Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/27/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: the phrase “the one or more position related events” in line 1 should be amended to read –the position related events--. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the phrase “the one or more position related events” in line 1 should be amended to read –the position related events--. 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 2-21 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.
Claims 2 and 15, recite “a plurality of sensors” this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know how ICP data or orientation data one can generated from a broad/non-specific plurality of sensors. As broadly as claimed the scope of the claim is indeterminate with respect to the claimed “a plurality of sensors”.
For purpose of examination, the “plurality of sensors” will be interpreted as pressure sensors.
Claim 15 recite “generating data related to intracranial pressure (ICP)” in the preamble, and does not recite any limitation about generating/determining ICP in the body of the claim, and/or how the claimed “determine one or more patient events based on the orientation data” is related to determining ICP. One with ordinary skill in the art would not be able to know how the body of claim 15 is related to the preamble of the claim. As broadly as claimed the scope of the claim is indeterminate.
Claim 20 recites the limitation "the baseline" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2, 3, 4, 6, 7 and 15 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Meyerson et al (WO 2001/050944).
As to claims 2, 3, 6, 7, 15, 17 and 21, Meyerson teaches a device for generating data related to intracranial pressure (ICP) (abstract, pages 11-17), comprising:
a plurality of sensors (sensors that measures ICP, ear probe 15, and/or transducers 74 and 75, fig.3, 4 and 8, page 13, lines 24-33 and page 14); and circuitry (signal processing 82 and 83, fig.8) configured to:
receive signals from the plurality of sensors (page 13, lines 24-33 and page 14 and page 17);
generate ICP data based on signals from a first one or more of the plurality of sensors (generate ICP measurement, page 11, lines 21-25, page 13, lines 24-33 and page 14, and page 17);
generate orientation data based on signals from a second one or more of the plurality of sensors (generate movement data/posture changes using an accelerometer or other suitable position sensor which is incorporated within the invention to compensate or otherwise offset the postural influences in ICP measurements, page 11 and calibrating the ICP by changing patient’s position, page 17, lines 15-23); and
determine ICP and/or patients events based on association of the ICP data with the orientation data and/or position related event for a period of time (an accelerometer or other suitable position sensor which is incorporated within the invention to compensate or otherwise offset the postural influences in ICP measurements, page 11, lines 21-25 and determining posture change to calibrate the ICP based on changing patient’s position, page 17, lines 15-23)(Examiner notes, that posture and/or patient’s position must be determined/measured to compensate the change in posture effect on ICP, to accurately determine the real value of ICP).
As to claims 4 and 16, Meyerson teaches the device, wherein the plurality of sensors are configured to generate the signals for a period of time and wherein, to determine the ICP based on the association of the ICP data with the orientation data, the circuitry is further configured to generate pressure data for the period of time (an accelerometer or other suitable position sensor which is incorporated within the invention to compensate or otherwise offset the postural influences in ICP measurements, page 11, lines 21-25 and determining posture change to calibrate the ICP based on changing patient’s position, page 17, lines 15-23).
As to claim 5, Meyerson teaches the device, wherein the circuitry is configured to compare current real-time pressure characteristics to an initial set of reference calibration features (measured ICP is calibrated using change of posture influence, an accelerometer or other suitable position sensor which is incorporated within the invention to compensate or otherwise offset the postural influences in ICP measurements, page 11, lines 21-25 and determining posture change to calibrate the ICP based on changing patient’s position, page 17, lines 15-23).
As to claims 9, 10, 19 and 20, Meyerson teaches the device, wherein the one or more position related events includes movement of a patient’s head from a baseline position to an angled position that is not parallel to the baseline position, wherein the baseline position is a supine position, and wherein the one or more position related events comprises movement of a patient’s head, sleeping, falling, or running (the patient’s posture is changed from moving the patient from prone position to head tilted down 30 degrees, page 17, lines 20-25).
As to claim 11, Meyerson teaches the device, wherein the circuitry is configured to transmit the ICP data and the orientation data in real time to a separate device configured to determine the ICP (protocol interface that transfers all measured data to multi system unit, pages 16-18, fig.8).
As to claim 12, Meyerson teaches the device, wherein the separate device comprises one or more remote servers or a mobile device (protocol interface that transfers all measured data to multi system unit, pages 16-18, fig.8)(Examiner respectfully notes multi system unit can be any smart handheld device).
As to claim 13, Meyerson teaches the device, further comprising a battery power supply electrically coupled to the circuitry (inherently the battery in the device in fig.8).
As to claim 14, Meyerson teaches the device, wherein the battery power supply is disposed within the device (inherently the battery in the device in fig.8).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 8 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Meyerson et al (WO 2001/050944), in view of Lenhardt et al (US 2007/0123796).
As to claims 8 and 18, Meyerson’s invention teaches the invention substantially as claimed above, but failed to teach the one or more patient events comprises a Valsalva maneuver.
However, Lenhardt teaches an analogous device the measures ICP (abstract, fig.3), wherein the one or more patient events comprises a Valsalva maneuver (the upper tracing 410 is under normal pressure and the lower tracing 420 is recorded during a valsalva maneuver, which elevated the ICP and dampened the recorded signal, par.34).
Since ICP is affected/elevated by valsalva maneuver event, so it would have been obvious to one having ordinary skill in the art at the time of the invention was made to determine ICP during valsalva maneuver event in Meyerson’s invention, as taught by Lenhardt’s invention to compensate the influence of valsalva maneuver event during measuring ICP, and generate accurate ICP data.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-21 are non-provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of U.S Patent No. 9901268, claims 1-20 of U.S Patent No. 10420479, and claims 1-20 of U.S Patent No.11564585. Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S Patent Application and the instance application are claiming a common subject matter including: a device for generating data related to intracranial pressure (ICP), comprising: a plurality of sensors; and circuitry configured to: generate ICP data based on the signals indicative of the ICP from a first sensor of the plurality of sensors, generate orientation data based on the signals indicative of the orientation of the ICP device from a second sensor of the plurality of sensors; and determine the ICP based on the association of the ICP data with the orientation data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791