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
Status of the Claims
Claims 1-15 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on July 26th 2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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.
Claim 11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 is indefinite because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. The claim recites “A method of treating a disease comprising administering to a patient a therapeutically effective amount of the compound of claim 1.” The term “disease” is overly broad in scope, encompassing everything from metabolic diseases and neurodegenerative diseases to cancers and viral infections, and thus one of ordinary skill in the art could not reasonably determine the entire scope of the patient population described by the claim language.
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.
Claim 11 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 is directed towards “A method of treating a disease comprising administering to a patient a therapeutically effective amount of the compound of claim 1.” The claim encompasses a method of treating any disease using the compounds of claim 1 (identified in the specification as inhibitors of dihydroorotate dehydrogenase). However, the specification fails to demonstrate that the applicant was in possession of the full scope of the invention at the time of filing. In particular, the specification describes the treatment of cancers and the treatment or prevention of viral infections. The relevant disclosure of the mechanistic nature of the compounds is in regards to the DHODH inhibition leading to reduced pyrimidine nucleotide levels and p53 activation:
Without wishing to be bound by theory, compounds as described herein are thought to be potent inhibitors of DHODH, which leads to activity as inhibitors of de novo pyrimidine nucleotide synthesis. Cancer cells are known to have greater susceptibility to nucleotide level modulation, due to their defective cell cycle check points. This allows for potent and selective inhibition of cancer cell growth and promotion of cancer cell death. Further, combining compounds as described herein with therapeutic agents that are able to decrease the level of nucleotides and nucleosides, such as pyrimidine nucleotides and nucleosides, in the cell (for example, by inhibiting uptake or preventing retention within the cell; such as the therapeutic agent nilotinib) are thought to provide an effective and synergistic combination therapy.
[Specification, paragraph [0512]]
Applicant has further cited relevant art regarding the treatment of viral infections with compounds of the described nature (Specification, paragraph [0009]). However, there is no description or even suggestion that the disclosed compounds, or even the disclosed method of activity (DHODH inhibition) would be relevant in the vast array of other conditions potentially described by the umbrella term “diseases.” The term, as written, is far broader than the disclosure, and applicant’s written description is considered inadequate to support the term as filed. See MPEP 2163.03(V).
Applicant will not be considered to have possession of the entire genus of claim 11, but only the treatment of cancers and treatment/prevention of viral infections.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2469431-94-3 (Entered STN on September 2nd 2020):
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384
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.
The compound is anticipatory of claims 1-5.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lain (U.S. Patent No. 10,889,564 issued on January 12th 2021) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claims 1-9 are directed towards compounds of formula I:
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.
One such compound is
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(see claim 9).
Lain teaches the compound,
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(Lain, col. 90, claim 37),
which differs from applicant’s compound only in the bioisosteric replacement of a ring -O- with a -CH2-. One of ordinary skill in the art would have had a reasonable expectation of success in performing such a bioisosteric replacement, because it is a well-known ring-equivalent substitution in the field of medicinal chemistry (Brown, pg. 19). Claims 1-9 are thereby prima facie obvious.
Claim 10 is directed towards a pharmaceutical composition comprising the compound of claim 1 and is rendered prima facie obvious by Lain (Lain, col. 88, claim 25), who teaches such a composition.
Claim 11 is directed towards the treatment of a disease via administration of the compound of claim 1, and is rendered prima facie obvious by Lain (Lain, col. 87, claim 22), who teaches the treatment of cancers.
Claim 12 is directed towards the treatment of cancer with the compound of claim 1, and is rendered prima facie obvious by Lain (Lain, col. 87, claim 22), who teaches the treatment of cancers.
Claim 13 is directed towards a combination product comprising the compound of claim 1 and an additional therapeutic agent, and is rendered prima facie obvious by Lain (Lain, col. 88, claim 28), who teaches such a product.
Claim 14 is directed towards a kit comprising the compound of claim 1 and additional agents, and is rendered prima facie obvious by Lain (Lain, col. 88, claim 29), who teaches such a kit.
Claim 15 is directed towards a particular preparation process for the compound of claim 1. Lain teaches a substantially identical preparation process, differing only in the ring O vs ring CH2 in the starting material (Lain, col. 88-89, claim 34). Claim 15 is thereby prima facie obvious.
Nonstatutory 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 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,889,564 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons listed in the above 103 rejection over the claims of U.S. Patent No. 10,889,564 and Brown.
Claims 1-8 and 10-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,795,157 in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,795,157 claims the treatment of particular cancers via administration of a subgenus of the compounds described in U.S. Patent No. 10,889,564, of which it is a continuation. Thereby, the rejections over U.S. Patent No. 10,889,564 and Brown analogously apply here.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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