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
Applicants’ election without traverse of group I, claims 21-31, in the reply filed on 7/28/2026 is acknowledged.
Examiner acknowledges newly added claims 52-70 are drawn to the elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/16/2024 was received and placed in the record on file. 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 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.
No limitations in the instant claims are being examined as invoking a 35 USC 112(f) interpretation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 57-69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claims 57-69 recite limitations to the functions the first physiological parameter monitoring device is configured to perform with signals collected from the physiological sensor associated with the first physiological parameter monitoring device and the motion detector. However, the specification as filed does not provide adequate written description support to show that the applicant had possession of the claimed functions at the time of filing. In this case, the claims and specification on file merely disclose the function without providing any description or evidence of the reduction to practice for how the functions as recited are carried out or completed. As such, they amount to a functional recitation without adequate support to show that the applicant had possession of the function, or the entire scope of the claimed function. Support for the functional limitations of the newly presented claims 57-69 appear to only come from paragraphs [0067] and [0079]-[0081] of the applicant’s submitted specification (the examiner invites the applicant to identify other areas of the specification which support said functional limitations). However, paragraphs [0067] and [0079]-[0081] (and the rest of the specification) fail to meet the requirements of the written description requirement because it does not establish that the applicant had possession of the claimed invention at the time of filing. Based on the preponderance of evidence, there does not appear to be sufficient support to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time the application was filed. Rather, paragraph [0067] and [0079]-[0081] provide a list of functions that the first physiological parameter monitoring device is configured to perform, but is silent to any description as to how those functions are completed/carried out, to show that the applicant had possession at the time of filing. e.g. claim 58 recites that “the first physiological parameter monitoring device is configured to determine at least one of a health level and a fitness level of the user based on the positional and movement information and the at least one physiological parameter.” Said function is recited in paragraph [0067], but the specification does not elaborate on what algorithms, calculations or steps are performed in order to determine a health level and a fitness level. In the absence of any description or explanation in the specification, the functional limitation does have sufficient written description to show that the applicant has possession of the scope of the claim at the time of filing. The same is true for the functions as recited in claims 57 and 59-67. Further claim limitations result in new matter for lack of written description. E.g. claims 61 and 69 recite that “duration of inactivity exceeds a threshold” and “the critical condition comprises a heart rate below a threshold[…]”. However, the specification does not once recite the word threshold, but rather just gives examples of times that an alarm may be set off without any further description of the methodology for determining when said condition exists, including that it meets threshold conditions.
The examiner further notes that it appears the functions of claims 57-69 are executed by a computer/processor, however no such computer/processor is recited. As such, there does not appear to be written description support to show how the physiological parameter monitoring device with the structural elements as recited in claim 21 is configured to provide the claimed functions, and even if the claims did provide a computer/processor, what algorithms/steps/processes are would need to be completed to carry out said claimed functions. See MPEP 2163 regarding the written description requirement and MPEP 2114 regarding functional language for apparatus claims implemented on a computer.
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 57-69 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 57-69 are rejected under 35 USC 112(a) written description above for lack of written description. The claims are further rejected under 35 USC 112(b) as indefinite as it is unclear what would be necessary for a claim to meet the functional limitations of the claims. Said another way, “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” See MPEP 2173.05(g). In the instant case, the claims do not recite particular structure, materials, or steps that accomplish the function or achieve the results, and as a result all means or methods of resolving the problem may be encompassed by the claim. Upon review and consideration of the claims, the examiner has determined that claims 57-69 are indefinite as the language does not set forth well defined boundaries of the invention and only states a result to be obtained and one of ordinary skill in the art would not know from the claim terms what structure or steps are encompassed by the claim. Accordingly, claims 57-69 are rejected as indefinite.
As the claim scope is indefinite, in order to advance prosecution for examination of the claims on the basis of prior art, the claims will be interpreted as follows:
Claim 57: wherein the physiological parameter monitoring device correlates positional and movement information with at least one physiological parameter which allows for the identification of a physiological abnormality.
Claim 58: not examined on the merits as it is unclear as to what a health level or a fitness level implies.
Claim 59: examined as recited, only rejected based on dependence on indefinite claim 57
Claim 60: wherein the physiological parameter monitoring device is configured to determine a posture of the user from the positional and movement information.
Claim 61: not examined on the merits as it is unclear as to what the scope of inactivity is in light of the specification.
Claim 62: not examined on the merits as it is unclear as to what the scope of a fall is in light of the specification.
Claim 63: examined as recited, only rejected based on dependence on indefinite claim 57
Claim 64: not examined on the merits because it is unclear as to what the scope of seizure, tremor, cough or rolling states are to differentiate between said movement in light of the specification
Claim 65: not examined on the merits because it is unclear as to the scope of when an event meets an apnea condition in light of the specification
Claim 66: not examined on the merits as it is unclear as to what the scope of engaged in an exercise regimen consists of in light of the specification
Claim 67: not examined on the merits as it is unclear as to what the scope of excessively active in light of the specification
Claim 68: not examined on the merits as it is unclear as to what the scope of “reducing false alarm associated with at least one of ST segment change, ventricular tachycardia, and ventricular run, based on the positional and movement data” consists of in light of the specification. i.e. the first physiological parameter monitoring device reduces false alarms, how is it determined that said reduction is associated with one of the identified in light of the specification.
Claim 69: not examined on the merits as the scope of the critical condition is unclear as there is no baseline pulse amplitude to compare to in order to determine a decrease in pulse amplitude for determining the critical condition.
Double Patenting
The nonstatutory 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 nonstatutory double patenting rejection is appropriate where the conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-31 and 53-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-19 of U.S. Patent No. 12,102,416. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant claims are anticipated by or made obvious to one of ordinary skill in the art at the time of the invention by claims 9-19 of US 12,102,416.
Regarding claims 21-31 and 53-70; claim 9 of US 12,102,416 discloses a system (ECG monitoring system) for monitoring at least one physiological parameter (ECG) of a user concurrently with detecting motion of the user (via motion detector), the system comprising:
a first physiological parameter monitoring device (monitoring device) comprising a first plurality of ports and a second port (at least two ports reads on first plurality and a second port), wherein each port of the first plurality of ports is configured to physically couple to a proximal end of a first wire (at least first electrocardiogram lead wire) and wherein a distal end of the first wire comprises a sensor configured to monitor the at least one physiological parameter of the user (electrocardiogram electrode); and
a motion detector (motion detector) adapted to physically attach to the user, wherein the motion detector comprises a second wire (second lead wire) having a proximal end and a distal end (first end and second end, respectively), wherein the proximal end of the second wire is adapted to physically couple to the second port (first end with connector connects to port), wherein the distal end comprises a motion sensor (second end with receptacle for receiving motion detector), and wherein the motion sensor is adapted to receive power from the first physiological parameter monitoring device (motion detector receives power from second printed circuit board of motion detector).
Further regarding claim 22; claims 9 and 10 of US 12,102,416 discloses the motion sensor is configured to transfer data bi-directionally and asynchronously communicate with the first physiological parameter monitoring device (wherein claim 10 says the second circuit board of the motion detector transfers data to and from the monitoring device).
Further regarding claim 23; claim 9 of US 12,102,416 discloses the motion sensor is configured as a slave to the first physiological parameter monitoring system (first circuit board is configured as a slave to the second circuit board).
Further regarding claim 24; claim 9 of US 12,102,416 discloses the motion sensor is configured to acquire positional and movement information of the user and transmit the positional and movement information over the second wire to the first physiological parameter monitoring device (acquires positional and movement information and transmits over second leave wire to monitoring device).
Further regarding claim 25; claim 9 of US 12,102,416 discloses the physiological parameter is ECG data.
Further regarding claim 26; claim 9 of US 12,102,416 discloses at least one ECG sensor (ECG lead electrode).
Further regarding claim 27; claim 9 of US 12,102,416 discloses the motion sensor comprises a first circuit board and the first printed circuit board is positioned in a receptable adapted to attach to the user (first printed circuit board in a receptacle at the end of the second lead wire).
Further regarding claim 28; claim 9 of US 12,102,416 discloses the first printed circuit board is configured to operate as a slave to a master printed circuit board positioned in the first physiological parameter monitoring device (second printed circuit board of ECG monitoring device).
Further regarding claim 29; claim 9 of US 12,102,416 discloses the first printed circuit board is configured to receive data from the master printed circuit board and compare said data to a reference value (compares power data from the master and compares to a reference power).
Further regarding claim 30; claim 9 of US 12,102,416 discloses the reference value is a voltage value (wherein voltage is a power value).
Further regarding claim 31; claims 9 and 12 of US 12,102,416 discloses the first printed circuit board having a power converter, a processor, a comparator and at least one of a three-axis accelerometer, a combination of a three-axis accelerometer and a gyroscope, or a combination of a three-axis accelerometer, a gyroscope, and a magnetometer (wherein the first printed circuit board receives power so must comprise a converter to convert it for use and must have a processor/comparator in order to do the processing and comparing recited in claim 9; and claim 12 discloses the types of motion detectors).
Further regarding claim 52-70; claims 9-19 disclose a system that encompasses the scope of claims 52-70 which includes limitations which the examiner takes official notice are obvious as well-known features of physiological monitoring systems, especially in view of the 35 USC 112(a) and (b) rejections provided above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 21, 24-27, 31, 52-57, 59, 60, 63 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Del Mar (US 6,605,046 B1) in view of Marek (US 2016/0206224 A1).
Regarding claims 21, 24-27, 31, 52-57, 59, 60, 63 and 70; Del Mar discloses a system for monitoring at least one physiological parameter of a user concurrently with detecting motion of the user (abstract, figures 1-3), the system comprising:
a first physiological parameter monitoring device (element 18) comprising a first plurality of ports (element 66, 68, 70, 72), wherein each port of the first plurality of ports is configured to physically couple to a proximal end of a first wire (element 67, 69, 71, 73) and wherein a distal end of the first wire comprises a sensor (elements 40, 42, 44 and 46) configured to monitor the at least one physiological parameter of the user (wherein ECG electrodes monitor electrical activity indicative of patient’s cardiac related physiological parameter; column 5, line 66 – column 11, line 19, specifically column 8, line 43 – column 11, line 19; figures 1-10, specifically 3, 6, 9 and 10); and
a motion detector (piezoresistive accelerometer chip, element 500; figure 10) adapted to physically attach to the user (wherein the motion transducer is coupled to the user), wherein the distal end comprises a motion sensor (accelerometer), and wherein the motion sensor is adapted to receive power from the first physiological parameter monitoring device and connect to the first physiological monitoring device via a connection (column 5, line 66 – column 11, line 19, specifically column 8, line 43 – column 11, line 19; figures 1-10, specifically 3, 6, 9 and 10).
However, Del Mar does not explicitly disclose the motion detector comprises a second wire having a proximal end a distal end, wherein the proximal end of the sensor wire is adapted to physically couple to a second port on the first physiological monitoring device.
Marek teaches known ECG type electrodes for use in an ECG monitoring system wherein the ECG electrodes further comprise an accelerometer with the ECG electrode in order to simultaneously acquire movement data with the ECG data which allows for correlation of the ECG data with the body movement/acceleration data to enhance diagnosis and reduce artifact due to motion wherein the combination ECG/accelerometers are connected to the monitoring device (element 15) via leads (elements 7) (paragraphs [0005], [0012], [0032]-[0033], [0062]; figure 1-5).
Regarding claims 21, 24-27, 31, 52-57, 59, 60, 63 and 70; Del Mar discloses a system with ports (elements 66, 68, 70, 72) for receiving electrical connectors (elements 67, 69, 71 and 73) of ECG electrodes and that the first physiological parameter monitoring device also recorded body motion with a body movement sensor as described above. Marek teaches known combination ECG electrodes with accelerometers which connect to a physiological monitoring device through leads so that ECG data can be correlated with body movement at the time of measurements of the physiological signal. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Del Mar system to utilize Marek’s combination ECG and accelerometer electrodes in order to collect body movement data from each ECG electrode to allow for more detailed analysis of the body motion corresponding to each measured ECG signal and therefore enhance diagnosis and reduce motion artifact as taught by Marek. Such a combination would meet the BRI of claim 21 as there would be motion detector associated with each electrode which would be coupled to Del Mar’s 4 ports (elements 66, 68, 70, 72) via a leads (elements 7 of Marek) with connectors (elements 67, 67, 71, 73 of Del Mar) to transmit both ECG and accelerometer data to the Del Mar’s physiological parameter monitoring device for processing and storing the data. Said Del Mar/Marek combination would further have a first plurality of ports (at least two of 66, 68, 70, 72) and a second port (one of ports other than the at least two first plurality of ports from element 66, 68, 70, 72) and the motion sensor would be adapted to receive power from the physiological parameter monitoring device as disclosed by both Del Mar and Marek.
Further regarding claim 24; Marek discloses the motion sensor (accelerometer of combined ECG/accelerometer electrodes) are configured to acquire positioned and movement information of the user and transmit the position and movement information over a lead wire to the physiological parameter monitoring device (can transmit both the ECG and accelerometer data over single lead wire, element 7; paragraphs [0043]-[0044]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Del Mar/Marek combination motion sensors to provide the same function.
Further regarding claim 25; both Del Mar and Marek disclose the physiological parameter comprises ECG data.
Further regarding claim 26; both Del Mar and Marek disclose the sensor is an ECG sensor (ECG electrode).
Further regarding claim 27; Marek discloses the motion sensor comprises a first printed circuit board (element 1) and wherein the first printed circuit board is positioned in a receptacle adapted to attach to the user (see figures 1-3). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing that the Del Mar/Marek combination would also provide the motion sensor comprising a first printed circuit board positioned in a receptacle adapted to attach to the user as taught by Marek in order to measure the corresponding body movement along with the ECG data at the measurement location of each combined ECG/acelerometer electrode.
Further regarding claim 31; Marek discloses the printed circuit board comprises all necessary support components for operation of the accelerometer such as a signal processor, a power circuit, a comparator and the three-axis accelerometer such as a MEMS(paragraphs [0043]-[0049]; figures 1-4). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to provide the same components for operation on the Del Mar/Marek combination in order to properly record and process the recorded physiological and movement signals.
Further regarding claim 52; Del Mar discloses an adapter for coupling channel 3 which connects to the electrical lead with at least one additional wire (output connection connecting to piezoelectric accelerometer chip, element 500) comprising an additional motion sensor (piezoelectric accelerometer chip, element 500) to the second port of the first physiological parameter monitoring device (port for channel 3) (column 10, line 65 – column 11, line 13). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Del Mar/Marek combination to include Del Mar’s adapter cable for coupling the piezoelectric accelerometer chip in the housing of the physiological measurement device with the second port as taught by Del Mar in order to correlate body movement data from the first physiological parameter monitoring device with the collected ECG data.
Further regarding claim 53; Marek discloses the receptacle at the distal end of the second wire is configured as a snap-connector adapted to attach to the user (via body electrode) (paragraph [0037]; figures 1). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Del Mar/Marek combination to have a snap connector at the distal end of the second wire as taught by Marek for connecting the ECG sensor to the body.
Further regarding claim 54; Marek discloses the receptacle at the distal end of the second wire is configured to use known fastening methods such as one of a wire dumbbell connector, a locking slot connector, or a keyhole connector adapted to attach to the user (via body electrode) (paragraph [0071]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Del Mar/Marek combination to use known electrode fastening connectors at the distal end of the second wire as taught by Marek for connecting the ECG sensor to the body.
Further regarding claim 55; Marek discloses the placement position of the motion sensor on the user is independent of a placement position of the sensor of the first wire (wherein the motion sensor of one of the combined ECG electrode/accelerometer is independently moveable with regards to others of the combined ECG electrode/accelerometer; see figure 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Del Mar/Marek combination to have the combined ECG electrode/accelerometer to be independent of the placement position of the sensor of the sensors on the first wire in order to place the sensors as required.
Further regarding claim 56; the examiner notes that the claim is drawn to an apparatus and that the placement position of the motion sensor does not limit the scope of the claim but instead is drawn to a functional/intended use limitation, and any prior art capable of performing the claimed limitation meets the BRI of the claim, see MPEP 2114. In this case, the placement location of the motion sensor of the Del Mar/Marek combination ECG electrode/accelerometer is capable of being located at a position to detect respiration activity of the user.
Further regarding claim 57; both Del Mar and Marek disclose the first physiological parameter monitoring device is configured to correlate positional and movement information of the user with the at least one physiological parameter to identify a physiological abnormality of the user (paragraphs [0050], [0061], [0065] of Marek and column 9, lines 8-33 of Del Mar).
Further regarding claim 59, 60 and 63; Marek teaches the body movement/accelerometer data is used to determine a subject’s motion or posture such sitting, lying down, standing, running etc… (paragraph [0036]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Del Mar/Marek combination to monitor and determine a subject motion and/or posture as taught by Marek in order to determine the effect of the ECG data. Furthermore, the examiner takes official notice that it is well known at the time of filing to use accelerometer data to determine patient motions including determining the number of steps taken, determining the patient’s posture/status, and particular motions such as exciting a bed.
Further regarding claim 70; Del Mar and Marek teaches the connector plug of the wires are structurally similar to a connector of a conventional ECG lead wire (paragraph [0042] of Marek and column 7, line 63 – column 8, line 6 and column 8, line 61 – column 9, line 7 of Del Mar).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over Del Mar in view of Marek as applied to claim 21 above, and further in view of Evers (US 5,558,638).
The Del Mar/Marek combination is described in the rejection of claim 21 above. Del Mar further discloses that data transfer in the device is bidirectional (send and receives data from the physiological parameter monitoring device and the accelerometer chip and/or transducer; column 9, lines 54-67) and controls the flow of data to and from the CPU and microprocessor. However, it does not explicitly disclose that the data transfer is asynchronous.
Evers teaches it is known to use asynchronous receivers/transmitters in patient monitoring devices as it provides clear-to -set and request-to-send processing to control data flow of a multiplexer for receiving and sending data with multiple sensors (column 11, lines 22-36).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Del Mar/Marek combination to make the data transfer asynchronous as taught by Evers in order to control the flow of data to and from the processor as known in the art.
Claims 23 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Del Mar in view of Marek as applied to claims 21 and 27 above, and further in view of Oliver et al (US 2007/0027367 A1).
Regarding claims 23 and 28-30; Del Mar/Marek combination discloses a first physiological parameter monitoring device connected to a plurality of combination ECG electrodes/accelerometer having a first printed circuit board.
However, both Del Mar and Marek as silent to the relationship of the physiological parameter monitoring and the circuit board of the combined ECG/accelerometer sensors.
Oliver teaches a health monitoring and analysis system which collects physiological parameter sensors with a control device wherein the main computing device for receiving and analyzing the data is set up as a master device which controls and receives data from the slaved sensor device (paragraph [0016]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Del Mar/Marek combination to set up the first circuit board of the body movement sensor as the slave to the master circuit board of the first physiological parameter measuring device in order to control and receive data from the sensor.
Further regarding claims 29 and 30; Del Mar discloses that the circuit board of the physiological parameter monitoring device is configured to send data to a accelerometer chip which receives the data and compares it on the first circuit board of the accelerometer chip to a reference value (as either 1.5 or 3 volts) to power the accelerometer (column 8, line 61 – column 9, line 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Del Mar/Marek/Oliver combination so that the first printed circuit board to receive data from the master printed circuit board and compare said data to a reference value which is a voltage to determine the appropriate power to supply and power the accelerometer as taught by Del Mar.
Conclusion
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
