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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn a wireless physiological parameter monitor apparatus, in the reply filed on 11/13/25 is acknowledged.
Claims 20, 21, 26 and 30-33 (now canceled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 5 positively recites “the wireless monitor is implanted in a patient”. Claim 5 is non-statutory for expressly and/or necessarily requiring a portion of a human organism as part of the scope of the claim. In the interest of compact prosecution, the examiner respectfully recommends instead reciting “the wireless monitor is configured to be implanted in a patient”, which would obviate the non-statutory issue.
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, 2, 4, 5, 7, 10-12, 14-18, and 127-131 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pflugh et al. (US 10,623,933 B2, hereinafter Pflugh).
For claim 1, Pflugh discloses a wireless monitor (Figs 1-8) (Cols 5-16), comprising inter alia:
a sensor (implantable monitoring device 400) (Figs 1-8) (Cols 5-16) configured to measure a physiological parameter (heart electrical activity) (Figs 1-8) (Cols 5-16) of a patient at a first resolution (slow announcement frequency) (Figs 1-8) (Cols 5-16); and
a processor (460) (Figs 1-8) (Cols 5-16) configured to generate physiological parameter data based on the measured physiological parameter of the patient at the first resolution (Figs 1-8) (Cols 5-16),
wherein the sensor is configured to measure the physiological parameter of the patient at a second resolution (fast announcement frequency) based at least in part on the physiological parameter data (Figs 1-8) (Cols 5-16).
For claim 2, Pflugh discloses the wireless monitor of claim 1, wherein the first resolution and second resolution comprise one or more of an amplitude of the physiological parameter, a timing of the physiological parameter, a number of bits per sample, a voltage, a current, a sampling rate, a sampling duration, a number of samples, an over-sampling ratio (OSR), a frequency, a phase, an impedance, and a filter cut-off frequency (Figs 1-8) (Cols 5-16).
For claim 4, Pflugh discloses the wireless monitor of claim 1, wherein measuring the physiological parameter at the first resolution consumes lower energy than measuring the physiological parameter at the second resolution (Figs 1-8) (Cols 5-16, esp Col 6).
For claim 5, Pflugh discloses the wireless monitor of claim 1, wherein the wireless monitor is implanted in a patient (Figs 1-8) (Cols 5-16).
For claim 7, Pflugh discloses the wireless monitor of claim 1, wherein the physiological parameter comprises one or more of an intracardiac pressure, an intravascular pressure, a blood pressure, a blood velocity, a blood flow, a blood oxygen level, a heart rate, a breathing rate, a temperature, a voltage, a current, an impedance, a neural signal, and a heart sound (Figs 1-8) (Cols 5-16).
For claim 10, Pflugh discloses the wireless monitor of claim 1, further comprising a memory (494) (Figs 1-8) (Cols 5-16) configured to store one or more of the measured physiological parameter at the first resolution, the measured physiological parameter at the second resolution, the physiological parameter data, and resolution data (Figs 1-8) (Cols 5-16).
For claim 11, Pflugh discloses the wireless monitor of claim 1, further comprising a wireless transmitter (424) (Figs 1-8) (Cols 5-16) configured to wirelessly transmit one or more of the measured physiological parameter at the first resolution, the measured physiological parameter at the second resolution, the physiological parameter data, and resolution data to a wireless device (230) (Figs 1-8) (Cols 5-16).
For claim 12, Pflugh discloses the wireless monitor of claim 11, wherein the wireless device is an external wireless device configured to be disposed physically separate from the wireless monitor (Figs 1-8) (Cols 5-16).
For claim 14, Pflugh discloses the wireless monitor of claim 1, wherein the sensor comprises a resolution setting of the sensor (Figs 1-8) (Cols 5-16).
For claim 15, Pflugh discloses the wireless monitor of claim 14, wherein the processor is configured to adjust the resolution setting of the sensor based at least in part on the physiological parameter data (Figs 1-8) (Cols 5-16).
For claim 16, Pflugh discloses the wireless monitor of claim 14, wherein the resolution setting comprises one or more of a number of bits per sample, a voltage, a current, a sampling rate, a sampling duration, a number of samples, an over-sampling ratio (OSR), a frequency, a phase, an impedance, and a filter cut-off frequency (Figs 1-8) (Cols 5-16).
For claim 17, Pflugh discloses the wireless monitor of claim 14, further comprising a memory (494) configured to store the resolution setting of the sensor (Figs 1-8) (Cols 5-16).
For claim 18, Pflugh discloses the wireless monitor of claim 14, further comprising a wireless transmitter (424) configured to wirelessly transmit the resolution setting of the sensor to a wireless device (230) (Figs 1-8) (Cols 5-16).
For claim 127, Pflugh discloses the wireless monitor of claim 1, wherein the sensor is configured to measure the physiological parameter of the patient at the first resolution periodically at a predetermined repetition interval (Figs 1-8) (Cols 5-16).
For claim 128, Pflugh discloses the wireless monitor of claim 1, wherein the measured physiological parameter at the first resolution and the second resolution comprises digital bits (Figs 1-8) (Cols 5-16).
For claim 129, Pflugh discloses the wireless monitor of claim 1, wherein the physiological parameter data comprises digital bits (Figs 1-8) (Cols 5-16).
For claim 130, Pflugh discloses the wireless monitor of claim 1, wherein the sensor comprises one or more of a pressure transducer, a velocity sensor, a flow sensor, a blood oxygen sensor, a temperature sensor, an impedance sensor, an electrical sensor, a heart rate sensor, a breathing rate sensor, a neural sensor, an audio sensor, a front-end amplifier, a filter, an analog-to-digital converter, a comparator, a reference generator, a supply generator, a digital controller, a timer circuit, an oscillator, and a clock circuit (Figs 1-8) (Cols 5-16).
For claim 131, Pflugh discloses the wireless monitor of claim 18, wherein the wireless device is an external wireless device (230) (Figs 1-8) (Cols 5-16) configured to be disposed physically separate from the wireless monitor (Figs 1-8) (Cols 5-16).
Conclusion
The cited prior art made of record on the accompanying PTO-=892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for wirelessly monitoring physiological parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791