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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided [The Examiner notes the use of legal phraseology of “said longitudinal body” and “said tip element” in the amended Abstract filed 17 December 2024].
The disclosure is objected to because of the following informalities:
The amendment filed 17 December 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [“This application claims priority to International Patent Application No. PCT/EP2023/066082, filed on June 15, 2023, and European Patent Application No. EP 22179649.3, filed on 17 June 2022, the contents of both of which are hereby incorporated by reference in their entirety” (Applicant’s Specification ¶0001), emphasis applied]. 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: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 5 is/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 5 recites the limitation “a second set of at least two LEDs” [line 2, the Examiner notes additional references to the “second set” in claim 5], which is considered lack antecedent basis, as based on the dependency chain of claim 5, there is no “first set” of at least two LEDS to provide antecedent basis to a “second set”, and is further considered to render claim 5 indefinite, as it is not clear whether claim 5 is meant to be dependent from claim 4, as claim 4 does recite a “first set of at least two LEDs” [line 2 in claim 4], such that the “second set” of claim 5 would have antecedent basis, or whether claim 5 is merely meant to define a “set of at least two LEDs” without reference to any other set of LEDs. For examination purposes, the Examiner has interpreted either interpretation to be applicable in light of any prior art applied under § 102 or § 103. The Examiner notes that claim 6 is considered to recite similar subject matter that is considered to lack antecedent basis and render claim 6 indefinite [“a third set of at least two LEDs” (line 2 of claim 6)], such that claim 6 is interpreted similar to claim 5 above mutatis mutandis.
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.
Claim(s) 1-2, 4-5, and 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange (US-20200069254-A1) in view of Ward (US-20200260975-A1, cited by Applicant).
Regarding claim 1, Lange teaches
An intracranial catheter for measuring a flow of blood through a body tissue [The measurement of the intracranial pressure, the cerebral blood flow and neuronal activities should be carried out according to the scheme shown in FIG. 2 (Lange ¶0045, Fig. 2)], comprising a longitudinal body adapted to be inserted into a craniospinal compartment [FIG. 1 shows an exemplary embodiment of the invention wherein the device for drainage of the brain 1 is shown in a cross-sectional view. The device for drainage of the brain has, for example, three regions: A, B, C… The device for drainage of the brain 1 has a rod-shaped hollow body 10 in which an inner drainage channel is provided (Lange ¶0043, Figs. 1-2)], the longitudinal body has having a tip element, which forms a distal end of said longitudinal body [Lange Fig. 1], and a channel extending from a proximal end of said longitudinal body to at least one opening of said tip element [Drainage openings 12 are provided in the rod-shaped hollow body 10, which connect the drainage channel 11 with the outside of the rod-shaped hollow body 10. The drainage openings 12 may either be provided only on the cylindrical part of region A so that the frontal area remains essentially integrally closed, as shown in FIG. 5, or they may also be provided on the frontal area, as shown in FIG. (Lange ¶0043, Fig. 1)], the intracranial catheter further including a sensor configured to detect a pulsatile pressure curve for pulse contour analysis performed by a processing unit [In region B, which lies in the area of the cerebral mass, a sensor arrangement 20 may be provided, which, in turn, may have a plurality of different individual sensors, which, however, may be combined into the sensor arrangement 20. The sensors 21, 22, 23, 24 may be pressure sensors, temperature sensors, brain activity sensors or oxygen saturation sensors… The sensors may be connected by means of a signal connection 40 to a signal interface 50, wherein the signal interface lies substantially outside the actual cranial region, here in the region C… By means of the signal interface 50, the signals may then be transmitted to a measuring arrangement or a measuring system via a corresponding signal line 64 or also wirelessly (Lange ¶0043, Figs. 1-2); The measurement of the intracranial pressure, the cerebral blood flow and neuronal activities should be carried out according to the scheme shown in FIG. 2… The measuring device for pressure, temperature, oxygen saturation and brain activity is situated in regions A and B. These signals are transmitted to the outside via a cable 64 and connected to the external measuring device. In this regard, data may also be transmitted to an external measuring device via RFID, WLAN or other wireless methods (Lange ¶0045, Fig. 2)].
However, while Lange discloses wherein the sensor is configured to detect a pressure curve for contour analysis performed by a processing unit [Lange ¶¶0043, 0045], Lange fails to explicitly disclose wherein the pressure curve is a pulsatile pressure curve for pulse contour analysis performed by the processing unit.
Ward discloses systems comprising an intracranial catheter for measuring a flow of blood through a body tissue [FIG. 4 illustrates an example pressuring sensing system 500 having a probe device 502 having multiple sensors for pressure monitoring, and in particular, for some examples, for intracranial pressure monitoring for cerebral hemodynamic monitoring, in accordance with examples herein. For example, in some implementations the probe device 500 may be an insertable catheter device, such as an intraparenchymal and/or intraventricular catheter used for ICP monitoring in subjects (Ward ¶0055, Fig. 4)], wherein Ward discloses wherein the catheter comprises a sensor configured to detect a pulsatile pressure curve for pulse contour analysis performed by a processing unit [FIGS. 2-5 illustrate example implementations of the vascular resistance estimator 108 and the blood flow estimate 112. FIG. 2 illustrates example waveforms from the piezoelectric sensor 104 and the optical fiber sensor 102, respectively, as the waveforms would be provided to the vascular resistance estimator 108. Each waveform is characterized by periodic peaks 202A and 204A occurring each heartbeat, where there is a varying phase delay between the peaks of each waveform… The estimator 108 compares these waveforms heartbeat-to-heartbeat and generates an estimated systemic vascular resistance (SVR). For example, the sensor 102 senses a change in volume in a sample region, such as changes in arterial volume, which the sensor 102 detects by illuminating sample region and measuring the amount of light reflected from that sample region (Ward ¶¶0049-0050, Fig. 2); With the systemic vascular resistance determined by the estimator 108, that signal is provided to the blood flow estimator 112, along with local pressure data from the ICP sensor 110 (and other ICP and MAP data 114), for calculating a blood flow, as shown in FIG. 3. Graph 400 shows a sample calculation of blood flow using the system 100 as shown in plot 402 compared against an external reference blood flow determined plot 404 (Ward ¶0054)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Lange to employ wherein the pressure curve is a pulsatile pressure curve for pulse contour analysis performed by the processing unit, so as to provide additional contextual information regarding cerebral blood flow, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [method for using intracranial sensors to determine intracranial blood flow] [MPEP § 2143(I)(D)].
Regarding claim 2, Lange in view of Ward teaches
The intracranial catheter according to claim 1, wherein the sensor comprises optical sensor devices including at least one light emitter for emitting light in a near infrared range into the body tissue and at least one light receiver for receiving light reflected in the body tissue and back to the longitudinal body and for generating a signal [FIG. 8 shows an exemplary embodiment of the outside of the rod-shaped hollow body 10 in which the structural design is explained here by using the example of a sensor 23. In the arrangement shown in FIG. 8, the oxygen sensor has one or more light sources 70 that are able to emit light of different wavelengths. The emitted light may, for example, be in the red range or in the infrared range. Wavelengths above 570 nm or above 600 nm, for example, are preferred. Corresponding photosensitive sensors 71 and 72 are provided, which are arranged in the arrangement shown in FIG. 8 at the same height next to the light source 70. The first photosensitive sensor 71 is a light sensor that is sensitive to a first wavelength of the light source 70 while the second light sensor 72 is a sensor that responds to a second different wavelength (Lange ¶0052)].
Regarding claim 4, Lange in view of Ward teaches
The intracranial catheter according to claim 1, including a first set of at least two LEDs, wherein a first LED of said first set emits light at a different wavelength than a second LED of said first set and wherein said LEDs of said first set are adapted to emit light in a near infrared range and wherein a light receiver adapted to receive reflected light of said first set generates a signal for monitoring cerebral blood flow [Lange ¶¶0045, 0052, 0056].
Regarding claim 5, Lange in view of Ward teaches
The intracranial catheter according to claim 1, including a second set of at least two LEDs, wherein a first LED of said second set emits light at a different wavelength than a second LED of said second set and wherein said LEDs of said second set are adapted to emit light in a near infrared range and wherein a light receiver adapted to receive reflected light of said second set generates a signal for monitoring cerebral oxygen saturation [Lange ¶¶0052, 0056].
Regarding claim 7, Lange in view of Ward teaches
The intracranial catheter according to claim 1, wherein the longitudinal body includes a connector with a fluid port and a data port [By means of measurement signals, which are not shown in FIG. 2, the measured signals may be forwarded to a signal interface 50 in order to then be forwarded to the measurement system via a signal or data line 64 (Lange ¶0046, Fig. 2); the device for drainage of the brain 1 may have a drainage line 63 through which drained liquid may be removed (Lange ¶0047, Fig. 2)].
Regarding claim 8, Lange in view of Ward teaches
The intracranial catheter according to claim 1, wherein the sensor comprises a pressure sensor device or an optical sensor device [The sensors 21, 22, 23, 24 may be pressure sensors, temperature sensors, brain activity sensors or oxygen saturation sensors (Lange ¶0043); Lange ¶0056].
Regarding claim 9, Lange in view of Ward teaches
The intracranial catheter according to claim 1, wherein the sensor comprises a pressure sensor device and an optical sensor device [Lange ¶¶0043, 0056].
Regarding claim 10, Lange in view of Ward teaches
The intracranial catheter according to claim 1, wherein the sensor comprises a temperature sensor device [Lange ¶0043].
Regarding claim 11, Lange in view of Ward teaches
A method for monitoring cerebral blood flow using an intracranial catheter according to claim 1 [See § 103 modification of claim 1 above; Lange ¶0045].
Regarding claim 12, Lange in view of Ward teaches
The method according to claim 11, including measuring changing absorbance, reflectance, and/or scattering of two different wavelengths of at least one set of LEDs [Lange ¶0056].
Regarding claim 13, Lange in view of Ward teaches
The method according to claim 11, wherein the cerebral blood flow is monitored by measuring a pulsatile pressure curve using signals generated by the sensor and/or optical signals, and analyzing said signals using pulse contour analysis employed by a processing unit [See § 103 modification of claim 1 above; Ward ¶¶0049-0050, 0054, Fig. 2].
Regarding claim 14, Lange in view of Ward teaches
The method according to claim 11, wherein the monitoring includes combining an analysis results of an oxygen saturation measurement and a pressure curve measurement [Lange ¶¶0045, 0056].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Ward, as applied to claim 2 above, in further view of Limacher (US-20150257705-A1, cited by Applicant).
Regarding claim 3, Lange in view of Ward teaches
The intracranial catheter according to claim 2.
However, while Lange discloses determining oxygen saturation by measuring different parameters using different wavelengths in the assessment of cerebral blood flow [Lange ¶0052; the oxygen saturation may be determined on the basis of two different wavelengths of light, which are, for example, in the range of the red or infrared light, i.e. for example, at a wavelength greater than 570 nm or 600 nm (Lange ¶0018); It should be understood that the sensors for detecting the light with different wavelengths may also detect a plurality of different wavelengths and that a plurality of such sensors can also form a corresponding detection array so that, due to the local distribution and the light intensities detected there with corresponding wavelengths, conclusions may be drawn, for example, about an oxygen saturation (Lange ¶0056)], Lange in view of Ward fails to explicitly disclose wherein the signal generated by the light receiver comprises information about a difference between an oxyhemoglobin concentration and a deoxyhemoglobin concentration, and the signal provides for continuous monitoring of cerebral blood flow.
Limacher discloses an intracranial catheter for measuring a flow of blood through a body tissue [The catheter probe is also suitable for tissue areas lying far within the brain… The catheter head can be inserted into the brain as far as the ventricle floor, for example, which then serves inter alia as reference point for locating the middle piece. The measurement of the flow of blood can thus be performed directly in situ in the areas of body tissue that are of interest (Limacher ¶0021); The device for measuring the flow of blood through a body tissue according to the invention also preferably comprises a holder which is placed on the surface of the head, over an insertion opening in the cranium, and which holds the catheter probe in a predetermined position (Limacher ¶0022)], wherein Limacher discloses using a light emitter and a light receiver to generate a signal that comprises information about a difference between an oxyhemoglobin concentration and a deoxyhemoglobin concentration, and the signal provides for continuous monitoring of cerebral blood flow [It is preferable to use a light source with coherent light, e.g. a laser or a laser diode, which can emit light in the near infrared range between 780 and 910 nm. Light in this wavelength range is able to penetrate biological tissue. It is preferable to specifically use wavelengths that are suitable for a chosen measurement technique. Light with wavelengths of 785 nm, 850 nm and 905 nm is preferably used, which in particular is absorbed and reflected by oxygenated and deoxygenated haemoglobin and the marker substance indocyanine green. It is also advantageous to use a pulsed light beam or pulsed light beams of variable frequency. The parts of the incident beam of light reflected on the tissue are transformed in the processing unit by means of an analog-digital converter into a meaningful signal relating to the time profile of the presence of oxygenated and deoxygenated blood and of the marker substance (Limacher ¶0019); To measure the flow of blood through the cerebral tissue, light in the near infrared range is conveyed through the light conductor in the channel 20 to the reflection surface 18. The light source can, for example, also be provided on the processing unit itself. The beam of light directed onto the surface 18 is reflected there and sent out into the cerebral tissue. There, it is absorbed and reflected among other things on the oxygenated and deoxygenated haemoglobin and, if appropriate, on the indocyanine green. Some of the reflected light falls back onto the reflection surface 18, as a result of which it is fed into the light conductor in the channel 20 by reflection on the surface 18. The channel guides the reflected light back to the processing unit, in which it is evaluated by, for example, an analog/digital converter (Limacher ¶0099)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Lange in view of Ward to employ wherein the signal generated by the light receiver comprises information about a difference between an oxyhemoglobin concentration and a deoxyhemoglobin concentration, and the signal provides for continuous monitoring of cerebral blood flow, as this modification would amount to mere application of a known technique to a known device (method, or product ready for improvement to yield predictable results [use of a difference in concentration of oxyhemoglobin and deoxyhemoglobin to determine oxygen saturation] [MPEP § 2143(I)(D)].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Ward, as applied to claim 1 above, in further view of Muchlemann (US-20140275891-A1, cited by Applicant).
Regarding claim 6, Lange in view of Ward teaches
The intracranial catheter according to claim 1, including a third set of at least two LEDs, wherein a first LED of said third set emits light at a different wavelength than a second LED of said third set and a light receiver adapted to receive reflected light of said third set [Lange ¶¶0052, 0056].
However, Lange in view of Ward fails to explicitly disclose wherein the light receiver is adapted to generate a signal for monitoring cytochrome-c-oxidase and/or water content.
Muchlemann discloses systems for using an optical sensor system to determine cerebral blood flow [the system 100 may be used to determine (or partially measure) physiological indicators (or measurable quantities leading to determination of such indicators) including arterial and venous oxygen saturation, oxygen extraction fraction, cerebral blood flow, cerebral metabolic rate of oxygen, and/or regional cerebral blood flow, among others (Muchlemann ¶0071)], wherein Muchlemann discloses using an optical sensor to generate a signal based on received light to monitor cytochrome-c-oxidase [The system 100 may be used to provide and/or analyze information relating to various physical conditions or characteristics. For example, the intensity, phase, and/or frequency of optical signals detected by an optical detector may be used to provide information relating to various physical conditions or characteristics. In some embodiments, the system 100 may be used to provide and/or analyze information relating to absorption (within a given spectral range) of endogenous biological chromophores, such as: oxygenated hemoglobin; de-oxygenated hemoglobin; lipids; water; myoglobin; bilirubin; and/or cytochrome C oxidase. In some embodiments, the system may monitor oxygenated and de-oxygenated hemoglobin concentrations in tissue, and absorption by the other listed chromophores may be considered in determining the oxygenated and de-oxygenated hemoglobin absorptions (Muchlemann ¶0068)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Lange in view of Ward to employ wherein the light receiver is adapted to generate a signal for monitoring cytochrome-c-oxidase and/or water content, so as to provide additional contextual information regarding cerebral blood flow, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [using an optical sensor signal to generate biological information] [MPEP § 2143(I)(D)].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
