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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/27/25 is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation of “form a sensor group, which sensor ground and/or the plug connection” in lines 6-7 is incorrect grammar. Appropriate correction is required.
Claim 7 objected to because of the following informalities: “USB” is not defined by the claim. Applicant is encouraged to change the limitation of “USB” to recite –universal serial bus (USB)--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the limitation of “a patient” in line 2. Claim 1, line 1 also recites “a patient.” For the purpose of examination, the Examiner is interpreting “a patient” in claim 10, line 2 to be the same patient. Applicant is encouraged to change claim 10, line 2 to recite –the patient--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “a patient” in line 2. Claim 11, line 1 also recites “a patient.” For the purpose of examination, the Examiner is interpreting “a patient” in claim 17, line 2 to be the same patient. If the dependency of claim 17 is corrected to depend from the process claim 11, Applicant is encouraged to change claim 17, line 2 to recite –the patient--. Appropriate correction is required.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“determining patient data by means of electrodes” in claim 1;
“the steps” in claim 11;
“a subsequent step” in claim 12;
“a prior step” in claim 13; and
“the step of signal connecting” in claim 15.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
For the limitation of “the steps” in claim 11, the Examiner is interpreting each of the steps performed as a step.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-17 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.
In claim 1, the limitation of “the patient data” in line 11 seems unclear. Claim 1, line 1 recites “acquiring patient data” and claim 1, line 3 recites “determining patient data.” It remains unclear which of these “the patient data” is referring back to. For the purpose of examination, the Examiner is interpreting “acquiring patient data” and “determining patient data” to be the same patient data. Dependent claim 2-10 and 12-17 are rejected for the same deficiency in independent claim 1.
In claim 4, the limitation of “the hub” in lines 1-2 seems unclear. While claim 1 recites “a hub signal” in line 13, it remains unclear whether “the hub” in claim 4 is referring back to the signal or is referring to a hub device. For the purpose of examination, the Examiner is interpreting claim 4, line 1 to be referring to a hub device and should recite –a hub--.
In claim 4, the limitation of “the adapter cable” in line 4 seems unclear. While claim 1 recites “adapter cables” in line 4, it remains unclear which of these “the adapter cable” is referring to. For the purpose of examination, the Examiner is interpreting “the adapter cable” in claim 4 to recite –an adapter cable of the adapter cables--.
Claim 6 recites the limitation "the at least one adapter cable" in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the limitation to recite –at least one adapter cable--.
Claim 9 recites “n” and “m” are indefinite. It remains unclear what “n” and “m” are referring to. While the specification discloses “an (n+m-1) lead measurement signal and a reference signal, i.e. an (n+m) lead, can be acquired by the data acquisition system from a first patient cable with n electrodes and a second patient cable with m electrodes” in ¶32, this does not define what the range of values for n and m would be.
In claim 11, the limitation of “the patient data” in line 7 seems unclear. Claim 11, line 1 recites “acquiring patient data” and claim 11, line 3 recites “determining patient data.” It remains unclear which of these “the patient data” is referring back to. For the purpose of examination, the Examiner is interpreting “acquiring patient data” and “determining patient data” to be the same patient data.
In claim 11, there is a missing “and” between the 2nd to last and last steps. It remains unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. See MPEP 2173.05(h). Applicant is encouraged to change the limitation of “with the common connector” to recite –and with the common connector--.
In claims 12-17, the limitation of “A process according to claim 10” seems unclear. MPEP 2173.05(p): 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. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). It is unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.") The Examiner thinks Applicant meant to recite “A process according to claim 11.” The Examiner will interpret claims 12-17 as depending from claim 11.
In claim 14, the limitation of “the data” in line 2 seems unclear. It remains unclear whether this is referring to “acquiring patient data” or “determining patient data.” For the purpose of examination, the Examiner is interpreting “acquiring patient data” and “determining patient data” to be the same patient data.
The term “several” in claim 15, lines 3-4 is a relative term which renders the claim indefinite. The term “several” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not define what is meant by several. The use of the term “several” renders the amount of times performed and the number of sensor groups 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 11 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Selvitelli (US 20220117502 filed on 10/19/21).
Regarding claim 11, Selvitelli teaches a process for acquiring patient data of a patient, the process comprising the steps of: providing a plurality of physiological sensors with a plurality of electrodes for determining patient data (¶5-a plurality of monitoring devices (also interchangeably referred to herein as “patient connectors”) that may be attached to a patient and electronically communicate with a patient monitor via a cable system, the lead sets may include a variety of sensors and/or other devices that are attachable or otherwise connectable to patient to provide health indicators, such as one or more temperature sensors, a plurality of electrodes or electrode connectors configured to selectively mount to electrodes for monitoring the electrical activity of the heart, and/or an SpO2 or other sensor for monitoring patient blood oxygen saturation levels); signal connecting at least two physiological sensors of the plurality of physiological sensors and/or adapter cables for a respectively assigned physiological sensor to one another directly via a plug connection to form a sensor group (¶6-the first lead interconnection feature and the second lead interconnection feature are interconnectable to removably connect a first portion of the first patient lead to a second portion of the second patient lead; ¶114-interconnection features allow any one or a combination of the individual or groups of leads; ¶122-any one or combination of the individual leads or cables described above may incorporate the interconnection features above with respect to FIGS. 14A-19D to allow for selective disconnection and/or connection of the individual leads or cables; Figs. 15A-15D); outputting the patient data determined by the sensor group to a data acquisition unit via a common connector (¶85-connected to the monitoring station 304 directly or via a multiparameter input device connector 312 of a multiparameter input device 310; ¶79-the monitoring station 304 may receive signals from the monitoring devices 302 via coupling facilitated by a cable section 306 , which may hereinafter also be interchangeably referred to as a “lead,” process the signals, and output readable and/or otherwise interpretable data; ¶90-the monitoring lead connector 308 may, for example, be configured as a male style multi-pin connector configured to recieveably interface with female connector of the multiparameter input device 310; Fig. 3); with the common connector, connecting the sensor group directly to the data acquisition unit, connecting the sensor group to a hub for the data acquisition unit and/or connecting the sensor group to an adapter cable for the data acquisition unit (¶85-connected to the monitoring station 304 directly or via a multiparameter input device connector 312 of a multiparameter input device 310; ¶79-the monitoring station 304 may receive signals from the monitoring devices 302 via coupling facilitated by a cable section 306 , which may hereinafter also be interchangeably referred to as a “lead,” process the signals, and output readable and/or otherwise interpretable data; ¶90-the monitoring lead connector 308 may, for example, be configured as a male style multi-pin connector configured to recieveably interface with female connector of the multiparameter input device 310; Fig. 3).
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.
Claims 1, 6, 8-9, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Rantala (US 20080081960 filed on 9/28/06).
Regarding claim 1, Selvitelli teaches a data acquisition system for acquiring patient data of a patient, the data acquisition system comprising: a plurality of physiological sensors for determining patient data by means of electrodes (¶5-a plurality of monitoring devices (also interchangeably referred to herein as “patient connectors”) that may be attached to a patient and electronically communicate with a patient monitor via a cable system, the lead sets may include a variety of sensors and/or other devices that are attachable or otherwise connectable to patient to provide health indicators, such as one or more temperature sensors, a plurality of electrodes or electrode connectors configured to selectively mount to electrodes for monitoring the electrical activity of the heart, and/or an SpO2 or other sensor for monitoring patient blood oxygen saturation levels), wherein at least two of the plurality of physiological sensors and/or adapter cables respectively associated with the at least two of the plurality of physiological sensors are arranged and configured to be signal connected to one another directly via a plug connection to form a sensor group (¶6-the first lead interconnection feature and the second lead interconnection feature are interconnectable to removably connect a first portion of the first patient lead to a second portion of the second patient lead; ¶114-interconnection features allow any one or a combination of the individual or groups of leads; ¶122-any one or combination of the individual leads or cables described above may incorporate the interconnection features above with respect to FIGS. 14A-19D to allow for selective disconnection and/or connection of the individual leads or cables; Figs. 15A-15D), which sensor group and/or the plug connection is configured to provide a measurement signal (¶79-the lead set 300 may include a combination of different types of monitoring devices 302 that measure or monitor a plurality of different parameters (e.g., patient health indicators), a plurality of different parameters associated with the monitoring devices, one or more portions (the “patient connectors”) of the monitoring devices 302 may be selectively placed in direct contact with the patient or may be connectable to a patch or electrode that is in direct contact with the patient, for example) and a data acquisition unit, which is configured to comprise at least one slot for a plug connection as a patient data interface (¶90-the monitoring lead connector 308 may, for example, be configured as a male style multi-pin connector configured to recieveably interface with female connector of the multiparameter input device 310 (e.g., similar to the configuration shown in FIGS. 4 and 12-14C); Fig. 3); and a common connector configured to output the patient data determined by the sensor group to the data acquisition unit, the common connector being configured for a direct plug connection with the data acquisition unit, for a plug connection with a hub signal connected to the data acquisition unit and/or for a plug connection with an adapter cable signal connected to the data acquisition unit (¶85-connected to the monitoring station 304 directly or via a multiparameter input device connector 312 of a multiparameter input device 310; ¶79-the monitoring station 304 may receive signals from the monitoring devices 302 via coupling facilitated by a cable section 306 , which may hereinafter also be interchangeably referred to as a “lead,” process the signals, and output readable and/or otherwise interpretable data; ¶90-the monitoring lead connector 308 may, for example, be configured as a male style multi-pin connector configured to recieveably interface with female connector of the multiparameter input device 310; Fig. 3).
However, Selvitelli does not teach a reference signal of the electrodes.
Rantala relates to a modular data acquisition system for obtaining physiological signals from a patient. The modular data acquisition units can be added to the system by a serial interface that communicates towards a serial bus thus forming a part of a floating patient applied part of the data acquisition system (¶1). Rantala further teaches the invention using the following step:
a reference signal of the electrodes (¶31-a reference voltage (the average of the other two electrodes)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include a reference signal of the electrodes of Rantala in order to calculate augmented leads aVR, aVL and aVF of an ECG signal (Rantala, ¶31) for the improved reliability and noise reduction of the ECG signal (Rantala, ¶20).
Regarding claim 6, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1, wherein one or both of the at least two of the plurality of physiological sensors and/or the at least one adapter cable of the adapter cables is configured for an analog-to-digital conversion of at least a part of the determined patient data (Rantala, ¶13-each of the patient side acquisition units comprises an analog-to-digital converter, a serial interface communicative towards a serial bus connecting the data acquisition unit with the patient monitor, and a serial interface controller processor; ¶31-front end amplifiers A1-A4 and it is converted into a digital ECG signal by A/D converter 7; ¶33-the EEG signal is converted into a digital signal by A/D converter 13; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein one or both of the at least two of the plurality of physiological sensors and/or the at least one adapter cable of the adapter cables is configured for an analog-to-digital conversion of at least a part of the determined patient data of Rantala in order to convert the electrophysiological signal into a digital signal (Rantala, ¶14).
Regarding claim 8, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1, wherein at least one sensor of the plurality of sensors comprises a patient cable with a plurality of the electrodes (Selvitelli, Fig. 3-cable section 306 and electrode connectors 314; ¶81-cable section 306 is ribbonized and/or partially ribbonized, individual monitoring leads in the cable ribbon may be selectively separated from one another to allow a medical employee and/or patient to provide suitable separation among any one of the plurality of patient connectors (e.g., electrode connectors 314)).
Regarding claim 9, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 8, wherein the sensor group comprises at least two patient cables connected to each other via the plug connection (Selvitelli, ¶6-the first lead interconnection feature and the second lead interconnection feature are interconnectable to removably connect a first portion of the first patient lead to a second portion of the second patient lead; ¶114-interconnection features allow any one or a combination of the individual or groups of leads; ¶122-any one or combination of the individual leads or cables described above may incorporate the interconnection features above with respect to FIGS. 14A-19D to allow for selective disconnection and/or connection of the individual leads or cables; Figs. 15A-15D), such that an n+m-1 measurement signal and a reference signal can be acquired by the data acquisition system from a first patient cable with n electrodes and a second patient cable with m electrodes (Rantala, Fig. 3-electrodes for measuring ECG and electrodes for measuring EEG; ¶31-comparing the measured voltage from each of the limb electrodes to a reference voltage (the average of the other two electrodes); ¶33-the signal acquired from the EEG measurement electrodes use the Wilson's terminal potential 6 as floating ground; MPEP 2114: [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include such that an n+m-1 measurement signal and a reference signal can be acquired by the data acquisition system from a first patient cable with n electrodes and a second patient cable with m electrodes of Rantala in order to provide a simple and reliable system and method for a floating patient data acquisition system with expandable ECG and EEG (Rantala, ¶12).
Regarding claim 14, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach further comprising providing an analog-to-digital conversion of at least a part of the data determined at the respective physiological sensor and data received by the data acquisition unit.
Rantala teaches further comprising providing an analog-to-digital conversion of at least a part of the data determined at the respective physiological sensor and data received by the data acquisition unit (Rantala, ¶13-each of the patient side acquisition units comprises an analog-to-digital converter, a serial interface communicative towards a serial bus connecting the data acquisition unit with the patient monitor, and a serial interface controller processor; ¶31-front end amplifiers A1-A4 and it is converted into a digital ECG signal by A/D converter 7; ¶33-the EEG signal is converted into a digital signal by A/D converter 13; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include providing an analog-to-digital conversion of at least a part of the data determined at the respective physiological sensor and data received by the data acquisition unit of Rantala in order to convert the electrophysiological signal into a digital signal (Rantala, ¶14).
Regarding claim 15, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach wherein the step of signal connecting at least two physiological sensors and/or adapter cables for respective associated physiological sensors is performed several times to form a sensor group of more than two physiological sensors and/or to form several sensor groups.
Rantala teaches wherein the step of signal connecting at least two physiological sensors and/or adapter cables for respective associated physiological sensors is performed several times to form a sensor group of more than two physiological sensors and/or to form several sensor groups (Rantala, Fig. 3-electrodes for measuring ECG and electrodes for measuring EEG; ¶20-allows the medical professionals to start with one measurement and expand the measurement by adding new patient side acquisition units; ¶26-expandable with separate measurement modules; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the step of signal connecting at least two physiological sensors and/or adapter cables for respective associated physiological sensors is performed several times to form a sensor group of more than two physiological sensors and/or to form several sensor groups of Rantala in order to allow the medical professionals to start with one measurement and expand the measurement by adding new patient side acquisition units (Rantala, ¶20).
Claims 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Rantala as applied to claim 1 above, and further in view of Frederick (US 9202008 filed on 6/8/07).
Regarding claim 2, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1. However, the combination of Selvitelli and Rantala does not teach wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection.
Frederick teaches wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection (col. 21 and lines 34-37-the data may be transmitted directly from the patient data acquisition box through a wireless cellular card then over the internet to a database).
Frederick relates to collecting physiologic and kinetic data from a subject with a wireless data acquisition system (col. 2 and lines 64-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection of Frederick in order to have the analyzed data in the database be accessible and can be requested and sent to multiple review stations located anywhere in the world for further analysis and review by clinicians, technicians, researchers, doctors and the like (Frederick, col 23 and lines 34-38). In addition, it results in ease of use and improved patient mobility by eliminating the need to tether the patient (Frederick, col. 3 and lines 48-52).
Regarding claim 3, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1. However, the combination of Selvitelli and Rantala does not teach wherein the data acquisition unit is configured to receive patient data from at least one physiological sensor of the plurality of physiological sensors via a wireless communication link.
Frederick teaches wherein the data acquisition unit is configured to receive patient data from at least one physiological sensor of the plurality of physiological sensors via a wireless communication link (col. 21 and lines 62-65-before or after the sensors are applied to the patient, they are connected to a wireless data acquisition system 6. The wireless data acquisition system collects some data from the sensors and transmits the data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is configured to receive patient data from at least one physiological sensor of the plurality of physiological sensors via a wireless communication link of Frederick in order to have the analyzed data in the database be accessible and can be requested and sent to multiple review stations located anywhere in the world for further analysis and review by clinicians, technicians, researchers, doctors and the like (Frederick, col 23 and lines 34-38). In addition, it results in ease of use and improved patient mobility by eliminating the need to tether the patient (Frederick, col. 3 and lines 48-52).
Regarding claim 5, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1. However, the combination of Selvitelli and Rantala does not teach wherein the data acquisition unit is powered via a battery.
Frederick teaches wherein the data acquisition unit is powered via a battery (Fig. 4-wiress data acquisition system 50 and power module 34; col. 23 and lines 3-4-the power module 34 can be battery-based; col. 14 and lines 23-27-the patient data acquisition system has a battery life of at least four hours, more preferably of at least eight hours, still more preferably at least twelve hours, even more preferably at least sixteen hours, and most preferably of at least twenty-four hours).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is powered via a battery of Frederick in order for portability of the patient interface box (Frederick, col. 23 and lines 2-4), so that the device is capable of being transported relatively easily (Frederick, col. 11 and lines 43-44).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Rantala as applied to claim 1 above, and further in view of Falk (US 20170367643 fled on 6/27/16).
Regarding claim 4, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1. However, the combination of Selvitelli and Rantala does not teach further comprising the hub, wherein the hub is configured to be connected to the data acquisition unit via the at least one slot and configured with a plurality of slots to provide a respective plug connection for connection to the sensor group, to a physiological sensor and/or to the adapter cable for a respective associated physiological sensor.
Falk teaches further comprising the hub (¶23-hub 12), wherein the hub is configured to be connected to the data acquisition unit via the at least one slot (¶30-transmission from the hub 12 to the base unit 20…through the cable 110; ¶27-hub 12 along a single USB cable 110 to a suitable cable port 113 on the base unit 20; Fig. 1-slot 113 accommodates for the USB cable 110 to connect the hub to the data acquisition unit) and configured with a plurality of slots to provide a respective plug connection for connection to the sensor group, to a physiological sensor and/or to the adapter cable for a respective associated physiological sensor (¶23-the leads 100 are connected to the hub 12 at a number of sensor input ports 102 (FIG. 2) that can be configured to match the particular sensor 14 to be connected to the particular port 102; Fig. 2-ports 102 are slots).
Falk relates to a system and method for monitoring the vital signs of a fetus using sensors disposed on the patient including a hub connected between the sensors and the monitor (¶21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include the hub, wherein the hub is configured to be connected to the data acquisition unit via the at least one slot and configured with a plurality of slots to provide a respective plug connection for connection to the sensor group, to a physiological sensor and/or to the adapter cable for a respective associated physiological sensor of Falk in order to enable the hub to transfer signals from the sensors to the monitor (Falk, ¶10) and enable the monitor to supply power to the hub (Falk, ¶10).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Rantala as applied to claim 1 above, and further in view of Vlach (US 20130225938 filed on 2/29/12).
Regarding claim 7, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1, and at least one slot of the data acquisition unit (Selvitelli, Fig. 3-plut 312 is inserted into a slot of 310). However, the combination of Selvitelli and Rantala does not teach a USB slot.
Vlach teaches wherein the at least one slot of the data acquisition unit is a USB slot (¶10-electrical connection with a modified USB plug having a slot that mates with the rib when inserted).
Vlach relates to a connector interface system used to acquire data--either biometric data or non-biometric data--from a sensor (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the at least one slot of the data acquisition unit is a USB slot of Vlach in order to facilitate interconnection between the data acquisition device and the receptacle (Vlach, ¶10).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Rantala as applied to claim 1 above, and further in view of Pan (CN 107280635 published on 10/24/17).
Regarding claim 10, the combination of Selvitelli and Rantala teaches a data acquisition system according to claim 1. However, the combination of Selvitelli and Rantala does not teach wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit for a medical treatment period.
Pan teaches wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit for a medical treatment period (page 3, ¶6-the data collecting unit is provided with a unique device distinguishing code which is easily identified by the data processing unit when connected; page 2, last ¶-the valid time is set as a time period from when the input patient identification information is obtained until the next piece of the inputted patient identification information is obtained, or as a preset time period; page 5, ¶2-once the data processing unit detects the inputted patient identification information, it means that the operator needs to start the association operation of the patient data).
Pan relates to the field of medical monitoring, and in particular to a multi-patient monitoring method and a device using the same (page 1, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit for a medical treatment period of Pan in order to provide a multi-patient monitoring method capable of monitoring a plurality of patients and facilitating the correlation of patient data (Pan, page 1, 6th to last ¶).
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Frederick.
Regarding claim 12, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach further comprising a subsequent step of wirelessly outputting the acquired patient data to a database.
Frederick teaches further comprising a subsequent step of wirelessly outputting the acquired patient data to a database (col. 21 and lines 34-37-the data may be transmitted directly from the patient data acquisition box through a wireless cellular card then over the internet to a database).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include a subsequent step of wirelessly outputting the acquired patient data to a database of Frederick in order to have the analyzed data in the database be accessible and can be requested and sent to multiple review stations located anywhere in the world for further analysis and review by clinicians, technicians, researchers, doctors and the like (Frederick, col 23 and lines 34-38). In addition, it results in ease of use and improved patient mobility by eliminating the need to tether the patient (Frederick, col. 3 and lines 48-52).
Regarding claim 16, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection.
Frederick teaches wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection (col. 21 and lines 34-37-the data may be transmitted directly from the patient data acquisition box through a wireless cellular card then over the internet to a database).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is configured to output the acquired patient data to a database via a wireless data connection of Frederick in order to have the analyzed data in the database be accessible and can be requested and sent to multiple review stations located anywhere in the world for further analysis and review by clinicians, technicians, researchers, doctors and the like (Frederick, col 23 and lines 34-38). In addition, it results in ease of use and improved patient mobility by eliminating the need to tether the patient (Frederick, col. 3 and lines 48-52).
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Pan.
Regarding claim 13, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach further comprising a prior step of uniquely associating the data acquisition unit with the patient.
Pan teaches further comprising a prior step of uniquely associating the data acquisition unit with the patient (page 3, ¶6-the data collecting unit is provided with a unique device distinguishing code which is easily identified by the data processing unit when connected; page 2, last ¶-the valid time is set as a time period from when the input patient identification information is obtained until the next piece of the inputted patient identification information is obtained, or as a preset time period; page 5, ¶2-once the data processing unit detects the inputted patient identification information, it means that the operator needs to start the association operation of the patient data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include a prior step of uniquely associating the data acquisition unit with the patient of Pan in order to provide a multi-patient monitoring method capable of monitoring a plurality of patients and facilitating the correlation of patient data (Pan, page 1, 6th to last ¶).
Regarding claim 17, Selvitelli teaches a process according to claim 11. However, Selvitelli does not teach wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit during a medical treatment period.
Pan teaches wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit during a medical treatment period (page 3, ¶6-the data collecting unit is provided with a unique device distinguishing code which is easily identified by the data processing unit when connected; page 2, last ¶-the valid time is set as a time period from when the input patient identification information is obtained until the next piece of the inputted patient identification information is obtained, or as a preset time period; page 5, ¶2-once the data processing unit detects the inputted patient identification information, it means that the operator needs to start the association operation of the patient data).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Selvitelli to include wherein the data acquisition unit is assigned unique patient data to associate physiological patient data of a patient with the data acquisition unit during a medical treatment period of Pan in order to provide a multi-patient monitoring method capable of monitoring a plurality of patients and facilitating the correlation of patient data (Pan, page 1, 6th to last ¶).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20060178030: relates to a medical cable (¶1).
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/LAURA HODGE/Examiner, Art Unit 3792
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