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
Applicant’s election without traverse of Group I, claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53 and declared species in the reply filed on 9/22/2025 is acknowledged. Upon further consideration the species requirements for Group I invention are no longer required.
Claims 20-21, 23, 27, 29, 31, 34, 54-55, 57, 61, 63, 65, 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/22/2025.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53 are under consideration in the instant Office Action.
Withdrawn Objections and Rejections
The objections to claims 1-2 and 35-36 is withdrawn in view of the claim amendments.
The rejection of claims 14 and 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the claim amendments.
The rejection of claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 14-16, 18-34, 38 and 41-60 of copending Application No. 17/839,669 and claims 1-17 of copending Application No. 18/443,416 is moot since these applications have been abandoned.
Modified Rejections Necessitated by Amendment
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.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 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 claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53, directed to determining the presence of Traumatic Brain Injury (TBI) in a patient, set forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors and the pathology itself and mentally reaching conclusions based on the reported observations. 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 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 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 and 53 encompass changes in the levels of GFAP and UCH-L1 during pathology of TBI, the process that is governed by a law of nature, and thus is a judicial exception. The GFAP and UCH-L1 are all naturally occurring factors that are expressed differently during pathology of TBI apart from any human action. The relation between the levels of expression of these factors and pathology of TBI exists in principle and is a consequence of the ways these factors are metabolized by the body, entirely natural process, a natural phenomenon, and thus a judicial exception. (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 in to 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, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring factors during a naturally occurring pathology. In the instant case, the independent claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring protein in TBI. Claims 4 and 38 sets forth the step of “treat it” or “apply it”. The newly amended claims now break down the TBI subjects into groups an set forth generic, non-specific and well know treatment methods. This new limitation does not defers greatly from the original limitation of just calling out treatment requirements that would be applied with or without the natural correlation being performed. The more specific limitations of claims 4 and 38 do not defer from the prior limitations for “treating the subject for a mild, moderate, moderate to severe, or severe TBI when the subject's levels of GFAP and UCH-L1are elevated” which is a generic statement of treatment without any guidance of what treatment to use in view of the levels that are detected in the instant method that requires the natural correlation. Finally, it is pointed out that even if these new limitations were sufficient from overcoming the101 rejection that this would be limited to these specific claims and would not be applicable to the independent claims that do not require anything more than the observation of the claimed natural correlation. (Step 2A/2: No).
Finally, claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 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— performing an assay to measure a level of a protein—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 claims 2, 12, 36 and 46, for example, reciting representative well-known assays and CT and MRI scans). The claims fail to include any limitations which would distinguish the method because they 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 and determining the levels of naturally occurring proteins − represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art, as shown by the prior art which show that the methods of monitoring TBI are well known in the art. The instant claims only require the naturally occurring correlation to be observed by applying the known methods in the art. For example, prior art shows that the methods of using assay to measure GFAP and UCH-L1 that indicate neuronal injury including traumatic brain injury required in the instant claims was known in the prior art as evidenced by McQuiston et al., US 20190376983 (IDS 6/5/25), McQuiston et al., US 20180306812 (1/7/2026 PTO-892) and McQuiston et al., US 20180364261 (1/7/2026PTO-892). The instantly rejected claims do not recite any elements in addition to the natural correlation that impose meaningful limits on the claim scope and would substantially foreclose others from using this natural correlation of the GFAP and UCH-L1 that are indicative TBI without significantly more. The intended use of this method does not further limit or apply any significant action once the natural correlation has been observed using the claimed method. The natural correlation is found in nature whether it is observed or not and would be present and act quite independently of any effort of the patentee. (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 and 53 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Response to Arguments
Applicant's arguments filed 4/7/2026 have been fully considered but they are not persuasive. Applicant argues that the amended independent claims 1 and 35 recite methods comprising multiple concrete, physical steps that impose meaningful limits on any alleged judicial exception. This is not found persuasive because the rejection is towards a natural correlation rejection and not over an abstract idea. It is also pointed out that instant claim limitations of performing an active step of obtaining and observing the natural correlation does not change the facts that one of ordinary skill in the art is just performing known and routine assays to obtain the observation of the natural correlation. This is not found persuasive because the Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015) clearly states:
“For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”).” (see page 10 of the decision).
Not only does the recitation of the cut-off values effectively amount to a mathematical algorithm or calculation, this recitation is contained within the mental process step of “diagnosing” by “comparing” levels of a particular biomarker in the patient sample to control levels of the biomarker. The “diagnosing” step thus encompasses the abstract idea of “comparing”, which is mental determination akin to assessing, evaluating, or forming a judgement, and thus is a patent-ineligible element. In contrast to applicants’ arguments, therefore, the recitation of the cut-off values does not aid in adding significantly more to transform the claimed invention into a patent-eligible method. Therefore, the cut-off value of the instant claims is not enough to overcome the 101 rejection.
The Courts have said that there must be an inventive concept beyond what is the judicial exception. Here, there is no inventive concept beyond the judicial exception; the steps recited in the claim do nothing more than spell out steps those practitioners already had been performing together. Note also that the steps within the claim are recited at a high level of generality (e.g., they encompass any immunoassay technique and the use of any antigen-specific antibody). Therefore, the claimed invention is not directed to patent eligible subject matter under 35 U.S.C. 101.
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.
Claims 1-4, 6, 8, 12, 16, 19, 35-38, 40, 42, 46, 50 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McQuiston et al., US 2018/0364261 (1/7/2026 PTO-892).
Claims 1-4, 6, 8, 12, 16, 19, 35-38, 40, 42, 46, 50 and 53 encompass methods of evaluating a subject for head injury by measuring the levels of GFAP and UCH-L1 to determine the presence of TBI. The critical levels are above 30 pg/mL for GFAP and above 360 pg/mL for UCH-L1.
McQuiston teaches of methods that determine the levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof and whether to perform imaging, such as magnetic resonance imaging (MRI) or computerized tomography (CT) scan on a human subject that has sustained or may have sustained an injury to the head. These methods involve detecting levels and changes in levels of UCH-L1 in samples taken from a human subject at time points within 12 hours (about 12-48 hours as claimed), after the subject has sustained or may have sustained an injury to the head (see abstract, paragraphs 5-6, 16-17, 19, 24-25) and reads on instant claims 1-2 and 35-36. McQuiston teaches that UCH-L1 levels are about 400pg/ml and GFAP levels are about 50pg/ml (see paragraphs 16-17, 30-31) and reads on the levels of instant claims 1-4, 35-38. McQuiston teaches TBI treatments for a subject suffering from a moderate, severe , or moderate to severe TBI, the treatment involves the administration of one or more therapeutics such as diuretics, anti – seizure drugs, performing one or more surgical procedures such as removal of a hematoma, repairing a skull fracture, decompressive crainiectomy and receipt or providing of one or more therapies such as rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, or any combinations thereof (see paragraph 48) and reads on the new limitations of newly amended claims 4 and 38. McQuiston teaches determining mild, moderate or severe TBI in a subject, administering treatment and monitoring the subject (see paragraphs 20, 48-49, 267) and reads on instant claims 4 and 38. McQuiston teaches that the sample can be obtained after the subject sustained a head injury caused by physical shaking, blunt impact by an external mechanical or other force that results in a closed or open head trauma, one or more falls, explosions or blasts or other types of blunt force trauma; after the subject has ingested or been exposed to a chemical, toxin or combination of a chemical and toxin and obtaining the sample from a subject who has an autoimmune disease, brain tumor, or other condition (paragraph 170) and reads on instant claims 8 and 42. McQuiston teaches that the biological sample can be obtained within 10 minutes, 15 minutes, 20 minutes, 12hrs and 24hrs after suspected head injury (see paragraphs 212-214) and reads on instant claims 6, 16, 40, and 50. McQuiston teaches using assay to determine the levels of the biomarker using a an immunoassay that used whole blood or serum and a point-of-care device (see paragraphs 183, 225, 280 and 286-287) and reads on instant claims 1, 12, 19, 35, 46 and 53
Response to Arguments
Applicant's arguments filed 4/7/2026 have been fully considered but they are not persuasive. Applicant argues that the McQuiston reference fails to teach the GFAP level of 30pg/ml and UCHL1 level of 360pg/ml. This is not found persuasive since the instant claims language only required equal to or above about 30pg/ml or 360pg/ml. Therefore, the reference clearly anticipates the instant limitations since they are above the lowest allowable limits as required in the instant claims.
Applicant argues that the McQuiston reference fails to teach repeating the test on the biomarkers. This is not found persuasive because McQuiston specifically teaches repeating the tests for GFAP and UCH-L1 with a subject while monitoring the subject (see paragraphs 160, 206 and 481, for example) and therefore, does in fact teach this step.
Applicant argues that the point-of care device taught by the McQuiston reference fails to teach a user interface. This is not found persuasive because the McQuiston reference teaches a “point-of-care device” in paragraph 183 and sets forth examples of these devices that are available to the public and clearly, even though it is implicit, discloses point-of-care device with user interfaces.
Finally, applicant argues the McQuiston reference fails to teach the sample window of the 48 hr maximum of the instant claims and that the McQuiston reference only teaches sample window of 24 hrs. This is not found persuasive because the instant limitation of claim 1 only requires that the sample be collected within about 12 to 48 hrs. Therefore, the timeframe taught by the McQuiston reference clearly reads on the limitation of 12-48 time frame set forth by the instant claims since it is within the required time limit.
For all the reasons set forth above, the arguments are not found persuasive and the rejection is maintained.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,849,548, 1-14 of U.S. Patent No. 10,866,251, claims 1-22 of U.S. Patent No. 10,877,048, claims 1-16 of U.S. Patent No. 10,877,038, claims 1-36 of U.S. Patent No. 11,016,105, claims 1-18 of U.S. Patent No. 11,931,161, claims 1-24 of U.S. Patent No. 12,099,069, claims 1-31 of U.S. Patent No. 12,105,098, claims 1-26 of U.S. Patent No. 11,022,617, claims 1-38 of U.S. Patent No. 12,105,100, claims 1-19 of U.S. Patent No. 12,092.647, and claims 1-18 of U.S. Patent No. 12,085,567. Although the claims at issue are not identical, they are not patentably distinct from each other because all the patented claims encompass diagnosis of TBI using the same biomarkers—GFAP and UCH-L1—and recite the same critical levels that stand for TBI. The U.S. Patents listed above all claim a version of: A method comprising: performing at least one assay for UCH-L1 and GFAP, or a combination thereof in at least one sample that is whole blood, serum, plasma, or cerebrospinal fluid obtained from a human subject, wherein the sample is obtained from the subject within about 12 hours of an actual or suspected injury to the head; and i. performing a head computed tomography (CT) scan or MRI on the subject when the level of GFAP is greater than or equal to 30 pg/mL and the level of UCH-L1 is greater than or equal to 360 pg/mL. Although the claims at issue are not identical, they are not patentably distinct from each other because present claims and the patented claims encompass very similar methods, which recite the same steps, use the same materials and accomplish identical results.
Claims 1-4, 6, 8, 12, 14, 16, 19, 35-38, 40, 42, 46, 48, 50 and 53 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-9, 11-15, 20-24, 26, 28-29, 31 and 33-34 of copending Application No. 17/747,397; claims 1-24 and 27-32 of copending Application No. 18/474,826; claims 1-19 of copending Application No. 18/509,717; claims 1-2, 10, 12-13, 20, 22-23, 25-29, 32, 34-35, 37 and 40 of copending Application No. 18/792,630; claims 47-64 of copending Application No. 18/795,240; claims 1, 5, 7-10, 12, 14-18, 20, 23-24, 26, 29, 31-32 and 34 of copending Application No. 18/804,253; 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 of copending Application No. 18/147,360;. Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because all the patented claims encompass diagnosis of TBI using the same biomarkers—GFAP and UCH-L1—and recite the same critical levels that stand for TBI wherein one sample that is whole blood, serum, plasma, or cerebrospinal fluid obtained from a human subject, wherein the sample is obtained from the subject within about 12 hours of an actual or suspected injury to the head; and performing a head computed tomography (CT) scan or MRI on the subject when the level of GFAP is greater than or equal to 30 pg/mL and the level of UCH-L1 is greater than or equal to 360 pg/mL. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 4/7/2026 have been fully considered but they are not persuasive. Applicant’s general argument for the rejections over the patents is that the issued patents have a varying scope over the instant claims. Applicant argues that the instant claims do not require measuring cTnI, delta analysis, MRI as so forth. This is not found persuasive because the instant claims do not have closed language and does not exclude other steps or biomarkers from being performed along with the required steps and biomarkers. It is noted that this is the reason why these are non-statutory double patenting rejections since the claims are not exactly the same invention as in the issued patents. The rejections are to show that these patents share overlapping scope with the instant claims and are not distinguishable as separate inventions but rather intertwined concepts of the claimed methods. Applicant also argues that the patents do not define the three categories of TBI as their instant claims do. This is not found persuasive because the patents do state that there are different levels of biomarkers to look for and therefore already set forth the idea that there are differences and categories for TBI injury and the mental steps of observation are being performed whether explicitly set forth or not. Therefore, these arguments are not found persuasive and the rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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