DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/01/2025 and 01/23/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 9: Although this figure includes the labels 78 and 80, these labels are not found in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0027]: As written it reads “Sensed changes in IVC diameter or area also may be combined with other parameters such as with BNP or pressure/edema signals to help guide therapy intervention of differentiate patient phenotype (HFrEF v HFpEF)”. However, this is the first indication of the term “BNP”, therefore, the term should be spelled out to provide clarity.
[0054]: As written it reads “For patient comfort, as well as repeatability in positioning, antenna/detector module 102 may be place in a pad or bed 106”. However, to be grammatically correct “place” should be “placed”.
[0062]: As written it reads “Capacitor portion 152 of implant 12b includes a capacitor element 160 to complete the RC circuit”. However, this is the first instance of the term “RC” therefore, the term should be spelled out to provide clarity.
[0064]: As written it reads “0.010” NiTi frame with 8 crowns (174 in FIG. 12C) - insulated with 0.013”x 0.00025” wall PET heat-shrink / parylene […] 25 turns, 25 strand, 46 AWG gold Litz wire”. However, this is the first instance of the terms “PET” and “AWG”, therefore, the terms should be spelled out to provide clarity.
[0067]: As written it reads “Examples of a machine-readable storage medium include, but are not limited to, a magnetic disk, an optical disc (e.g., CD, CD-R, DVD, DVD-R, etc.), a magneto-optical disk, a read-only memory “ROM” device, a random access memory “RAM” device, a magnetic card, an optical card, a solid-state memory device, an EPROM, an EEPROM, and any combinations thereof”. However, this this the first instance to the terms “CD”, “CD-R”, “DVD”, “DVD-R”, “EPROM”, and “EEPROM” therefore, the terms should be spelled out to provide clarity.
[0070]: As written it reads “FIG. 13 shows a diagrammatic representation of one embodiment of a computing device in the exemplary form of an IVC diameter/area measuring implant control and communication system 1000 within which a set of instructions for causing an implant control and communication system, such as a waveform generator, an oscilloscope, an EFM circuit, or an implant, among other systems and devices disclosed herein, to perform any one or more of the aspects and/or methodologies of the present disclosure may be executed”. However, this this the first instance to the term “EFM”, therefore, the term should be spelled out to provide clarity.
[0072]: As written it reads “Example interfaces include, but are not limited to, SCSI, advanced technology attachment (ATA), serial ATA, universal serial bus (USB), IEEE 1394 (FIREWIRE), and any combinations thereof”. However, this this the first instance to the terms “SCSI” and “IEEE”, therefore, the terms should be spelled out to provide clarity.
[0074]: As written it reads “Examples of a network interface device include, but are not limited to, a network interface card (e.g., a mobile network interface card, a LAN card), a modem, and any combination thereof”. However, this this the first instance to the term “LAN”, therefore, the term should be spelled out to provide clarity.
[0075]: As written it reads “control and communication system 1000 may further include a video display adapter 1052 for communicating a displayable image to a display device, such as display device 1036”. However, the examiner believes this sentence should begin with “The”.
Appropriate correction is required.
Claim Objections
Claims 1-3, 5-6, 8-9, and 12-13 are objected to because of the following informalities:
Regarding claim 1, as written the claims read “generate with said one or more processors a notification to the patient including instructions for self-care actions when patient fluid status determined to fall outside of the normal range” (Claim 1)”. However, to be grammatically correct, the word “is” should be added between “status” and “determined”.
Regarding claims 2 and 12, the claim recites “wherein the pre-set thresholds or limits comprise patient fluid status within the euvolemic range outside of the defined normal range for the patient”. The examiner respectfully notes that claims 1 and 11 recites “determine(ing) based on the received periodic readings and patient-specific information, using a stored diagnostic or treatment algorithm executed on said one or more processors, whether patient fluid volume status falls within or outside of a normal range, […]”. However, to avoid potential antecedent basis issues the examiner would recommend removing the word “defined” from claims 2 and 12.
Regarding claims 3 and 13, the claim reads “wherein the pre-set thresholds or limits comprise at least one of a hypovolemic warning zone within the patient euvolemic range at a hypovolemic end of the patient euvolemic range and a hypervolemic warning zone within the patient euvolemic range at a hypervolemic end of the patient euvolemic range”. The examiner notes that claims 1 and 11, on which this claim indirectly depends recites “wherein the normal range is defined as a portion of a euvolemic range of fluid state for the patient”. However, to avoid potential antecedent basis issues, the examiner would recommend amending claim 3 to recite “the euvolemic range” instead of “the patient euvolemic range”.
Regarding claim 5, as written it reads “and patient fluid volume status is based at least in part on determined IVC collapsibility”. However, the examiner believes “the” should be included between “on” and “determined”.
Regarding claim 6, as written it reads “further comprising a patient-implanted wireless IVC dimension sensor as one said patient-implanted sensor, wherein said periodic readings comprise periodic readings of IVC dimensions versus time data over plural respiratory cycles generated by patient-implanted wireless IVC dimension sensor”. However, the examiner believes “the” should be added before “patient-implanted wireless IVC dimension sensor” (underlined above).
Regarding claims 8 and 9, the claims recite “wherein the processing system comprises a cloud-based processing system and the control module comprises a software application executed on a patient personal device configured to provide said notifications and instructions through a personal device user interface” (Claim 8) and “wherein the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device” (Claim 9). However, the examiner notes that claim 7 on which these claims depend recites “a sensor control module”. The examiner would recommend updating claims 8 and 9 to recite “the sensor control module” to avoid potential antecedent basis issues.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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: [sensor] control module in claims 7-9; 17-19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the [sensor] control module is described in the specification when it states “Healthcare provider device 20 may be configured with appropriate user interface, processing and communications modules for data input and handling, communications and processing, as well as treatment and control modules, which may include treatment algorithms as described herein for determining treatment protocols based on collected IVC diameter or area measurements, and systems for automated remote control of treatment devices based on determined treatment protocols as elsewhere described herein” [0033]; “Such implants 12 may in some embodiments include control and communications modules, and one or more remote systems such as processing systems, user interface/displays, data storage, etc., communicating with the control and communications modules through one or more data links, preferably remote/wireless data links. FIG. 10 shows aspects of such systems, which in some embodiments may comprise all or part of home system 42 as shown in FIG. 6B. Such a system may include an antenna/detector module 102 to communicate with and, in some embodiments, power or actuate the implant. Antenna/detector module 102 is controlled by controller 104, which may comprise a bedside console as previously described” [0054]. Therefore, the examiner is interpreting the [sensor] control module to be processing circuitry (i.e. processor carrying out treatment algorithms) configured to power or actuate the implant. Thus, claims 7-9 and 17-19 are not subject to further rejection under 35 U.S.C. 112(a)/112(b).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claims 1 and 11, the examiner notes that the claims are directed to: 1) a heart failure patient self-care system and 2) a heart failure patient self-care method. Therefore, the claims fall within the statutory categories of invention.
With reference to Step 2A, Prong One, the claims recite “determine based on the received periodic readings and patient-specific information, using a stored diagnostic or treatment algorithm executed on said one or more processors, whether patient fluid volume status falls within or outside of a normal range, wherein the normal range is defined as a portion of a euvolemic range of fluid state for the patient; generate with said one or more processors a notification to the patient indicating normal range when patient fluid status is determined to fall within the normal range” (Claim 1); “determining based on the received periodic readings and patient-specific information, using a stored diagnostic or treatment algorithm executed on said one or more processors, whether patient fluid volume status falls within or outside of a normal range, wherein the normal range is defined as a portion of a euvolemic range of fluid state for the patient; generating with said one or more processors a notification to the patient indicating normal range when patient fluid status is determined to fall within the normal range” (Claim 11).
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on analyzing received periodic readings and patient-specific information and distinguishing whether patient fluid status falls within a normal range and issuing a notification (i.e. alert, mark, indicator) when is does. In this case, analyzing periodic readings/patient-specific information and distinguishing whether patient fluid volume status falls within or outside a range, represent actions which can be practically performed in the human mind by a user analyzing data and comparing fluid volume status to a known threshold/range. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “wirelessly receive periodic readings from one or more patient-implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status […] receive patient-specific information […] generate with said one or more processors a notification to the patient including instructions for self-case actions when patient fluid status determined to fall outside of the normal range; and generate with said one or more processors a notification to a care provider when patient fluid status is determined to exceed pre-set thresholds or limits” (Claim 1) and “wirelessly receiving at one or more processors periodic readings from one or more patient implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status; receiving patient-specific information at said one or more processors […] generating with said one or more processors a notification to the patient including instructions for self-care actions when patient fluid status is determined to fall outside of the normal range; and generating with said one or more processors a notification to a care provider when patient fluid status is determined to exceed pre-set thresholds or limits” (Claim 11).
These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these receiving steps do not integrate the judicial exception into a practical application because they add insignificant extra-solution activity (i.e. in the form of data gathering and post-solution activity) to the judicial exception using a well-known device (i.e. implanted sensor) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (i.e. “wirelessly receive periodic readings from one or more patient-implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status […] receive patient-specific information […] generate with said one or more processors a notification to the patient including instructions for self-case actions when patient fluid status determined to fall outside of the normal range; and generate with said one or more processors a notification to a care provider when patient fluid status is determined to exceed pre-set thresholds or limits” (Claim 1) and “wirelessly receiving at one or more processors periodic readings from one or more patient implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status; receiving patient-specific information at said one or more processors […] generating with said one or more processors a notification to the patient including instructions for self-care actions when patient fluid status is determined to fall outside of the normal range; and generating with said one or more processors a notification to a care provider when patient fluid status is determined to exceed pre-set thresholds or limits” (Claim 11)) do not amount to significantly more than the judicial exception the these limitations represent data gathering steps which utilize conventional tools (i.e. implanted sensor)) to perform well understood, routine and conventional activity (i.e. measure one or more physiological parameters associated with patient fluid volume status, see Mann: US 2006/0079793 A1: [0328], [0330]) in the field, to perform the abstract idea.
Regarding claims 2-10 and 12-20, the claims add additional limitations that append the judgement of claims 1 and 11 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they disclose:
steps that can be practically performed within the mind (i.e. “said determination of patient fluid volume status comprises determining WC collapsibility based on the WC dimension versus time data; and patient fluid volume status is based at least in part on determined WC collapsibility”, see claims 5 and 15; );
provide additional information about the pre-set thresholds or limits/periodic readings (i.e. “wherein the pre-set thresholds or limits comprise patient fluid status within the euvolemic range outside of the defined normal range for the patient”, see claims 2 and 12; “wherein the pre-set thresholds or limits comprise at least one of a hypovolemic warning zone within the patient euvolemic range at a hypovolemic end of the patient euvolemic range and a hypervolemic warning zone within the patient euvolemic range at a hypervolemic end of the patient euvolemic range”, see claims 3 and 13; “wherein: said periodic readings comprise inferior vena cava (IVC) dimension versus time data over plural respiratory cycles”, see claims 5 and 15; “wherein said periodic readings comprise periodic readings of WC dimensions versus time data over plural respiratory cycles generated by patient-implanted wireless WC dimension sensor”, see claims 6 and 16.);
provide additional information about the one or more patient-implanted sensors/sensor control modules (i.e. wherein said one or more patient implanted sensors comprise one or more of a blood pressure sensor, electrodes and an ultrasound transducer, and said received periodic readings comprise sensor data produced by said one or more patient- implanted sensors”, see claims 4 and 14; “further comprising a patient-implanted wireless WC dimension sensor as one said patient-implanted sensor”, see claims 6 and 16; “further comprising a sensor control module configured to receive and transmit signals to and from the patient-implanted wireless WC dimension sensor, and to receive and transmit signals to and from a processing system comprising said one or more processors”, see claim 7; “wherein the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device”, see claims 9 and 19; “further comprising transmitting control signals to and receiving data signals containing the periodic readings from the patient-implanted wireless VC dimension sensor through a control module, said control module also receiving and transmitting signals to and from a processing system comprising said one or more processors”, see claim 17; .)
and/or constitute insignificant extra-solution activity (i.e. “wherein the processing system comprises a cloud-based processing system and the control module comprises a software application executed on a patient personal device configured to provide said notifications and instructions through a personal device user interface”, see claims 8 and 18; “further comprising an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy in response to a generated patient self-care instruction”, see claim 10; “further comprising the patient self-delivering a patient therapy in response to a generated patient self-care instruction using an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy communicating with the processing system”, see claim 20.).
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.
Claim(s) 1, 4-11, and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mann et al. US 2006/0079793 A1 “Mann” and further in view of Scheurer et al. US 20100076398 A1 “Scheurer”.
Regarding claims 1 and 11, Mann teaches “A heart failure patient self-care system, comprising one or more processors configured to wirelessly receive periodic readings from one or more patient-implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status, said one or more processors further configured to:” (Claim 1) (“The apparatus includes a sensor, an implantable cardiac rhythm management apparatus, an implantable lead, a signal processor, and a signaling device. The sensor is operable to generate a sensor signal indicative of a fluid pressure within a left atrium of a heart” [0010]; “FIG. 1 shows an apparatus for treating cardiovascular disease, such as congestive heart failure, which includes an implantable module 5 in accordance with one embodiment of the invention. The implantable module 5 includes a housing 7 and a flexible, electrically conductive lead 10. The lead 10 is connectable to the housing 7 through a connector 12 that may be located on the exterior of the housing. […] The flexible lead 10 is also generally similar to leads used in defibrillator and pacemaker systems, except that a compact sensor package 15 is disposed at or near the distal end 17 of the lead 10, the opposite end from the connector 12 on the housing 7. The sensor package 15 contains sensors to measure one or more physical parameters” [0090], “FIG. 4 shows one embodiment of a system for treating cardiovascular disease 9. The system 9 includes an implantable module 5, such as that described with reference to FIG. 2, and an external patient advisory module 6, such as that described below with reference to FIG. 5 […] In this embodiment, signals are communicated between the implantable module 5 and an external device, such as a patient advisory module 6, via the antenna coil of the housing 7 and a second external coil (not shown) coupled to the external device 6” [0096]; and “Communication of the prescriptive treatment instructions to the patient may appear as written or graphic instructions on a display of the patient advisory module 6. These treatment instructions may include what medications to take, dosage of each medication, and reminders to take the medications at the appropriate times” [0100]. As shown in FIG. 4, the implantable module 5 (i.e. located internal to a patient) communicates wirelessly with patient advisory module 6 of the system 9, the patient advisory module 6 to communicating instructions to the patient. Therefore, since the system 9 is used to treat cardiovascular disease (i.e. such as congestive heart failure, see [0090]) and includes a patient advisory module 6, the system 9 represents a heart failure patient self-care system, comprising one or more processors (i.e. within the patient advisory module 6), configured to wirelessly receive periodic readings from one or more patient implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status (i.e. fluid pressure, see [0010]).);
“A heart failure patient self-care method, comprising: wirelessly receiving at one or more processors periodic readings from one or more patient implanted sensors configured to measure one or more physiological parameters associated with patient fluid volume status” (Claim 11) (See [0010], [0096], and [0100] above, and “In one embodiment of the invention, the apparatus and/or method for treating cardiovascular disease is configured to treat or prevent congestive heart failure” [0045]. Therefore, Mann discloses a heart failure patient-self-care method, comprising wirelessly receiving at one or more processors (i.e. within the patient advisory module 6) periodic readings from one or more patient implanted sensors (i.e. implant module 5) configured to measure one or more physiological parameters associated with patient fluid volume status (i.e. fluid pressure, see [0010]).);
“receive patient-specific information” (Claim 1); “receiving patient-specific information at said one or more processors” (Claim 11); (“In one embodiment, the external device will further instruct the patient, using its graphical interface, to enter additional information relevant to the patient's condition, such as weight, peripheral blood pressure, and symptoms. The signal processing apparatus of the external device then compares the measured physiological parameters from the implanted device, together with information entered by the patient, with ranges and limits corresponding to different therapeutic actions as predetermined by the physician and stored in the external device as a dynamic prescription or "DynamicRx.TM. (Savacor, Inc.)." The prescribed therapeutic action will then be communicated to the patient on the graphic display” [0328]. Therefore, the system is configured to receive patient-specific information (i.e. information relevant to the patient’s condition such as weight, peripheral blood pressure and symptoms), at said one or more processors.);
“determine(ing) based on the received periodic readings and patient-specific information, using a stored diagnostic or treatment algorithm executed on said one or more processors, whether patient fluid volume status falls within or outside of a normal range, […]” (Claims 1 and 11) (See [0328] above and “As an example of a DynamicRx.TM. for a congestive heart failure patient, the level and rate of change of left atrial blood pressure (LAP) may be used by the physician to determine the dosage of diuretic. If the LAP remains in the normal range for that patient, the patient signaling device would display the normal dosage of diuretic. As in Example 1 above, if the LAP falls below the patient's normal range, the doctor may prescribe a reduction or withholding of diuretic, and that instruction would appear on the graphical interface. In another embodiment of DynamicRx.TM. the patient may be instructed to take some other kind of action, such as calling the physician or caregiver, altering diet or fluid intake, or getting additional rest. Thus, the apparatus and methods of the present invention allow the physician to conditionally prescribe therapy for the patient, and to communicate the appropriate therapy to the patient in response to dynamic changes in the patient's medical condition” [0330]. Therefore, when the left atrial blood pressure (i.e. indicative of fluid volume status) is within the normal range for the patient, the patient signaling device (i.e. patient advisory module 6) displays the normal dosage of diuretic. Conversely when the left atrial blood pressure falls below the patient’s normal range, the doctor may prescribe reducing or withholding diuretic use, that instruction being presented on the graphical interface (i.e. of the patient advisory module 6). Therefore, the method carried out by the system involves determining based on the received periodic readings and patient-specific information, using a stored diagnostic or treatment algorithm (i.e. DynamicRX, see [0328], for example) executed on said one or more processors, whether patient fluid volume status falls within or outside of a normal range.);
“generate(ing) with said one or more processors a notification to the patient indicating normal range when patient fluid status is determined to fall within the normal range” (Claims 1 and 11) (See [0330] above. Therefore, since the patient signaling device (i.e. patient advisory module 6) displays the normal dosage of diuretic when the left atrial blood pressure is within the normal range for the patient, the method carried out by the system involves generating with said one or more processors a notification to the patient indicating normal range when patient fluid status is determined to fall within the normal range.);
“generate(ing) with said one or more processors a notification to the patient including instructions for self-care actions when patient fluid status determined to fall outside of the normal range” (Claims 1 and 11); (See [0330] above. Therefore, when the left atrial blood pressure falls below (i.e. outside) the patient’s normal range, the doctor may prescribe a reduction or withholding of diuretic and that instruction appears on the graphical interface (i.e. of the patient advisory module 6). Additionally, the patient may be instructed to take some other kind of action, such as calling the physician or caregiver, altering diet or fluid intake or getting additional rest in response to the left atrial blood pressure falling below the normal range for the patient. Thus, the method carried out by the system involves generating with said one or more processors a notification to the patient including instructions for self-care actions (i.e. reduce/withhold diuretic, contact physician/caregiver, alter diet/fluid intake, get rest, see [0330]) when patient fluid status determined to fall outside of the normal range.); and
“generate(ing) with said one or more processors a notification to a care provider when patient fluid status is determined to exceed pre-set thresholds or limits” (Claims 1 and 11) (See [0330]. In order for the doctor (i.e. care provider) to prescribe a reduction or withholding of diuretic when the left atrial blood pressure is below the patient’s normal range (i.e. exceeds pre-set threshold, specifically a lower threshold of the normal range), the doctor must have received a notification regarding patient fluid status. Therefore, the method carried out by the system involves generating with said one or more processors a notification to a care provider (i.e. doctor) when patient fluid status is determined to exceed pre-set thresholds or limits.).
Mann does not teach “wherein the normal range is defined as a portion of a euvolemic range of fluid state for the patient”.
Scheurer is within the same field of endeavor as the claimed invention because it involves an implantable system for monitoring a hydration state of a patient and adjusting fluid removal from the patient includes a pressure sensor implantable within an inferior vena cava of a patient and a processor (See [Abstract]).
Scheurer teaches “wherein the normal range is defined as a portion of a euvolemic range of fluid state for the patient” (“In one embodiment, adjusting the fluid or volume overload therapy includes either reducing or increasing the rate of fluid removal from the patient. For example, if the inferior vena caval pressure value is higher than the baseline inferior vena caval pressure value, greater ultrafiltration goals are used to bring the patient back to a euvolemic state” [0031]. In this case, the euvolemic state represents a fluid state within the normal range of fluid state for the patient. Therefore, the normal range is defined as a portion of a euvolemic range of fluid state for the patient.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that the normal range is defined as a portion of a euvolemic range (i.e. euvolemic state) of fluid state for the patient as disclosed in Scheurer in order to allow the system to perform/suggest adjustments to patient care based on the normal/euvolemic state of the patient. When a patient is outside of the normal/euvolemic state it is necessary for the patient to make adjustments (i.e. see Mann: [0330]), such that their fluid levels can be properly regulated (i.e. through administering a diuretic; increasing/decreasing fluid intake, etc.) with a reasonable expectation of success. Thus, modifying the system and method of Mann such that the normal range is defined as a portion of a euvolemic range (i.e. euvolemic state) of fluid state for the patient as disclosed in Scheurer would yield the predictable result of enabling a patient to be appraised of their fluid state, such that self-care actions can be taken to cause the patient to return to the euvolemic range.
Regarding claims 4 and 14, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 1 and 11 above, and Mann further teaches “wherein said one or more patient implanted sensors comprise one or more of a blood pressure sensor, electrodes and an ultrasound transducer, and said received periodic readings comprise sensor data produced by said one or more patient-implanted sensors” (See [0330] as discussed with respect to claims 1 and 11 above and “The sensor package 15 contains sensors to measure one or more physical parameters” [0090]; “Referring to the embodiment depicted in FIG. 8, the system is implanted through the left atrial septum 41 such that the pressure sensor 15 is exposed to the pressure in the left atrial chamber 36 of the heart” [0118]; “In one embodiment of the current invention, a method and apparatus for continuous ambulatory detection, diagnosis and treatment of acute congestive heart failure is provided. It will be understood that the current invention may be implemented using digital signal processing methods in which various input signals are sampled and the described procedures are performed on a set of samples. Hence, a periodic determination of the physiological parameter of interest is within the definition of the term continuous” [0138]; “Kojima (U.S. Pat. No. 4,109,644), incorporated by reference herein, describes another implantable ultrasound transducer that could be used in the manner described above to determine left atrial dimension and thus derive a signal indicative of left atrial pressure” [0163]. Therefore, said one or more patient implanted sensors comprise one or more of a blood pressure sensor 15 (i.e. pressure sensor 15, used to measure left arterial blood pressure, see [0330].), electrodes and an ultrasound transducer and said received periodic readings (see [0138]) comprise sensor data produced by said one or more patient-implanted sensors.).
Regarding claims 5 and 15, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 1 and 11 above, and Scheurer further teaches “wherein: said periodic readings comprise(ing) inferior vena cava (IVC) dimension versus time data over plural respiratory cycles; said determination of patient fluid volume status comprises determining IVC collapsibility based on the IVC dimension versus time data; and patient fluid volume status is based at least in part on [the] determined IVC collapsibility” (Claims 5 and 15) (“The pressure sensor 12 may be in the form of a capsule and is anchored in the inferior vena cava using an anchoring means. In one embodiment, the anchor may also provide information by, for example, measuring changes in the vascular bed. The changes could be quantified by capturing movement, such as expansion or contraction of the inferior vena cava as the fluid status of the patient fluctuates with the fluid or volume overload therapies” [0014]; “In various embodiments, the inferior vena caval pressure values are sensed before, during and after administration of the fluid or volume overload therapy. […] While the fluid or volume overload therapy is being administered, the pressure sensor 12 can be programmed to either gather data at shorter intervals or optionally on an "on-demand" basis in which the physician or clinician can request a real-time reading from the pressure sensor 12” [0019]; “To determine whether and how the fluid or volume overload therapy should be adjusted, a pre-volume fluid or overload therapy inferior vena caval pressure value, or baseline inferior vena caval pressure value, is first established by trending a plurality of inferior vena caval pressure values gathered before the fluid or volume overload therapy is administered. […] During the fluid or volume overload therapy, the trends in pressure within the inferior vena cava are compared to the baseline inferior vena caval pressure values and the fluid or volume overload therapy is accordingly adjusted. In one embodiment, adjusting the fluid or volume overload therapy includes either reducing or increasing the rate of fluid removal from the patient. For example, if the inferior vena caval pressure value is higher than the baseline inferior vena caval pressure value, greater ultrafiltration goals are used to bring the patient back to a euvolemic state” [0031].
In this case, since the pressure sensor 12 includes an anchor which fixes it to the inferior vena cava and the anchor may also provide information by measuring changes in the vascular bed (i.e. expansion or contraction of the inferior vena cava) as the fluid status of the patient fluctuates with the fluid or volume overload therapies, the pressure sensor 12/anchor is configured to perform periodic readings, said periodic readings comprising inferior vena cava (IVC) dimension (i.e. expansion or contraction of vena cava) versus time (i.e. during the course of fluid or volume overload therapy) over plural respiratory cycles. Furthermore, since the inferior vena caval pressure and the expansion or contraction of the inferior is used to determine how to adjust the fluid or volume overload therapy such that a patient is brought back to the euvolemic state, said determination of patient fluid volume status comprises determining IVC collapsibility based on the IVC dimension versus time data and patient fluid volume status based at least in part on determined IVC collapsibility.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that periodic reading comprise inferior vena cava (IVC) dimension versus time data, said determination of patient fluid volume status comprises determining IVC collapsibility based on the IVC dimension versus time data, the patient fluid volume status being based at least in part on the determined IVC collapsibility as disclosed in Scheurer in order to reliably assess patient fluid status. Measuring interior vena caval pressure and changes in the vascular bed (i.e. expansion or contraction of the inferior vena cava, see [0014]) is one of a finite number of techniques which can be assess the fluid state of a patient with a reasonable expectation of success. Thus, modifying the system and method of Mann such that periodic reading comprise inferior vena cava (IVC) dimension versus time data, said determination of patient fluid volume status comprises determining IVC collapsibility based on the IVC dimension versus time data, the patient fluid volume status being based at least in part on the determined IVC collapsibility as disclosed in Scheurer would yield the predictable result of distinguishing the fluid status of a patient such that adjustments can be made to bring the patient back to a euvolemic state, see Scheurer: [0031].
Regarding claims 6 and 16, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 5 and 15 above, and Scheurer further teaches “further comprising a patient-implanted wireless IVC dimension sensor as one said patient-implanted sensor, wherein said periodic readings comprise periodic readings of IVC dimensions versus time data over plural respiratory cycles generated by patient-implanted wireless IVC dimension sensor” (Claim 6); “wherein the one or more patient-implanted sensors comprise a patient-implanted wireless IVC dimension sensor, and said method further comprises generating said periodic readings of IVC dimensions versus time data over plural respiratory cycles with the patient-implanted wireless IVC dimension sensor” (Claim 16) (See [0014] and [0019] as discussed with respect to claims 5 and 15 above and “In the illustrated embodiment, the IMD 14 is operatively coupled to the pressure sensor 12 via a communication link 19. The IMD 14 is configured to receive and process the output signal(s) from the pressure sensor 12” [0025]; “In the illustrated embodiment, the IMD 14 in turn is in communication with the external device/system 16 via a communication link 23” [0030]. Therefore, the pressure sensor 12 (i.e. along with its anchor, see [0014]), represents a wireless sensor (i.e. communicates with other devices using communication links 19 and 23, respectively). In this case, since the anchor of the pressure sensor 12 provides information by measuring changes in the vascular bed (i.e. expansion or contraction of the inferior vena cava, see [0014]), the anchor of the pressure sensor 12 represents a wireless IVC dimension sensor which generates periodic readings of IVC dimensions versus time data (i.e. during fluid or volume overload therapies). Therefore, the system further comprises a patient-implanted wireless IVC dimension sensor as one said patient-implanted sensor, wherein said periodic readings comprise periodic readings of IVC dimensions versus time data over plural respiratory cycles (i.e. during the course of fluid or volume overload therapies) generated by patient-implanted wireless IVC dimension sensor. Furthermore, the method further comprises generating said periodic readings of IVC dimensions versus time data over plural respiratory cycles with the patient-implanted wireless IVC dimension sensor (i.e. anchor of the pressure sensor 12).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that it further comprises a patient-implanted wireless IVC dimension sensor and wherein said periodic readings comprise periodic readings of IVC dimensions versus time data over plural respiratory cycles generated by the patient-implanted wireless IVC dimension sensor as disclosed in Scheurer in order to reliably assess patient fluid status. Measuring interior vena caval pressure and changes in the vascular bed (i.e. expansion or contraction of the inferior vena cava, via the anchor of the pressure sensor 12, see [0014]) is one of a finite number of techniques which can be assess the fluid state of a patient with a reasonable expectation of success. Thus, modifying the system and method of Mann such that it further comprises a patient-implanted wireless IVC dimension sensor and wherein said periodic readings comprise periodic readings of IVC dimensions versus time data over plural respiratory cycles generated by the patient-implanted wireless IVC dimension sensor as disclosed in Scheurer would yield the predictable result of distinguishing the fluid status of a patient such that adjustments can be made to bring the patient back to a euvolemic state, see Scheurer: [0031].
Regarding claims 7 and 17, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 6 and 16 above, Scheurer and further teaches “further comprising a sensor control module configured to receive and transmit signals to and from the patient-implanted wireless IVC dimension sensor, and to receive and transmit signals to and from a processing system comprising said one or more processors” (Claim 7); “further comprising transmitting control signals to and receiving data signals containing the periodic readings from the patient-implanted wireless IVC dimension sensor through a control module, said control module also receiving and transmitting signals to and from a processing system comprising said one or more processors” (Claim 17) (See [0025] and [0030] as discussed with respect to claims 6 and 16 above and [0014] as discussed with respect to claims 5 and 15 above and “During the fluid or volume overload therapy, the pressure in the inferior vena cava is sensed at periodic intervals and communicated to a processor, which could, in various embodiments, be located within the IMD 14 and/or the external device/system 16. (Block 110)” [0040]. Therefore, since the IMD 14 (i.e. implantable medical device) is configured to receive and process the output signal(s) from the pressure sensor 12 (i.e. including the anchor to measure changes in the vascular be, specifically expansion or contraction of the inferior vena cava, see [0014]) and the IMD 14 communicates with the external device/system 16 (i.e. containing processor, see [0040]) via communication link 23 (i.e. see FIG. 1), the IMD 14 represents a sensor control module configured to receive and transmit signals to and from the patient implanted wireless IVC dimension sensor (i.e. pressure sensor 12 with anchor, see [0014]) and to receive and transmit signals to and from a processing system (i.e. external device system 16) comprising said one or more processors (See [0040]). Therefore, the system further comprises a sensor control module (i.e. IMD 14) configured to receive and transmit signals to and from the patient-implanted wireless IVC dimension sensor, and to receive and transmit signals to and from a processing system comprising said one or more processors. Furthermore, the method carried out by the system involves transmitting control signals to and receiving data signals containing the periodic readings from the patient-implanted wireless IVC dimension sensor through a control module (i.e. IMD 14, via the communication link 19), said control module also receiving and transmitting signals to and from a processing system comprising said one or more processors (i.e. from the external device/system 16, via communication link 23).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that it further comprises a sensor control module configured to perform the steps of receiving and transmitting signals to and from the patient-implanted wireless IVC dimension sensor (i.e. pressure sensor 12 with anchor, see) and receiving and transmitting signals to and from a processing system comprising said one or more processors as disclosed in Scheurer in order to facilitate the transfer of data between the patient-implanted wireless IVC dimension sensor and one or more processors for assessing patient fluid volume status. Including a sensor control module to receive and transmit signals to and from a patient-implanted wireless IVC dimension sensor and to and from one or more processors is one of a finite number of techniques which can be used to facilitate the transfer of information therebetween with a reasonable expectation of success. Thus, modifying the system and method of Mann such that it further comprises a sensor control module configured to perform the steps of receiving and transmitting signals to and from the patient-implanted wireless IVC dimension sensor (i.e. pressure sensor 12 with anchor, see) and receiving and transmitting signals to and from a processing system comprising said one or more processors as disclosed in Scheurer would yield the predictable result of enabling patient fluid volume data to be communicated to and from a patient and physician such that adjustments to patient treatment can be performed as necessary.
Regarding claims 8 and 18, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 7 and 17 above, and Mann further teaches “wherein the processing system comprises a cloud-based processing system and the control module comprises a software application executed on a patient personal device configured to provide said notifications and instructions through a personal device user interface” (See [0330] as discussed with respect to claims 1 and 11 above and “In another embodiment, the data from the external device is uploaded to the physician PC via the Internet, telephone, or cellular telephone network. In this case, the data may be uploaded at regular intervals, or whenever the patient or physician determines there is a need for physician review of the patient's management” [0310]; “ The prescription editor is a software program on the physician's PC that allows the physician to create, view, and modify the dynamic prescription for each patient” [0311]; “The instructions are communicated to the patient via the signaling module 166, or another module. The patient advisory module 166 is located externally and used by the patient or his direct caregiver. It may be part of system integrated with a personal digital assistant, a cell phone, or a personal computer, or as a Stand-Alone device” [0099]. Therefore, since data from the external device (i.e. patient advisory module 6, for example, see FIG. 4), can be uploaded to the physician PC via the internet at regular intervals or when there is a need for patient management, the processing system comprises a cloud-based processing system. Furthermore, since the user is provided with instructions via the patient advisory module 6/166 (see [0330] and [0099]), the control module comprises a software application executed on a patient personal device (i.e. personal digital assistant, cell phone, personal computer) configured to provide said notifications and instructions through a personal device user interface (i.e. screen of cell phone or personal computer, for example).).
Regarding claims 9 and 19, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 8 and 18 above, and Scheurer further teaches “wherein the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device” (“In one embodiment, the external device/system 16 is a wearable monitor that is worn and carried by the patient, which may be particularly advantageous for providing ambulatory inferior vena caval pressure data” [0032]; “If the indicator 18 is designed to notify the patient, for example through a wristwatch remotely connected to the pressure sensor 12, the patient is alerted that he/she should either schedule a visit with a physician, report to an emergency room or take other preventative measures” [0035]. In order for the wearable monitor/wristwatch to receive a notification to alert a patient when he/she should schedule a visit with a physician, report to an emergency room or take other preventative measures (see [0035]), it must include a patient wearable antenna to communicate with the patient personal device (i.e. cell phone, personal computer, etc.) and/or processor. Therefore, the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device as disclosed by Scheurer in order to provide a patient with notifications when patient fluid volume is outside of the euvolemic range. A patient wearable device with an antenna for communicating with a patient personal device (i.e. such as a cell phone or personal computer, for example) is one of a finite number of devices which can be used to quickly provide notifications to a patient with a reasonable expectation of success. Thus, modifying the system and method of Mann such that the control module further comprises a patient wearable device including a patient wearable antenna communicating with the patient personal device as disclosed by Scheurer would yield the predictable result of enabling a user to be notified when it is necessary to either schedule a visit with a physician, report to an emergency room or take other preventative measures to address patient fluid volume (i.e. return to the euvolemic state).
Regarding claims 10 and 20, Mann in view of Scheurer discloses all features of the claimed invention as discussed with respect to claims 9 and 19 above, and Scheurer further teaches “further comprising an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy in response to a generated patient self-care instruction” (Claim 10); “further comprising the patient self-delivering a patient therapy in response to a generated patient self-care instruction using an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy communicating with the processing system” (Claim 20) (“In one embodiment, the external device is integrated into the dialysis console/system or other fluid removal system when the patient is receiving a non-ambulatory treatment” [0032]. In this case, the dialysis console/system or other fluid removal system is configured to execute a predefined treatment algorithm to deliver patient therapy in response to a generated patient self-care instruction. Therefore, since the external device can be integrated into a dialysis console/system or other fluid removal system (i.e. to execute a predefined treatment), the system further comprises an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy in response to a generated patient self-care instruction. Additionally, the method carried out by the system further comprises the patient self-delivering a patient therapy in response to a generated patient self-care instruction (i.e. see [0035]) using an interventional device (i.e. dialysis console/system, for example) configured to execute a predefined treatment algorithm for delivering a patient therapy communicating with the processing system.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mann such that the system further comprises an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy in response to a generated patient self-care instruction and the method further comprises the patient self-delivering a patient therapy in response to a generated patient self-care instruction using an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy communicating with the processing system as disclosed in Scheurer in order to facilitate the adjustment of the patient fluid volume. A dialysis console/system is one of a finite number of interventional devices which can be used to execute a predefined treatment algorithm (i.e. dialysis and/or ultrafiltration) with a reasonable expectation of success. Thus, modifying the system and method of Mann such that the system further comprises an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy in response to a generated patient self-care instruction and the method further comprises the patient self-delivering a patient therapy in response to a generated patient self-care instruction using an interventional device configured to execute a predefined treatment algorithm for delivering a patient therapy communicating with the processing system as disclosed in Scheurer would yield the predictable result of providing treatment to a patient in response to the determination of their fluid state being outside of the euvolemic range.
Allowable Subject Matter
Claims 2-3 and 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 2 and 12, the examiner acknowledges that Mann in view of Scheurer does not teach “wherein the pre-set thresholds or limits comprise patient fluid status within the euvolemic range outside of the defined normal range for the patient”.
Furthermore, during the examiner’s search, no prior art references were found to teach the above limitations both alone or in combination with the limitations of claims 1 and 11 on which these claims depend.
Therefore, claims 2 and 12 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 3 and 13, the examiner acknowledges that Mann in view of Scheurer does not teach “wherein the pre-set thresholds or limits comprise at least one of a hypovolemic warning zone within the patient euvolemic range at a hypovolemic end of the patient euvolemic range and a hypervolemic warning zone within the patient euvolemic range at a hypervolemic end of the patient euvolemic range”.
Furthermore, during the examiner’s search, no prior art references were found to teach the above limitations both alone or in combination with the limitations of claims 1 and 11 on which these claims depend.
Therefore, claims 3 and 13 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dalal et al. US 2013/0165802 A1 “Dalal” is pertinent to the applicant’s disclosure because it discloses “In accordance with an exemplary embodiment of the invention, techniques are provided for use by an implantable medical device for detecting and discriminating euvolemia, hypervolemia and hypovolemia” [0007].
Brian, III et al. US 2007/0043409 A1 “Brian” is pertinent to the applicant’s disclosure because it discloses “FIG. 4B shows an embodiment where a vessel diameter sensor 52, such as an intravascular ultrasound (IVUS) device, is positioned on the proximal catheter shaft 21a proximal to heat exchanger 28. The catheter 12 may be advanced until the vessel diameter sensor 56 senses (and provides a perceptible signal to the operator) that it has passed from the smaller diameter iliac vein IV into the larger diameter inferior vena cava IVC” [0052].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
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, Anne M Kozak can be reached at (571) 270-0552. 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.
/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797