconsideration and withdrawal of the rejections over the '047 patent, the '854 patent, the '807 patent, and the '107 patent is respectfully requested.”
Again, this is unpersuasive. Note also In re Deuel 34 USPQ2d 1210, 1214, which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” See also MPEP 2144.09, second paragraph.
Thus, the rejections are maintained.
Claims 1-4, 11, 13, 15, 19, 23-25 and 27-31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6, 7, 9-13, 16, 18-21, 24, 26, 28-30, 33 and 35 of copending Application No. 18027027. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease. The disclosed mode of action is through the NRLP pathway using a GPCR-P2X7R, see page 6 of the specification, which describes a screening system.
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The claims of the ‘027 application are drawn to a method of screening a substance that regulates interaction between GPCR19 and P2Xn receptor in their complex.
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant respectfully requests that the rejection be held in abeyance until such time that the claims are otherwise in allowable form.
Thus, the rejection is maintained.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of copending Application No. 18708357 in view of Shah et al. (Frontiers in Immunology, 2020, 11, 1-5). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘357 application are drawn to a method of treating a viral infection comprising administering an inflammasome inhibitor, wherein the inflammasome inhibitor is taurodeoxcholic acid, the compound of formula 2, see above right, in combinaton with an antiviral.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Shah et al. teach the inhibition of inflammasomes to treat a viral infection, see first paragraph.
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant states, “Applicants submit that the instant application is the national stage of PCT/KR2022/010998, filed on 26 July 2022. The '357 application is the national stage of PCT/KR2022/016721, filed on 28 October 2022. Accordingly, the instant application has a patent term filing date, which is earlier than that of the '357 application.”
This is not persuasive since the patent term filing date is not being considered; and thus, the rejection is maintained.
Claims 1-4, 11, 13, 15, 19, 25 and 27-29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1-7 of copending Application No. 18906683 in view of Ding et al. (Front. Pharmacol., 2020, 11, 1-12). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims in the ‘683 application are drawn to a method for the treatment or prevention of pulmonary fibrosis comprising administering taurodeoxycholic acid. Claim 3 of the ‘683 application is drawn to a pharmaceutical composition comprising taurodeoxcholic acid, compound of formula 2, see above right.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Ding et al. teach inhibiting NLRP3 inflammasome activation may improve fibrosis, see abstract.
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant states, “As noted previously, the instant application is the national stage of PCT/KR2022/010998, filed on 26 July 2022. The '683 application is the national stage of PCT/KR2023/004665, filed on 6 April 2023. Accordingly, the instant application has a patent term filing date, which is earlier than that of the '683 application and the Office should withdraw the provisional double patenting rejection in this application.”
This is not persuasive since the patent term filing date is not being considered; and thus, the rejection is maintained.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of copending Application No. 18561881. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘881 application are drawn to a method of treating a lower respiratory tract infectious disease comprising administering a taurodeoxcholic acid, compound of formula 2, see above right.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Moreover, there is no patentable distinction between compounds and methods of intended use of said compounds.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant respectfully requests that the rejection be held in abeyance until such time that the claims are otherwise in allowable form.
Thus, the rejection is maintained.
Claims 1-4, 11, 13, 15, 19, 25 and 27-31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of copending Application No. 18694190 in view of Shah et al. (Frontiers in Immunology, 2020, 11, 1-5). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims compounds of formula 1, bottom left, and a method of treating inflammatory disease.
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The claims of the ‘190 application are drawn to a method of treating a lower respiratory tract infectious disease comprising administering an inflammasome inhibitor, wherein the inhibitor is taurodeoxcholic acid of formula 2 (claims 2 and 3), see above right, in combination with an antiviral.
The compound of formula 2 is embraced by the genus of the present claims and is a homologue of species NC10001, NC10002, among others, in present claims 27 and 28. Also, adding a methyl group to R1 or R2 would be a homologue. The MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Shah et al. teach the inhibition of inflammasomes to treat a viral infection, see first paragraph. It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from having been individually taught in prior art.
Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Furthermore, there is no patentable distinction between compounds and methods of intended use of said compounds.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant states, “As noted previously, the instant application is the national stage of PCT/KR2022/010998, filed on 26 July 2022. The '683 application is the national stage of PCT/KR2022/013768, filed on 15 September 2022. Accordingly, the instant application has a patent term filing date, which is earlier than that of the '190 application and the Office should withdraw the provisional double patenting rejection in this application.”
This is not persuasive since the patent term filing date is not being considered; and thus, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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