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 .
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24, “the target pathology” lacks antecedent basis with claim 16. 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.
Claim 16-26 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.
In Claim 16, the phrase “wherein the at least one optode is arranged to be directly coupled with a near-infrared radiation detector unit which comprises an imaging sensor such that received near-infrared radiation passes directly from the at least one optode to the near-infrared radiation detector unit” is confusing because it could be construed as having additional components in between the imaging sensor and the optode, e.g. lens, filter, since the near-infrared radiation detector unit is not limited to only being an imaging sensor. However, that interpretation does not support Applicant’s intention as stated in the September 18, 2025 response (e.g. “directly coupling the optode with the near-infrared radiation detector unit avoids additional components positioned between the optodes and detectors such as optical components used to split received near-infrared radiation into different wavelengths prior to imaging as are required for spectrophotometry systems such as Chance.”). In order to be consistent with the intended scope, during examination, the claim will be construed to read as “wherein the at least one optode is arranged to be directly coupled with a near-infrared radiation detector unit which comprises an imaging sensor such that received near-infrared radiation passes directly from the at least one optode to the imaging sensor”.
Claims 17-26 are rejected by virtue of their dependency from a rejected claim.
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)(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 16-22, 25-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 10955918 to Wettersten.
Regarding Claim 16, Wettersten teaches a near-infrared imaging system for identifying a target feature in a subject’s head (Figure 1), the system comprising:
an optode array (Figure 1, optodes 123a) comprising a plurality of optodes (optodes 128b, Figure 1B) arranged to transmit near-infrared radiation into a region of a subject’s head and to detect corresponding near-infrared radiation emitted from the region of the subject’s head (transmit via light emitters 112b, receive via sensors 132b, Figure 1B), at least one optode of the optode array comprising a plurality of resilient optical fibres (fiber optic cable 755a, Figure 7A) arranged to receive corresponding near-infrared radiation (receive fibers 128b, Figure 1B), the plurality of optical fibres each comprising a distal end arranged to make contact with a subject’s head (the terminal end of the optical fibers contacts the person’s head as shown in Figure 1B, 7B), wherein the distal ends of the plurality of optical fibres are movable relative to each other (each optode includes a ferrule 724b that houses the terminal end of the fiber optic and includes a spring 760b so it can deform in order to conform to the person’s head contours, as in Figure 7B, 7C), and wherein the at least one optode is arranged to be directly coupled with a near-infrared radiation detector unit which comprises an imaging sensor (detector subsystem 130b, Figure 1B; 830, Figure 8A; utilized for imaging, as in col. 7, line 62 – col. 8, line 12) such that received near-infrared radiation passes directly from the at least one optode to the imaging sensor (as shown in Figure 1B, there are no intermediary elements between the optode and the imaging sensor, e.g. lens, filters); and
a data processing system configured to process detected near-infrared radiation in accordance with a near-infrared imaging model to identify the presence or absence of a target feature within the subject’s head (predictive model is used to decode the detected signals to identify the existence of the target signal, e.g. intents, commands, col. 2, lines 50-67, as in Figures 14A-14F).
Regarding Claim 17, Wettersten further teaches wherein the near-infrared radiation detector unit comprises one of a plurality of near-infrared radiation detector units each coupled to a respective optode of the optode array (dedicated pixel groups 834 each coupled to a respective optode via fibers 828, as in Figure 8A).
Regarding Claims 18-20, Wettersten further teaches wherein each of the plurality of near-infrared radiation detector units comprises an imaging sensor, comprising a plurality of pixels, for detecting near-infrared radiation detected by a respective optode that is coupled to the near-infrared radiation detector unit (dedicated pixel groups 834, types of imaging sensors, each coupled to a respective optode via fibers 828, as in Figure 8A).
Regarding Claim 21, Wettersten further teaches wherein the imaging sensor is a charge coupled device (CCD) or a complementary metal oxide semiconductor (CMOS) imaging sensor (col. 17, lines 33-46, the imaging sensor 832 can be CCD or CMOS type).
Regarding Claim 22, Wettersten further teaches wherein the target feature is a change in perfusion or liquid content of biological tissue (characterization of blood flow including content of the blood/liquid, col. 7, line 61-col. 8, line 12).
Regarding Claim 25, Wettersten further teaches wherein the near-infrared imaging system is a near-infrared spectroscopy or near-infrared tomography system (several types of NIRS and optical tomography are listed in col. 7, line 61-col. 8, line 12).
Regarding Claim 26, Wettersten further teaches wherein the data processing system is configured to perform a demodulation process on detected near-infrared radiation prior to processing the detected near-infrared radiation in accordance with the near-infrared imaging model (as described in col. 31, lines 7-31, additional factors are utilized to determine if the detected near-infrared radiation is used or weighted, i.e. demodulated, before it is input into the model).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 10955918 to Wettersten in view of US 6618614 to Chance.
Regarding Claim 23, although Wettersten teaches utilizing medical imaging modalities (col. 7, line 61-col. 8, line 12), Wettersten’s analysis of the images is primarily directed towards non-medical uses, including brain-computer interface for control of computers, for example. As such, Wettersten does not teach analysis related to target pathology.
Regarding Claim 24, Wettersten further teaches wherein the target pathology is an intracranial haematoma, intracranial haemorrhage, or change in blood flow, blood oxygenation or blood volume characteristic of cerebral ischaemia.
Chance teaches an optode for conforming to the skin surface and detecting near-infrared radiation from the head as in Figure 1. Chance further teaches wherein the target feature is indicative of a target pathology (hematoma based on change in blood flow, tumor or metabolic trend detection including blood oxygenation, col. 6, lines 55-63 – any of which indicate a pathology, i.e. abnormal condition).
As suggested by Wettersten to utilize his invention for medical purposes, Chance demonstrates that the analysis for identifying pathology utilizing an optode signal is known. As such, it would have been obvious to utilize the signals of Wettersten to identify pathology in the person’s head as in Chance in order to provide increased functionality of the base optode device.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. While Applicant’s arguments are persuasive in that Chance does not teach the exact hardware elements as now claimed, Wettersten teaches this hardware.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799