DETAILED ACTION
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 .
Claims 2-3, 5-7, 10, 12-13, 15, 17, 19-38, 41, 43-56, 60 and 63-69 have been canceled.
Claims 1, 4, 8-9, 11, 14, 16, 18, 39-40, 42, 57-59, 61-62, 70, 72, 94 and 96 are pending and under examination.
Claim Objections
Claims 61 and 96 are objected to because of the following informalities: please omit using abbreviation “i.e.” in the claim. 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 9, 62, 70, 72 and 94 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.
As to claim 9, the term “preferably” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 14, the term “preferably” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 16, the term “for example” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 42, the term “e.g.” (meaning for example) imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 58, similarly the term “e.g.” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 62, similarly the term “e.g.” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 70, the term “preferably” imposes uncertainty with respect to metes and bounds. Please clarify.
As to claim 62, according to Example 2 of specification under Title “Immune Response in Vaccinated Individuals”, there is a need of “control” group for comparison. One ordinary skilled person in the field would not be able to distinguish by mere presence of the effector molecule, e.g. IL2 or IFN-γ, because both molecules exist even in the unvaccinated “control” subjects. Moreover it would also be more precise if “cross-reactive” non spike proteins are used to eliminate false positive for the assay (See Example 2).
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)(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, 4, 8, 11, 14, 16, 18, 39-40, 42, 57-59, 61 and 96 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zelba (MedRxiv2 posted 8/13/2020, total 17 pages; IDS reference).
As to claim 1, Zelba teaches a method of determining cell-mediated immune response activity in coronavirus infected patients (COVID-19). Zelba teaches contacting the blood samples from the patients with a plurality of coronavirus peptide library (SARS-COV-2 spanning-overlapping antigens) followed by detecting immune effector biomarkers IL2 and IFN-γ (See Abstract, Materials and Methods).
As to claim 11 and 72, the COVID-19 infected patients are inherently immunosuppressed or immunodeficient.
As to claims 14 and 18, at least 12 SARS-CoV2 spanning overlapping peptides, and other more than 100 peptide antigens are also tested (see Materials and Methods).
As claim 16, cross-reactivity protein, such as ORF10, ORF9B, non-structural protein 7A, Y14 are also measured (See Materials and Methods).
As to claim 39, the disclosure by Zelba reads on the composition claim based on (1) the blood of patients inherently contains (1) immune effector IL-2 and IFN-γ reacting to the at least antigenic peptides of coronavirus COVID-19 in the blood and (2) reagents, such as antibodies that bind IL-2 and IFN-γ (see Materials and Methods).
As to claim 42, the recited “cross-reactive” proteins are detected (see above).
As claim 59, 61, 96 the peptides used for testing include the coronavirus overlapping SARs-CoV2 peptides (See Materials and Methods).
Claims 39-40, 42, 57-59 and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (Lancet 2020 395:497-506).
Huang studies clinical features of patients infected with coronavirus (COVID-19). The results show from the blood samples of the COVID-19 patients have increased levels of IL2 in the ICU COVID-19 infected patients (see Abstract).
Therefore the composition based on the disclosure reads on the claim based on (1) the blood of patients contains (1) immune effector IL-2 reacting to the at least peptides of coronavirus COVID-19 in the blood and (2) reagents, such as antibodies for determining IL-2 (see Materials and Methods).
As to claim 42, besides the proteins from COVID-19 coronavirus, the so-called “cross-reactivity” with various proteins are inherent characteristic existing in nature.
As to claims 57-58, the blood preparation involves using anti-coagulants (See Methods).
As claim 59 and 61, the peptides used for testing include the coronavirus whole protein.
Claims 39-40, 42, 57, 59 and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han (Emerging Microbes & Infections 2020 9: 1123-1130; published online 5/31/2020).
Han studies clinical features of patients infected with coronavirus (COVID-19). The results show from the blood samples of the COVID-19 patients having higher levels of IL2, IFN-γ, IL4, IL6 (see Abstract).
Therefore the composition based on the disclosure reads on the claim based on (1) the blood of patients contains (1) immune effector IL-2 and IFN-γ reacting to the at least one peptides of coronavirus COVID-19 in the blood; (2) antibodies for IL-2 and IFN-γ and internal standards of the above cytokines for determining the amount of the IL-2 and IFN-γ (see Materials and Methods).
As to claim 42, besides the proteins from COVID-19 coronavirus, the so-called “cross-reactivity” with various proteins are inherent characteristic existing in nature.
As claim 59 and 61, the peptides used for testing include the coronavirus whole protein.
Claims 62, 70, 72 and 94 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gaspar (US 20220381769).
Gasper teaches a method of determining the immunocompentency of a vaccinated subject to a virus protein (see Title and Abstract). Gasper teaches contacting a blood sample from a vaccinated patient with a plurality of peptides antigens corresponding to at lease one virus protein (see Examples 2-3; the plurality of virus P4a protein peptides are listed in Table 3). The patients’ blood cells are capable of producing immune effector cytokines, such as IFN-γ in response to the immunological response to the antigen peptides of virus (see examples 2-3). Gasper then determines the immunocompentency of the vaccinated patient based on the presence of the immune effector cytokines.
As to claim 70, anticoagulant, e.g. heparin, is used for processing collected blood samples (section 0025, 0027).
As to claim 72, the study of Gasper is for identifying immunosuppressed or immunodeficient patients.
As to claim 94, table 3 shows the overlapping peptides of P4 virus protein (see above).
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678
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