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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4 in the reply filed on 07/17/2026 is acknowledged.
Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/17/2026.
Applicant’s election without traverse of species in the reply filed on 07/17/2026 is acknowledged.
For claims 3 and 4, applicant elected an antibody species corresponding to the CDR3 alignment CQQYNNYWAF (SEQ ID NO: 2), identified in Table 6 and A4 and associated with Class 3/C135.
Claims 1-4 are under consideration.
Priority
This application is a national stage filing under U.S.C. 371 of international application number PCT/US2022/079552, filed on 11/09/2022 which claims priority from U.S. provisional patent applications 63/378,365 and 63/378,366, filed on 10/04/2022 and from U.S. provisional patent application 63/277,475, filed on 11/09/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/2024, 05/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Claim 1(c): Change “identifying critical intervention time” to “identifying a critical intervention time”.
Claim 1(d): Change “a therapy” to “a therapeutic”.
Claim 2: Change “generated by patients that” to “generated by patients who”.
Appropriate correction is required.
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 3-4 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.
See claims 3-4 as submitted 07/17/2026.
See U.S.C. 112b rejection below and the noted ambiguity. One interpretation of the claim language, and the one used in this rejection, is that “the one or more antibodies” refers to antibody species with the CDR3, SEQ ID NO: 2 – CQQYNNYWAF and not the antibodies, such as C135, known in the art.
Each of the claims is drawn to an antibody species, with a corresponding CDR3 alignment CQQYNNYWAF (SEQ ID NO: 2), obtained from COVID-19 patients which is used in a method for treating COVID-19 patients. Thus, the claims are drawn to a method of using compositions comprising an antibody that has CDR3, SEQ ID NO: 2 homology. It is unclear from the claim language if the CDR3 is heavy or light chain.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
The state of the prior art is such that it is well established in the art that the formation of an intact antigen-binding site of antibodies generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs or hypervariable regions, which provide the majority of the contact residues for the binding of the antibody to its target epitope (Paul et al.)(Paul)(See PTO-892 Notice of References Cited). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (Paul, p. 293).
Additionally, Bendig et al. (Bendig)(See PTO-892 Notice of References Cited) reviews that the general strategy for “humanizing” antibodies involves the substitution of all six CDRs from a rodent antibody that binds an antigen of interest, and that all six CDRs are involved in antigen binding (see entire document, but especially Figures 1-3). It is noted that Bendig used Kabat CDRs in their humanization process (Pg. 86, Column 2, Paragraph, second). Similarly, the skilled artisan recognized a “chimeric” antibody to be an antibody in which both the heavy chain variable region (which comprises the three heavy chain CDRs) and the light chain variable region (which comprises the three light chain CDRs) of a rodent antibody are recombined with constant region sequences from a human antibody of a desired isotype (see entire document, but especially Figures 1-3).
Thus, the state of the art recognized that it would be highly unpredictable that a specific antibody comprising less than all six parental CDRs would have antigen binding function. The minimal structure which the skilled artisan would consider predictive of the function of binding the antigen of a murine or humanized antibody includes six CDRs (three from the heavy chain variable region and three from the light chain variable region) in the context of framework sequences which maintain their correct spatial orientation and have the requisite binding function. One of skill in the art would neither expect nor predict the appropriate functioning of the antibody fragments and mutated antibodies of the instant claims as broadly as claimed. In the instant claims only one CDR3 of the isolated antibody is provided and no distinction is made as to whether it is light or heavy chain within the claim. Further, the instant claims broadly read on a therapeutic antibody comprising one or more antibodies from Table 6 (as recited in claim 3) and Table A4 (as recited in claim 4) that have CDR3 alignment with SEQ ID NO: 2. Table 6 presents antibodies identified as unique to survivors and non-survivors on day 0.
Table A4 (p. 36, [0052]) provides a full list of antibodies identified as unique to the COVID-19 survivors. Among the survivors, most antibodies categorize as Class 3 with other classes of antibodies having fewer reads. The Class 3 sequence of light chain CDR3 from the most frequent RNAseq reads exclusive to surviving patients was modeled into a Cryo-EM structure of the C135 antibody bound to the SARS-CoV-2 spike protein (FIG. 2A, PDB: 7K8Z). This model shows the strong intermolecular forces between the light chain CDR3 and the RBD epitope. The antibody bound structure was then aligned to a structure of the SARS-CoV-2 spike protein bound to the extracellular domain of ACE2 (FIG. 2B, PDB: 6M0J). The latter model highlights Class 3 CDR3 binding at a location distinct from ACE2. This contrasts Class 2 antibodies commonly detected in non-survivors, which share a binding site with the ACE2 receptor on the SARS-CoV-2 spike RBD [0147]. The specification does not specifically identify the antibodies with alignment to the CDR3/SEQ ID NO: 2 as the, from above, “The Class 3 sequence of light chain CDR3 from the most frequent RNAseq reads exclusive to surviving patients”.
In the case of antibodies, it is especially important to disclose which residues are permissive to mutation. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al. (Rudikoff)(See PTO-892 Notice of References Cited). Rudikoff teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
In view of the fact that that the application has not identified a sufficient amount antibody components, e.g., all six CDRs, to define the therapeutic antibody, beyond a CDR3 alignment, there is insufficient written description support for the indicated genus.
For the reasons above, the application has not provided sufficient written description support for a therapeutic antibody.
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 1, 2, 3 and 4 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.
See claims 1, 2, 3 and 4 as submitted 07/17/2026.
Claim 1 (as a whole): It is unclear how each of the steps relate to one another as a method for treating COVID-19 in patients. It is unclear, for example, if the antibodies from 1(a) are meant to be the “therapy” in 1(d). The use of “efficacious” in both 1(a) and 1(d) is insufficient as a linker of the steps.
Claim 1(a): The meaning of the phrase “a structural classification of COVID-19 antibodies to categorize” is unclear. The term “efficacious” in claim 1(a) is a relative term which renders the claim indefinite. The term “efficacious” is not defined by the claim, 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.
Claim 1(b) and Claim 1(c): The phrase “certain types of antibodies” is unclear.
Claim 1(c): It is unclear what is meant by “critical intervention time”. The phrase, “in the patients who lack the certain types of antibodies to COVID-19 patients when the patients have reduced levels of COVID-19 antibodies” is very confusing. It is also unclear what parameter is being used for the best time for therapeutic intervention if that is what is meant by intervention – lack of antibodies or a reduced level of antibodies. The specification teaches “When looking at COVID-19 patients across several time points, the inventors identified what was shown to be a critical intervention point in patients with reduced levels of COVID-19 antibodies. A cocktail of antibodies from TABLE 6 may be beneficial in treating COVID-19 patients, as a treatment in addition to COVID-19 vaccinations”[0054]…and “When looking at patients across time points, there appears to be a critical intervention point in patients with reduced levels of this antibody” [0140].
For compact prosecution, claim 1(c) is being interpreted as identifying a critical therapeutic intervention time in COVID-19 patients with reduced or absent antibody levels in response to COVID-19 infection.
Claim 1(d): The term “efficacious” in claim 1(d) is a relative term which renders the claim indefinite. The term “efficacious” is not defined by the claim, 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.
Claim 2: The term “severe” in claim 2 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, 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.
Claims 3 and 4: Based on the claim language, it is unclear if the “therapeutic antibody comprising one or more antibodies” from either Table 6 or Table A4 is supposed to refer to antibody species, with specific CDR3 (e.g., SEQ ID NO: 2) as noted in the alignment or to the antibodies, known in the art and available commercially, such as C135. However, antibodies (or their own identification number) are not listed in Tables 6 or A4, only CDR3 information (such as SEQ ID NO:2) and their alignment counts. Furthermore, a CDR3 is not an antibody in and of itself. However, it is noted that in the specification, Table A1 (p. 88) clearly defines C135’s CDRL3 as CQQYNSYPW (SEQ ID NO: 66).
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 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1 and 2 as submitted 07/17/2026.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claim 1 does not recite something significantly different than a judicial exception. The rationale for this determination is explained below. Claim 2 is rejected based on being dependent on claim 1.
The claims are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an abstract idea as further detailed below.
In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below, the claims are directed to a process or processes (Step 1); an abstract idea, which sets forth a judicial exception.
In this case, claim 1 recites or is directed to a process (Step 1) and recite further steps of “identifying” that are directed to judicial exceptions (in this case, an abstract idea)(Step 2A). The step of identifying could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, claim 1 is directed to at least one exception (Step 2A: YES), which may be termed an abstract idea.
Thus the claims are directed to a judicial exception, and the claim as a whole is focused on an abstract idea (See also Example 29, Claim 2 (Diagnosing and Treating Julitis) of the Subject Matter Eligibility Examples: Life Sciences found at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf).
The claim as a whole is focused on identifying antibodies, identifying patients, and identifying critical intervention time points and not on the product/composition per se. Thus, there is no need to perform the markedly different characteristics analysis.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite an abstract idea.
As to Prong 2 of Step 2A, the instant claim does not recite additional elements that integrate the judicial exception (abstract idea) into a practical application. The claims do not recite any particular treatment or prophylaxis. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of “(2019 PEG)” training at http://ptoweb.uspto.gov/patents/exTrain/101.html ).
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. The instant claims recite: administering, which is well-understood, routine and conventional activity in view of the dependent references cited below (See Westendorf et al., as cited in the IDS submitted 12/11/2024, # 21). Further, the steps are recited at a high level of generality. The instant claims merely instruct one to identify antibodies, identify patients without certain types of antibodies to COVID-19, identify a time to administer to the patients a “therapy”. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. The claims do not invoke any of the considerations that courts have identified as providing significantly more than the exceptions. Even when viewed as a combination, the additional elements fail to transform the exceptions into a patent eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception.
Thus, it is asserted that the claims are directed to judicial exceptions (by reciting mental steps associated with production steps as part of routine and conventional steps known in the art) without reciting more or additional elements that amount to significantly more than the judicial exception.
Therefore, claim 1 does not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter. Claim 2 is dependent on claim 1.
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 3 and 4 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Nussenzweig et al. (Nussenzweig)(US20210332110A1)(See PTO-892 Notice of References Cited).
See claims 3 and 4 as submitted 07/17/2026.
See U.S.C. 112b rejection above. One interpretation of the claim language, and the one used in this rejection, is that “the one or more antibodies” refers to C135, an antibody known in the art.
Nussenzweig teaches novel broadly neutralizing anti-SARS-CoV-2 antibodies or antigen-binding fragments thereof (Abstract). Nussenzweig also teaches reference claim 1, “ An isolated anti-SARS-CoV-2 antibody or antigen-binding fragment thereof that binds specifically to a SARS-CoV-2 antigen comprising a Spike (S) polypeptide of a human or an animal SARS-CoV-2”. Nussenzweig teaches reference claim 24, “A method of preventing or treating a SARS-CoV-2 infection, comprising administering to a subject in need thereof a therapeutically effective amount of the antibody or antigen-binding fragment thereof of claim 1”. And Nussenzweig teaches antibody C135 (FIGS. 5A-5D; 31A and 31B).
Accordingly, the claimed invention was anticipated by Nussenzweig.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Westendorf et al. (Westendorf)(US20210292393A1)(as cited in the IDS submitted 12/11/2024, # 21) in view of Cervia et al. (Cervia)(See PTO-892 Notice of References Cited) and Esmaeilzadeh et al. (Esmaeilzadeh)(See PTO-892 Notice of References Cited).
See claim 1 as submitted 07/17/2026.
Regarding claim 1 (preamble), Westendorf teaches “The present disclosure relates to methods, compositions of matter, and articles of manufacture that may be used in the diagnosis, monitoring, and treatment or prevention of SARS-Co-V and SARS-CoV-2-linked diseases such as COVID-19” [0018].
Regarding claim 1(a), Westendorf teaches “To that end, provided herein is a large library of fully human antibodies against the spike (S) protein of coronaviruses, e.g., SARS-CoV-2. The sequences of the heavy chain and light chain variable regions (VH and VL) of these antibodies were originally identified from a convalescent patient following infection with a coronavirus, converted to full-length human IgG1 isotype (e.g., IgG1m3 allotype), and the recombinant versions of these antibodies were subsequently produced and characterized as described herein. Therefore, these antibodies are recombinant in nature. The antibodies provided herein each binds to the spike protein of SARS-CoV-2 virus, and some of the antibodies cross-react with the spike protein of one or more other coronaviruses” [0018]. Regarding “identifying antibodies produced by COVID-19 patients”, Westendorf teaches “Donors who have been infected with (and have recovered from) SARS-CoV-2 are an ideal source of immune cells to discover, test, develop and manufacture antibodies as therapeutic treatments, prophylactic countermeasures, and diagnostic reagents to rapidly address emerging and recurring viral threats. Such antibodies can be discovered from a blood sample drawn from a donor that has been infected with SARS-CoV-2, a minimum of 2 weeks, e.g., a minimum of 7-8 weeks, prior to the blood draw. As such, the earliest confirmed patients, and even index patients can be a source of therapeutic, prophylactic, and diagnostic antibodies, using a minimally-invasive blood draw”[1463].
Regarding claim 1(d): Westendorf teaches reference claim 45, “A method of treating or preventing a SARS-Co-V or SARS-Co-V-2-linked disease comprising administering to a patient a therapeutically effective amount of the antibody or antigen-binding fragment thereof of claim 1” and reference claim 46, “A method of treating or preventing COVID-19 comprising administering to a patient a therapeutically effective amount of the antibody or antigen-binding fragment thereof of claim 1” (reads on the general “a therapy…for treating COVID-19 patients”).
Westendorf teaches “In some embodiments, the patient has moderate to severe COVID-19, but is not hospitalized. In some embodiments, the patient has mild to moderate COVID-19”[1593]. But, Westendorf does not teach identifying patients who lack certain types of antibodies to COVID-19 (as recited in claim 1(b)).
Regarding claim 1(b), Cervia, however teaches systemic and mucosal antibody responses toward SARS-CoV-2 in mild versus severe coronavirus disease 2019 (COVID-19) cases (p. 546, Abstract). Cervia also teaches “Using immunoassays specific for SARS-CoV-2 spike proteins, we determined SARS-CoV-2–specific IgA and IgG in sera and mucosal fluids of 2 cohorts, including SARS-CoV-2 PCR-positive patients (n = 64) and PCR-positive and PCR-negative health care workers (n = 109)” (p. 546, Abstract). Cervia further teaches “SARS-CoV-2–specific serum IgA titers in patients with mild COVID-19 were often transiently positive, whereas serum IgG titers remained negative or became positive 12 to 14 days after symptom onset (reads on instant claim 1(b) patients who lack certain types of antibodies and on instant). Conversely, patients with severe COVID-19 showed a highly significant increase of SARS-CoV-2–specific serum IgA and IgG titers after symptom onset. Very high titers of SARS-CoV-2–specific serum IgA were correlated with severe acute respiratory distress syndrome”(p. 546, Abstract).
Cervia does not teach identifying a critical therapeutic intervention time in COVID-19 patients with reduced or absent antibody levels in response to COVID-19 infection (as recited in claim 1(d)).
Regarding 1(c), Esmaeilzadeh, however, teaches “The body will have one of three responses to the SARS-CoV-2 antigens arising from the spike glycoprotein or the nucleocapsid: strong, weak, or difficult to detect the response. Interestingly, weaker antibody responses to the infection have been shown to lead to a higher viral clearance rate and better prognosis in patients, while a strong response is associated with a more severe clinical course…Therefore, the level of the patient antibody response to virus exposure can be considered as an independent prognostic factor…In addition to this, antibodies are not completely able to clear virus particles from the body shortly after production, as a patient can still have prolonged virus shedding even after seroconversion…”One interesting study conducted to investigate the acute antibody responses to SARS-CoV-2 in 285 COVID-19 patients found that all patients develop detectable antibody responses to the virus within 19 days of symptom onset, with Day 13 being the median day of seroconversion. Regarding the time of immunoglobulin M (IgM) and immunoglobulin G (IgG) seroconversion, the study demonstrated that IgM seroconversion could occur not only before IgG seroconversion but also concurrently or even later than IgG…This is an interestingly unique result because the usual antibody response to infections consists of IgG seroconversion following IgM. It has been suggested that IgG and IgM assessment is not very useful in identifying the stage and severity of the infection, but it can be used to diagnose polymerase chain reaction-negative patients and perhaps get a grasp of the clinical course and disease severity” [p. 1391]. Esmaeilzadeh also teaches “Preferably, antibodies should be applied within the first days of collection and may show the maximum potency if they are applied at the early phase of the disease…Several attempts are being made to use antibody therapy to calm COVID-19 severity until a better medication is found.
One of ordinary skill in the art would have been motivated to combine the teachings of Westendorf (identifying and administering antibodies to COVID-19 patients, Cervia (identifying types and levels of antibody in COVID-19 patients) and Esmaeilzadeh (antibody use and time of intervention) to arrive at the method for treating COVID-19 patients during a global pandemic in the absence of other therapeutics or vaccines (See MPEP 2143, Rationale A. Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success for combining the teachings of Westendorf (identifying and administering antibodies to COVID-19 patients, Cervia (identifying types and levels of antibody in COVID-19 patients) and Esmaeilzadeh (antibody use for intervention). There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of coronavirus vaccinology, therapeutics and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Westendorf in view of Cervia and Esmaeilzadeh as applied to claim 1 above, and further in view of Xiao et al. (Xiao)(See PTO-892 Notice of References Cited).
See claim 2 as submitted 07/17/2026.
Westendorf, Cervia, and Esmaeilzadeh teach claim 1 but do not teach “wherein the antibodies are generated by patients that survived severe COVID-19”. Westendorf teaches “Donors who have been infected with (and have recovered from) SARS-CoV-2 are an ideal source of immune cells to discover, test, develop and manufacture antibodies as therapeutic treatments, prophylactic countermeasures, and diagnostic reagents to rapidly address emerging and recurring viral threats”[1463] but does not specify patients that survived severe COVID-19.
Xiao, however, teaches “A total of 56 COVID-19 survivors were followed up for 12 months, with examinations including serum virus-specific antibodies, chest CT, and cardiopulmonary exercise testing”(p. 1, Abstract). Thirty-six of the patients had non-severe COVID-19, while twenty had severe COVID-19 (p. 3, Table 1). Xiao teaches “Some studies have found that IgG can be detected 3 years after the onset of symptoms. The antibody kinetics are positively associated with the severity of the disease: the more severe the symptoms are, the longer the antibody-detectable duration is…Other studies have found that the protective effect may last only 1–2 years after coronavirus infection…Chen et al. followed up patients with COVID-19 for 100 days and found that IgG levels dramatically decreased 3–4 months after symptom onset…Our results were in agreement with their findings, in that the IgG levels gradually decreased over time. Interestingly, this decline was more pronounced in the first 6 months after discharge, and we found that IgG remained stable during the next 6 months of follow-up.
One of ordinary skill in the art would have been motivated to identify antibodies produced by patients that survived severe COVID-19 as taught by Xiao in order to discover, test, develop and manufacture antibodies as therapeutic treatments, prophylactic countermeasures, and diagnostic reagents to rapidly address emerging and recurring viral threats as taught by Westendorf above (See MPEP 2143, Rationale A. Combining prior art elements according to known methods to yield predictable results and Rationale G. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention).
One of ordinary skill in the art would have had a reasonable expectation of success for identifying antibodies produced by patients that survived severe COVID-19 as taught by Xiao. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of coronavirus vaccinology, therapeutics and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Elected embodiment SEQ ID NO: 2 is free of the prior art on record (See us-18-708-467-2.rag in supplemental contents tab).
No claims allowed.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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