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
1. Applicant’s election without traverse of Group II, encompassing claims 11-19 and 21-23, in the reply filed on July 28, 2025 is acknowledged.
2. Claims 1-4 and 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 28, 2025.
3. Claims 11-19 and 21-23 are under examination in the current office action.
Information Disclosure Statement
4. The information disclosure statement (IDS) filed 01/27/2022 has been considered and the references therein are of record.
Nucleotide and/or Amino Acid Sequence Disclosures
5. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See, for example, Figures 2, 3A and 3B.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in Figure 2 (i.e., the amino acid sequences of chimpanzee, monkey, rat, mouse, dog and cow LSMSM2). These sequences are not found in the CRF.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Objections
6. Claims 11, 15, 17 and 19 are objected to because of the following informalities:
Claim 11 recites an acronym that is not spelled out in its first use in the claims (i.e., LSMEM2). It would be remedial to amend the claim language in claim 11 such that the acronym is clearly defined.
Claim 15 recites a step “(b)” but there is no step “(a)” recited in the claim or independent claim 11.
Claim 17 recites dependency on a claim that is part of a non-elected invention.
Claim 19 requires an “or” preceding the last assay type recite (i.e., “or immunoradiometric assay”).
Appropriate correction is required.
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.
7. Claim(s) 11-19 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gundry (WO 2016/209876 A1).
Regarding claim 11, Gundry teach and claim a method for predicting, diagnosing, or monitoring a cardiovascular injury in a subject, the method comprising: measuring the level of expression of LSMEM2 in a biological sample obtained from the subject; and comparing the level of LSMEM2 with the LSMEM2 level from a control sample, wherein a measured level of characteristic of LSMEM2 that is different than the control level or characteristic is indicative of a cardiovascular injury (see [00011] and claim 11 at p. 31), which clearly anticipates the instantly recited invention of claim 11.
Regarding present claim 12, Gundry teach and claim that the biological sample may be selected from whole blood, a blood fraction, plasma, serum, urine, and heart tissue sample (see [00012] and claim 12 at p. 31), which are the same sample types of present claim 12.
Present claims 13-14 are anticipated because Gundry teaches and claims that the cardiovascular injury may be selected from cardiac ischemia, myocardial infarction, acute coronary syndrome, cardiomyopathy, heart failure, cardiac remodeling, and cardiac dilation (see [00012] and claims 13-14 at p. 32).
Regarding claims 15-19, Gundry teaches and claims the identical recited limitations, including: wherein the measuring comprises contacting a LSMEM2 binding agent to the sample and measuring the level of LSMEM2 bound the binding agent; wherein the binding agent is an antibody or antigen-binding fragment thereof; wherein the binding agent is a monoclonal antibody capable of binding an epitope of a LSMEM2 polypeptide having the amino acid sequence of SEQ ID NO: 2; wherein the antibody or antigen-binding fragment thereof is immobilized to a solid support; and wherein the level of LSMEM2 is measured using an assay selected from RIA, ELISA, mass spectroscopy, fluoroimmunoassay, immunofluorometric assay or immunoradiometric assay. See [00012] and claims 15-19 at p. 32.
Finally, present claims 21-23 are anticipated because Gundry teaches and claims (see [00080A] and claims 21-23 at p. 33) the identical diagnostic method (A method for detecting, diagnosing, or monitoring myocardial recovery in a subject) comprising identical steps (measuring the level of expression of LSMEM2…; and comparing the level of LSMEM2 with the LSMEM2 level from a control sample, wherein a measure level that is different…is indicative of a myocardial recovery), and identical dependent limitations (the measuring is performed non-invasively; the biological sample is selected from the group consisting of whole blood, a blood fraction, plasma, serum, urine, and heart tissue sample).
Accordingly, the teachings of Gundry clearly anticipate the invention of present claims 11-19 and 21-23.
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.
8. Claims 11-19 and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a method for predicting, diagnosing, or monitoring a cardiovascular injury in a subject, the method comprising measure the level of expression of LSMEM2 in a biological sample obtained from the subject; and comparing the level of LSMEM2 with the LSMEM2 level from a control sample, wherein a measured level or characteristic of LSMEM2 that is different than the control level or characteristic is indicative of a cardiovascular injury. And claims 21-23 are directed to a method for detecting, diagnosing, or monitoring myocardial recovery in a subject, the method comprising the same “measuring” and “comparing” steps as in claim 11.
The claims are directed a series of steps and is a process and, therefore, a statutory category. The answer to Step 1 of the analysis is yes.
The claims recite a natural phenomenon correlation judicial exception (wherein a measured level or characteristic of LSMEM2 that is different from control levels/characteristics is indicative of a cardiovascular injury/myocardial recovery) which is the natural correlation between the level of a biomarker (LSMEM2) and the presence of disease or injury. The limitations of detecting, diagnosing, monitoring and comparing, as drafted and under their broadest reasonable interpretation, cover performance of the limitations in the mind, and thus fall within the “mental processes” grouping of abstract ideas judicial exceptions. Therefore, the answer to Step 2A, Prong 1, is also yes. The claims recite the judicial exceptions of a natural phenomenon and an abstract idea.
These judicial exceptions are not integrated into a practical application. In particular, the claims only recite a step directed to measuring the level of LSMEM2 in a biological sample obtained from a subject, which step ultimately provides the LSMEM2 level that is used to perform the “comparing” and “diagnosing” steps. This measurement step must be performed in order to perform the diagnostic method, and therefore is considered a data gathering step. This additional element does not integrate the judicial exception(s) into a practical application because it does not impose any meaningful limits on practicing the method. Thus, the answer to Step 2A, Prong 2, is no, the judicial exception(s) is/are not integrated into a practical application.
Finally, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the natural correlation/abstract idea into a practical application, the additional element of measuring a level of LSMEM2 in a biological sample amounts to routine and conventional activity that is performed by those of ordinary skill in the art in order to apply the natural correlation. See, for example, Gundry (WO 2016/209876 A1) cited above which teaches the identical method of the instant claims. Accordingly, the obtaining of biological samples from subjects and the measurement of biomarker levels in a biological sample, such as by using an immunoassay format and a monoclonal antibody specific for the biomarker of interest, were concepts that were well-understood, routine and conventional within the prior art at the time of filing. See, for example, Beck et al. (Transl. Proteomics, 2015, 7, 40-48) and Koenig (Circulation, 2007, 116, 3-5).
Accordingly, when all of the elements are considered, both individually and in combination, the claims as a whole do not amount to significantly more than the judicial exception(s). Therefore, the answer to Step 2B is no, the claims are not patent eligible.
Conclusion
9. No claims are allowed.
Advisory Information
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675