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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 6, 2026 has been entered.
Status of Claims/Rejections
Claims 1, 12-13, 17, 19-22, 28-29, and 32-36 are currently pending and under examination on the merits in the instant application.
Any rejections not repeated in this Office action are withdrawn, and the following objections/rejections are the only objections/rejections applied in this application.
Response to Arguments
Applicant’s arguments with respect to previous grounds of rejection as filed on May 6, 2026 been considered but are moot as they do not pertain to the claim objections/rejections set forth in this Office action.
Claim Objections
Claims 1, 17, 22, and 28 are objected to because of the following informalities: “and miR-21, or any combination thereof” in claim 1, line 6; claim 17, lines 4-5; claim 22, lines 6 and 8-9; and claim 28, lines 4-5 should be “, miR-21, and any combination thereof”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “or surgery.” in the last line should be “and surgery.” Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “an amount” in line 2 should be “the amount”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “graphite or graphene” in line 2 should be “graphite, graphene”. Appropriate correction is required.
Claim 22 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 17. Note that both claim 17 and claim 22 requires that the TBI should be diagnosed/monitored using a sensor element comprising a substrate functionalized with the same probes. That is, the mere word “kit” recited in claim 22 does not differentiate the subject matter of claim 17.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 13, 19, 21, 29, and 32-36 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 that “administering to the subject one or more neuroprotective therapies” includes “avoiding resuscitation”, “removing the subject from activity”, and “admitting the subject to hospital”. It is unclear how the aforementioned limitations qualify as administering neuroprotective therapies.
Claim 13 recites limitations pertaining to TBI subtype identification based on a single, individual miRNA recited in claim 12, which requires determining the amount of a combination of “a first miRNA” and “a second miRNA”. Now, it is noted that claim 13 inherently recites the limitation of claim 12 by virtue of claim dependency. As such, it is unclear how the determination of the amount of the combination of the first and second miRNAs is related to the TBI subtype identification that is determined by a single, individual miRNA, wherein the single, individual miRNA-based determination/identification of a specific TBI subtype patient is already recited in claim 1, which is inherently recited in claim 13. That is, claim 13 appears to be the same subject matter as claim 1, except that claim 13 excludes “miR-143” whose increased amount in the serum sample is determined to identify an m-sTBI subject. Again, the TBI identification recited in claim 13 has nothing to do with the combination of the first and second miRNAs. Hence, it is unclear whether how the combination of the two miRNAs should be related to the actual identification method that is recited to be determined by only one miRNA.
Claim 19 recites the limitation "the target miRNA" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites that the detection system for diagnosing TBI comprises “a detection device that is capable of detecting the binding of the target mRNA to the probe.” It is noted that claim 21 inherently recites and requires all limitations recited in claim 1 by virtue of claim dependency. Now, it is noted that claim 1 recites that TBI is diagnosed/identified by “contacting the serum sample with a probe” and “determining an amount of the at least one miRNA in the serum sample”. As such, it is unclear how the method step of “detecting the binding” between at least one miRNA in the serum sample and the probe is related to the “amount” of the at least one miRNA in the serum sample for diagnosing/identifying TBI.
Claim 29 recites that the composition of claim 28 “comprises a plurality of the probes.” It is noted that claim 28 recites that the composition comprises “one or more of the probes”, thereby reading on at least any of the two (thus plurality) probes recited in claim 28. Hence, claim 29 fails to particularly point out and distinctly claim the specific species of “the probes” (e.g., specific for miR-335 and miR-143) within the “plurality” (same as “more” that one) that is already required in claim 28.
Claims 32-36 each recite identifying a specific TBI subtype subject. However, the claims are drawn to a “method of treating traumatic brain injury (TBI) in a subject in need thereof”. As such, the differently identified TBI subtype subject in each of claims 32-36 should be treated differently depending on the severity of the TBI the subject is identified to suffer from. However, claims 32-36 do not particularly point out and distinctly claim which of the “neuroprotective therapies” recited in claim 1 (hence claims 32-36) should be administered to the differently identified TBI subtype subject in each of claims 32-36.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 recites that the method of claim 1 “further” uses a composition comprising one or more probes for the same miRNAs recited in claim 1 for “diagnosing and/or monitoring” TBI. It is noted that using “at least one” (thus same as “one or more”) probe binding to the recited miRNAs for “identifying” a TBI subject (thus same as diagnosing or monitoring a TBI subject) is already clearly recited and required by claim 1 as evidenced by “contacting the serum sample with a probe comprising a nucleic acid able to bind to at least one miRNA”, which is followed by “identifying the subject” as having a different subtype of TBI. As such, claim 28 merely repeats the method step already recited and required in claim 1, thereby failing to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claims 1, 12, 17, 20, 22, and 28 are objected to.
Claims 1, 13, 19, 21, 28-29, and 32-36 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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