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 .
Drawings
The drawings are objected to because “changees” of the title of Fig. 7 should be amended to be “changes”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Amended ¶ [00102], line 7: “the above” should be replaced with –a first–;
Amended ¶ [00102], line 8: in “Sensor the below curve”, the recitation of “Sensor” should be deleted;
Amended ¶ [00102], line 8: “the below” should be replaced with –a second–;
Amended ¶ [00141], line 7: “The curve below” should be replaced with –A first curve–; and
Amended ¶ [00141], line 8: “the curve above” should be replaced with –a second curve–.
Appropriate correction is required.
The amendment filed 11/20/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
¶ [0052] was amended to recite “When intracranial pressure increases, venous return is restricted, reducing the filing capacity and consequently decreasing the pulse wave velocity along the vein. Therefore, changes in intracranial pressure can be measured by measuring changes in the jugular vein pulse wave velocity”, which is new matter. The originally filed specification indicates that a pulse wave velocity is faster as intracranial pressure rises, which is contradictory to the amended language. The rest of the originally filed specification does not appear to provide support for the amended language.
¶ [0052] was amended to recite “With a fixed sensor spacing, the time difference between the pulsation feature points measured by the two sensors is inversely proportional to the pulse wave propagation speed, which is also inversely proportional to jugular venous blood pressure. However, there is a positive correlation between this time difference and intracranial pressure. In other words, if this time difference is larger than the time difference under normal intracranial pressure, it means that intracranial pressure is elevated, and the magnitude of the elevation is positively correlated with the increase in the time difference” which is new matter. The originally filed specification indicates that a shorter time difference means that the intracranial pressure has increased, which is contradictory to the amended language. The rest of the originally filed specification does not appear to provide support for the amended language.
¶ [0053] was amended to recite “If increased intrathoracic pressure is caused by conditions such as pneumothorax, emphysema, cancer, chest trauma, or shortness of breath, it leads to increased venous pressure. This pressure is transmitted to the intracranial cavity, also causing increased intracranial pressure. In this case, the time difference measured by the two sensors is inversely related to intracranial pressure. In other words, the higher the intrathoracic pressure, the greater the jugular venous filling, and the more significantly intracranial pressure is affected, but the shorter the time difference measured by the two sensors. Therefore, when using the technology of this invention, different mechanisms of intracranial pressure formation need to be addressed separately. That is, for increased intracranial pressure caused by intracranial lesions, the time difference is positively correlated with intracranial pressure; for increased intracranial pressure caused by increased intrathoracic pressure, the time difference is inversely correlated with intracranial pressure” which is new matter. The originally filed specification does not provide any support for the amended language.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 1-4, 6, and 9 are objected to because of the following informalities:
Claim 1, line 3: “wherein” should be deleted;
Claim 1, line 10: –the– should be inserted before “signals”;
Claim 1, line 16: “a host” should be replaced with –the host–;
Claim 2, line 7: “Venous” should be lowercase;
Claim 3, lines 3-4: instances of –a– should be inserted before “piezoelectric”, “pressure”, “Doppler”, “photoelectric”, and “pulse”;
Claim 4, line 3: –and– should be inserted after “other jugular veins;”
Claim 6, line 2: “a calculation process of” should be replaced with –calculating–;
Claim 6, line 5: “tA” should be replaced with –ta–;
Claim 6, line 9: “a given time period” should be replaced with –the sampling time–;
Claim 6, line 11: “given period” should be replaced with –sampling time–;
Claim 9, line 4: “biocompatibility” should be replaced with –biocompatible–;
Claim 9, line 4: “two methods” should be deleted;
Appropriate correction is required.
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 compared with other intracranial pressure measurement methods,” in lines 20-25. 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. What constitutes the “lower than normal, normal and higher than normal” intracranial pressure states? How are they determined? How are the pressure states compared to real intracranial pressure values of the subject to arrive at the coefficients? How are these pressure states related to the average value of the time difference? 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 by comparing an intracranial pressure value below normal, normal, and above normal with a real intracranial pressure value” which is new matter. There is no indication in the specification that the intracranial pressure state below normal, normal, and above normal of ¶¶ [0027], [0121] of the specification filed 11/20/2025 is the same as an intracranial pressure value.
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 “An information processing method for intracranial pressure monitoring” in lines 1-2. However, claim 1 recites “fixing two sensing probes on a skin surface” in lines 4-5, which is not a step for processing information. Instead, the step in lines 4-5 appears to be a step for acquiring information. Therefore, it is unclear whether claim 1 is directed to only an information processing method or is also directed to a broader method. For the purposes of examination, the preamble will be interpreted to be “A method for monitoring intracranial pressure”. The preambles of claims 2-9 will be interpreted accordingly.
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 20-25, 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 filed 11/20/2025. However, this description is not clear. What constitutes the “lower than normal, normal and higher than normal” intracranial pressure states? How are they determined? And how are the pressure states compared to real intracranial pressure values 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.
Claim 1 recites “a calibration process compared with other intracranial pressure measurement methods” in lines 24-25. It is unclear how the calibration process is compared with other intracranial pressure methods? The specification does not provide any details regarding how the comparison of the process and other methods is performed. At most, the specification suggests that the intracranial pressure states are compared with real or true intracranial pressures to arrive at the coefficients. However, the comparison of intracranial pressure states with real or true intracranial pressures is not the same as the comparison of a calibration process with other intracranial pressure measurement methods. Clarification is required.
Claim 1 recites “obtaining an intracranial pressure change curve for reference, by monitoring a change of a jugular venous pressure” in lines 31-33. It is unclear how the “monitoring” alone results in obtaining an intracranial pressure change curve. The specification does not provide clarification. Additionally, it is unclear how “monitoring a change of a jugular venous pressure” and “obtaining an intracranial pressure change curve for reference” are related to the previously-recited limitations in the claim. Does either using the at least two sensing probes or calculating the average time difference amount to monitoring the jugular venous pressure? Or is the monitoring performed in some other manner? The specification does not provide clarification.
Claims 2-9 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “wherein a sensing method adopted in the information processing method for monitoring intracranial pressure is piezoelectric sensing” in lines 2-3. Claim 1 recites “sending a jugular pulsation signal measured by each probe” in line 7, which indicates that the probe is used in a sensing method. It is unclear whether the sensing method of claim 2 is the same as, related to, or different from the sensing method performed by using the probe in claim 1. The Examiner suggests deleting the recitation of “a sensing method adopted in the information processing method for monitoring intracranial pressure is piezoelectric sensing; and” in lines 2-3 of claim 2.
Claim 2, line 5 recites “the information processing method using intracranial pressure monitoring”. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite an information processing method using intracranial pressure monitoring. The Examiner suggests deleting “using intracranial pressure monitoring”.
Claim 2 recites “acquiring the jugular vein pulsation map in a manner of array arrangement of the two sensing probes” in lines 6-7, which is unclear. How is a map acquired “in a manner of array arrangement”? What is an “array arrangement of the two sensing probes”?
Claim 4 recites “characteristic points” in line 4. It is unclear how these characteristics points are related to the feature points of claim 1. The specification suggests that they are the same because the specification does not create a distinction between the terms and uses the terms interchangeably, but the difference in claim terminology suggest that they are different. For the purposes of examination, the recitation of “characteristic points” will be interpreted to be “the feature points”. Claim 6 recites a similar limitation, so it is rejected on similar grounds.
Claim 5 recites “the sampling method” in line 5, “the jugular pulsation” in line 5, “the pulse amplitude” in lines 5-6. There are insufficient antecedent bases for these limitations in the claim.
Claim 5 recites “the sampling method” in line 2. Claim 1 recites “a jugular pulsation signal measured by each probe” in line 7, which appears to be a sampling method. It is unclear how these recitations are related. If they are the same, consistent terminology should be used. If they are different or related, the relationship should be made clear.
Claim 5 recites “using the piezoelectric sensor to trace an electrical signal value generated by the jugular pulsation” in lines 4-5. Claim 1 recites “a jugular pulsation signal” in line 7. It is unclear whether the trace of the electrical signal value of claim 5 is the same as, related to, or different from the jugular pulsation signal of claim 1. If they are the same, consistent terminology should be used. If they are different or related, the relationship should be made clear.
Claim 6 recites “sensor probes A and B” in lines 3-4. Claim 1 recites “at least two sensing probes” in line 4. It is unclear whether the sensor probes of claim 1 are the same as, related to, or different from the sensor probes A and B of claim 6. If they are the same, consistent terminology should be used. If they are different, the relationship should be made clear.
Claim 6 recites “jugular pulsation amplitude-time curves” in line 4. Claim 1 recites “a jugular pulsation signal” in line 7. It is unclear whether the curves of claim 5 are the same as, related to, or different from the jugular pulsation signal of claim 1. If they are the same, consistent terminology should be used. If they are different or related, the relationship should be made clear.
Claim 6 recites “wherein a calculation process of the time difference comprises” in lines 2-3 and “using an arithmetic mean from time difference values between all sensing probes as an average time difference
t
a
b
-
required for intracranial pressure calculation” in lines 9-11. Claim 1 recites “calculating an average value of the time difference” in line 16-17. First, it is unclear whether these calculations of the average are the same as, related to, or different from each other. Second, claim 1 indicates that the calculation of the time difference and the average are different steps, but claim 6 indicates that the determination of the time difference and the average are a part of the same calculation process of the time difference. Therefore, it is unclear whether the determination of the time difference includes the calculation of the average or not.
Claim 6 recites “an intracranial pressure value” in line 16. Claim 1 recites “an intracranial pressure” in line 5 and “an average intracranial pressure” in line 21, both of which are understood to correspond to a value. It is unclear how “an intracranial pressure value” in claim 6 are related to the pressures in claim 1. The different terminology suggests that they are different. However, the specification suggests that the intracranial pressure value is one of the intracranial pressure or the average intracranial pressure. Clarification is required.
Claim 7 recites “An intracranial pressure monitoring device implementing the information processing method” in lines 1-2, which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). For the purposes of examination, the recitation will be interpreted to be “An intracranial pressure monitoring device for implementing the method for monitoring intracranial pressure of claim 1”.
Claim 7 recites “it” in the last line. It is unclear what the recitations refer to. The Examiner suggests positively reciting the which element “it” refers to.
Claim 8 recites “in the intracranial pressure display option, set up two display modes: the current intracranial pressure value and the curve of the intracranial pressure change trend in the past period” in lines 12-14. It is unclear how the value and the curve are related to “set up two display modes” because values and curves are not understood to be “display modes”. The Examiner suggests amending the recitation to be “in the intracranial pressure display option, set up two display modes: a first mode in which the current intracranial pressure value displayed, and a second mode in which the curve of the intracranial pressure change trend in the past period”.
Claim 8 recites “these data” in line 15. However, the grammatical structure makes it is unclear which data is being referred to by “these data”. The Examiner suggests positively reciting the which element “these data” refers to.
Claim 9 recites “the BluetoothTM module” in line 13. There is insufficient antecedent basis for this limitation in the claim.
No 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.
Response to Arguments
Objections to Drawings
There are new grounds of objections to the drawings necessitated by the replacement drawings filed 11/20/2025.
Status of the Abstract
In view of the amendments to the abstract filed 11/20/2025, the objections to the abstract are withdrawn.
Objections to Specification
There are new grounds of objections to the specification necessitated by the amendments to the specification filed 11/20/2025.
Claim Objections
There are new grounds of claim objections necessitated by the amendments to the claims filed 11/20/2025.
Claim Rejections under 35 U.S.C. §112(a)
Applicant's arguments filed have been fully considered but they are not persuasive.
The Applicant asserts that “lower than normal, normal and higher than normal” intracranial pressure states and “compared to real intracranial pressure values of the subject” are well-known by those skilled in the art.
This argument is not persuasive because it amounts to a bare assertion that the features are known to those skilled in the art without having the detail necessary to show that the applicant had possession of the claimed subject matter.
The Examiner maintains that the specification does not provide sufficient description of what constitutes the “lower than normal, normal and higher than normal” intracranial pressure states; how the states are determined; how the pressure states are compared to real intracranial pressure values of the subject to arrive at the coefficients; and how these pressure states are related to the average value of the time difference. It is not evident to one of ordinary skill how a comparison of intracranial pressure states with real intracranial pressure values alone could possibly arrive at the coefficients without consideration of the time differences.
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.
The Applicant further asserts that “normal intracranial pressure is the current technology: the pressure in the lateral ventricle of a normal adult when lying down or in a relaxed state is 6-13.5mmHg (8.16-18.36 cmH20), while in children it is 3-6.75mmHg (4.08-9.18 cmH2O). When the intracranial pressure of an adult remains above 15 mmHg (20.4cmH20) while lying flat, it is called intracranial hypertension.” The Applicant further provides Reference documents 1-4.
This argument is not persuasive.
First, the specification does not indicate that the three intracranial pressure states (lower than normal, normal and higher than normal) of ¶ [0121] of the specification filed 11/20/2025 is the same as or related to the pressure ranges of ¶ [0002]. Applicant merely asserts that the normal intracranial pressure state and higher than normal intracranial pressure state correspond to the respective ranges, without any evidence that one of ordinary skill would understand that the intracranial pressure states and their normal, lower than normal, and higher than normal ratings correspond to the ranges of ¶ [0002]. Furthermore, there is no indication that the “higher than normal” intracranial pressure state corresponds to intracranial hypertension.
Second, the Examiner performed a review of the reference documents, but did not find any evidence of indications of what corresponds to the lower than normal, normal, and higher than normal intracranial pressure states. Therefore, the reference documents did not provide any evidence of what the intracranial pressure states correspond to.
Claim Rejections under 35 U.S.C. §112(b)
There are new grounds of claim rejections under 35 U.S.C. §112(b).
There are several previously-presented rejections under 35 U.S.C. §112(b) that were maintained because Applicant's arguments and amendments filed 11/20/2025 were not persuasive.
Claim 6 was rejected for reciting “sensor probes A and B” in lines 3-4. Applicant did not amend the claim language and asserted that the two sensing probes are the same sensor probe A and sensor probe B. This argument is not persuasive because they amount to a mere allegation that they are the same without any clarifying amendments. The claim language must be amended to clarify that the two sensing probes are the same.
Claim 8 was rejected for reciting “in the intracranial pressure display option, set up two display modes: the current intracranial pressure value and the curve of the intracranial pressure change trend in the past period” in lines 12-14. However, the Examiner maintains that it is unclear how the value and the curve are related to “set up two display modes” because values and curves are not understood to be “display modes”. The Examiner suggests amending the recitation to be “in the intracranial pressure display option, set up two display modes: a first mode in which the current intracranial pressure value displayed, and a second mode in which the curve of the intracranial pressure change trend in the past period”.
Claim 8 was rejected for reciting “these data” in line 15. However, the grammatical structure makes it is unclear which data is being referred to by “these data”. The Examiner suggests positively reciting the which element “these data” refers to. Applicant did not amend the claim language and asserted that the data refers to intracranial pressure values and the curve of intracranial pressure changes over time. This argument is not persuasive because it amounts to a mere allegation that these data refers to the elements without clarifying the claim language. The claim language must be amended to clarify what data is being referred to.
Claim Rejections under 35 U.S.C. §101
In view of the claim amendments filed 11/20/2025, the claim rejections under 35 U.S.C. §101 were withdrawn.
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.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791