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 .
Response to Arguments
For clarity of the record, Applicants have provided a new set of claims and have not seemingly provided any arguments related to the art of record in the last rejection dated 1/9/20. Examiner would recommend a telephonic interview to discuss Applicants proposed amendment.
Examiner reminds Applicant that for claim amendments in response to this action, Applicants are to follow 37 CFR § 1.121 which discusses the formalities of indicating added and deleted subject matter among other elements regarding amendments. Specifically, Examiner notes that ”[t]he text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters.”
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28 recites “[or the monitor)” the parentheticals appear to be a typographical error.
Claim 28 recites “control module, the displaying module, the evaluation module” the claim is missing the ‘and/or” or the “or”.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“front-end unit” in claim 28 see [0017], [0191], [0182], [0191], [0194], Figs. 2-3 – analog signal processing filters or digitization and filters (using PG Pub for paragraph numbers).
“cooperating units” in claim 28 see [0025] “cooperating units preferably formed of watch, mobile phone with auxiliary functions, auxiliary device with mobile phone standard, control unit and in case that selected cooperating unit preferably is transmitting alarm to selectable remote unit preferably formed by server and/or suitable device at other participants preferably PC or mobile phone standard.”.
“control module” in claim 28 see [0008], [0011] wrist device, mobile phone, PC.
“displaying module” in claim 28 see [0012], [0014], [0016] – display on mobile phone, PC, laptop etc.
“a communication unit” in claim 28 see [0192], [0194].
“the evaluation module” in claim 28 see [0007], [0009], [0015]-[0016] –PC and/or server.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 28-37 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites “a live holter comprising: a monitor of heart signals on a chest strap . . . a front end unit . . . a memory . . .” etc. causes confusion. To start it’s unclear what the scope of “live holter” is, is it a device or a system? Is the holter a system with the combination of the strap with electrodes and the monitor? Is it just the monitor (i.e. a device)? Is it a system with the monitor the strap and a separate device (i.e. the evaluating and displaying device). Additionally, the current way the claim is recited it is unclear if the front end, communication and memory part of the of the monitor? For the above reasons the claim does not clearly define the metes and bounds of what is claimed and is indefinite. The claims which depend from this claim share this issue and are also rejected. Examiner would recommend an interview to clarify this.
Claim 28 recites “for storing the digital heart signals for later processing into holter record and for live displaying of the ECG on nearby cooperating units”, while the “for . . .” elements are intended use they seem to directly contradict each other which causes confusion. Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected. Examiner would recommend something like “memory configured to store the digital heart signals”.
Claim 28 recites “of the heart signals from the front end [or the monitor)” which is unclear as to what the scope of this. Previously in the claim there are analog and digital heart signals recited. It’s unclear if the “heart signals” is referring to the analog heart signals, the digital heart signals, both or some additional heart signals? Additionally, in view of the “comprising” language which encompasses other alternatives perhaps applicants are trying to claim some further processed “heart signals”. Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim 28 recites “cooperating units formed by a control module or a displaying module” and “an evaluating and displaying device formed by at least one of a control module, a displaying module, an evaluation module, and further comprising at least one of the control module, the displaying module, the evaluation module” its unclear what the scope of these are. Are the “corresponding units” the same as the “evaluating and displaying device” or something else? Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim 28 recites “at least one of the control module, the displaying module, the evaluation module for generating of a holter record and live displaying” What the scope of this is as its reciting “at least one” which means control module, the displaying module and/or the evaluation module. Therefore, in one interpretation it just requires a display module; which if so, what is capable of performing the intended use of “generating”. Examiner would recommend reciting the “evaluating and display device” being “configured to generate . . .” Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim 28 recites “of the processed hearts signals in to an ECG curve.” However, there are no “processed heart signals” recited earlier in the claim, thus the element lacks antecedent basis. There are “analog heart signals” and “digital heart signals” recited earlier in the claim but it is unclear what the processed heart signals is referring to. Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim 30 contains the trademark/trade name “SD” card. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a memory card and, accordingly, the identification/description is indefinite.
Claim 32 recites “external electrodes” however this is unclear because its unclear what the electrodes are “external” to. Is this reciting additional electrodes not part of the “live holter” (system)? Is it just reciting additional electrodes which are not on the chest strap? Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim 33 recites “live holter is expandable from holter for basic functions to holter for communication with control module and further to holter for communication with displaying module and further to holter for communication with evaluation module.” but it’s unclear what the scope of this claim is. It is unclear what the scope of “expandable” is in view of claim 28 from which this claim depends. Claim 28 recites a communication element which provides communication with external devices (aka the modules) and that seems to be the structural element which provides the expansion. Additionally, does this require all three (control module, displaying module, evaluation module) or do you just need communication with one of the three to be expanded (Examiner also notes that a single device such as a smartphone can include one or more of the recited modules based on Applicants specification see 112f) and thus have an ”expandable” live holter. Therefore, the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims which depend from this claim share this issue and are also rejected.
Claim Rejections - 35 USC § 102/103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 28, 31 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by US 20050049515 to Misczynski et al. (hereinafter Misc) or, in the alternative, under 35 U.S.C. 103 as obvious over Misc in view of US 20020198473 to Kumar et al. (hereinafter Kumar).
Regarding Claim 28, an interpretation of Misc discloses Live holter comprising:
a monitor of heart signals (140 Fig. 1, [0015]) on a chest strap (100 Fig. 1, [0015]-[0016]) with electrodes on the chest strap for sensing of an analog heart signals for an ECG (110, 120, 130 Fig. 1, , [0015]-[0017]; to the extent “for sensing. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a front-end unit connected to the electrodes for converting the analog heart signals into digital signals (320 Fig. 3, [0020]-[0021] including “The analog-to-digital converter is also a common device”; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a memory for storing the digital heart signals for later processing into holter record ([0022] including “Raw digitized ECG data can also be stored in the SPU 140 and downloaded for further processing at a later time”) and for live displaying of the ECG on nearby cooperating units formed by a control module or a displaying module placed within reach of monitored person ([0022]-[0023] including “The remote unit 360 may be a unit that is designed and dedicated to ECG processing or it may be a more generic device such as a PC, PDA or smart phone that is equipped with ECG acquisition and analysis software with which the cardiac data can be processed.”; to the extent “for later processing . . . for live displaying. . .” is/are an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a communication unit for transmission of the heart signals from the front end [or the monitor) to (340 Fig. 3, [0022] including “This transmission may be through wire 330, 350 or wireless 340 means. The transmission standard is not a limitation in that, for example, Bluetooth or Wi-Fi are both viable options.”; to the extent “for . . .” is/are an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use) an evaluating and displaying device formed by at least one of a control module, a displaying module, an evaluation module ([0022]-[0023] including “The remote unit 360 may be a unit that is designed and dedicated to ECG processing or it may be a more generic device such as a PC, PDA or smart phone that is equipped with ECG acquisition and analysis software with which the cardiac data can be processed.”), and further comprising
at least one of the control module, the displaying module, the evaluation module for generating of a holter record and live displaying of the processed hearts signals in to an ECG curve ([0022]-[0023] including “The remote unit 360 may be a unit that is designed and dedicated to ECG processing or it may be a more generic device such as a PC, PDA or smart phone that is equipped with ECG acquisition and analysis software with which the cardiac data can be processed.”; to the extent “for generating . . . and live displaying. . .” is/are an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
While Examiner believes the “for . . . “ to recite an intended use, if the “for live displaying” is determined to be more than an intended use then, in the alternative, Misc may not explicitly disclose live displaying of the processed hearts signals in to an ECG curve.
However, in the same field of endeavor (medical diagnostic systems), Kumar teaches the live displaying of the processed hearts signals in to an ECG curve a separate device ([0075], [0077], [0079], [0213]-[0214], Fig. 27 see also [0010], [0017], [0078])
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing and transmission of data to external device for additional processing as recited by Misc to include the live displaying of the ECG waveforms as recited by Kumar because it a healthcare provider is then able to monitor the user and provide treatment in real-time to the patient ([0078]).
Regarding Claim 31, an interpretation of Misc further discloses wherein the monitor of heart signals is placed on the chest strap ([0016]; to the extent “is placed on. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
Claim Rejections - 35 USC § 102/103
Claim(s) 28, 31-34, 36 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by US 20150005608 to Evans et al. (hereinafter Evans) or, in the alternative, under 35 U.S.C. 103 as obvious over Evans in view of US 20080027341 to Sackner et al. (hereinafter Sackner).
Regarding Claim 28, an interpretation of Evans discloses a Live holter comprising:
a monitor of heart signals on a chest strap ([0043] including “ECG system 100 comprises a base unit 102 and two or more electrode units”, [0044], [0104], Figs. 4a, 9; discloses base unit mounted on chest strap. to the extent “on . . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use) with electrodes on the chest strap ([0043]-[0044], [0104] including “may be integrated into or embedded within harness 901 and/or straps 910 or attached to harness 901 and/or straps 910 by hooks, clips, compression clips, hook and loop systems, and the like.”, Figs. 4a, 9 see also [0138]; discloses electrodes integrated into chest straps. to the extent “on . . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use) for sensing of an analog heart signals for an ECG ([0043]-[0044], [0064] including “Each electrode unit 104 generates a corresponding analog signal 502”, [0104], Figs. 4a, 9 see also [0138]; to the extent “for sensing. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a front-end unit connected to the electrodes for converting the analog heart signals into digital signals ([0046]-[0047] including “analog to digital converters”, [0063]-[0064], [0066], Fig. 4A, 5A-B; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a memory for storing the digital heart signals for later processing into holter record ([0046]-[0047] including “Data storage 116 may comprise any suitable memory (e.g. solid state memory) that may be used to store digital ECG data.”, [0104], Figs. 4A see also [0138]; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use) and for live displaying of the ECG on nearby cooperating units formed by a control module or a displaying module placed within reach of monitored person ([0049] including “communications hardware 130 may facilitate communication of ECG data (e.g. data stored in data storage 116, real time ECG waveforms 110 and/or the like) from base unit 102 to another device 126A (e.g. a computer or the like) via a network 126 or via a direct communication link (not shown) for further processing and/or display.”, Figs. 4A, 9 see also [0138]; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use),
a communication unit ([0048]-[0049], [0104]-[0105], Figs. 4A, 9 see also [0138]) for transmission of the heart signals from the front end [or the monitor) to an evaluating and displaying device formed by at least one of a control module, a displaying module, an evaluation module, ([0048]-[0049] including “communications hardware 130 may facilitate communication of ECG data (e.g. data stored in data storage 116, real time ECG waveforms 110 and/or the like) from base unit 102 to another device 126A (e.g. a computer or the like) via a network 126 or via a direct communication link (not shown) for further processing and/or display.”, [0104]-[0105] including “external ECG systems or to other devices (not shown) such as a smartphone, tablet, laptop, computers, and/or the like”, Figs. 4A, 9 see also [0138]) and further comprising
at least one of the control module, the displaying module, the evaluation module for generating of a holter record and live displaying of the processed hearts signals in to an ECG curve ([0045], [0048]-[0049] including “communications hardware 130 may facilitate communication of ECG data (e.g. data stored in data storage 116, real time ECG waveforms 110 and/or the like) from base unit 102 to another device 126A (e.g. a computer or the like) . . . for further processing and/or display.”, [0104]-[0105], [0156], Figs. 3, 4A, 9 see also [0062], [0138]; signals are wirelessly transmitted from base unit to external device which performs analysis and displays the ECG waveform/curve. to the extent “for generating . . . and live displaying . . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
In the alternative, Evans may not explicitly disclose the “chest band” carrying the electrodes and monitor therefore, in the alternative, Sackner is provided which disclose the chest band with the electrodes and monitor.
Additionally, for clarity, Evans disclose processing to determine the holter or ecg waveform and that the secondary device can provide additional processing and/or display the live waveforms, but recites the processing to determine the holter or ecg waveform on the base unit of the device; which if the “for . . .” elements are intended use then the external device has the elements structurally capable of performing the intended use. However, if the “for transmission of the heart signals from the front end [or the monitor) to an evaluating and displaying device” and “for generating of a holter record” are determined to be more than an intended use then, in the alternative, Evans may not explicitly disclose the digitized (aka preprocessed) signals from the ADC being sent to the external device for processing to holter record or ECG waveform.
However, in the same field of endeavor (medical diagnostic systems), Sackner teaches the chest band with the electrodes and monitor ([0016], [0034]-[0036], Fig. 1A); the digitized (aka preprocessed) signals from the ADC being sent to the external device for processing to holter record or ECG waveform ([0036] including “wireless transmission of raw and/or processed signal data for immediate review”, [0094]-[0095], Figs. 1A, 3A, 4A-4B, 5A-B see also [0012], [0043]-[0045]; discloses transmitting of digitized data which is further processed by the external device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing and transmission of data to external device for additional processing as recited by Evans to include a chest band with the monitor the electodes as well as the processing of digitized signals at an external processor as recited by Sackner because it is the simple substitution of one known element (processing of digitized signals on wearable) for another (processing of digitized signals on external device) to obtain predictable results of the digitized signals being processed to ECG waveform.
Regarding Claim 31, an interpretation of Evans further discloses wherein the monitor of heart signals is placed on the chest strap ([0044], Figs. 4A, 9 see also [0138]; to the extent “is placed on. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
Regarding Claim 32, an interpretation of Evans further discloses external electrodes for sensing up to twelve lead ECG for processing in the monitor of heart signals ([0004], [0044], [0051], [0104], Figs. 4A, 9; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
Regarding Claim 33, an interpretation of Evans further discloses wherein live holter is expandable from holter for basic functions to bolter for communication with control module and further to bolter for communication with displaying module and further to holter for communication with evaluation module ([0048]-[0049] including “communications hardware 130 may facilitate communication of ECG data (e.g. data stored in data storage 116, real time ECG waveforms 110 and/or the like) from base unit 102 to another device 126A (e.g. a computer or the like) via a network 126 or via a direct communication link (not shown) for further processing and/or display.”, [0104]-[0105] including “external ECG systems or to other devices (not shown) such as a smartphone, tablet, laptop, computers, and/or the like”, [0149], [0156], Figs. 4A, 9 see also [0138]; The reference discloses communication with multiple external devices both local devices such as a smartphone or PDA and remote devices such as a cloud server. To the extent the elements of the claim are intended use the system/device the elements disclosed by the prior are structurally capable of performing the intended use).
Regarding Claim 34, an interpretation of Evans further discloses wherein the monitor of heart signals is adapted for backup operation realized by doubling at least one of: the electrodes for sensing the heart signals ([0148] including “a plurality of ECG systems 100, 200, 300, 400, 900, . . . may be implemented together in a vehicle for the purpose of having redundant systems.”; discloses applying a plurality of ECG systems each with their own sets of electrodes for redundancy. to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
Regarding Claim 36, an interpretation of Evans further discloses comprising at least one of: detector EMG ([0118], [0122], [0136] see also [0138]) for storing or live displaying in at least one of PC, the control module, the displaying module, the evaluation module ([0049], [0122], [0125], [0149], [0156] see also [0048], [0050], [0136], [0138]; to the extent “for. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
Claim Rejections - 35 USC § 103
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Gawlick (hereinafter Gawlick) or, in the alternative, under 35 U.S.C. 103 as obvious over Evans in view of Sackner in further view of Gawlick.
Regarding Claim 29, an interpretation of Evans further discloses characterized in that live holter is activating a warning signal if parameters of heart signals are abnormal ([0050] including “identify abnormal ECG rhythms; . . . provide . . . alarms and/or alerts”, [0147]; discloses issuing alarm for a heart attack or similar condition. to the extent “activating. . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
an interpretation of Evans may not explicitly disclose adjustable limits for heart parameters for alarm.
However, in the same field of endeavor (medical diagnostic systems), Gawlick teaches adjustable limits for heart parameters for alarm ([0021]-[0022], [0055], [0061], Figs. 10-11).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing and transmission of data to external device for additional processing as recited by Evans to include adjustable alarm thresholds for heart parameters as recited by Gawlick because the adjustable thresholds provide customization of the thresholds for the particular user/need ([0001], [0005]-[0006]).
Claim Rejections - 35 USC § 103
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of US 20090306485 to Bell et al. (hereinafter Bell) or, in the alternative, under 35 U.S.C. 103 as obvious over Evans in view of Sackner in further view of Bell.
Regarding Claim 30, an interpretation of Evans further discloses wherein the memory ([0046]-[0047] including “Data storage 116 may comprise any suitable memory (e.g. solid state memory) that may be used to store digital ECG data.”, [0104], Figs. 4A see also [0138]), is transferable for downloading the digital heart signals or the digital heart signals is downloaded wirelessly into at least one of PC, a control module, a displaying module, an evaluation module, for processing into holter report and/or for displaying of the processed heart signals ([0046]-[0047] including “Data storage 116 may comprise any suitable memory (e.g. solid state memory) that may be used to store digital ECG data.”, [0104], Figs. 4A see also [0138]; Reference discloses the wireless transmission of digitized heart signals to an external computing (with display) device for processing and/or display. To the extent “is downloaded wirelessly . . . for . . . and/or for . . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use).
While Evans recites various forms of memory it may not explicitly recite the memory is in the form of a memory card.
However, in the same field of endeavor (medical diagnostic devices), Bell teaches the memory is in the form of a solid state removable memory card ([0012], [0016] including “The choice of removable memory storage device is likely to be a solid-state flash type device such as SanDisk memory cards.”, [0038], Figs. 1-2). The memory card removable able to transfer the data ([0012], [0016] including “The choice of removable memory storage device is likely to be a solid-state flash type device such as SanDisk memory cards.”, [0038], Figs. 1-2).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing, memory including solid state memory and transmission of data to external device for additional processing as recited by Evans to include the solid state memory is in the form of a removable memory card as recited by Bell which is combining prior art elements (the known type of solid state memory from Evans combined with the specifics of a the SanDisk memory card as the solid state memory as recited by Bell) according to known methods to yield predictable results of solid state memory card providing storage for information.
Claim Rejections - 35 USC § 103
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of US 20070142715 to Banet et al. (hereinafter Banet) or, in the alternative, under 35 U.S.C. 103 as obvious over Evans in view of Sackner in further view of Banet.
Regarding Claim 35, an interpretation of Evans may not explicitly disclose wherein the control module is placed on wrist on bracelet, advantageously removable.
However, in the same field of endeavor (medical diagnostic systems), Banet teaches wherein the control module is placed on wrist on bracelet, advantageously removable ([0002] including “Typically the chest strap additionally includes a short-range wireless transmitter that sends the heart rate to a body-worn component (e.g. a wrist watch)”, [0011], [0021]; To the extent “is placed . . .” is an intended use of the device the elements disclosed by the prior art are structurally capable of performing the intended use. Examiner notes, “placed on the wrist” without the intended use may represent a 101 issue for reciting a human organism and Examiner would recommend amending the claim to recite “configured to be placed” or something similar).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing, and transmission of data to external device for additional processing as recited by Evans to include the control module is on a wrist (i.e. a watch) as recited by Banet because it is merely combining prior art elements (a control module on an external device combined with the more specific external control device being a watch) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of US 6454708 to Ferguson et al. (hereinafter Ferguson) or, in the alternative, under 35 U.S.C. 103 as obvious over Evans in view of Sackner in further view of Ferguson.
Regarding Claim 37, an interpretation of Evans may not explicitly disclose wherein the hearts signals are processed additionally in to at least one of: variability numerical value.
However, in the same field of endeavor (medical diagnostic systems), Ferguson teaches wherein the hearts signals are processed additionally in to at least one of: variability numerical value (Col 13:29-40, Col 15:61-Col 16:6 including “also perform other types of processing on the received ECG data such as heart rate variability analysis, atrial fibrillation detection, ST episode detection, QT analysis, and other flagging events . . . such processing techniques are believed to be known to those skilled in the art.” see also Col 18:44-Col 19:78, Col 29:1-18).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering, processing, and transmission of data to external device for additional processing as recited by Evans to include the additional processing of determining a value for heart rate variability (HRV) which are known to those of skill in the art as recited by Ferguson because is its merely combining prior art elements (processing as recited by Evans combined with additional processing of HRV as recited Ferguson) according to known methods to yield predictable results of determining the additional heart parameter of HRV.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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, James Kish can be reached at (571) 272-5554. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James Moss/Examiner, Art Unit 3792