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 .
Claim 1 is presented for examination.
Claims 2-10 are withdrawn from examination.
Restriction/Election
Applicant’s election without traverse of group I, claim 1 in the reply filed on 04/08/2026 is acknowledged.
Claims 2-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/08/2024.
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.
Claim 1 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 1 is indefinite as to the phrases “NMPT inhibitor”, “HDAC8 inhibitor” and “SIRT6 inhibitor”. Such phrases fail to set forth the intended meaning. From the claimed language it is not clear what NAMPT, HDAC8 and SITR6 stand for.
Claim Rejections - 35 USC § 112
Claim 1 is 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. The following precedent is believed relevant to the instant case.
Regents of the University of California V. Eli Lilly & Co., 119 F.3d 1559, 1968 (Fed, Cir. 1997), cert. Denied, 523 U.S. 1089, 118 S.Ct. 1548 (1998), hold that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F. 3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") guidelines. for Examination of Patent Applications under the 35 U.S.C. 112. "Written Description" requirement ("Guidelines"). 66 Fed Reg. 1099 (Jan.5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, "including, inter alia' functional characteristics when coupled with a known or disclosed correlation between function and structure "Enzo biochem, inc.v.Gen-probe inc., 296 F.3d, 316, 1324-25 (Fed. Cir 2002) (quoting guideline, 66 Fed. Reg. At 1106 (emphasis added. Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structure in general. Univ. of Rochester V. G.D. Searle & CO., 249 F.supp.2d 216, 225 (W.D>N.Y. 2003).
Applying the reasoning of the above-cited case law to facts at hand, the instant specification fails to provide an adequate written description of “at least one NAMPT inhibitor, or a pharmaceutically acceptable salt, hydrate, solvate or polymorph thereof” and “at least one HDAC8 inhibitor” and/or “at least one SIRT6 inhibitor” . The specification describes only a limited number of such agents. When functional claims are drawn this broadly, they are inclusive of any NAMPT inhibitor or its salt, hydrate , solvate or polymorph, any HDAC8 inhibitor, and any SIRT6 inhibitor, which can be small molecules, peptides, peptide mimetics or RNA-DNA based structures. The instant specification quite simply, discloses a few compounds within the scope of the claimed language. As such, it cannot possibly provide any direction for using any peptides, peptide mimetics, or RNA-DNA based structure; no identifying characteristics of any kind, e.g. sequences, are provided. Accordingly, the instant specification fails to provide an adequate written description.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roulston et al. (US20090162454) in view of Bernstein et al. (US 20210308171) and further in view of Ma et al. (US 20170044185), Dong et al. (Small Molecule Inhibitors Simultaneously Targeting Cancer
Metabolism and Epigenetics: Discovery of Novel Nicotinamide Phosphoribosyl transferase (NAMPT) and Histone Deacetylase (HDAC) Dual Inhibitors) and Cea et al. ( Synergistic Interactions between HDAC and Sirtuin Inhibitors in Human Leukemia Cells).
The claim is drawn to a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of: (a) at least one disclosed NAMPT inhibitor, or a pharmaceutically acceptable salt, hydrate, solvate, or polymorph thereof; and (b) at least one HDAC8 inhibitor and/or at least one SIRT6 inhibitor, or a pharmaceutically acceptable salt, hydrate, solvate, or polymorph thereof.
Regarding claim 1, Roulston teaches methods and compositions useful for effecting NAD.sup.+ levels in a patient or a cell, and to methods and compositions useful in treating cancer deficient in nicotinic pathway. See Para [0002]. Roulston teaches that The invention is based, in part, upon the discovery that a Pyridyl Cyanoguanidine or a Prodrug thereof inhibits nicotinamide phosphoribosyl transferase (NMPRT), an enzyme involved in NAD.sup.+ biosynthesis; and, in part, on the discovery that a cancer deficient in nicotinic acid pathway can be advantageously treated with a NMPRT inhibitor and nicotinic acid. See Para [0011]. Roulston teaches that he patient in need of DNA damaging therapy has Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia/Other Myeloid Malignancies. See Para [0198]. Roulston makes clear that NAMPT inhibitors have been previously used in a pharmaceutical composition for the treatment of AML.
Roulston does not teach the addition of HDAC8 inhibitors and/or at least one SIRT6 inhibitor. However, Bernstein teaches a method of treating cancer, wherein the one or more agents comprise a histone acetylation inhibitor, histone deacetylase (HDAC) inhibitor, histone lysine methylation inhibitor, histone lysine demethylation inhibitor, DNA methyltransferase (DNMT) inhibitor, inhibitor of acetylated histone binding proteins, inhibitor of methylated histone binding proteins, sirtuin inhibitor, protein arginine methyltransferase inhibitor or kinase inhibitor. See claim 41. The treatment of Acute myeloid leukemia is taught in claim 54. Bernstein makes clear that HDAC8 inhibitors and SIRT inhibitors have been previously used for the treatment of Acute myeloid leukemia. Ma teaches that histone deacetylase inhibitors comprises, Histone deacetylase (HDAC)-1 inhibitor; HDAC2 inhibitor; HDAC3 inhibitor; HDAC4 inhibitor; HDAC5 inhibitor; HDAC6 inhibitor; HDAC7 inhibitor; HDAC8 inhibitor; HDAC9 inhibitor; HDAC10 inhibitor; HDAC11 inhibitor. Ma also makes clear that Sirtuin inhibitors comprises Sirtuin (SIRT)-1 inhibitor; SIRT2 inhibitor; SIRT3 inhibitor; SIRT4 inhibitor; SIRT5 inhibitor; SIRT6 inhibitor; SIRT7 inhibitor. See Para [0003] and claim 8. Ma in paragraph [0008] teaches that HDAC8 regulate
One skilled in the art would have been motivated to a person skilled in the art to add a HDAC8 inhibitor and sirtuin6 inhibitor to the composition of Roulston, motivated by the teachings of Bernstein and Ma. Bernstein teaches the use of HDAC inhibitors and Sirtuin inhibitors in general for the treatment of AML. MA teaches HDAC8 inhibitor as one of HDAC inhibitors and sirtuin6 inhibitor as one of sirtuin inhibitors. Dong teaches the synergistic effect of the combination of NAMPT inhibitors and histone deacetylase inhibitors in targeting cancer cells. See the abstract. Cea et al. teach the combination of HDAC inhibitors and SIRT inhibitors for treating leukemia. See the conclusion.
It would have been obvious to combine ingredients being used for the same purpose. Applicant’s attention is drawn to In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), wherein the court states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In the instant case to combine ingredients being used individually for the treatment of AML would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
Additionally, Dong et al. teach the synergistic effect of the combination of NMPT inhibitors and HDAC inhibitors for treating cancer. To select HDAC8 would have been obvious in view of Bernstein, which teaches HDAC8 has been used for treating myeloid leukemia.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZOHREH A FAY/Primary Examiner, Art Unit 1617
Prosecution Insights