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
This application is a 371 of PCT/JP2023/024953.
Status of Claims
Claims 1-9 are pending.
Claims 1-9 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 1, 2026, January 23, 2025, and December 2, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 9 is objected to due to the double recitation of “antiviral agent”. Appropriate correction is required.
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.
Claims 7-9 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 terms “severity risk” and “high severity risk” in claims 7-9 are relative terms, which render the claims indefinite. The terms ““severity risk” and “high severity risk”” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to how much risk of a virus infection is considered as “severity risk” and “high severity risk”. A perusal of the specification did not provide a clear definition for the above terms. Without a clear definition in terms of numerical value, those skilled in the art would be unable to ascertain what risk of a virus are “severity risk” and “high severity risk”.
Claim 9 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 9 recites the phrase “administering to the test subject determined to be administered with an antiviral agent..”. The metes and bounds of the limitation in the context of the above claim are not clear. It is unclear which subjects are administered the antiviral agent. Clarification is requested.
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 1-9 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.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, claims 1-5 have been broadly interpreted to encompass a method of inactivating any virus by cleaving any disulfide bond of any protein that constitutes the virus, spike protein, envelope protein, or a capsid protein with any protein having a disulfide bond cleavage activity, any protein disulfide isomerase family protein, or PDI, Erp46, Erp57, Erp72, and/or P5. Claims 6 and 9 have been broadly interpreted to encompass a method of treating or preventing a virus infection by administering any protein having disulfide bond cleavage activity or any antiviral agent. Claim 7 has been broadly interpreted to encompass a directed to a kit for evaluating a virus infection severity risk comprising any binding substances for any protein having disulfide bond cleavage activity. Claim 8 has been broadly interpreted to encompass a method of evaluating a virus infection severity risk by measuring the contraction of any protein having disulfide bond cleavage activity. Therefore, the claims are drawn to method of inactivating, treating, or preventing any virus or any virus infection using a genus of proteins having disulfide bond cleaving activity that cleaves the disulfide bond of any protein constituting a virus, spike proteins, envelope proteins, or capsid proteins of any virus.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitation of “virus”, “protein that constitutes a virus”, “spike protein”, “envelope protein, “capsid protein”, “protein having a disulfide bond cleavage activity”, “protein disulfide isomerase family protein”, “PDI”, “Erp46”, “Erp57”, “Erp72”, and/or “P5” fails to provide a sufficient description of the genus of virus and proteins as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
The specification is limited to a method of determine disulfide bond cleavage activity or antiviral activity against SARS-CoV-2 using PDI, Erp46, Erp57, Erp72, and/or P5 having the amino acid sequence of SEQ ID NO:2, 4, 6, 8, 12, 16, and 20, respectively and a method of determining antiviral activity said PDIs. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” The specification does not provide disclosure of a method of treating or preventing a virus infection. In view of the widely variant species encompassed by the genus, the examples described above is not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 1-9.
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 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.
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (Protein disulfide isomerases (PDIs) negatively regulate ebolavirus structural glycoprotein expression in the endoplasmic reticulum (ER) via the autophagy-lysosomal pathway. Autophagy. 2022 Oct;18(10):2350-2367. Epub 2022 Feb 7- form PTO-1449).
Regarding claims 1-4, Wang discloses a method of inactivating ebolavirus (EBOV) comprising cleaving a disulfide bond of a glycoprotein of EBOV with PDI or PDIA3/Erp57, a protein disulfide isomerase family protein (abstract and page 2353-2354). Wang discloses that high levels of EBOV-Glycoprotein 1,2 expression triggers cell rounding, detachment, and downregulation of many surface molecules that is thought to contribute to its high pathogenicity (page 2351, 2nd paragraph). Wang discloses that PDIs and catalyze the formation and breakage of disulfide bonds between cysteine residues within proteins as they fold, ensuring that proteins are in a properly folded state (page 2351, 3rd paragraph). Wang discloses that ebolavirus, EBOV, places a heavy burden on the ER protein folding machinery during infection and PDIs negatively regulate ebolavirus (page 2351, 4th 3rd paragraph).
Regarding claim 5, the glycoprotein of Wang for the envelope protein, as evidenced by Sugita (see Fig 3. "Ebola Virus", (with English abstract), Virus, Vol. 69, 2019, pp. 119-128 – form PTO-1449). Further, Wang discloses that EBOV is a filovirus which are enveloped viruses (page 2351, 1st paragraph).
Regarding claim 7, an intended use recitation that appears in the body of a claimed apparatus generally does not impart a patentable distinction if it merely states an intention. An intend used recitation in the body of a claim is a description of how the claimed product is to be used. See MPEP 2111.04. In the instant case, the claim is directed to a virus infection severity risk evaluation kit comprising a specific binding substance for a protein having a disulfide bond cleavage activity. Therefore, the claim is directed to a kit for use in evaluation a virus infection risk. Such intended use limitation would not distinguish the claimed product from a prior art prior that satisfies all the structural limitations of the claimed product (a composition comprising a specific binding substance for a protein having a disulfide bond cleavage activity). Wang discloses a composition comprising a glycoprotein, a specific binding substance, for disulfide bond cleavage activity by PDI (page 2351).
Therefore, the reference of Wang anticipates claims 1-5 and 7.
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) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Protein disulfide isomerases (PDIs) negatively regulate ebolavirus structural glycoprotein expression in the endoplasmic reticulum (ER) via the autophagy-lysosomal pathway. Autophagy. 2022 Oct;18(10):2350-2367. Epub 2022 Feb 7- form PTO-1449).
Regarding claims 6-9, Wang discloses a method of inactivating ebolavirus (EBOV) comprising cleaving a disulfide bond of a glycoprotein of EBOV with PDI or PDIA3/Erp57, a protein disulfide isomerase family protein (abstract and page 2353-2354). Wang discloses that high levels of EBOV-Glycoprotein 1,2 expression triggers cell rounding, detachment, and downregulation of many surface molecules that is thought to contribute to its high pathogenicity (page 2351, 2nd paragraph). Wang discloses that PDIs and catalyze the formation and breakage of disulfide bonds between cysteine residues within proteins as they fold, ensuring that proteins are in a properly folded state (page 2351, 3rd paragraph). Wang discloses that ebolavirus, EBOV, places a heavy burden on the ER protein folding machinery during infection and PDIs negatively regulate ebolavirus (page 2351, 4th 3rd paragraph). Wang discloses that PDI (PDIA3) inhibits EBOV structural Glycoprotein expression (page 2351, “Results”).
Wang does not disclose a method of treating a virus infection by administering to a subject a protein having disulfide cleavage activity, a virus infection severity risk evaluation kit comprising the glycoprotein and method for evaluating a virus infection severity risk, and a method of treating a virus infection by measuring the concentration of the glycoprotein, evaluating the severity risk, and administering an antiviral agent.
Regarding claim 6, one having ordinary skill in the art would have recognized to apply the teachings of Wang in a method of treating a virus infection by administering to the subject PDI since Wang teaches that PDI inactivates EBOV.
Regarding claim 7, one having ordinary skill in the art would have recognized to apply the teachings of Wang in making a virus infection severity risk evaluation kit comprising the glycoprotein since Wang discloses that high levels of glycoprotein expression triggers cell rounding, detachment, and downregulation of many surface molecules and contributes to its high pathogenicity.
Regarding claim 8, one having ordinary skill in the art would have recognized to apply the teachings of Wang in a method of evaluating a virus infection severity risk by measuring the concentration of the PDI since Wang discloses that PDI (PDIA3) inhibits EBOV structural glycoprotein expression and high levels of EBOV-Glycoprotein 1,2 expression triggers cell rounding, detachment, and downregulation of many surface molecules that is thought to contribute to its high pathogenicity.
Regarding 9, one having ordinary skill in the art would have recognized to apply the teachings of Wang in a method of treating a virus infection by (1) measuring a concentration of the PDI in a biological sample from a test subject, (2) evaluating a severity risk of a virus infection in the subject by measuring the concentration of the PDI, (3) determining whether the subject determined to have a high risk severity risks is a test subject to be administered with an antiviral agent (PDI), and (4) administering to the test subject the antiviral agent (PDI) since Wang discloses that PDI is inhibits EBOV structural glycoprotein expression, high levels of EBOV-Glycoprotein 1,2 expression triggers cell rounding, detachment, and downregulation of many surface molecules that is thought to contribute to its high pathogenicity, and PDI reads on a antiviral agent, inactivating EBOV.
Therefore, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to use PDI in a method f treating EBOV by administer PDI to a subject, making a kit comprising a glycoprotein to evaluate the virus infection severity risk and evaluating the virus injection severity risk, and a method of treating a virus injection by measuring PDI, determining a severity risk to virus infection and subject, and administering to the subject PDI. One of ordinary skill in the art at the time the invention was made would have been motivated to do so in order to identify subjects in need of treatment of EBOV infection. One of ordinary skill in the art would have had a reasonable expectation of success since Wang discloses that PDI inactivates EBOV.
Therefore, the above reference of Wang renders claims 6-9 prima facie obvious.
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.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim interpretation
Claim 7 has been broadly interpreted as generic kit comprising a glycoprotein, a substance for a protein a disulfide bond cleavage activity. Wang discloses that EBOV expresses and produces glycoproteins, wherein the disulfide bond is cleaved by PDI. Therefore, claim 7 is directed to a naturally occurring glycoprotein.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to a kit comprising a glycoprotein, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES)
Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The claimed kit comprising a glycoprotein is not considered to have markedly different characteristics from what occurs in nature, glycoproteins expressed and produced by EBOV as discussed above and is considered to be a law of nature exception. There is no indication in the specification that placing the glycoprotein results in the glycoprotein having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring EBOV glycoprotein. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed glycoprotein and the naturally occurring EBOV glycoprotein, the claimed kit comprising the glycoprotein is directed to a judicial exception.
Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. There are no additional elements recited in the claim beyond the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed glycoprotein is found naturally occurring in nature (EBOV glycoprotein). Further, the claim recites a generic kit comprising the naturally occurring glycoprotein but does not recite any components of the kit other than the glycoprotein. (Step2 A: YES)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claims only recite the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions. (Step 2B: NO)
As such, the claims do not qualify as eligible subject matter.
Conclusion
Claims 1-9 are pending.
Claims 1-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652
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