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
Claims 1-7 are objected to because of the following informalities:
Claims 1-7 contain multiple sentences. The claims must be in one sentence form only.
In claim 2 lines 11 & 15, the limitation “the beam outlet” should recite “the optical fiber beam outlet.
Claim 2 “7 min” in line 7 should recite “7 minutes”.
Claim 2 “1s” in line 11 should recite “1 second”.
Claim 5 the limitation “ … that any point within the radius of 0~3cm with the irradiation site as the center of the circle” should recite “a detection site in the step S3 is any point within a radius of 0-3cm from the irradiation site”.
Claim 7 the limitation “the data” in line 5 should recite “the background spectral intensity data”.
Claim 7 the limitation “the noise values” in lines 12 and 16 should recite “the noise value”.
Claims 3-7 objected to because of the following informalities: For dependent claims …: The dependent claims should begin/start with “The”.
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 1-7 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claims 1-7 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 (claims 2-7 by virtue of dependency) recites “the output” and “the input” in line 6. There is insufficient antecedent basis for these limitations in the claim. The limitations are suggested to recite “an output” and “an input”.
Claim 1 (claims 2-7 by virtue of dependency) recites “the optical path” in line 7. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an optical path”.
Claim 1 (claims 2-7 by virtue of dependency) recites “the output end” in line 7. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an output end”.
Claim 1 (claims 2-7 by virtue of dependency) recites “the optical fiber beam outlet” in line 8. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an optical fiber beam outlet”. Furthermore, it is unclear what structure the optical fiber beam outlet is outputting from as it merely recited being connected to the monitoring object and there is no recitation of an optical fiber beam that has an optical fiber beam outlet.
Claim 1 (claims 2-7 by virtue of dependency) recites “the monitoring object” in line 9. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a monitoring object”.
Claim 1 (claims 2-7 by virtue of dependency) recites “the probe” in line 9. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a probe”.
Claim 1 (claims 2-7 by virtue of dependency) recites “the same plane” in line 10. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a same plane”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the irradiation site” in line 6. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an irradiation site”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the subject’s skull” in line 6. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a subject’s skull”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the intensity of the incident laser” in line 9. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an intensity of an incident laser”.
Claim 2 (claims 3-7 by virtue of dependency) recites “a cycle” in line 13. It is unclear if this is referring to a different or the same cycle as recited in line 12. The limitation is suggested to recite “the cycle”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the optical end” in line 15. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an optical end”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the intensity of the transmitted laser” in line 14. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “an intensity of a transmitted laser”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the fiber beam” in line 15. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a fiber beam”.
Claim 2 (claims 3-7 by virtue of dependency) recites “the monitored subject” in line 18. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the monitored object”.
Claim 3 (claims 4-5 by virtue of dependency) recites “the hair of the middle part” in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “disinfecting hairs of a middle part of the skull”.
Claim 3 (claims 4-5 by virtue of dependency) recites “the monitoring subject” in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the monitoring object”.
Claim 3 (claims 4-5 by virtue of dependency) recites “the body position” in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a body position”.
Claim 3 (claims 4-5 by virtue of dependency) recites “the head” in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a head”.
Claim 4 (claim 5 by virtue of dependency) recites “the midpoint of the anterior fontanelle” in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a midpoint of an anterior fontanelle”.
Claim 5 recites “the detection site” in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the irradiation site”.
Claim 6 recites “a certain wavelength” in line 3. It is unclear if this is the same as or different than the certain wavelength recited in claim 2. The limitation is suggested to recite “the certain wavelength”.
Claim 7 recites “the noise value” in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a noise value”.
Claim 7 recites “the first 2 minutes” in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a first 2 minutes of the 7 minutes”.
Claim 7 recites “the resolution of the spectrometer” in line 6. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a resolution of the spectrometer”.
Claim 7 recites “the minimum value in the three columns … of a certain wavelength, a certain wavelength
±
resolution” in lines 7-9. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what the three columns of the background spectral intensity data is referring to as it is not previously defined, it is unclear whether the certain wavelength is the same or different than the certain wavelength recited in line 6, and it is unclear what a certain wavelength
±
resolution is referring to. The limitation is suggested to recite “a minimum value in the background spectral intensity data of the certain wavelength”.
Claim 7 recites “the average of the three minimum values”. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the minimum value is taken as the noise value”.
Claim 7 recites “the average value” in lines 12 and 16. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what data/measurements the average value is an average of.
Claim 7 recites “the absorbance … the energy of transmitted light, the energy of the incident laser”. There is insufficient antecedent basis for these limitation in the claim. Furthermore, it is unclear what the absorbance is referring to. The limitations are suggested to recite “wherein, A is the meningeal absorbance, IT(λ) denotes the energy of transmitted light IO(λ) denotes the energy of the incident laser”.
The examiner was not able to apply prior art to claims 2-7 due to the narrative form and plurality of indefiniteness issues in the claims.
Claim Rejections - 35 USC § 101
Claims 2-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 2 follows.
STEP 1
Regarding claim 2, the claim recites a series of steps or acts, including a device. Thus, the claim is directed to a method/process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
Turn on the spectrometer and place the spectrometer probe at the irradiation site;
Turn on the laser and preheat the optical parametric oscillator. The spectrometer probe is placed at the irradiation site of the subject’s skull;
Keep the spectrometer probe in the same plane as the beam outlet;
Turn on the spectrometer and place the spectrometer probe at the skull probe site of the monitored subject;
Data processing and absorbance calculations;
set forth a judicial exception. These steps describe certain methods of organizing human activity (sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions) and/or a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to Organizing Human Activity and a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 6 recites an interface operable to present the intrinsic frequency to a user, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The detecting background spectral activity, detecting the intensity of the incident laser, and detecting the intensity of the transmitted laser does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the detected background spectral activity/intensity, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
Pretreatment and fixation of monitoring objects;
Spectrometer continuously records the background spectral intensity in real time for 7 min and obtains the background spectral intensity data;
The probe spectrometer is irradiated twice with a near-infrared pulsed laser of a certain wavelength in a cycle
Record the intensity of the incident laser for 10 cycles
The intensity data of the transmitted laser is collected every 0.1 s;
The pretreatment and fixation, recording, irradiating, and collecting steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the pretreatment and fixation, recording, irradiating, and collecting steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 2, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited device, laser, spectrometer, optical parametric oscillator, and spectrometer probe are generic sensors configured to perform pre-solutional data gathering activity, and the device is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. See J. G. Haub, M. J. Johnson, and B. J. Orr, "Spectroscopic and nonlinear-optical applications of a tunable β-barium borate optical parametric oscillator," J. Opt. Soc. Am. B 10, 1765-1777 (1993).
The dependent claims also fail to add something more to the abstract independent claims. Claims 3-7 are directed to insignificant pre-solution activity (e.g. data gathering) and further limitation of abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
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 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Parker (US 20250339047 A1) in view of Kim (US 20080259973 A1), and further in view of He (CN110048298A English Translation).
Regarding claim 1, Parker discloses an in vivo non-invasive intracranial pressure monitoring device based on meningeal absorbance changes (“intracranial pressure sensing apparatus … interferometric near infrared spectroscopy”; “brain tissue … absorption”; “coupled to patient’s head”, Abstract, para. [0028, 0040]), which is characterized in that: it comprises a signal excitation module (light source modifier 22 and light source 20, fig. 1), a spectral data acquisition module (iNIRS system 10 comprising plurality of light detectors 30, fig. 1 & “software”, para. [0134]), a data processing module (controller 40, fig. 1, para. [0046, 0134]), and the signal excitation module (light source modifier 22 and light source 20, fig. 1) comprises a laser (“laser”, para. [0042, 0061]) and a light source modifier (“22 … source for providing a variable electrical control signal”, para. [0041, 0056]). The spectral data acquisition module (iNIRS system 10 comprising plurality of light detectors 30, fig. 1 & “software”, para. [0134]) includes a spectrometer and its supporting data acquisition software (“interferometric near infrared spectroscopy (‘INIRS’) system … plurality of light detectors 30”; “software”, para. [0038-0039, 0045, 0134]). The output end of light source modifier (unlabeled, but as seen in fig. 1) is successively set up with a lens (“refraction … lenses … spatially distributing sample light”, para. [0048]) and a fiber bundle (“optical fibres”, para. [0048]), and the optical fiber beam outlet is connected to the monitoring object (“sample delivery probe 25a … placed at a location on the subject's scalp”, para. [0042]). The probe (probe 35a, fig. 1, para. [0044]) of the spectrometer (light detectors 30, fig. 1) is in contact with the monitoring object (as seen in fig. 1, “placed on the subject's scalp”, para. [0044]), and the probe is in the same plane as the optical fiber beam outlet (unlabeled but as seen in figs. 1 & 4a, the probes 25a and 35a are on the same plane of the subject’s scalp). Parker further discloses that the iNIRS system 10 may include lenses, reflection and/or refraction devices for beam steering, as relevant, that the light source modifier 22 is arranged to control the wavelength emission of light from the light source 20, and that the light source may be configured to sweep in optical frequency over a range of 50 GHz (para. [0048, 0056, 0058]).
Parker does not disclose an optical parametric oscillator, that several mirrors are arranged between the output of the laser and the input of the optical parametric oscillator to adjust the optical path.
However, Kim directed to a wavelength converted laser apparatus comprising a laser oscillator 11 providing an excitation laser beam (fig. 1) discloses an optical parametric oscillator (optical parametric oscillator 15, fig. 1, para. [0021]) and that several mirrors (first and second mirrors 14a and 14b, fig. 1) are arranged between the output of the laser (as seen in fig. 1) and the input of the optical parametric oscillator (as seen in fig. 1) to adjust the optical path (“required for changing an optical path”, para. [0021], fig. 1). Kim further discloses that the optical parametric oscillator (OPO) crystal 16 capable of selectively converting the laser beam into a beam having a predetermined wavelength range and that a beam having a wavelength of 200 to 2000 nm can be selectively provided for medical and industrial purpose (para. [0025, 0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Parker such that the device comprises an optical parametric oscillator and several mirrors are arranged between the output of the laser and the input of the optical parametric oscillator to adjust the optical path, in view of the teachings of Kim, as this would aid in changing/adjusting the optical path and selectively converting the laser beam into a beam having a predetermined wavelength range between 200 to 2000 nm by incorporating the mirrors and OPO of Kim into the optical path of Parker.
Parker, as modified by Kim hereinabove, does not disclose a coaxial lens group.
However, He directed to a lightweight, compact long-wave infrared laser generating device comprising a pump laser 1, half-wave plate 2, a first coupling system 3, composite optical parametric oscillator 4, a second coupling system 5 (fig. 1) discloses the output end of the optical parametric oscillator (as seen in fig. 1) is successively set up with a coaxial lens group (fig. 1, “coupling system 5 is a plano-convex lens group… shape and focus the two output beams”, para. [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Parker, as modified by Kim hereinabove, such that the output end of the optical parametric oscillator is successively set up with a coaxial lens group, in view of the teachings of He, as this would aid in shaping and focusing the output beams of the optical parametric oscillator by incorporating the plano-convex lens group of He.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schwab (US 20210404875 A1) directed to a spectrophotometer system discloses that the pulse laser emits 10 pulses per second, operating for 2-3 seconds at each λ, collecting 20-30 sample values, and for a narrow range of λ, 20 minutes provides time for more than 240 λ settings (para. [0065-0066]);
Parker (US 20250169726 A1) directed to an interferometric near infrared spectroscopy, iNIRS, system;
Kyriacou (US 20220409080 A1) directed to a system for in-vivo monitoring of intracranial pressure;
Jaffe (US 20090234245 A1) directed to non-invasive detection of intracranial pressure (ICP) variations in an intracranial compartment of a patient using optical radiation;
Sutin (US 20180103861 A1) directed to a method for non-invasively monitoring intracranial pressure using diffuse correlation spectroscopy (DCS);
Konecky (US 20230029744 A1) directed to intracranial diagnostics using optical imaging of coherent light interference;
Franceschini (US 20250366723 A1) directed to optical patient monitoring systems and a system and setup designed to measure intracranial pressure (para. 0082-0083]);
Swoboda (US 20100204589 A1) directed to a system and method for non-invasively detecting intracranial pressure (ICP) of a living being;
Yin (US 20220163866 A1) directed to an all-optical optical parametric oscillator;
Yun (US 20250194967 A1) directed to a brain water monitoring method and apparatus based on near-infrared spectroscopy.
Lin (CN 1369251 A) directed to an intracranial pressure detecting device;
Wang (CN 110786843 A) directed to a non-invasive intracranial pressure optical measuring method;
Wu (CN 109009064 A English Translation) directed to a non-invasive monitoring of intracranial pressure device.
Roldan M, Bradley GRE, Mejía-Mejía E, Abay TY, Kyriacou PA. Non-invasive monitoring of intracranial pressure changes: healthy volunteers study. Front Physiol. 2023 Aug 8;14:1208010. doi: 10.3389/fphys.2023.1208010. PMID: 37614754; PMCID: PMC10443643;
Müller, S. J., Henkes, E., Gounis, M. J., Felber, S., Ganslandt, O., & Henkes, H. (2023). Non-Invasive Intracranial Pressure Monitoring. Journal of Clinical Medicine, 12(6), 2209. https://doi.org/10.3390/jcm12062209
Blockx et al. (2009). Use Of A Codman® Microsensor Intracranial Pressure Probe: Effects On Near Infrared Spectroscopy Measurements And Cerebral Hemodynamics In Rats. In: Liss, P., Hansell, P., Bruley, D.F., Harrison, D.K. (eds) Oxygen Transport to Tissue XXX. Advances in Experimental Medicine and Biology, vol 645. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-85998-9_48
Relander et al., "Using near-infrared spectroscopy and a random forest regressor to estimate intracranial pressure," Neurophoton. 9(4) 045001 (11 October 2022) https://doi.org/10.1117/1.NPh.9.4.045001
Ruesch A, Schmitt S, Yang J, Smith MA, Kainerstorfer JM. Fluctuations in intracranial pressure can be estimated non-invasively using near-infrared spectroscopy in non-human primates. J Cereb Blood Flow Metab. 2020 Nov;40(11):2304-2314. doi: 10.1177/0271678X19891359. Epub 2019 Nov 27.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.E.H./
Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791