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 I in the reply filed on February 02, 2026 is acknowledged.
2. Claims 20, 21, 23, 27, 29, 31, 34, 54, 55, 57, 61, 63, 65 and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 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.
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.
4. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 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.
5. Claims 1 and 35 are vague and ambiguous for reasons that follow. First, the claims specifically require to repeat the assays for UCH-L1 and GFAP in section (3) without specifically pointing out to the intended result, such as repeating how many times. For example, if the levels of both UCH-L1 and GFAP stand as “cannot be determined or [are] not reported,” is the step (3) to be repeated until the levels change? Second, section “c.” reads as follows, “communicating the determination from step b (1)-(3) on or from at least one instrument, wherein the instrument is a non-point-of-care device.” It is not clear and cannot be determined from the claim or the specification as filed what physical, objective and repeatable step are intended to support the limitation “communicating […] on or from [an] instrument.”
6. Claims 3 and 37 recite the limitation “CT scan” in claims 1 and 35, respectively. There is insufficient antecedent basis for these limitations in the claims.
7. 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 § 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 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Method claim(s) 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 set forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors and the pathology of TBI, and set forth abstract ideas and mental steps. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. __, __ (2010) (slip op., at 5). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 encompass a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 encompass changes in the levels of UCH-L1 and GFAP during pathology of head injury, the process that is governed by a law of nature, while reciting a diagnostic step and an abstract step of “communicating” the results of measurements, judicial exceptions. (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration into a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, 1, 3, 6, 8, 12, 14, 16, 19, 35, 37, 40, 42, 46, 48, 50, 52 and 53 encompass abstract steps of communicating the results of measurements of the levels of UCH-L1 and GFAP and diagnostic measures. Claims 4 and 38 recite a step of treatment of TBI; however, the claims also encompass “monitoring the subject,” which reads on observation of changes in the levels of naturally occurring factors during naturally occurring pathology. Claims 2 and 36 recite as an additional element to communicating results a step of performing a head CT scan or MRI procedure, which are additional steps of testing, and therefore cannot be construed as an integration of the judicial exception into a practical application. (Step 2A/2: No).
Finally, claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claims – collecting biological samples, measuring the amount of markers − represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art (see claim 12, for example, generally reciting immunoassay or a clinical chemistry assay for measuring protein levels). (Step 2B: No).
Thus, for reasons fully explained above, claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
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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.
9. Claim(s) 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 is/are 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, published Applicant filed patent application later on issued as US Patent 10,866,251 (citation is provided to the ‘251 patent on 892 form).
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 encompass methods to diagnose traumatic brain injury, TBI, by measuring the higher levels of UCH-L1 and/or GFAP as compared to reference levels in samples of subjects who have or are suspected to have sustained an injury to the head. The claims further recite communicating the determined levels to or from an instrument, monitoring and treating the subjects, and assessing the injury further by CT scan or MRI. The cited published patent application fully teaches the diagnostic measure of evaluating higher levels of UCH-L1 and/or GFAP as compared to reference levels in samples of subjects with TBI, see the whole text of the ‘983 document. The cited art further teaches performing MRI and treatment steps, see the text of the document and claims. The art does not teach specifically communicating the results of the measurement to or from a non-point-of-care device; however, this limitation by broadest reasonable interpretation and consistent with the understanding within relevant art indicates registration of the resulting data using any laboratory device. Because the results of an assay are usually recorded, as opposed to left unattended, using various known laboratory devices for statistical and record keeping purposes, the cited prior art of record, which discloses these recorded data, fully teaches use of such devices, absent evidence to the contrary. This makes the instant claims fully anticipated, 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.
10. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are 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. Although the claims at issue are not identical, they are not patentably distinct from each other because present claims and the patented claims encompass identical methods, which recite the same steps, use the same materials (see “comprising” language that identifies biomarkers in the claims) and accomplish identical results.
11. Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50, 52 and 53 are further 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). Although the claims at issue are not identical, they are not patentably distinct from each other because present claims and the pending claims of the above-mentioned patent applications encompass identical methods, which recite the same steps, use the same materials and accomplish essentially the same results. The claims, when compared against each other and by broadest reasonable interpretation, encompass essentially the same subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. No claim is allowed.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
March 11, 2026
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