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
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/KR2022/000736, filed on January 14, 2022, which claims priority to Korean application no. KR10-2021-0005318, filed on January 14, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 07/13/2023 is acknowledged. Claims 1-14 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Abstract
The Abstract of the disclosure is objected to because of the following informalities:
The Abstract exceeds the word limit for the application. See MPEP 608.01(b)
608.01(b) Abstract of the Disclosure [R-9] 37 C.F.R. 1.72 Title and abstract.
(b) A brief abstract of the technical disclosure in the specification must commence on a separate sheet, preferably following the claims, under the heading "Abstract" or "Abstract of the Disclosure." The sheet or sheets presenting the abstract may not include other parts of the application or other material. The abstract in an application filed under 35 U.S.C. 111 may not exceed 150 words in length. The purpose of the abstract is to enable the United States Patent and Trademark Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure.
The Office of Patent Application Processing (OPAP) will review all applications filed under 35 U.S.C. 111(a) for compliance with 37 CFR 1.72 and will require an abstract, if one has not been filed. In all other applications which lack an abstract, the examiner in the first Office action should require the submission of an abstract directed to the technical disclosure in the specification. See Form Paragraph 6.12 (below). Applicants may use either "Abstract" or "Abstract of the Disclosure" as a heading.
If the abstract contained in the application does not comply with the guidelines, the examiner should point out the defect to the applicant in the first Office action, or at the earliest point in the prosecution that the defect is noted, and require compliance with the guidelines. Since the abstract of the disclosure has been interpreted to be a part of the specification for the purpose of compliance with paragraph 1 of 35 U.S.C. 112 (In re Armbruster, 512 F.2d 676, 678-79, 185 USPQ 152, 154 (CCPA 1975)), it would ordinarily be preferable that the applicant make the necessary changes to the abstract to bring it into compliance with the guidelines. See Form Paragraphs 6.13-6.16 (below). Replies to such actions requiring either a new abstract or amendment to bring the abstract into compliance with the guidelines should be treated under 37 CFR 1.111(b) practice like any other formal matter. Any submission of a new abstract or amendment to an existing abstract should be carefully reviewed for introduction of new matter, 35 U.S.C. 132, MPEP § 608.04. Upon passing the application to issue, the examiner should make certain that the abstract is an adequate and clear statement of the contents of the disclosure and generally in line with the guidelines. If the application is otherwise in condition for allowance except that the abstract does not comply with the guidelines, the examiner generally should make any necessary revisions by a formal examiner' s amendment after obtaining applicant' s authorization (see MPEP § 1302.04 rather than issuing an Ex parte Quayle action requiring applicant to make the necessary revisions. Under current practice, in all instances where the application contains an abstract when sent to issue, the abstract will be printed on the patent. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
1. The following order of arrangement of specification elements is preferable in framing the nonprovisional specification and each of the lettered items should appear in upper case, without underlining or bold type, as section headings. If no text follows the section heading, the phrase "Not Applicable" should follow the section heading. It is recommended that provisional applications follow the same general format, although claims are not required. If an application data sheet (37 CFR 1.76 ) is used, data supplied in the application data sheet need not be provided elsewhere in the application except that the citizenship of each inventor must be provided in the oath or declaration under 37 CFR 1.63 even if this information is provided in the application data sheet. If there is a discrepancy between the information submitted in an application data sheet and the information submitted elsewhere in the application, the application data sheet will control except for the naming of the inventors and the citizenship of the inventors. See 37 CFR 1.76 (d) and MPEP § 601.05.
MPEP 608.01(a) Arrangement of Application
¶ 6.02 Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 201.11.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71 (g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.52(e) and MPEP § 608.05. Computer program listings (37 CFR 1.96 (c)), "Sequence Listings" (37 CFR 1.821 (c)), and tables having more than 50 pages of text were permitted as electronic documents on compact discs beginning on September 8, 2000.
(f) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled "Technical Field."
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant' s invention. This item may also be titled "Background Art."
(g) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(i) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter. Appropriate correction is required.
Claim Objections
Claims 1-14 are objected to for the following informalities:
Claims 1-14 are objected to as not being consistent in form. The claim’s recitation should begin on the same line as the indicated claim number. For example,
An extracellular vesicle comprising a coronavirus-derived antigen protein or a gene encoding the protein.
The extracellular vesicle of claim 1, wherein the coronavirus is severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1 and 5 are determined to be directed to laws of nature and natural products. The rationale for this determination is explained below:
The claims are directed to: an extracellular vesicle comprising a coronavirus-derived antigen protein or a gene encoding the protein.
Here, the claimed peptides can be compared to its naturally occurring counterpart in its natural state, namely to the extracellular vesicles that are released during coronavirus infection from cells found in naturally occurring infectious stages of SARS-CoV-2. Specifically, the claim terminology causes the claims to read on naturally occurring viral proteins/antigens found in nature as the claims are directed to the product (coronavirus-derived antigen proteins or a gene encoding the protein). There are no apparent differences in structure, biological or pharmacological functions or activities, or other properties relative to the naturally occurring counterpart.
See MPEP 2106.04(c)(II)(C)(2):
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual' s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad' s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions. In this case, whole viruses (i.e. genes encoding the protein), proteins, or protein fragments that infect cells can naturally be released within extracellular vesicles (EVs), thus, having the capability to target new cells (even immune cells) for infectivity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, the claims are directed to an ineligible ‘production of nature' exception.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 112
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.
Claims 1-14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to an extracellular vesicle comprising a coronavirus-derived antigen protein or a gene encoding the protein.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The grounds for the written description rejection are as follows: (1) The claims recite an “a coronavirus-derived antigen" with no guidance in the specification as to how the “derived antigen” as it is a “derived” protein that can read on any protein or gene encoding the protein. For example, the claim can read on an amino acid sequence having 1% sequence identity as long as it is derived from coronavirus antigen. Thus, the sequence can have an exponential number of amino acid sequences that read on the claims. The protein can have any type of mutation (e.g., deletion, insertion, substitution), anywhere along the sequence. There is some general teaching in the art that some amino acid variations are tolerated without losing a protein' s tertiary structure, but conservation of structure is not necessarily a surrogate for conservation of function. While one of skill in the art could, with the aid of a computer as suggested, could identify nucleic acid sequences that encode the protein and amino acid sequences that may be derived from a coronavirus antigen, it does not appear applicants were in possession of all of the claimed sequences at the time of filing. Given that there is no identification of any particular portion of the structure that must be conserved, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115). Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The polypeptide itself is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
Furthermore, In The Reagents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that "An adequate written description of a DNA...'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".
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
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 1-5, 8-10 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polak et al. “Polak” (Extracellular vesicle-based vaccine platform displaying native viral envelope proteins elicits a robust anti-SARS-CoV-2 response in mice, bioRxiv, 2020:1-30, IDS of record dated 07/13/2023).
The claims are directed to an extracellular vesicle comprising a coronavirus-derived antigen protein or a gene encoding the protein.
Regarding claims 1, 9 and 13-14, Polak discloses extracellular vesicles comprising a coronavirus-derived antigen protein or a gene encoding the protein; and a vaccine for preventing or treating coronavirus infections, the vaccine comprising the extracellular vesicles (see Abstract, pages 3 and 6-7, and figures 1-3).
Regarding claims 2-4, Polak discloses that the extracellular vesicles include a SARS-Co V-2 coronavirus-derived spike protein and a receptor binding domain (RBD) thereof (see the abstract and pages 3 and 6).
Regarding claim 5, Polak discloses that the extracellular vesicles are derived from animal cells (see page 6).
Regarding claim 8, Polak discloses that the extracellular express the CD63 marker (see page 6 line 15).
Regarding claim 10, Polak discloses that the a vaccine induces antigen-specific antibody production and T cell-mediated responses (see the abstract and page 7).
Therefore, the cited prior art anticipates the claimed invention.
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 made 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 6-7 and 11-12 are rejected under 35 U.S.C. 103(a) as being unpatentable over Polak et al. “Polak” (Extracellular vesicle-based vaccine platform displaying native viral envelope proteins elicits a robust anti-SARS-CoV-2 response in mice, bioRxiv, 2020:1-30, IDS of record dated 07/13/2023) as applied to claims 1-5 and 9 above. The teachings of Polak et al. are outlined above and incorporated herein.
The claims are directed to the extracellular vesicle of claim 5, wherein the animal cells comprise one or more cells selected from the group consisting of somatic cells, germ cells, immune cells, neurons, and tumor cells; and activated immune cells.
Regarding claims 6-7, it is not inventive and considered obvious to one of ordinary skill in the art that the extracellular vesicles comprising the SARS-Cov-2 antigen protein would comprise the claimed cells. Polak discloses a vaccination protocol to mice and a skilled artisan would readily derive, absent unexpected results, that the extracellular vesicles are derived from any cell in the mice challenged by Polak.
Regarding claims 11 and 12, it is not inventive and considered conventional, routine and obvious to one of ordinary skill in the art to generate a freeze-dried vaccine or health functional food. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the purpose of efficient manufacturing, distribution and stability of the vaccine.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672