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
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Paragraph 0046 and 0050, every instance of “silicon” should be “silicone”.
Paragraph 0049, “right and left sealing covers 22, 24” should likely be “right front and left front sealing covers 20, 22”.
Paragraph 0054 “(laptope” should be “laptop”.
Appropriate correction is required.
The use of the term Bluetooth and boardcon, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1-3 and objected to because of the following informalities:
Claims 1, 4, and 6, it appears that every instance of “silicon” should instead refer to “silicone”.
Claim 1, line 8 “between of” should be “between”.
Claim 1, line 10 “forming a water tight seals” should be “each forming a watertight seal”.
Claim 1, line 10-11 “the periphery edge of the silicon membranes” should be “a peripheral edge of the respective silicone membrane” or “a periphery of the respective silicone membrane” or similar.
Claim 1, line 16-17 “the watertight chamber” should be “the respective watertight chamber” in each instance.
Claim 1, line 23 “PCB board” should be “printed circuit board (PCB)”.
Claim 2, line 2 “the two watertight chambers are” should be “the first and second watertight containers are each”.
Claim 3, line 2 “transmission sent” should be “transmission is sent”.
Claim 5 “wherein the pressure sensors are digital” should be “wherein each pressure sensor is digital”.
Claim 6, line 3 “an intracranial pulse wave monitor” should be “the intracranial pulse wave monitor”.
Claim 6, line 4 “a goggle system” should be “the goggle system”.
Claim 6, line 4 “a right side sensor assembly” should be “the right side sensor assembly”.
Claim 6, line 5 “a left side sensor assembly” should be “the left side sensor assembly”.
Claim 6, line 8 “the water chambers” should be “each water chamber”.
Claim 7, line 1 “where in” should be “wherein”.
Claim 7, line 2 “CSF” should be “cerebrospinal fluid (CSF)”.
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 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 the limitation “the first silicon member” in line 8. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the first silicone membrane.
Claim 1 recites the limitation “the second silicon member” in line 8. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the second silicone membrane.
Claim 1 recites “the respective back cover” in line 16 of the claim. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the respective back sealing cover.
Claim 2 recites the limitation “filled with water at a pressure”. It is unclear if the limitation is intended to refer to the pressure within the watertight chambers or the pressure at which water fills the watertight chambers. The limitation is interpreted as referring to the watertight chambers being filled to a pressure between 1.0mmHg and 3.00mmHg.
Claim 4 recites the limitation “wherein the silicon membranes are between 40 microns to 50 microns”. Furthermore, the limitation is unclear as to which dimension of the first and second silicone membranes is between 40 microns to 50 microns. The limitation is interpreted as referring to a thickness.
Claim 6 recites the limitation “the pressure wave signals” in line 9 of the claim. There is insufficient antecedent basis for this limitation of the claim.
Claim 6 recites “the water chamber” and “the pressure sensor” in line 9-10 of the claim. There is insufficient clarity in this limitation as two water chambers and two pressure sensors have been recited. The limitation is interpreted as referring to measuring within each water chamber with the respective pressure sensor.
Claim 6 recites the limitation “the pressure signals” in line 11 of the claim. There is insufficient antecedent basis for this limitation of the claim. Furthermore, it is unclear if “pressure wave signals” from line 9 and “pressure signals” are intended to refer to the same signals. The limitation is interpreted as referring to the same pressure wave signals.
Claim 6 recites “the intracranial pressure waves” in line 11-12. There is insufficient antecedent basis for this limitation of the claim. Furthermore, it is unclear if “intracranial pressure waves” are intended to be the same as “intracranial pulse waves” as introduced in line 1. The limitation is interpreted as referring to the same intracranial pulse waves.
Claim 6 recites “filtering out” the intracranial pressure waves in line 11-12. It is unclear if the limitation is intended to refer to removing intracranial pressure waves from a signal or if it refers to isolating these waves (such as for later analysis). The limitation is interpreted as referring to isolating the intracranial pressure waves by filtering the signals.
Claim 7 recites the limitation “the pulse waves”. There is insufficient antecedent basis for this limitation. The limitation is interpreted as referring to the pulsating wave forms introduced in claim 1.
Claim 7 recites “the axial pulsation”. There is insufficient antecedent basis for this limitation of the claim. It is recommended that the limitation be amended to refer to “axial pulsation”.
Claim 7 recites “the sheath” and “the optic nerve”. There is insufficient antecedent basis for this limitation of the claim because a person generally has two sheaths and two optic nerves. It is recommended that the limitations be amended to a sheath and an optic nerve or to otherwise refer to the left and right sensor assembly monitoring pulsation in a respective sheath and optic nerve.
Claims 2-7 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1 which has been rejected as indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Berdahl (US 20210068657 A1).
Regarding claim 1, Berdahl teaches a non-invasive intracranial pulse wave monitor (Feedback control system 500 in communication with apparatus 200; Fig. 5; paragraph 0086) comprising:
a goggle system (Goggle enclosure 210), a right side sensor assembly and a left side sensor assembly (Left and right sides of the goggle enclosure 210), the goggle system comprising a right front sealing cover (Cap 426, right eye portion of goggles 210), a left front sealing cover (Cap 426, left eye portion of goggles 210), a back right sealing cover (Base 424, right eye portion of goggles 210), and a back left sealing cover (Base 424, left eye portion of goggles 210);
a flexible connector for connecting the right front and left front sealing covers (See connection between left and right eye portions of the goggles, Fig. 2);
an adjustable strap connected to the right front and left front sealing covers configured to adjust around a patient's head (Locating device 240, Paragraph 0062);
two silicon membranes (Interface 428), the first silicon member positioned between of the right front sealing cover and the back right sealing cover and the second silicon member positioned between the left front sealing cover and the back left sealing cover forming a water tight seals around the periphery edge of the silicon membranes (Paragraph 0070-- The interface 428 can form a hermetic seal between the base 424 and the cap 426… a continuous seal component, such as an O-ring gasket… configured to deform and seal against the base 426);
the right side sensor assembly configured to form a first watertight chamber with the right front sealing cover and the left side sensor assembly configured to form a second watertight chamber with the left front sealing cover (Paragraph 0070—hermetic seal… configured to deform and seal against the cap 426);
the right side sensor assembly and left side sensor assembly each containing a pressure sensor that extends through the respective back cover of the sensor assembly into the watertight chamber and can measure pressure changes in the watertight chamber (Enclosure pressure sensor 506, detector device 508; Paragraph 0087-0106—details of different pressure sensor embodiments);
the right side sensor assembly having a first valve configured to allow water to be injected through the right side sensor assembly and into the first watertight chamber (Port 320, right eye portion of the goggle enclosure 210; paragraph 0066-0067);
the left side sensor assembly having a second valve configured to allow water to be injected through the left side sensor assembly and into the second watertight chamber (Port 320, left eye portion of the goggle enclosure 210; paragraph 0066-0067);
at least one of the right side sensor assembly and left side sensor assembly have a powered PCB board configured to transmit measurement data from at least one of the two pressure sensors wirelessly to a receiver adapted to process the measurement data for pulsating wave forms (Control circuit 230; Paragraph 0084, 0087--transmit an indication of a processed data signal to another component of the apparatus 200).
It is noted that at present the PCB is not claimed as being directly onboard or otherwise physically incorporated within either sensor assembly, but merely is described as an element which at least one of the sensor assemblies “has”, such that the broadest reasonable interpretation encompasses either assembly being in communication with such an element.
Regarding claim 3, Berdahl teaches the non-invasive intracranial pulse wave monitor of claim 1. Berdahl additionally teaches wherein the measurement data transmission sent to a mobile device (Paragraph 0084, 0122-- a user interface (UI), such as a UI designed to receive an indication of a data input signal, such as information derived from a user interaction with the apparatus 200, and display an indication of a data output signal).
Regarding claim 5, Berdahl teaches the non-invasive intracranial pulse wave monitor of claim 1. Berdahl additionally teaches wherein the pressure sensors are digital (Paragraph 0106).
Regarding claim 6, Berdahl teaches the non-invasive intracranial pulse wave monitor of claim 1. Berdahl additionally teaches a noninvasive method for measuring intracranial pulse waves using the monitor of claim 1 comprising the steps of:
positioning an intracranial pulse wave monitor on a patient's closed eyelids, the intracranial pulse wave monitor comprising a goggle system, a right side sensor assembly and a left side sensor assembly (Paragraph 0064, 0068-- The goggle enclosure 210 can be positioned over the eye 100, such that the seal material 214 can be located against the patient);
the right side and left side sensor assembly each having a hermetically sealed water chamber with a pressure sensor and a silicon membrane for positioning on the patient's eyelids (Paragraph 0068, 0070-- The interface 428 can form a hermetic seal between the base 424 and the cap 426… a continuous seal component, such as an O-ring gasket… configured to deform and seal against the base 426…),
filling the water chambers with water (Paragraph 0054, 0061, 0065-0067-- inhibit or prevent gas or liquid or other fluid from traveling between the cavity 212 and the atmosphere surrounding the goggle enclosure 210 NOTE: such that the fluid which has filled the cavity may be liquid);
measuring the pressure wave signals of the water within the water chamber with the pressure sensor (Enclosure pressure sensor 506, detector device 508; Paragraph 0087-0106, 0116-0122);
transmitting the pressure signals to a processor for filtering out the intracranial pressure waves (Fig. 5; paragraph 0049, 0059, 0088, 0093, 0116-0122-- estimating ICP using the venous outflow data and at least one of a pulsatility or resistivity relationship…).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl in view of Ragauskas (US 20160022246 A1).
Regarding claim 4, Berdahl teaches the non-invasive intracranial pulse wave monitor of claim 1. However, Berdahl is silent as to wherein the silicon membranes are between 40 microns to 50 microns.
Ragauskas, in the same field of endeavor of a goggle system for non-invasive ICP measurement, discloses a membrane having a thickness between 40 and 50 microns (Paragraph 0028-- elastic film 22, in some embodiments is made of synthetic polyisoprene latex having a thickness between 40 and 60 microns).
It would have been obvious to one having ordinary skill in the art at the time of filing to provide a membrane having a small thickness as described by Ragauskas in order to predictably improve the accuracy of any pulsating measurements by ensuring that the membrane does not distort or attenuate signals (see Ragauskas, paragraph 0028).
Conclusion
No prior art rejection has been applied to claim 2 at this time. Berdahl (cited above) discloses applying pressure via the sealed chambers at a pressure of at least 10mmHg with no suggestion of a smaller pressure. Similarly, US 9125724 B2 also to Berdahl discloses applying a pressure of at least 5.0mmHg with no suggestion of any functional use of a smaller pressure application. Ragauskas (cited above) additionally teaches that a chamber may be sealed under pressures up to 100mmHg, but provides no teaching or motivation to limit this pressure to between 1.0mmHg and 3.00mmHg.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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