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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 11/23/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: it appears there is a missing “,” or “;” at the end of line 18. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-8, and 10-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the secondary brain insult" in line 6. There is insufficient antecedent basis for this limitation in the claim. Depending claims 3-8 and 10-13 inherit and do not remedy the indefiniteness.
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.
Claim(s) 1, 3-8, and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seule et al. (IDS 11/12/24 NPL citation #1: “Seule Martin et al, “Evaluation of a New Brain Tissue Probe for Intracranial Pressure, Temperature, and Cerebral Blood Flow Monitoring in Patients with Aneurysmal Subarachnoid Hemorrhage", NEUROCRITICAL CARE, SPRINGER US, NEW YORK, Vol. 25, No. 2, 1 June 2016 (2016-06-01), pages 193-200”, and hereinafter Seule).
For claim 1, Seule discloses a system for detecting second brain injury, comprising inter alia:
at least one probe (NIRS—ICP probe and NIRS—ICP control unit) (Figs 1a-1b) (Tables 1-3) (pgs 194-199) configured for obtaining from a brain tissue at least one near infrared measurement when said at least one probe is positioned at a predetermined proximal location to brain tissue (Fig 1d) (Tables 1-3) (pgs 194-199), wherein the near infrared measurement is associated with at least one predetermined compound that is an exitotoxicity agent produced due to biomechanical cascading resulting in the second brain insult (CBF and/or CBV) (Fig 1d) (Tables 1-3) (pgs 194-199);
a processor (personal computer with NeMo software) (Fig 1c) (Tables 1-3) (pgs 194-199) configured to:
receive said at least one near infrared measurement from said at least one probe (Tables 1-3) (pgs 194-199);
compare said at least one near infrared measurement with a predetermined threshold value for at least one predetermined compound (Tables 1-3) (pgs 194-199) (especially detection of secondary neurologic dysfunction section and associated discussion);
determine said at least one near infrared measurement is above said predetermined threshold value (Tables 1-3) (pgs 194-199) (especially detection of secondary neurologic dysfunction section and associated discussion);
generate an indication indicating the presence of a secondary brain insult in the brain tissue (Tables 1-3) (pgs 194-199) (especially detection of secondary neurologic dysfunction section and associated discussion); and,
provide the indication to an output, thereby notifying an operator of said at least one probe of the presence of the secondary brain insult in the brain tissue (Tables 1-3) (pgs 194-199) (especially detection of secondary neurologic dysfunction section and associated discussion),
wherein a first probe of said at least one probe is inherently capable of being positioned adjacent to a primary insult and a second probe of said at least one probe is inherently capable of being positioned adjacent to a medulla oblonganta of a subject.
For claim 3, Seule discloses the system according to claim 1, wherein said at least one probe includes at least one camera operative to provide visual feedback of the location of said at least one probe within the brain tissue (pgs 194-199, especially CT scan at end of multimodal neuromonitoring using NIPS-OCP probe section on right column of pg 194).
For claim 4, Seule discloses the system according to claim 1, wherein the output includes a display operative to display the indication as a color (color screen of personal computer with NeMo monitor software of Fig 1c and/or green dye) (Tables 1-3) (pgs 194-199), .
For claim 5, Seule discloses the system according to claim 1, wherein said at least one probe comprises: an emitter (emitter portion of NIRS—ICP probe and NIRS—ICP control unit) (Figs 1a-1b) (Tables 1-3) (pgs 194-199) configured to emit near infrared light in a direction of the brain tissue (Figs 1a-1b) (Tables 1-3) (pgs 194-199); a detector (detector portion of NIRS—ICP probe and NIRS—ICP control unit) (Figs 1a-1b) (Tables 1-3) (pgs 194-199) configured to detect a reflected light from the brain tissue and provide said at least one near infrared measurement of the reflected light (Figs 1a-1b) (Tables 1-3) (pgs 194-199).
For claim 6, Seule discloses the system according to claim 1, wherein said at least one probe comprises: a first fiber bundle configured to direct the near infrared light from said emitter to the brain tissue (Figs 1a-1b) (Tables 1-3) (pgs 194-199); and, a second fiber bundle configured to direct the reflected light from the brain tissue to said detector (Figs 1a-1b) (Tables 1-3) (pgs 194-199).
For claim 7, Seule discloses the system according to claim 1, further comprising a memory unit (memory of personal computer with NeMo software) (Fig 1c) (Tables 1-3) (pgs 194-199) configured to: store said predetermined threshold value (Fig 1c) (Tables 1-3) (pgs 194-199); store at least one near infrared measurement (Fig 1c) (Tables 1-3) (pgs 194-199); and, store a location where the secondary brain insult is detected (Fig 1c) (Tables 1-3) (pgs 194-199).
For claim 8, Seule discloses the system according to claim 1, wherein the processor is configured to operate said at least one probe to obtain said at least one infrared measurement (Fig 1c) (Tables 1-3) (pgs 194-199).
For claim 10, Seule discloses the system according to claim 1, wherein said predetermined compound is Glutamate (the near IR measurement calibrations are necessarily inherently associated with Glutamate concentrations associated with secondary insult, pgs 194-199, especially left column pg 193 and study protocol section on left column of pg 195).
For claim 11, Seule discloses the system according to claim 1, wherein said predetermined compound is Glucose (pgs 193-199, especially left column pg 193 and study protocol section on left column of pg 195).
For claim 12, Seule discloses the system according to claim 1, wherein said predetermined compound is Lactate (pgs 193-199, especially left column pg 193 and study protocol section on left column of pg 195).
For claim 13, Seule discloses the system according to claim 1, wherein said predetermined compound is Pyruvate (pgs 193-199, especially left column pg 193 and study protocol section on left column of pg 195).
Response to Arguments
Applicant's arguments filed 11/23/25 have been fully considered but they are not persuasive. Applicant specifically argues the following:
In the current claims, the NIR measurements correlate directly to the intracranial probe, thereby showing directly through NIR Lactate/pyruvate ratio and other metabolites ratios the presence of secondary traumatic brain injury.
Amended claim 1 recites having at least two probes to record a quantity of excitotoxicity agents in brain tissue and to track the progression, thereby enabling the system to provide an indication that a secondary brain injury is imminent. Furthermore, the claimed invention increases the likelihood of determining the location of the secondary brain injury and can better direct a medical professional to provide better and more accurate treatment to the subject.
In view of the foregoing and the claim amendments, the Applicant respectfully asserts that Seule is silent regarding: "wherein the near infrared measurement is associated with at least one predetermined compound that is an excitotoxicity agent produced due to biomechanical cascading resulting in the secondary brain insult...wherein a first probe of said at least one probe is positioned adjacent to a primary insult and a second probe of said at least one probe is positioned adjacent to a medulla ablaganta of a subject.
In response, the Examiner respectfully disagrees, and notes the following:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “NIR measurements correlate directly to the intracranial probe, thereby showing directly through NIR Lactate/pyruvate ratio and other metabolites ratios the presence of secondary traumatic brain injury”, “at least two probes to record a quantity of excitotoxicity agents in brain tissue and to track the progression, thereby enabling the system to provide an indication that a secondary brain injury is imminent”, “record a quantity of excitotoxicity”, “provide an indication that a secondary brain injury is imminent”, “increases the likelihood of determining the location of the secondary brain injury and can better direct a medical professional to provide better and more accurate treatment to the subject”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that “Seule is silent regarding: "wherein the near infrared measurement is associated with at least one predetermined compound that is an excitotoxicity agent produced due to biomechanical cascading resulting in the secondary brain insult...wherein a first probe of said at least one probe is positioned adjacent to a primary insult and a second probe of said at least one probe is positioned adjacent to a medulla ablaganta of a subject”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, as broadly as structurally claimed, the cited device of Seule is more than capable of performing the recited functions and/or intended placements, is at least the structural equivalent of the claimed invention, and is inherently capable of performing the recited functions/positioning.
Conclusion
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791