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 .
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant has amended the instant claims in an attempt to overcome the rejections under 35 U.S.C. 112(b) and 35 U.S.C. 103, and argued that the claims are in condition for allowance. The Examiner respectfully disagrees.
With respect to the prior art rejections, Applicant has amended independent claim 1 to recite a diagnostic device having a sample chamber and an assay module. Applicant has also introduced the optional steps of detecting amounts of the early, intermediate, and late biomarkers, and specifically measuring Tau, P-Tau isoforms, or combinations thereof for low phosphorylation levels. The Examiner notes that reference to Mondello et al., teach a diagnostic device comprising a sample chamber and an assay module wherein the assay module can comprise any assay known in the art. Mondello et al., also teach that the assay should be optimized for detection of neural biomarkers. As such, the Examiner contends that reference to Mondello et al., meets the claimed diagnostic device. The Examiner also notes that the optional limitations are not required to be performed in the claimed method, and therefore are not given patentable weight in the claims.
With respect to the rejections under 35 U.S.C. 112(b), the Examiner maintains that claim 1 is indefinite as the claim recites several limitations that do not comply with the statute. Additionally, the Examiner has identified additional limitations in the dependent claims that do not comply with 35 U.S.C. 112(b), all of which are detailed below. Therefore, in light of the teachings of the prior art, and the arguments provided here, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the rejection is maintained.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the phrase “present in said first biological sample of the injury, disease, or repair” is oddly phrased. The Examiner notes that the biological sample originates from the subject, and not the injury, disease, or repair as stated in the claim at lines 9-10, 15, and 19-20.
For claim 2, the phrase “early one or more early biomarkers” is oddly phrased and should be amended to recite --one or more early biomarkers--.
For claim 3, the phrase “intermediate one or more intermediate biomarkers” is oddly phrased and should be amended to recite --one or more intermediate biomarkers--.
For claim 4, the phrase “late one or more late biomarkers” is oddly phrased and should be amended to recite --one or more late biomarkers--.
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 1-5, 8, and 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.
Claim 1 recites the limitation "the phase, type or amplitude" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the amounts" in line 27. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that it is unclear if “the amounts” references the early peak amount, intermediate peak amount, or late peak amount as recited in claim 1.
Claim 1 recites the limitation "the Tau" in line 30. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the P-Tau isoforms" in line 30. There is insufficient antecedent basis for this limitation in the claim.
For claims 1-4 and 9, the phrase “combinations thereof” is indefinite as the Examiner is unable to determine if “combinations thereof” references the term biomarkers, or the specific biomarkers recited in the claim.
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) 1-5, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., (WO 2015/157390) in view of Mondello et al., (US 2014/0018299).
Regarding claim 1, Wang et al., teach protein biomarkers for injuries of the central nervous system wherein a biological sample is obtained from a subject (paragraphs 0021, 0077), detecting biomarkers in time frames of 1-3 days postinjury (early biomarkers, paragraph 0017), 1-7 days post injury (intermediate biomarkers, paragraph 0017), and 30-180 days post injury (late biomarkers, paragraph 0019), and detecting the severity of the injury based on the biomarkers (Abstract, paragraphs 0013, 0017, 0025). Wang et al., teach utilizing capture and detection antibodies (paragraphs 00111, 00113, 00131) which reads on the early, intermediate, and late agents for detecting specific biomarkers. Wang et al., do not teach an in vitro diagnostic device comprising reagents to detect biomarkers.
Mondello et al., teach an in vitro diagnostic device (paragraph 0036) wherein the device comprises a sample chamber (paragraph 0057) an assay module (paragraph 0059) wherein the assay module comprises an assay optimized for detection of neural biomarkers (paragraph 0059), and a user interface (claim 9). Mondello et al., also teach the in vitro diagnostic device comprising capture antibodies (agents) specific to the biomarker intended to be measured (paragraph 0078). Additionally, Mondello et al., teach that it is advantageous to provide an in vitro diagnostic device as a means of providing a test that can be performed in a laboratory or health professional setting, and by a consumer at home (paragraph 0036).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wang et al., to utilize an in vitro diagnostic device in order to provide a test that can be performed in a laboratory setting, or at home by a consumer as taught by Mondello et al.
Regarding claims 2-4, Wang et al., teach visinin-like-protein-1, myelin basic protein, and Tau as suitable biomarkers (paragraphs 0019, 0021, 0022, Table 1).
Regarding claim 5, Wang et al., teach TBI as a possible injury (paragraph 0020).
Regarding claim 8, Wang et al., teach blood, serum, plasma, CSF, saliva, sweat, and urine as suitable samples (paragraph 0024).
Regarding claim 9, Wang et al., teach Tau as a suitable biomarker, and an antibody for Tau T-181 (paragraphs 0032, figure 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797