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
Summary
This is the Non-Final Office Action based on application 18/147094 RCE filed 03/02/2026.
Claims 1-2, 4-12, 14-21 are pending and have been fully considered.
Claims 3 & 13 are cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Double Patenting
The non-statutory 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 non-statutory 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.
Claims 1-2, 4-12, 14-21 are rejected on the ground of non-statutory double patenting as being unpatentable over Claims 1-16 of U.S. Patent No. 10849548, 1-14 of U.S. Patent No. 10,866251, 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 in view of McQUISTON in US 20190376983.
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.
The U.S. Patents listed above all claim a version of:
A method comprising: performing at least one assay for ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (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 2 hours of an actual or suspected injury to the head; and i. performing a head computed tomography (CT) scan on the subject when the level of GFAP is greater than about 9.0 pg/mL; ii. performing a head CT scan when the level of UCH-L1 is greater than about 73.5 pg/mL; or iii. performing a head CT scan when when the level of GFAP is greater than about 9.0 pg/mL and the level of UCH-L1 is greater than about 73.5 pg/mL.
Some of the patents do not include mention of performing a CT scan- although in the instant claims 1 & 2--- a CT scan is not always required, but only sometimes or when certain conditions are met, and some of the claimed patents do not teach of taking the sample around 24 hours.
McQUISTON is used to remedy as shown by the rejection below.
It would have been obvious to one of ordinary skill in the art to perform a CT scan and take a sample around 24 hours as instantly claimed as done in McQUISTON since GFAP is known to have advantage of being an early biomarker for TBI (McQUISTON, paragraph 0023) and to perform a CT scan in addition to a test of GFAP since CT can offer other advantages like knowing if interventions such as surgery are warranted (McQUISTON, paragraph 0004).
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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 1-2, 4-12, 14-21 are directed to non-statutory subject matter without significantly more.
Through 101, inquiry:
Inquiry: Are the claims directed to a statutory category of invention?
Yes, independent Claims 1-2 and all claims depending therefrom are drawn towards a statutory category of a method.
Step 2A, Prong 1: Do the claims involve a Judicial Exception?
Yes, independent Claims 1-2 and those that depend therefrom involve the judicial exceptions which are an abstract idea and also a natural correlation.
For independent Claim 1, it including the limitation, “identifying the subject as having a level of the biomarker higher than a reference level and a negative head CT scan.” This claimed, “identifying,” is a mental process, which is an abstract idea. “Identifying,” a higher level than a reference also seems to be indicating a natural correlation is also present, but without directly stating the judicial exception.
Further--- though is it understood this is not what is intended, the claimed performing of an “assay,” as claimed through broadest reasonable interpretation can read on a mental process, since to “assay,” something can mean to mentally consider.
Independent Claim 2 is drawn towards a “method of treating,” however again involves the judicial exceptions of an abstract idea and also a natural correlation. It is claimed that an assay is performed for “identifying a subject as having a TBI,” based on a level of GFAP biomarker higher than a reference. To identify or identifying is again a mental process which is an abstract idea judicial exception. The subject is then treated for TBI so even though “diagnosis,” is not used as a term in the claimed the natural correlation of a diagnosis which is TBI state or lack thereof with the amount present of GFAP biomarker, is still implicitly claimed.
See USPTO subject matter eligibility example 29 for claims which show somewhat similar examples.
See MPEP 2106.03 & 2106.04.
Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application?
In Claims 1-2, there is no particular practical application.
For Claim 1, after the claimed “identifying,” is performed, nothing further is done. Therefore- there is no application, much less a practical one. The additional steps claimed of performing an “assay,” and a “head computerized tomography (CT) scan), are data-gathering steps which is insignificant extra-solution activity which is used to accomplish the judicial exceptions. See MPEP 2106.05(g).
For Claim 2, the same as for Claim 1 applies with respect to the CT scan and claimed performing of an assay. Claim 2 further includes a “treating,” step. However, the step of performing the assay does not always identify the patient as having a level of biomarker higher than the reference. Further, the claimed treatments are not considered to be particular practical applications. First of all, the claim is left open to instances where treatment does not occur. This amounts to the claimed treatment being a contingent limitation and not required in all readings of the claim. See MPEP 2111.04. and Ex parte Schulhauser.
Even further, the claimed treatments amount to claiming of “applying,” the judicial exception and not being anything which is particular and specific practical application. This is because some of the treatments read as really, doing nothing. “Rest,” “avoiding light,” “abstaining from physical activities,” read this way. Also the claimed treatments of “wearing protective eyewear,” and the claimed “therapeutic agents selected from…” also do not read as particular/specific treatments. The other claimed treatments also do not read as particular and specific practical application due to the large array and variety of claimed treatment possibilities among other reasons.
See Vanda memorandum.
Further MPEP 2106.04 (d)(2)(a) “Consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.”
Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea?
In Claims 1-2, there is nothing that adds significantly more to the judicial exceptions.
The following steps are required for Claims 1-2:
(1) assay on a sample obtained 24 hours -3 weeks after head injury to detect level of glial fibrillary acidic protein (GFAP), and comparing to reference level.
(2) For Claim 1- Head CT scan. For Claim 2- if no CT scan is performed, it is not even a positive method step that is required by the claim.
(3) For Claim 1-Diagnosing subject as likely having TBI or just “identifying,” as claimed for Claim 1, if level of GFAP is higher than a reference, and the head CT scan is negative for TBI. For Claim 2- if no CT scan is performed, it is not even a positive method step that is required by the claim.
All of the above steps including obtaining test samples and assaying and comparing to reference levels for analysis and diagnosis, are well understood, routine and conventional (WURC) in the art. Things that are WURC in the art do not add significantly more to the claimed judicial exceptions.
The time period the sample is taken does not change matters, because it is WURC that samples are taken soon and monitored after one is thought to maybe have a disease or condition. For Claim 2- no CT scan is even required.
As claimed both performing of CT scans and assays to detect GFAP are standard laboratory technique ad WURC.
There is nothing claimed which requires the claimed biomarkers to be derivatized or processed in any way which is not WURC, and further no unconventional way of performing a comparison nor an unconventional treatment is claimed, since as claimed both analyses are judicial exceptions themselves and are not performed in a way which claims or shows any actual improvement in technology.
Further, the claimed treatments for Claim 2, especially at the level of generality claimed are WURC in the art and some of the claimed treatments are only considered to be mental decisions so further abstract ideas ( anger management, counseling psychology, cognitive behavioral therapy, and things like avoiding light, and abstaining from physical activity.”
See MPEP 2106.05 (a) & MPEP 2106.05 (d).
The dependent claims are reviewed for additional limitations dependent on the independent claim above.
Claim 4 specifies that the reference is “associated with,” many possibilities for what the control is. Comparison to a control/reference regardless of what it is as claimed is a mental process, and at best simple math. This is part of the natural correlation (diagnosis) and abstract idea judicial exceptions themselves and therefore does not practically apply at step 2 A/2 nor does it add significantly more at step 2B.
Claims 5 & 9-12 specify when the sample is taken or what types of patients it is taken from. Despite when the sample is taken or who from, it is still a natural sample in which the natural correlation is measured/detected. Therefore, this is part of the natural correlation judicial exception itself. Therefore, this does not practically apply at step 2 A/2 nor does it add significantly more at step 2B.
Claims 6-7 specify that the GFAP is measured by a clinical chemistry assay or point of care assay. The assay itself as claimed is used as a data pull so is insignificant extra solution activity to perform the judicial exception, and also using both these very general types of assays are WURC in the art. Therefore, this does not practically apply at step 2 A/2 nor does it add significantly more at step 2B.
Claims 8, & 15-16 specify that the sample is a body fluid sample from a human. This is part of the judicial exception itself (biomarker in natural sample=likelihood of TBI is patient, is the natural correlation). Therefore, this does not practically apply, nor does it add significantly more.
Claim 14 specifies that the patient is “monitored”. This is a mental process/abstract idea and therefore a judicial exception itself. Therefore, this does not practically apply, nor does it add significantly more.
Claims 17-21 specify the level of biomarker GFAP that is present in the reference the sample is compared to. The amount of GFAP in the reference and whether it is indicative of disease or not is part of the judicial exception/natural correlation itself. Therefore, this does not practically apply at step 2 A/2 add significantly more at step 2B.
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 2 is 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.
With respect to Claim 2, it claims different treatments options for mild TBI versus moderate to severe TBI, but does not claim how one determines if either of these conditions is met. Therefore the claim is unclear and confusing on when to use which options of treatment.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-12 & 14-21 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by McQUISTON in US 20190376983.
With respect to Claims 1-2, McQUISTON teaches of methods that aid in the determination of whether to perform imaging, such as magnetic resonance imaging (MRI) or computerized tomography (CT) scan (an “improvement,”) on a human subject that has sustained or may have sustained an injury to the head using an early biomarker, such as ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof. These methods involve detecting levels and changes in levels of UCH-L1 in samples taken from a human subject at time points within 24 hours (about 24 hours as claimed), after the subject has sustained or may have sustained an injury to the head (abstract, paragraph 0451).
McQUISTON’s teaches of performing a baseline blood drawn within 24 hours and CT scan from Day 1 (paragraph 0446-0448, 0451 and associated figures) and also of a blood draw for serum within 3-6 hours of the baseline draw (so this can be after the 24 hours from injury) which reads on the claims “after,” 24 hours through broadest reasonable interpretation.
McQUISTON further teaches of detecting an increase by at least an absolute amount of the early biomarker can be used to “rule out” or rule in a need for an imaging procedure. For example, human subjects having a change in levels of the early biomarker, such as UCH-L1, GFAP, or combination thereof, less than an absolute amount may be identified as likely to have a negative head CT scan or a negative MRI, i.e., an absence of an intracranial lesion, and thus a head CT scan or MRI would not be needed or performed (paragraph 0103).
McQUISTON even further teaches of using the test to “rule in” (more likely than not patient has TBI) and perform an imaging procedure. For example, human subjects having a level of the early biomarker, such as UCH-L1, GFAP, or combination thereof, higher than a reference level of the early biomarker, such as UCH-L1, GFAP, or a combination thereof, may also be identified as likely to have a positive head CT scan or a positive MRI, i.e., a intracranial lesion present, (e.g., thus indicating a potential TBI) and thus benefit from having a head CT scan or MRI (paragraph 0102). McQUISTON teaches of using these methods to diagnose/aid in diagnosis of TBI (paragraph 0185,004).
McQUISTON teaches of treating when the level measured is higher than a cut-off or reference value (paragraph 0429, 0019).
McQUISTON teaches that the cut-off or reference level is associated with mild, moderate, or severe TBI (paragraph 0121) and that the treatments are associated with the level of TBI determined (paragraph 0019, 0032, 0058, 0084, 0179-0180), and specifically of using a treatment such as rest, or abstaining from physical activities or using antinausea medication among other things (paragraph 0212).
With respect to Claim 4, McQUISTON teaches that the cut-off or reference level is associated with mild, moderate, or severe TBI (paragraph 0121).
With respect to Claim 5, McQUISTON teaches of taking the sample at about 24 hours (paragraph 0062)- which reads on “about 24.5 hours,” though broadest reasonable interpretation.
With respect to Claim 6, McQUISTON teaches that the assay is a clinical chemistry assay (paragraph 0061).
With respect to Claim 7, McQUISTON teaches that the assay is a point-of-care assay system (paragraph 0061).
With respect to Claim 8, McQUISTON teaches that the sample can be selected from the group consisting of a whole blood sample, a serum sample, a cerebrospinal fluid sample, and a plasma sample (paragraph 0059).
With respect to Claim 9, 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 (paragraph 0033).
With respect to Claim 10, McQUISTON teaches that the sample can be obtained after the subject has ingested or been exposed to a chemical, toxin or combination of a chemical and toxin (paragraph 0020).
With respect to Claim 11, McQUISTON teaches that the sample can be obtained after the subject has ingested or been exposed to a chemical, toxin or combination of a chemical and toxin. Examples of chemicals or toxins are fire, mold, asbestos, a pesticide, an insecticide, an organic solvent, a paint, a glue, a gas, an organic metal, a drug of abuse (paragraph 0020).
With respect to Claim 12, McQUISTON teaches of obtaining the sample from a subject who has an autoimmune disease, brain tumor, or other condition (paragraph 0020).
With respect to Claim 14, McQUISTON teaches of monitoring the subject (paragraph 0019).
With respect to Claim 15, McQUISTON teaches of the sample being blood or serum (paragraph 0020).
With respect to Claim 16, McQUISTON teaches of the subject being a human subject (abstract).
With respect to Claim 17, McQUISTON teaches of the GFAP reference biomarker cutoff being measured at 100 pg/ml and the cutoff being and also of the cut-off range being between 20 and 200 pg/ml (paragraph 0009, 0013, Table 5, paragraph 0452). This falls in the claimed range.
With respect to Claim 18, McQUISTON teaches of the GFAP reference biomarker cutoff being measured at 100 pg/ml and the cutoff being and the cutoff being and also of the cut-off range being between 20 and 200 pg/ml (paragraph 0009, 0013, Table 5, paragraph 0452). This falls in the claimed range.
With respect to Claim 19, McQUISTON teaches of the GFAP reference biomarker cutoff being measured at 100 pg/ml and the cutoff being and the cutoff being and also of the cut-off range being between 20 and 200 pg/ml (paragraph 0009, 0013, Table 5, paragraph 0452). This reads on “about,” 90 pg/ml through broadest reasonable interpretation.
With respect to Claims 20-21, McQUISTON teaches of the GFAP reference biomarker cutoff being measured at 100 pg/ml and the cutoff being and the cutoff being and also of the cut-off range being between 20 and 200 pg/ml (paragraph 0009, 0013, Table 5, paragraph 0452). This includes the claimed range.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
With respect to the Double Patenting rejection, applicant argues that the Patent under question in the rejection do not recite “around 24 hours,” after the injury and performing a CT scan “from Day 1,” and “within 2 weeks of injury,” which the examiner equate with the “clinically relevant timeframe” of “about 24 hours to about 3 weeks,” as instantly claimed, and that the McQUISTON reference was used to remedy this.
Applicant argues that this analysis is a 103 rejection and not a Double Patent rejection. Applicant argues that the Examiner does not identify each pending claim or claim group with respect to the patents in the double patenting rejection, or explain how the patent claims render the “After 24 hours, to about 3 weeks,” obvious.
The examiner disagrees with this and notes that obvious type double patenting rejections in view of another reference are permitted. See MPEP 804 Double Patenting, Form Paragraph 8.36, in that what is inserted after the “in view of,” in the form paragraph must be prior art.
Therefore, the Double Patenting rejection is maintained.
Applicant further argues that the instantly claimed “after 24 hours to about three weeks,” methods of the instant claims are patentably distinct from the acute phase methods claimed in the cited patents. In applicant’s arguments for this, they argue that the time line for the cited patents is “”at most 48 hours.” The examiner notes that “at most 48 hours,” also reads on “after 24 hours,” as instantly claimed through broadest reasonable interpretation. Further, as shown above, if there is a deficiency, McQUISTON remedies this, and use of a secondary reference is permitted in Double Patenting rejections.
This is particularly true to the ‘105 and ‘617 patents which requires, “within 48 hours,” and the ‘251 and ‘048 patents which cite “within about 24 hours,” and “about 2 hours” respectively are make the instant claims obvious in light of the broad language, since “about 24 hours,” reads on “after 24 hours,” through broadest reasonable interpretation, and the ‘048 patent which cites “about 2 hours,” the instant claims are made obvious in light of McQUISTON.
Applicant further argues that none of the prior patents recite interpreting an elevated level of GFAP at a late timepoint, “after 24 hours,” as instantly claimed. The examiner maintains that this late timepoint or in the very least, around this late time point--- so making the instant claim obvious, is recited in the cited patents, through broadest reasonable interpretation.
Applicant further argues that the instant claims and the cited patents are directed to different clinical questions, again emphasizing the timing claimed. Again--- the examiner disagrees.
Therefore--- the double patenting rejection is maintained, especially at this time since claim amendments are frequent throughout prosecution. If applicant overcomes other rejections on the record at a time point down the line in prosecution, the examiner will review the double patenting rejection further to see if it still applies at that timepoint.
The 101 rejections are maintained for the amended claims as shown above.
With respect to the 101 rejection applicant argues oddly Step 2 A, Prong 2 before Step 2A, Prong 1. The examiner assumes that this is a typo.
More specifically, applicant argues that the examiners position that the claimed “identifying,” step is a mental process/abstract idea and the claimed treatment steps do not constitute a particular practical application--- are “incorrect as a matter of law and fact.” Applicant doesn’t elaborate about this under the first heading. The examiner disagrees, and as applicant has elaborated, the examiner maintains that they have elaborated their points to this affect in the rejection above.
Applicant argues that the claims are not directed to a judicial exception. The examiner disagrees.
At Step 2 A, Prong Two, applicant argues that their claims require two concrete physical steps, the steps being the claimed “assay,” and a “head CT scan.” With respect to this, the examiner disagrees with applicant--- and though the examiner appreciates that these steps are physical steps, they are not something which practically applies the claimed abstract idea and natural correlation. Both of these steps are performed before the ”identifying,” od diagnosing is finalized. And therefore--- it is data gathering.
The claimed timing of “24 hours to about 3 weeks,” also does not do anything to change these matters. The timing of taking a sample does not change the fact that the sample measured and identified is still a natural sample. Though--- it is possible that this timing is useful in a way to aid in diagnoses. The examiner notes that diagnoses are generally more scientific discoveries. For scientific discoveries to be patent eligible, they must practically apply the discovery or judicial exception or they need be done in a way which is non well understood routine and conventional. Taking a sample at differing times after a patient has an injury is very routinely done.
Therefore, applicant’s arguments are not convincing.
With respect to Claim 2, applicant argues that Claim 2 is “squarely analogous to Vanda.” The examiner disagrees. Though there are similarities, the examiner notes that the instantly claimed treatments for Claim 2 are not particular and specific, unlike like those in Vanda, which were particular and specific. Many of the claimed “treatments,” for Claim 2 amount to a person doing nothing. For example, “rest,” “abstaining from light,” “abstaining from physical activities,” for example. While the examiner appreciates, that this is general recommend guidance post- TBI, this does not practically apply the judicial exception, since these things essentially amount to doing nothing. The examiner notes that most people in the world do these things including rest, abstaining from physical activity, and light, on a daily basis, when they sleep.
The examiner notes that “pharmaceutical or biopharmaceutical medications,” and generalized claiming of “rehabilitation,” and “anger management,” are also not particular and specific.
The examiner maintains that doing nothing/rest is not a particular and specific treatment in light of Vanda and 101 guidance provided by the USPTO. The applies to many of the other instantly claimed treatments, including the ones notes in the paragraph above this--- though that is not a comprehensive list.
Applicant argues that the instant Claims are limited to subjects identified as having a TBI, however the examiner notes--- again, that as claimed, the instant claims do not always require treatment. Due to the “when,” clause in Claim 2b) this is the case.
Applicant further argues that under Step 2B) that the claims recite significantly more than the judicial exceptions. The examiner disagrees.
Applicant argues that this is the case since the instant claims recognize a diagnostic gap and treatment solution for patients who fall through a diagnostic gap of CR only evaluation. Though the examiner understands that the claimed method might be useful, as claimed---- if there are actually any surprising or unexpected results, it is not clear if they are claimed. The parts of the instant claims outside of the claimed judicial exception (diagnostic marker in biological sample- TBI or no TBI), so the CT scan and claimed treatments, and also taking samples through condition experience are all considered WURC.
Applicant further argues that the claimed assay cannot be a mental process. Though the examiner understands that applicant does not mean it to read on a mental process--- to assay--- something can absolutely be a mental process and claims are read in light of the broadest reasonable interpretation. Further, even if “assay,” in the instant claims is supposed to mean something more specific like “detect,” or “measure,” these measurements are claimed at such a high level of generality that they too are considered to be WURC in the art, so do not add significantly more to the claimed judicial exceptions.
Therefore, the 101 rejection is maintained.
Some of the prior 112 b issues are overcome, though some are maintained as shown above.
With respect to the prior art, applicant argues that McQUISTON teaches within 24 hours, which is before the claimed after 24 hours.” The examiner disagrees. McQUISTON’s teaches of performing a baseline blood drawn within 24 hours and CT scan from Day 1 (paragraph 0446-0448, 0451 and associated figures) and also of a blood draw for serum within 3-6 hours of the baseline draw (so this can be after the 24 hours from injury) which reads on the claims “after,” 24 hours through broadest reasonable interpretation. Therefore, McQUISTON anticipates the claims. If applicant means something more specific in the claims, then they should claim it.
All claims remain rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758