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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/01/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/01/2026 was considered by the examiner.
Drawings
Replacement drawings were received on 05/01/2026. These drawings are accepted.
Specification
Amendments to the specification were received on 05/01/2026. These amendments are accepted.
Claim Objections
Claims 1 and 6-8 are objected to because of the following informalities: Appropriate correction is required.
Claim 1, line 7: “signals” should be replaced with –signal–;
Claim 1, line 8: “time” should be replaced with –times–;
Claim 1, line 9: “on each” should be replaced with –for each–;
Claim 1, line 10: “a time difference” should be replaced with –time differences–;
Claim 1, line 15: “difference” should be replaced with –differences–;
Claim 1, line 20: “each” was replaced with–the–;
Claim 6, line 12: “pressure within the sampling time y” should be replaced with –pressure (y) within the sampling time–;
Claim 6, line 18: –the– should be inserted before “real”;
Claim 7, lines 4-5: “detected by the sensing probes” should be replaced with –from each probe–;
Claim 7, line 5: –the jugular pulsation signals– should be inserted before “to a cloud”;
Claim 7, line 6: “signal enters” should be replaced with –signals enter–;
Claim 7, line 7: –average– should be inserted before “intracranial”;
Claim 7, line 7: “sent back a settlement result to the host for display via Wi-Fi” should be replaced with –receive a result via Wi-Fi–;
Claim 7, line 9: “and” should be replaced with –wherein–;
Claim 7, line 10: –are– should be inserted before “equipped”;
Claim 7, line 18: “to display” should be replaced with –for display–;
Claim 8, line 4: “applicable to the installation of AppleTM mobile phones” should be replaced with –is suitable for AppleTM mobile phone installation–;
Claim 8, line 10: “set up” should be replaced with –provide–;
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As indicated in MPEP 2161.01, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the algorithm, steps, or procedure for performing the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. In other words, the algorithm, steps, or procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Claim 1 recites “establishing a mathematical formula for calculating an average intracranial pressure within the sampling time based on the average value of the time difference of the same feature point, wherein coefficients in the mathematical formula for calculating the average intracranial pressure are determined by programming software of the host through a calibration process with a real intracranial pressure value measured by intracranial pressure measurement methods,” in lines 14-19. There is insufficient description of the algorithm, steps, or procedure for performing the claimed function of determining the coefficients through a calibration process. At most, the specification recites “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)” in ¶ [0127] of the published application. However, this description is not sufficient. How are the pressure states compared to a real intracranial pressure value of the subject to arrive at the coefficients? Without a sufficient description of the algorithm, steps, or procedure for arriving at the coefficients, one of ordinary skill in the art would not understand how the inventor intended the function to be performed.
Claims 2-9 are rejected by virtue of their dependence from claim 1.
Claim 6 has been amended to recite “a, b, and c are calibration coefficients calculated with real intracranial pressure values measured in a first state with a first preset intracranial pressure value range, a second state with a second preset intracranial pressure value range and a third state with a third preset intracranial pressure value range, wherein an intracranial pressure value in the first preset intracranial pressure value range of the first state is less than an intracranial pressure value in the second preset intracranial pressure value range of the second state, and an intracranial pressure value in the second preset intracranial pressure value of the second state is less than an intracranial pressure value in the third preset intracranial pressure value range of the third state” which is new matter. ¶ [0127] of the published application indicate that that “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)”. However, there is no indication in the specification that there are a plurality of real intracranial pressure values. Additionally, there is no indication that the plurality of real intracranial pressure values correspond to the below normal, normal, and above normal intracranial pressure states (i.e., the first, second, and third states).
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 1-9 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 “fixing two sensing probes on a skin surface adjacent a jugular vein to obtain an intracranial pressure” in lines 3-4. First, claim 1 also recites “intracranial pressure” in lines 1-2. It is unclear if these recitations of “intracranial pressure” are the same as, related to, or different from each other. Second, the recitation in lines 3-4 suggest that the fixation of the probes results in the acquisition of the intracranial pressure. It is unclear how a fixation of probes alone results in the acquisition of an intracranial pressure. The Examiner suggests deleting the recitation of “to obtain an intracranial pressure”.
Claim 1 recites “calculating each beat” in line 10. It is unclear how one calculates each beat. The specification does not provide clarification. The Examiner suggests deleting the recitation of “each beat”.
Claim 1 recites “establishing a mathematical formula for calculating an average intracranial pressure within the sampling time based on the average value of the time difference of the same feature point, wherein coefficients in the mathematical formula for calculating the average intracranial pressure are determined by programming software of the host through a calibration process compared with other intracranial pressure measurement methods,” in lines 14-19, which is unclear in light of the specification. At most, the specification recites “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)” in ¶ [0121] of the specification. However, this description is not clear. How are the pressure states compared to a real intracranial pressure value of the subject to arrive at the coefficients? Because the explanation in the specification is not clear, it follows that the claim limitation which relies on that explanation is not clear.
Claims 2-9 are rejected by virtue of their dependence from claim 1.
Claim 6 recites “the same feature point appears for each sensing probe in each beat”. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests replacing the recitation with “the same feature point appears for each sensing probe for each pulsation”.
Claim 8 recites “the personal information input options” in lines 8-9, “the intracranial pressure display option” in line 10. There are insufficient antecedent bases for these limitations in the claim. The Examiner suggests replacing “set personal information input, an intracranial pressure calibration and display options” in lines 8-9 was replaced with –provide personal information input options, an intracranial pressure calibration option, and an intracranial pressure display option–;
Claim 9 recites “a connection with the host includes: the sensing probes are connected to the host through data cables and power cables, and a power supply is provided in the host; and the sensing probes are connected to the host by a BluetoothTM wireless transmission method configured to transmit signals between the host and the sensing probes, the power supply or rechargeable battery is set in the sensing probes” in lines 3-9. It is unclear how a power supply being provided in the host or the power supply or rechargeable batter being set in the sensing proves being a component of a connection with a host. The specification does not provide clarification. The Examiner suggests replacing claim 9 with:
9. The intracranial pressure monitoring device according to claim 8,
wherein the sensing probes are configured to be pasted on the skin surface adjacent the jugular vein of the patient with a biocompatible adhesive, and
wherein:
the sensing probes are connected to the host through data cables and power cables, and a power supply is provided in the host; or
the sensing probes are connected to the host by a BluetoothTM wireless transmission method configured to transmit signals between the host and the sensing probes, wherein the power supply or a rechargeable battery is provided in the sensing probes and a distance between the host and the sensing probes does not exceed a maximum transmission distance of a Bluetooth TM module.
Prior Art Rejections
There are no prior art rejections of claims 1-9.
With regards to claim 1, the prior art does not teach or suggest “calculating each beat and a time difference of the same feature point appearing on each probe, by a programming software of a host, and calculating an average value of the time difference of the same feature point appearing on each probe within a sampling time”; “establishing a mathematical formula for calculating the average intracranial pressure within the sampling time based on the average value of the time difference of the same feature point, wherein coefficients in the mathematical formula for calculating the average intracranial pressure are determined by the programming software of the host”; and “calculating the average intracranial pressure in each sampling time in real time, by the programming software of the host, based on the mathematical formula” along with the other features of claim 1.
The prior art does not teach or suggest the features of claim 2-9 by virtue of their dependence from claim 1.
US 2022/0054029 A1 (Sweeney) (previously cited) teaches using at least two sensing probes applied to a vessel (¶ [0006]), determining a time difference of arrival of a pulsation (¶ [0012]), and determining a compliance and pressure of the vessel (¶¶ [0053], [0059]). Also see ¶¶ [0021]-[0022]. Sweeney does not teach or suggest determining an average time difference of the feature points, and calculating an average intracranial pressure based on the average time difference, along with the other features of claim 1.
US 2021/0076958 A1 (Pierro) (previously cited) teaches calculation of intracranial pressure based on a pulse transit time from one location on the human subject to a cranium (¶ [0007]). However, Pierro does not teach or suggest how the intracranial pressure is determined based on a time difference of arrival of a feature point of a jugular vein pulsation using at least two sensing probes fixed on the skin surface near the jugular vein, along with the other features of claim 1.
US 4,204,547 A (Allocca) (previously cited) teaches noninvasive monitoring of intracranial pressure based on occlusion of the jugular vein (Abstract). US 2019/0069876 A1 (Michael) teaches determining an intracranial reserve space (ICRS) parameter based on a volume velocity (linear velocity times cross-section area of the IJV) of the blood flowing across the IJV for example just before partial occlusion (¶¶ [0122]-[0124]), and using the ICRS to predict an ICP of the subject (¶¶ [0127]-[0128]). However, Allocca and Michael do not teach or suggest the use of a time difference of arrival of a feature point of a jugular vein pulsation using at least two sensing probes to determine the intracranial pressure, and calculating an average intracranial pressure based on the average time difference, along with the other features of claim 1.
Extracting the Jugular Venous Pulse from Anterior Neck Contact Photoplethysmography (Garcia-Lopez) (cited by Applicant) includes jugular venous pulse detection using reflectance photoplethysmography and identifying a, c, v pressure waves. However, Garcia-Lopez does not teach or suggest the use of a time difference of arrival of a feature point of a jugular vein pulsation using at least two sensing probes to determine the intracranial pressure, and calculating an average intracranial pressure based on the average time difference, along with the other features of claim 1.
Response to Arguments
Objections to Drawings
In view of the replacement drawings filed 05/01/2026, the objections to the drawing were withdrawn.
Claim Objections
There are new grounds of claim objections.
Rejections under 35 U.S.C. §§112(a) and 112(b).
Applicant's arguments filed 05/01/2026 have been fully considered but they are not persuasive.
On page 12 of the response filed 05/01/2026, the Applicant asserts:
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Applicant further asserts the quadratic equation would be solved by persons having ordinary skill on page 12 of the response filed 05/01/2026.
These arguments are not persuasive. The Applicant’s arguments rely upon “the actual intracranial pressure values”, which would be new matter. The specification recites “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)” in ¶ [0127] of the published application. There is no recitation that a plurality of pressure values are used. Additionally, there is no recitation that the calibration involves conventional mathematical modeling techniques (such as best fit or least squares). There is Therefore, the Applicant’s arguments are not commensurate with the scope of the Applicant’s specification, and they are not persuasive.
On page 13 of the response filed 05/01/2026, the Applicant asserts:
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This argument is not persuasive. The specification recites “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)” in ¶ [0127] of the published application. However, there is no indication or suggestion that calibration is conventional or well-known. Instead, the specification indicates that a single real intracranial pressure value is used for the determination of the three coefficients. However, such a calibration is not well-understood or conventional. Therefore, the specification must describe the algorithm for performing the calibration is performed in order to show that the inventor was in possession of the invention.
On pages 15-16 of the response filed 05/01/2026, the Applicant asserts that the amendment to claim 6 provides support for the coefficient determination of claim 1 and clarifies the unclear original wording.
These arguments are not persuasive because they rely upon new matter. Paragraph [0127] of the published application indicate that that “the proportional coefficients a, b and c need to be calculated by comparing the three intracranial pressure states (lower than normal, normal and higher than normal) with the real intracranial pressure value of the subject (this process is called calibration)”. However, there is no indication in the specification that there are a plurality of real intracranial pressure values. Additionally, there is no indication that the plurality of real intracranial pressure values correspond to the below normal, normal, and above normal intracranial pressure states (i.e., the first, second, and third states).
In view of the foregoing, the amended claims 1-9 are not fully supported by the specification and are indefinite, and the rejections of claims 1-9 under 35 U.S.C. §112 were maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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