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 .
Status of Claims
Claims 1-17 are pending in the instant application.
Priority
This application claims priority to Application No. PCT/EP2014/059896, filed May 14th, 2014. This application also claims priority to provisional Application No. 61/823,169, filed May 14th, 2013, and is a continuation of the following applications, 14120366, filed May 14th, 2014, 15/434,685, filed February 16th, 2017, 16/124,139, filed September 6th, 2018, 16/695,528, filed November 26th, 2019, 17/228,819, filed April 13th, 2021 and 18/295,091, filed April 3rd, 2023.
Specification
The use of the term PREDICTOR™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Although the use of marks having definite meanings is permissible in patent applications, the proprietary nature of the marks should be respected. Marks should be identified by capitalizing each letter of the mark (in the case of word or letter marks) or otherwise indicating the description of the mark (in the case of marks in the form of a symbol or device or other nontextual form). Every effort should be made to prevent their use in any manner which might adversely affect their validity as marks. See MPEP § 608.01(v) II.
Claim Rejections - 35 USC § 112 (a)
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 1-17 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 pharmaceutically acceptable salt or amino acid conjugate thereof, does not reasonably provide enablement for solvate.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Factors to be considered in making an enablement rejection are summarized as: a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in the art, g) the predictability or unpredictability of the art, and h) the breadth of the claims.
The instant claims recite a compound of formula I or “pharmaceutically acceptable salts, solvates, or amino acid conjugate thereof”.
The claims, insofar as they embrace solvates are not enabled. The present specification merely mentions the Applicant’s intention to make solvates, without teaching the preparation thereof. As stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190, 1194 (Fed.Cir. 1993):
The specification purports to teach, with over fifty examples, the preparation of the claimed compounds ... However ... there is no evidence that such compounds exist ... [T]he examples ... do not produce the postulated compounds ... [T]here is ... no evidence that such compounds even exist.
The same circumstance appears to be true here. There is no evidence that solvates of these compounds actually exist; if they did, they would have formed. Hence, applicants must show that solvates can be made, or limit the claims accordingly.
See MPEP 2164.01(a), discussed supra, justifying the conclusion of lack of enablement commensurate with the claims. Without guidance in the present application, undue experimentation will be required to practice Applicant’s claimed invention.
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 1-11, 13, 14 and 17 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.
The instant claims are indefinite for the following reasons:
Claims 1 and 13 recite “one or more symptoms of intrahepatic cholestasis or extrahepatic cholestasis” and claim 17 recites “wherein the one or more symptoms of intrahepatic cholestasis or extrahepatic cholestasis is biliary atresia, obstetric cholestasis, neonatal cholestasis, drug induced cholestasis, or cholestasis arising from Hepatitis C infection”.
The present specification sets forth one or more symptoms of intrahepatic or extrahepatic cholestasis, as including without limitation, “biliary artesia, obstetric cholestasis, neonatal cholestasis, drug induced cholestasis, cholestasis arising from Hepatitis C infection, chronic cholestatic liver disease such as primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC)”. However, the “symptoms” as set forth in the specification and recited in claim 17 are types of cholestasis. It is unclear how said recited forms of cholestasis can also be symptoms of intra- or extrahepatic cholestasis.
Additionally, apart from these “symptoms”, it is unclear what else is encompassed by the phrase “one or more symptoms of intrahepatic or extrahepatic cholestasis”; and
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “fibrosis due to pathological conditions or diseases”, and the claim also recites “fibrosis due to physical trauma, fibrosis due to radiation damage, fibrosis due to exposure to chemotherapeutics, liver fibrosis, fibrosis of the kidneys, fibrosis of the lung, or fibrosis of the intestine” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (6) a required feature of the claims.
For these reasons, the skilled artisan in the art at the time of the present would have been unable to determine the metes and bound of the claimed invention.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,000,532 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 12-17, the patent claims a method of treating intrahepatic cholestasis and fibrosis comprising administering to the subject an effective amount of the following compound (claims 10 and 14):
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this compound is embraced by instant formula I, wherein R1 is hydroxyl, R2 is hydroxyl, R3 is hydrogen, R4 is alkyl, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 2, this compound is of instant formula III.
Regarding claim 3, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 4, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 5, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 6, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 7, R2 is hydroxyl and R3 is hydrogen and R5 is hydroxyl and R6 is hydrogen.
Regarding claims 8-10, R4 is ethyl.
Regarding claim 11, the compound above is the compound of instant claim 11.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,532,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 12-17, the patent claims a method of treating a chronic liver disease or condition comprising administering to the subject an effective amount of the following compound (claim 1 and 6):
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this compound is embraced by instant formula I, wherein R1 is hydroxyl, R2 is hydroxyl, R3 is hydrogen, R4 is alkyl, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 2, this compound is of instant formula III.
Regarding claim 3, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 4, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 5, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 6, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 7, R2 is hydroxyl and R3 is hydrogen and R5 is hydroxyl and R6 is hydrogen.
Regarding claims 8-10, R4 is ethyl.
Regarding claim 11, the compound above is the compound of instant claim 11.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,611,289 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 12-17, the patent claims a method of treating fibrosis and cholestasis comprising administering to the subject an effective amount of the following compound (claim 16 and 20):
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this compound is embraced by instant formula I, wherein R1 is hydroxyl, R2 is hydroxyl, R3 is hydrogen, R4 is alkyl, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 2, this compound is of instant formula III.
Regarding claim 3, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 4, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 5, R2 is hydroxyl and R3 is hydrogen.
Regarding claim 6, R5 is hydroxyl and R6 is hydrogen.
Regarding claim 7, R2 is hydroxyl and R3 is hydrogen and R5 is hydroxyl and R6 is hydrogen.
Regarding claims 8-10, R4 is ethyl.
Regarding claim 11, the compound above is the compound of instant claim 11.
Closest Prior Art
The closest prior art in terms of similarity to the instantly claimed method is Baghdasaryan et al (HEPATOLOGY, Vol. 54, No. 4, 2011). Baghdasaryan teaches the administration of the following compounds to improve liver injury, specifically to suppress fibrosis in mice. The compounds include,
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However, there are differences between the compounds of the prior art and the compounds of instant formula I. First, when looking at compound INT-747, instant formula I requires a hydroxyl group, where the compound has a hydrogen. Further, INT-777, has a hydroxyl group, but not in the R1 position and also has an extra methyl group.
There is no motivation to arrive at the instantly claimed compounds and then in turn, the instantly claimed method found In Baghdasaryan. As such, the method is novel and nonobvious over the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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