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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “a communications link established by the LPWAN module” is not apparent whether the LPWAN module itself establishes the link or merely enables communications over a link established by a different network component, whether external or part of the LPWAN module. Appropriate clarification is required.
Claim 1 is objected to because of the following informalities: the phrase “Wearable Cardioverter Defibrillator” should be lowercase amended to recite “wearable cardioverter defibrillator”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “Wearable Medical Device” should be lowercase amended to recite “wearable medical device”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the phrase “The WMD recited in claim 1 further…” is missing a comma and should be amended to recite “The WMD recited in claim 1, further…”. 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:
“location module” in claim 1. The instant specification fails to define the “location module” but [0064] of the PG Pub US 20250262445 discloses that the location can be determined via triangulation using WIFI, or by a GPS sensor. However, “location module” is not associated with either.
“LPWAN module” in claims 1 and 5. The instant specification discloses the LPWAN radio can be LoRaWAN or Helium in [0054] and [0072] of the PG Pub US 20250262445.
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 1-6 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.
Regarding claim 1, it is unclear if the phrase “location module” is directed to software or structure. The instant specification fails to define the “location module” but [0064] of the PG Pub US 20250262445 discloses that the location can be determined via triangulation using WIFI, or by a GPS sensor. However, “location module” is not associated with either, and is further unclear if the “location module” is directed to a different structure.
Claim 5 recites the limitation "The method" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the LPWAN communication link" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the location detecting sensor" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "The method" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 is directed to a WMD and not a method.
Claims 2-4 and 6 are dependent on rejected claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4 and 6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the phrase “while the WMD is being worn by the patient” is claiming the mammal subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “while the WMD is configured to being worn by the patient”.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 5 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 5, the following step is an abstract idea:
“determine a location of the WMD”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine the location.
“determining whether a predetermined time has expired without reporting the location of the WMD;
upon determining that the predetermined time has expired, identifying the location of the WMD by retrieving the location from a location detecting sensor associated with the WMD”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine when a time expires and identifying a location of the WMD. Examiner notes that a processor is not recited in the claim, but even if a processor were recited, the abstract idea would be implemented onto a processor.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 5, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “WMD”, “communication link”, “remote server”, and “LPWAN module” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “medical (monitoring) sensor(s)”, “location module”, and “location detecting module” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “patient information”, “physiological parameters”, “location”, “predetermined time”, and “wireless low-power communications” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “transmitting the location of the WMD to the remote server over the LPWAN communication link” - mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “WMD”, “communication link”, “remote server”, and “LPWAN module” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “medical (monitoring) sensor(s)”, “location module”, and “location detecting module” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “patient information”, “physiological parameters”, “location”, “predetermined time”, and “wireless low-power communications” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “transmitting the location of the WMD to the remote server over the LPWAN communication link” - mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).
The additional elements of claims 1 and 5, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the WMD, LPWAN module, communication link, and remote server, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The support structure along with the medical sensor are generic structure and generic gathering structure, respectively, which are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Hui et al. (US 10777062) teaches a heart rate sensor for detecting heart rate along with the bracelet that is the support structure (Fig. 2 and Col. 11 lines 41-43).
Dependent claims 2-4 and 6 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to generic structure and gathering structure (claims 2 and 6), is generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h) (claim 3) and to mere instructions to apply the exception in a generic way (claim 4), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-6 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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.
Claim(s) 1, 4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hui et al. (US 10777062)(Hereinafter Hui).
Regarding claims 1, 4, and 6, Hui teaches A Wearable Medical Device (WMVD) (Abstract “A wearable device may monitor one or more parameters of a wearer”), comprising:
a support structure configured to be worn by a patient and to support the WMVD (Fig. 2 shows bracelet [support structure] along with the WMD components.);
a medical sensor configured to collect patient information while the WMVD is being worn by the patient (Col. 11 lines 41-43 “The sensors may include, but are not limited to, a heart rate sensor, temperature sensor, altimeter, accelerometer, fall detection sensor, etc.”);
a location module configured to determine a location of the WMD… wherein the location detecting sensor comprises a Global Positioning System component (Col. 11 lines 43-45 “The GPS receiver may be used for determining the location or positioning of the smart bracelet 102.”);
a low-power wide-area-network (LP WAN) module configured to enable wireless low- power communications between the WMVD and a remote server over a communications link established by the LPWAN module (Col. 1 lines 39-42 “connecting the wearable device to a low-power wide area network; and transmitting the emergency alert to a remote location over the established connection to the low-power wide area network.”).
Regarding claim 4, Hui teaches wherein the WMD is further configured to transmit the patient information, the location of the WMVD, or both over the communications link (Col. 11 lines 30-35 “the memory may store information regarding what constitutes a notification condition, what constitutes a triggering condition for an emergency, how to respond when an emergency condition is determined, how often to turn on location services, how often to transmit measured parameters, etc.”).
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Randall et al. (US 20230127315)(Hereinafter Randall).
Regarding claim 5, Rohera teaches The method for reporting a location of a Wearable Medical Device (WMVD) (Abstract “A method of sending an emergency alert from a wearable device. The wearable device is connected to a low-power wide area cellular network and to global positioning services as soon as it is turned on.”), the WMD comprising a support structure and medical monitoring sensors, the WMVD being configured to monitor physical parameters of a patient wearing the WMVD using the medical monitoring sensors (Abstract “The determining of an emergency condition occurs based on the inputs received through the wearable device or by the inputs received by the at least one sensor corresponding with a set of rules established for determining if an emergency alert should be sent.”), the method comprising:
determining whether a predetermined time has expired without reporting the location of the WMD ([0064] “The user can then cancel the alert initiated by the fall detection by pressing and releasing button 14 within a specified timeframe (e.g., within 60 seconds).”);
upon determining that the predetermined time has expired, identifying the location of the WMD by retrieving the location from a location detecting sensor associated with the WMD ([0065] “Emergency contacts can track the user's location through the application by requesting periodic updates (e.g., every 60 seconds), even if an emergency alert has not be triggered by the user.”);
initiating a communication link with a remote server over a low-power wide-area- network module (LPWAN) ([0064] “When an alert or SOS request is initiated, device 10 is configured to send the GPS coordinates at the time of the request to the emergency contact(s) over the LTE-M network.” [0065] “In addition to alerting emergency contacts, in an embodiment, a call center [server] able to handle emergency requests may be notified.”); and
transmitting the location of the WMD to the remote server over the LPWAN communication link ([0064] “When an alert or SOS request is initiated, device 10 is configured to send the GPS coordinates at the time of the request to the emergency contact(s) over the LTE-M network.”).
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.
Claim(s) 1-2, 4, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rohera (US 20220330821)(Hereinafter Rohera) in view of Stapleford et al. (US 20190200168)(Hereinafter Stapleford).
Regarding claims 1 and 6, Rohera teaches A Wearable Medical Device (WMVD) ([0026] “a medical therapeutic device that is wearable.”), comprising:
a support structure configured to be worn by a patient and to support the WMVD ([0088] “the device 100 is a portable and wearable device. The device 100 may be customized as per the patient's requirement. It can be designed in the form of a wrist watch, a wrist band, or even a hospital bed [support structure].”);
a medical sensor configured to collect patient information while the WMVD is being worn by the patient (Fig. 1 (104a-n));
a low-power wide-area-network (LP WAN) module configured to enable wireless low- power communications between the WMVD and a remote server over a communications link established by the LPWAN module (Fig. 3 (100 to 302) [0077] “the device 100 is embedded with a wireless communication module selected from a group consisting of … narrowband IoT (NB-IoT/5G) [LPWAN because this optimizes batter life due to low power consumption and is a known wide-area network in the art]…modules for facilitating wireless communication with a remote cloud server 302. The device 100 facilitates real-time monitoring of the parameters remotely via a monitoring device 300 communicatively coupled to the remote cloud server 302.”).
However, Rohera does not teach a location module configured to determine a location of the WMD. Stapleford, in the same field of endeavor, teaches an AED that transfers information through a LPWAN (Abstract), and further teaches a location module configured to determine a location of the WMD… wherein the location detecting sensor comprises a Global Positioning System component ([0037] “as discussed hereinafter, the extracted payload also includes location information, such as current GPS coordinates of the AED 2.”) to indicate an alert condition ([0037]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Rohera, with the location module configured to determine a location of the WMD of Stapleford, because such a modification would allow to indicate an alert condition.
Regarding claim 2, Rohera teaches wherein the WMD comprises a Wearable Cardioverter Defibrillator ([0034] “The waveform generator unit includes a second signal generator unit configured to generate the electrical signal…the second signal generator unit is connectable to a current control unit to provide electrical stimulation therapies including at least one of … Defibrillation”).
Regarding claim 4, Rohera teaches wherein the WMD is further configured to transmit the patient information, the location of the WMVD, or both over the communications link ([0081] “The server 302 may store a log of detection values and the selected programs for a plurality of devices 100 associated with a plurality of patients.” [0082] “the server 302 coordinates with the therapeutic devices 100 of multiple patients to receive the detection values, identifies discrepancies or medical conditions and corresponding treatment program to be selected based on the received detection values and the mathematical function, generates corresponding control signals, and sends the control signals to the therapeutic devices 100 for automatic selection of programs to provide treatment to the patients using the devices 100.”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hui et al. (US 10777062)(Hereinafter Hui) in view of Piha et al. (US 20160331986)(Hereinafter Piha) and Brink et al. (US 5929764)(Hereinafter Brink).
Regarding claim 3, Hui teaches the invention of claim 1. However, Hui does not teach the battery is configured to communicate with an external battery charger and to transmit the recorded data to the external battery charger. Piha, in the same field of endeavor, teaches a WCD with a support structure that transmits communication (Abstract), and further teaches wherein the battery is configured to communicate with an external battery charger and to transmit the recorded data to the external battery charger ([0006] “The portable antenna is configured to transmit wirelessly to the charger an encoded message from components [including a battery] that are worn by the patient on the support structure. The charger also includes a charger antenna configured to receive the encoded message, and a user interface configured to output a human-perceptible indication responsive to the received encoded message.”) to alert an attendant of a status ([0093]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Hui, with the battery is configured to communicate with an external battery charger and to transmit the recorded data to the external battery charger of Piha, because such a modification would allow to alert an attendant of a status.
However, Hui and Piha do not teach further comprising a battery, the WMD being further configured to record data to a memory within the battery. Brink, in the same field of endeavor, teaches a defibrillator and heart monitor (Col. 2 lines 18-20), and further teaches further comprising a battery, the WMD being further configured to record data to a memory within the battery (Col. 2 lines 21-23 “If the electronic device finds an error condition with the battery, it transmits error data to a mailbox located in the battery's memory.”) to avoid interruption of unexpected battery failure (Col. 1 lines 64-66). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Hui in view of Piha, with the WMD being further configured to record data to a memory within the battery of Brink, because such a modification would allow to avoid interruption of unexpected battery failure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/ Examiner, Art Unit 3796
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