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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-17) and Species 1: cardiotropic T cells in the reply filed on 06/29/2026 is acknowledged.
The traversal is on the ground(s) that the claims are unified by the special technical feature of using cMet-positive T cells in a sample obtained from a subject with COVID-19, suffering from one or more morbidity associated with COVID-19, or who has been vaccinated against COVID-19 virus (SARS-CoV-2), in order to determine if that subject has a cardiac inflammatory condition.
However, the requirement for lack of unity identified method(s) as stated: Group I, for diagnosing a cardiac inflammatory condition, Group II, for predicting a cardiac inflammatory condition, and Group III for treating a cardiac inflammatory condition. Therefore, the Applicant’s characterization that the special technical feature is “to determine if that subject has a cardiac inflammatory condition” is not a special technical feature because it is not found in Groups II and III. Accordingly, the Applicant’s argument is not persuasive.
The Applicant further argues that neither Komarowska et al., nor Nassar et al., disclose cMet as a biomarker for myocarditis. However, this is not the special technical feature identified by Applicant. Not only has the Applicant failed to identify a unified special technical feature, they further, after identifying a special technical feature, redefine it from “to determine if subject has a cardiac inflammatory condition”, to now requiring the special technical feature to be “cMet as a biomarker for myocarditis”. Myocarditis is only mentioned in Claim 3 and is not a shared feature. Accordingly, none of the Applicant’s arguments are found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2 and 22-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/29/2026.
Claim Status
Claims 1, 3, 5-8, 10, 11, 17 and 21 are pending and under examination. Claims 4,9,12-16,18-20 are cancelled. Claims 2,22-29 are withdrawn.
Claim Objection
Claim 1(i; line 3) recites COVID-19 virus, COVID-19 is the disease and the abbreviated virus name commonly used is SARS-CoV-2. Applicants are requested to provide corrections.
Claim 3 (line 2) recites “or pericarditis” as a repeated statement. Applicants are requested to provide corrections.
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 1, 3, 5-8, 10, 11, 17 and 21 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.
Claim 1 (c; line 12) recites “administering to the patient”, the limitation lacks antecedent basis—it is not clear as to whom the population identified as “the patient” is in reference to, as there is no evidence in the claims regarding the limitation.
The dependent claims are rejected since they inherit and do not resolve the indefinite issues.
Claim 5 recites “method of prediction”, the limitation lacks antecedent basis—it is not clear as to what encompasses prediction, as there is no evidence in the claims regarding the limitation.
Claim 10 recites, alternatively, that the reference value is predictive of whether the subject will develop cardiac inflammatory condition. Independent claim 1 recites that the reference value is indicative of presence or absence of the cardiac inflammatory condition. It is not clear as to how the same reference value can both indicate presence or absence of the cardiac inflammatory condition, as well as be predictive of whether the subject will develop cardiac inflammatory condition.
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, 3, 5-8, 10, 11, 17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (abstract idea) without significantly more. The claim(s) recite(s) a method for diagnosing and treating a cardiac inflammatory condition comprising a series of steps.
With regards to Step 1, claim 1 is considered to be in a statutory category of process.
With regards to Step 2A, prong 1, claim(s) 1, and 2,5-8,10,11, 17, 21 recite(s) the abstract idea of determining a level of cMet positive T cells in a subject’s sample and comparing the expressed level of the antigenic marker to a reference value indicative of the presence or absence of a cardiac inflammatory condition.
The limitation of comparing the determined level of cMet-positive T cells to a reference value and further assessing the absence and/or presence of a cardiac inflammatory condition is a mental process. This limitation constitutes evaluations and judgments that can practically be performed in the human mind and therefore falls within the mental process grouping of abstract ideas under the 2019 Patent Subject Matter Eligibility Guidance (PEG).
With regards to Step 2A, prong 2, in claim(s) 1, and 2,5-8,10,11,17 21, the claim(s) recite(s) additional steps which are merely to gather information for use in the abstract comparison(s). They do not improve technical methods of cMet detection or specified therapeutic/diagnostic application(s) resulting from cMet detection. The additional steps merely gather information for use in the abstract comparison and do not integrate the judicial exception into a practical application.
Further, the administration of treatment (Claim 1, step (c)), therapy, or prophylaxis does not recite a specific regimen, dosage, or other agent(s) nor does it require the result(s) of cMet positive T cell evaluation.
Claim 1, Step (c) generally and conventionally recites the administration of an effective amount of any treatment, therapy, and/or prophylaxis. Accordingly, the limitation does not provide specificity regarding treatment(s) and does not further integrate the judicial exception into a practical application and provides a general “apply it” exception.
Step (c) of administering for a cardiac inflammatory condition is not linked to the indication in claim 1 step (b). Therefore, although claim 21 recites a treatment, therapy, or prophylaxis for a cardiac inflammatory condition, it is not in response to or otherwise linked to the finding in claim 1 step (b) that the reference value is indicative of a cardiac inflammatory condition. Therefore, there is no meaningful relationship between the judicial exception and the treatment, and the claim does not integrate into a practical application.
With regards to Step 2B in claim(s) 1, 2,5-8,10,11,17 and 21, the additional elements beyond the abstract idea (mental processes) of determining cMet positive T cells levels from subject samples and comparing levels to a reference, are routine and conventional in the prior art, as evidenced by Siripanthong, B. et al (2020) and/or Stephenson, E. et al., (2018). Accordingly, the claim, as a whole, does not recite additional elements that amount to significantly more than the judicial exception itself and does not integrate the exception into a practical application.
Claim 3 recites the limitation of myocarditis and/or pericarditis, that merely indicates a general type(s) of cardiac inflammatory condition that is conventional and well-known in the art and does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Claims 5,6,7, 8 and 17 recites the limitations of subject(s) who have been vaccinated against SARS-CoV-2 (the infectious agent causing COVID-19), subjects experiencing “long-COVID”, and/or subject that received an mRNA vaccination, and/or demographic information of the subjects. The limitations merely characterize the subjects from which samples were collected for comparison of cMet positive T cells and do not further integrate the judicial exception.
Claims 10 and 11 recite the limitation of cardiotropic T cells assessed and compared for absence or presence in subjects as compared to a reference level for predicting or generally indicating a cardiac inflammatory condition. The limitation merely recites in general terms a diagnostic evaluation of a subset of cMet positive T cells for the purpose of evaluating and/or predicting a cardiac inflammatory condition and does not further integrate the judicial exception into a practical application.
Summarily, the claims characterize an immune specific antigenic marker to detect and evaluate a cardiac inflammatory condition in subjects who have experienced COVID-19 and/or been vaccinated with an mRNA vaccine to SARS-CoV-2 and do not further apply the determination to integrate the judicial exception into a practical application.
For the forgoing reasons, claims 1, 2,5-8,10,11,17 and 21 are not deemed to encompass patent eligible subject matter under 35 USC § 101.
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.
Claims 1, 3,10, 11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Siripanthong, B. et al., Recognizing COVID-19–related myocarditis: The possible pathophysiology and proposed guideline for diagnosis and management. Heart Rhythm. 2020. (17:9); pp. 1463-1471, and in view of Stephenson, E. et al., c-Met as a novel T-cell marker in patients with acute myocarditis and dilated cardiomyopathy. European Heart Journal.2018; (39:1); P4527 (Abstract)
Regarding Claim 1 (i and (c)): Siripanthong, et al., teaches myocarditis by SARS-CoV-2 infection (claim 3), resulting from Naïve lymphocytes which can be primed for viral antigens via antigen-presenting cells and cardiotropism by the heart-produced hepatocyte growth factors (HGF). The HGF binds c-Met, an HGF receptor on T lymphocytes, further illustrating cardiotropic T-cell response (page 1466, Figure 1). Patients demonstrated morbidity, including edema and/or scarring (page 1466, Section ‘Diagnostic evaluation for COVID-19-related myocarditis’; page 1469, Figure 4). Siripanthong et al., provides administration and treatment management for patients relative to specific diagnostic(s), including a beta-blocker (metoprolol) among other therapeutics relative to patient-specific morbidities (claim 21) (page 1469, Figure 4).
Siripanthong et al., does not teach determining and comparing the level of cMet-positive T cells from subject samples to a reference value indicative of the presence or absence of a cardiac inflammatory condition.
Siripanthong et al., also does not teach claims 10 and 11.
Claim 1 (a, b): However, Stephenson et al., teaches acute myocarditis, diagnosed with expression of c-Met, which are selectively expressed by heart-homing T-cells (‘Background’). Stephenson et al., also teaches plasma samples from 39 patients with acute myocarditis, collected and examined in comparison to 10 healthy controls (reference values) using flow cytometry methods (‘Methods’) to determine the presence or absence of a cardiac inflammatory condition based on increases in cardiotropic cMet-positive T cells relative to reference samples (Figure 1; Conclusion’) (claims 10 and 11).
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective date of filing, to have modified Siripanthong et al. as taught by Stephenson et al., to examine cMet-positive T cells specifically expressed in cardiac tissues from patients experiencing myocarditis, and to compare the expression to a reference sample (control) to determine if cMet predicts for localized disease. The motivation to do so is to establish cMet as an efficacious diagnostic indicator of myocarditis and/or cardiac inflammatory conditions(s), to then further predict and/or assess risk and/or treatment management strategies before significant morbidity results in irreversible cardiac tissue damage in subjects that respond poorly to SARS-CoV-2 infection.
One would have expected success, since the combined prior art of Siripanthong et al. and Stephenson et al. teaches the same antigenic markers and subset(s) of T cells, from the same cardiac inflammatory disease (myocarditis), produced by the same infectious agent as instant application.
Claims 5-8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Siripanthong, B. et al., Recognizing COVID-19–related myocarditis: The possible pathophysiology and proposed guideline for diagnosis and management. Heart Rhythm. 2020. (17:9); pp. 1463-1471, and Stephenson, E. et al., c-Met as a novel T-cell marker in patients with acute myocarditis and dilated cardiomyopathy. European Heart Journal.2018; (39:1); P4527 (Abstract) as previously applied to claims 1,3,10,11, and 21 and further in view of Bozkurt, B et al., Myocarditis with COVID-19 mRNA Vaccines. Circulation. August 2021; (144); pp. 471-484.
The teachings of Siripanthong et al. and Stephenson et al., are previously discussed.
Siripanthong et al. and Stephenson et al., do not teach claims 5-8 in subjects vaccinated against COVID-19 virus (SARS-CoV-2) and claim 17.
However, Bozkurt, et al., does teach myocarditis in patients who received vaccination(s) against SARS-CoV-2 (page 474, Table 2), within 30 days of receiving mRNA vaccination (claim 5), the vaccines were BNT162b2 and mRNA-1273 (claims 7 and 8), the population(s) examined include males (ages 14-56 years) (claim 17) (pages 476-479, Table 4). Bozkurt, et al., also teaches vaccination, resulting in myocarditis, and post-acute sequelae in patients with long-COVID (page 480, Section ‘Assessing the Risk’) (claim 6).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective date of filing to have combined the teachings of Siripanthong et al., as modified by Stephenson et al., and Bozkurt et al., to examine patients presenting with myocarditis and who received the mRNA vaccination(s) against SARS-CoV-2, since patients experienced myocarditis resulting from infection by SARS-CoV-2 (as described by Siripanthong et al), and Bozkurt et al., describes myocarditis resulting from mRNA vaccine(s) to SAR-CoV-2 in the described demographics.
The motivation to combine the teachings of Siripanthong et al., as modified by Stephenson et al., and Bozkurt et al., at., are to examine if the same immunogenic agents and tissue-specific responses are responsible for myocarditis in subjects that experienced infection by SARS-CoV-2 alongside patients who received an mRNA vaccination to SARS-CoV-2. One would have expected success, since the combined teachings provide the same cardiotropic inflammatory response by the same subset of T cells, molecular pathology and physiological response as instant application.
Conclusion
No claims are currently deemed patentable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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