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
Response to Amendment
1. Claims 1, 4, 35, 37 and 38 have been amended as requested in the amendment filed on June 16, 2026. Following the amendment, claims 1-4, 6, 8, 12, 14, 16, 19-21, 23, 27, 29, 31, 34-38, 40, 42, 46, 48, 50, 52-55, 57, 61, 63, 65 and 68 are pending in the instant application.
2. Claims 20, 21, 23, 27, 29, 31, 34, 54, 55, 57, 61, 63, 65 and 68 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 02, 2026.
3. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on June 16, 2026 have been fully considered but found to be not persuasive for reasons set forth below.
Claim Objections
6. Claims 1 and 35 are objected to because of the following informalities:
The claims recite “TBI” without first providing the full name of the term. It is suggested that the term be spelled out at its first use and in all independent claims so that it is clearly understood what it stands for. Appropriate correction is suggested.
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.
7. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 stand 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.
8. Claims 1 and 35 stand indefinite for reasons of record in section 5 of Paper mailed on March 27, 2026. Applicant argues at p. 16 of the Response that, “claim 1 has been amended to recite "communicating the determination from step b (1)-(3) using at least one instrument, wherein the instrument is a non-point-of-care device." Applicant respectfully submits that the "communicating" step is a meaningful, concrete, and affirmative step in the claimed method.” While this has been fully considered, the argument is not persuasive because the meaning of “communicating” without clear understanding who is the intendent recipient of the communication is not obvious. When one readily appreciates how to display or record the data on a device, one would not know how to communicate the results.
Further, Applicant submits at p. 17 that, “[T]he scope of "repeating" assays in the context of a diagnostic method i.e., performing the assay again when initial results are inconclusive is well understood by persons of ordinary skill in clinical diagnostics. The claim does not require a specific number of repetitions because the step of obtaining a determinative result is satisfied when the repeat assay yields a reportable value.” Applicant’s argument has been fully considered but found to be not persuasive for reasons that follow.
Claims 1 and 35 specifically recite limitations that define the level of biomarkers, UCH-L1 and GFAP, as “cannot be determined or is not reported,” followed by the requirement that, if this is the case, “the assays for UCH-L1 and GFAP should be repeated.” Thus, the claims appear to describe specific working situations that, first, depend on ability of someone to detect the levels, see “cannot be determined,” or, second, the failure of someone to report the data.
MPEP 2173.05(b) IV, Subjective terms, states When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase "unobtrusive manner" indefinite because the specification did not "provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary"). In the instant case, the Examiner maintains that the claims, as written, describe variable, subjective situations that occur during the process of analyzing the results of determining the levels of biomarkers, thus, rendering the claims indefinite.
Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
9. Claims 2-4, 6, 8, 12, 14, 16, 19, 36-38, 40, 42, 46, 48, 50, 52 and 53 are indefinite for being dependent from indefinite claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
10. Claim(s) 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 stand rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious at least over US 2019/0376983 (cited as the ‘251 patent) for reasons of record in section 9 of Paper mailed on March 27, 2026.
Applicant traverses the rejection at pp. 20-22 of the Response. Specifically, Applicant submits that, First, the '983 publication does not disclose the recited 48-hour sampling window. Claim 1 of the '983 publication requires performing the assay "within about 24 hours after a suspected injury to the head," and the '983 specification uniformly describes obtaining the sample within about 24 hours of injury, enumerating time points only up to "about 24 hours." […] The '983 publication nowhere discloses a sampling window extending to about 48 hours”. Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
MPEP § 2111 Claim Interpretation; Broadest Reasonable Interpretation, states,
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” (The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard:
The Patent and Trademark Office (“PTO”) determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving claims their
broadest reasonable construction “in light of the specification as it would be interpreted
by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d
1359, 1364[, 70 USPQ2d 1827] (Fed. Cir. 2004)). See also, In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to
amend the claims during prosecution, and broad interpretation by the examiner reduces
the possibility that the claim, once issued, will be interpreted more broadly than is
justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA
1969).
The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach. In re Cortright, 165 F.3d 1353,
1359, 49 USPQ2d 1464, 1468 (Fed. Cir. 1999) (The Board’s construction of the claim limitation “restore hair growth” as requiring the hair to be returned to its original state was held to be an incorrect interpretation of the limitation. The court held that, consistent with applicant’s disclosure and the disclosure of three patents from analogous arts using the same phrase to require only some increase in hair growth, one of ordinary skill would construe “restore hair growth” to mean that the claimed method increases the amount of hair grown on the scalp, but does not necessarily produce a full head of hair.).
Thus, the recitation “within about 48 hours after an actual or suspected injury to the head,” reasonably includes any time immediately after the injury to about 48 hours, which includes the period of 24 hours after the injury, as in the cited art.
Applicant argues next that, “the '983 publication does not disclose the recited three-way determination, and in particular the branch directing that the assays for UCH-L1 and GFAP "should be repeated" when a result ‘cannot be determined or is not reported.’”
While this has been fully considered, the arguments is not persuasive because it addresses the limitations currently rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, see section 8 earlier. The Examiner maintains that the recited limitation appears to be an attempt to describe insignificant activity associated with collecting scientific data and does not rise to the level of a novel inventive concept.
Next, Applicant argues that, “the 983 publication does not disclose the recited threshold values, about 35 pg/mL for GFAP and about 400 pg/mL for UCH-L, as the operative decision thresholds applied in the claimed combinatorial logic. The ‘983 publication's worked example applies UCH-L1 and GFAP cut-offs of 100 pg/mL and 300 pg/mL ('983 paragraphs [0452]-[0453] and Table 5), and the only UCH-L1 reference
levels the '983 publication exemplifies are "about 80 pg/mL to about 150 pg/mL” (Id. claim 11; paragraphs [0198]-[0199]). Although the '983 specification contains a
lengthy list of candidate reference levels that, among many others, recites "at least about 400
pg/mL" (Paragraph [0199]), a generic listing of numerous candidate values does not anticipate
the specific claimed pairing of about 35 pg/mL (GFAP) and about 400 pg/mL (UCH-L1) applied in the recited three-way logic, which a skilled reader would not at once envisage from such a list.” Applicant’s arguments have been given full consideration but found to be not persuasive for reasons that follow.
Regarding the levels of GFAP, the ‘251 patent teaches 20-200 pg/mL as a diagnostic measure for moderate or severe TBI, see also claim 5. The instant claim 1 encompasses a method of treating moderate or severe TBI when the subject’s levels of GFAP are equal or above 35 pg/mL, which is fully disclosed within the ‘251 patent. Further, important to claim 1 interpretation is that the claim in at least section b.1.(i) does not require any change in the levels of UCH-L1, see “cannot be determined or [is] not reported.” Moreover, the changes in the levels of UCH-L1 are interpreted as any change, see either below or above 400 pg/mL. The Examiner maintains that the cited art fully anticipates the intent invention or, in the alternative, obvious over the cited prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
11. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,849,548, claims 1-14 of U.S. Patent No. 10,866,251, claims 1-16 of U.S. Patent No. 10,877, 038, claims 1-22 of U.S. Patent No. 10,877,048, claims 1-19 of U.S. Patent No. 11,016,092, claims 1-36 of U.S. Patent No. 11,016,105, claims 1-26 of U.S. Patent 11, 022,617, claims 1-18 of U.S. Patent 11, 931,161, claims 1-18 of U.S. Patent 12,085,567, claims 1-19 of U.S. Patent 12,092,647, claims 1-24 of U.S. Patent 12,099,069, claims 1-31 of U.S. Patent 12,105,098¸ claims 1-38 of U.S. Patent 12,105,100 and claims 1-19 of U.S. Patent 12,163,958 for reasons of record in section 10 of paper mailed on March 27, 2026.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 further stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-34 of copending Application No. 17/747,397 (reference application) for reasons of record in section 11 of paper mailed on March 27, 2026.
Applicant’s request to hold the rejections in abeyance, p. 23 of the Response, has been acknowledged.
Conclusion
12. No claim is allowed.
13. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 28, 2026
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