The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3, 5, 9, 14-28, are pending in this application.
Claims 4, 6-8, 10-13, 29-30, are deleted.
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 1-3, 5, 9, 14-28, are 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 structures of derivatives (claims 1, 9, 20), click motif, click target, click complement, protein target (claims 19-20), linking group, first click motif (claim 21), click complement, second click motif (claim 23), azide (claim 24), and the structures of other cysteine proteases (claim 26), are not disclosed in the claims. The claims invite a POSA to identify the applicable embodiments and make them using any means/procedure known to the artisan. Adding to the claims, specific embodiments which have support in the specification, including enablements, will overcome the rejection.
How to perform identifying, contacting (claim 19), detecting (claims 19-20), are not disclosed in the claims. There is no incorporation-by-reference of US document where the enablements can be found. To ascertain how to perform the steps, a POSA must read the specification and/or other external sources into the claims contrary to several precedent decisions by the US courts. Appropriate corrections are required.
Prevention, claim 27, implies the disease has not occurred. The specification fails to disclose how to identify a “normal” subject who may be infected with the virus, and how to treat the subject to not acquire infection. Deleting “preventing or” will obviate the rejection. It is not clear what applicant means by “delaying the onset”. Does delaying the onset means prior to viral infection or delaying the onset of coronavirus sickness after infection?
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 19-20, 23, 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.
Comprises in claim 19, line 10; claim 20, line 11; claim 23, line 2, is an open-ended term, implying other embodiments, such as, other click motifs, not cited in the claims are claimed. Replacing comprises with “is” will overcome the rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-18, are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 16-18, relate to viral cysteine protease, while claim 1, cites non-viral cysteine protease. The claims improperly depend from claim 1, by expanding the scope of claim 1, instead of further limiting it. Cathepsin L is involved in cancer, atherosclerosis, and viral infections.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 5, 9, 14-18, 27-28, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al., Antiviral Res (2015), 116:76-84, which teaches a process of making K11777, its derivatives and composition thereof useful for treating diverse viruses, e.g. Ebola, SARS-coronavirus and MERS-coronavirus. The prior art teaches K11777 is a broad-spectrum antiviral agent, a cysteine protease inhibitor, it targets cathepsin-mediated cell entry, and useful for treating parasitic diseases, e.g. chagas disease (non-viral cysteine protease inhibition). See the entire document, particularly the abstract, introduction, materials and methods, Scheme 1, discussion, tables 1-3, and the results.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was filed to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 19-26, are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ong et al., PNAS (2009), 106(12): 4617-22, in view of Chan et al., Trends in Pharmacological Sci (2009), 31(12): 82-88; Bakheet et al., Bioinformatics (2009), 25(4): 451-57; Bantscheff et al., Bioorg Med Chem (2012), 20:1973-7; Su et al., BMC System Biol. (2017) 11(Suppl. 7):132, pp. 69-80.
Ong et al., teaches a process for identifying proteins to which small molecule probes and drugs bind in cells. The prior art teaches the process is a powerful combination of quantitative proteomics and affinity enrichment, which provides unbiased, robust and comprehensive identification of the proteins that bind to small-molecule probes and drugs. The process is scalable and general. It requires little optimization across different compound classes, and transforms studies of small-molecule probes. See the entire document, particularly, the abstract, the results, the figures and tables.
Chan et al., teaches a succinct overview of several approaches for identifying drug targets by employing genetics, proteomics, expression profiling or bioinformatics, for systemic characterization of the targets of biomedical compounds. The prior art discusses the criticality of existing technologies, and offers a perspective on the future of innovative and emerging techniques. See the entire document, particularly, the abstract, results, the figure and table.
Bakheet et al., teaches the analysis of 148 human drug target proteins and 3573 non-drug targets, and identifies the differences in their properties, which are used to predict new potential drug targets. The prior art teaches the outcomes are used as inputs to a support vector machine (SVM). SVM allows assignment of any sequence, with 96% accuracy, to the drug target or non-target classes. See the entire document, particularly, the abstract, results, the figures and tables.
Bantscheff et al., teaches experimental strategies in chemical proteomics research, and the successful applications to drug target identification and drug profiling. The prior art highlights areas in drug discovery, wherein chemical proteomics assays using native endogenous proteins are expected to have substantial impact. See the entire document, particularly, the abstract, results and the figure.
Su et al., teaches investigation and identification of functional protein post-translational modification (PTM) sites associated with drug binding and protein-protein interactions. It teaches an integrated platform (CruxPTM), with a variety of methods and online molecular docking tools for exploring the structures of PTM. The prior art teaches all tertiary structures of PTM sites on a protein are visible using the system. See the entire document, particularly, the abstract, results, the tables and figures.
Having known as set forth above, a POSA would have known how to identify the instant protein target and be motivated to do so at the time the invention was made, with reasonable expectation of success.
The invention is obvious over the combination of the prior arts and knowledge known in the art.
Objection
The specification is objected because the structures in the table at page 31, are very faint and not clear.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/Primary Examiner, Art Unit 1625
July 28, 2025