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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 3/22/26, amended claim(s) 20-24 and 28-30 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/997,327 (hereinafter “the ‘327 Application”), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, independent claim 20 recites “measuring gravitational data generated by the inertial measurement unit,” and “the first internal microprocessor with a CPU used to calculate angular pitch data over time” and this subject matter is supported para [0077]-[0080] of Applicant’s specification of the instant application, which is not present in the specification of the ‘327 Application. As a result, the effective filing date of claims 20-32 is 08/1/23.
Claim Objections
Claim 20 is objected to because of the following informalities: “by to average” (line 23) appears that it should be “to average.”
Appropriate correction is required.
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.
Claim(s) 20-32 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claim 20, the claim language “wherein the sensor control and monitoring unit processes the movement data to generate a real time graphic data output to provide a graphical display feedback to the patient movement monitor visible to the patient to show processed movement data in real time of relative patient movement to depict a movement threshold that meets acceptable movement parameters for the medical procedure along with a secondary indicator that patient movement is not excessive and also meets the acceptable movement parameters and/or 1) a breath hold duration of time that the patient has been able to hold their breath and/or 2) time the patient has maintained their body position within the acceptable movement parameters” (lines 27-37) is ambiguous. The claim language is a run-on clause and therefore makes it difficult to understand what limitation is modifying what object. For example, “to the patient movement monitor to the patient,” which is it? Is the “graphical display feedback” just provided to the patient movement monitor, is it provided to the patient, or is it both? The claim is examined as both. Another example, is the patient maintain their body, breath hold duration, secondary indicator, acceptable movement parameters, movement threshold, and movement data in real time all further limitations of the claimed “graphical display feedback? The claim is examined as it is.
For claim 20, the claim language “wherein the patient movement monitor provides a visual feedback to the patient that patient movement meets or exceeds the acceptable movement parameters for the medical procedure” (lines 37-40) is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “[a]n apparatus for monitoring patient movement during a medical procedure,” but instead to “a method.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as being configured to as such.
For claim 24, the claim language “wherein the patient movement monitor receives pitch data from the wireless sensor module and autonomously processes this movement data by averaging pitch data over the number of data points to display as a graphic indicating movement within at least one movement parameter to display to the patient” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “[a]n apparatus for monitoring patient movement during a medical procedure,” but instead to “a method.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as being configured to as such.
For claim 25, the claim language “wherein the wireless sensor module collects data sensitive to movement of multiple areas of a patient body” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “[a]n apparatus for monitoring patient movement during a medical procedure,” but instead to “a method.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as being configured to as such.
For claim 26, the claim language “wherein the wireless sensor module attaches to a patient body using a medical adhesive” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “[a]n apparatus for monitoring patient movement during a medical procedure,” but instead to “a method.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as being configured to as such.
Dependent claim(s) 21-32 fail to cure the deficiencies of independent claim 20, thus claim(s) 20-32 is/are rejected under 35 U.S.C. 112(b).
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.
Claim 26 is 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).
For claim 26, the claim language “wherein the sensor module attaches to a patient body using a medical adhesive” is directed to or encompasses a human organism. Specifically, the sensor module “attaches” to “a patient body.” To infringe the claim, a patient body is necessary (since the sensor module is attached to the patient body), thereby making the patient body (i.e., a human organism) part of the claim.
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) 20-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0145317 to Markovic in view of “Roll and Pitch Angles From Accelerometer Sensors,” By Michael Wrona’s Blog (hereinafter “Wrona”).
For claim 20, Markovic discloses an apparatus for monitoring patient movement during a medical procedure (Abstract), comprising:
a single calibrated wireless sensor module (230) (Fig. 2A) (para [0057]) comprising an internal microprocessor with a CPU (para [0011] and [0057]) coupled to an associated first memory (para [0011] and [0057]) and first radio (para [0011] and [0057]), the single calibrated wireless sensor module responsive to movement using an inertial measurement unit to measure angular pitch changes (para [0011]-[0012]) comprising measuring gravitational data generated by the inertial measurement unit (para [0071]) and having angular pitch data over time (para [0070]-[0071]);
a patient movement monitor (“patient movement monitor,” para [0012]) comprising a display to show processed patient movement data including visual data graphically depicting movement within one or more movement parameters required to execute the medical procedure, the visual data visible to a patient during the medical procedure (para [0012]), said patient movement monitor interfaced with the wireless sensor module (para [0012]);
a sensor control and monitoring unit (“sensor control and monitoring unit,” para [0011]-[0012]) comprising a second internal microprocessor with a CPU (para [0011]-[0012]), an associated second memory (para [0011]-[0012]), second radio (para [0060]), and associated work station display remotely interfaced with the wireless sensor module (para [0011]-[0012]) (also see para [0060]) to control the wireless sensor module and to receive movement data (para [0011]-[0012]) (also see para [0060]) as calculated angular pitch data over time (para [0071]-[0072]), process the movement data to average pitch data over a number of data points and generate a graphic output (para [0072]), and display the processed movement data as a graphic to indicate movement within at least one movement parameter (para [0072]), said sensor control and monitoring unit connected to the patient movement monitor and the work station display (para [0011]-[0012]) (also see para [0060]);
wherein the sensor control and monitoring unit processes the movement data to generate a real time graphic data output to provide a graphical display feedback to the patient movement monitor visible to the patient to show processed movement data in real time of relative patient movement to depict a movement threshold that meets acceptable movement parameters for the medical procedure along with a secondary indicator that patient movement is not excessive and also meets the acceptable movement parameters and/or 1) a breath hold duration of time that the patient has been able to hold their breath and/or 2) time the patient has maintained their body position within the acceptable movement parameters (para [0064]-[0067]),
wherein the patient movement monitor provides a visual feedback to the patient that patient movement meets or exceeds the acceptable movement parameters for the medical procedure (para [0064]-[0067]), with the real time graphic data output visible on both said patient movement monitor and work station display (para [0064] and [0067]).
Markovic does not expressly disclose the first internal microprocessor with a CPU used to calculate angular pitch data over time.
However, Wrona teaches measuring gravitational data generated by an inertial measurement unit and calculating angular pitch data over time (see whole document).
It would have been obvious to a skilled artisan to modify Markovic to include the first internal microprocessor with a CPU used to calculate angular pitch data over time, in view of the teachings of Wrona, because Markovic uses angular pitch data over time to compare patient’s movements over time to a threshold to make sure that the patient is in compliance with a medical procedure.
For claim 21, Markovic further discloses wherein the wireless sensor module further comprises the first internal microprocessor with a CPU and executable computer code stored in the first associated memory with said inertial measurement unit connected to the first internal microprocessor with a CPU and sensitive to angular pitch changes of the patient when attached to said patient (para [0011]).
For claim 22, Markovic further discloses wherein the patient movement monitor further comprises a third microprocessor and executable computer code stored in a third associated memory (para [0011]).
For claim 23, Markovic further discloses wherein the sensor control and monitoring unit further comprises the second internal microprocessor with a CPU and executable computer code stored in the second associated memory (para [0011]).
For claim 24, Markovic further discloses wherein the patient movement monitor receives pitch data from the wireless sensor module and processes this movement data (para [0066]) by averaging pitch data over the number of data points to display as graphic data to indicate movement within at least one movement parameter to display to the patient (para [0072]).
For claim 25, Markovic further discloses wherein the wireless sensor module collects data sensitive to movement of multiple areas of a patient body (claim 3).
For claim 26, Markovic further discloses wherein the wireless sensor module attaches to a patient body using a medical adhesive (claim 4).
For claim 27, Markovic further discloses wherein the sensor control and monitoring unit comprises a touch sensitive display screen (claim 5).
For claim 28, Markovic further discloses wherein the sensor control and monitoring unit comprises a control input transmitted from a touch sensitive graphical user interface for selecting a graphics display mode (claim 6) (also see para [0054]).
For claim 29, Markovic further discloses wherein the sensor control and monitoring unit comprises a control input transmitted from a touch sensitive graphical user interface for calibrating the wireless sensor module (claim 7) (also see para [0054]).
For claim 30, Markovic further discloses wherein the sensor control and monitoring unit comprises a control input transmitted from a touch sensitive graphical user interface for sound (claim 8) (also see para [0054]).
For claim 31, Markovic further discloses wherein the sensor control and monitoring unit comprises a status indicator for at least the wireless sensor module (claim 9).
For claim 32, Markovic further discloses a non-transitory tangible storage media storing computer code for configuring at least one of said wireless sensor module, patient movement monitor, and sensor control and monitoring unit to monitor patient movement (claim 10); said patient movement monitor further comprising a CPU (para [0054]-[0055]).
Response to Arguments
Applicant’s arguments filed 3/22/260 have been fully considered.
With respect to the objection to the Abstract, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the 112(f) invocation, Applicant’s amendments and arguments are persuasive and the invocation is removed.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive with respect to some of the rejections, while some of the rejections are maintained. With respect to the maintained rejection, the issue is not the use of “wherein” clauses. The issue is that active method steps are being recite in apparatus-type claims. Active verbs such as “provides,” “receives,” and “collects” are not structural in nature, but rather describe an action being taken. Therefore, the examiner respectfully suggests amending these active verbs to include “configured to” to make them compliant with the apparatus-type claims that they are recited in.
With respect to the 101 rejection, the issue is not whether claim 26 is a medical treatment. The issue is that to infringe the claim, a human organism is required, i.e., the claimed “patient body.” The claim cannot be infringed without a patient body since the claimed wireless sensor modules “attaches” to the claimed patient body.
With respect to the 103 rejections, the priority claim doesn’t state that the claimed subject matter is “only” supported by para [0077]-[0080] of Applicant’s instant application. Instead, it identifies that para [0077]-[0080] describes subject matter that support the claim language and this subject matter was not described in the parent application. The issue is not complicated, the present application has disclosure that supports the claim language that the parent did not. So based on this fact, the prior application did not adequately describe the claimed subject matter, preventing priority from being established due to this 112(a) deficiency. If the reverse was true, and priority could be established while still adding subject matter to a later-filed application, that would lead to a policy where patent applicants could be entitled to protection of ideas at earlier dates than they actually disclose them to the public.
Applicant does provide numerous arguments that the claimed subject matter was well-known, that it doesn’t need to be described, that it is inherently present in the parent application, and that the claimed subject matter is not novel. However, the evidence doesn’t support any of these assertions. First, the instant application is a CIP and not a CON of the parent application. A CIP application is reserved when new subject matter is introduced into the disclosure, while a CON is used if the description remains the same. Since a CIP is used, and the new description provides support for the claims, then new subject matter is present in this application that was not in the parent. And if this subject matter was well-known, then it wouldn’t need to be described in such detail in the instant application.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Patent Application Publication No. 2014/0134586 to Stein et al. (hereinafter “Stein”) discloses an apparatus for monitoring patient movement during a medical procedure (Abstract), comprising: a single calibrated (i.e., see 2810) (Fig. 9) (para [0189]) wireless sensor module (“motion and orientation sensing device,” para [0158] and/or “motion and orientation sensing module,” para [0287]) comprising an internal microprocessor with a CPU (4106) (Fig. 22) (para [0287]) coupled to an associated first memory (4136) (Fig. 22) (para [0287]) and first radio (4120 and/or 4122) (Fig. 22) (para [0296]) responsive to movement using an inertial measurement unit (4104, 4118) (Fig. 22) (para [0287]) (also see “…although accelerometers are provided as enabling examples [in] the description of embodiments, any tracking device (e.g., a GPS chip, acoustical ranging, magnetometer, gyroscope) can be used within the scope of the embodiments described,” para [0071]) measuring angular pitch changes (para [0069]) (also see para [078], [0080], [0294], and [0300]) consisting of measuring gravitational data (Examiner’s Note: construed in view of para [0007] and [0071] of Applicant’s specification as originally filed, which identifies gravitational data as data from an accelerometer, gyro, or magnetometer) and generated by the inertial measurement unit with the internal microprocessor calculating (i.e., “analyzing,” para [0153]) (also see “[m]icro control unit 4106 controls … data processing functions,” para [0287]) angular pitch data over time (“real time,” para [0076]) (also see para [0087] and [0153]); a patient movement monitor (4204 or 4206) (Fig. 23) (para [0289]) comprising a display (as can be seen in Fig. 23) with processed patient movement data (“..real time motion of … patients…,” para [0058]) displayed including visual data graphically depicting movement (“…data can be graphically displayed…,” para [0076]) within one or more movement parameters required (i.e., 3610) (see Figs. 17-21) (para [0276]) to execute the medical procedure (para [0088]) and visible to (Examiner’s Note: functional language/intended use, i.e., capable of) a patient during the medical procedure (as can be seen in Fig. 23) (para [0289]), said patient movement monitor interfaced with the wireless sensor module (as can be seen in Fig. 23); a sensor control and monitoring unit (Examiner’s Note: made up of the elements it comprises) comprising a microprocessor with CPU (2014) (Fig. 1) (para [0158]), an associated second memory (Examiner’s Note: a “computer” inherently having a memory, para [0158] or alternatively, the “remote system” including “control logic,” the control logic necessarily being stored in some type of memory, para [0337])), second radio (4210) (Fig. 23) (para [0289]), and associated work station display (2016) (Fig. 1) (para [0158]) remotely interfaced with the wireless sensor module (as can be seen in Fig. 23) to control the wireless sensor module (“remotely controlled,” para [0165]) and to receive movement data as calculated angular pitch data over time (para [0289]), and display the movement data as a graphic indicating movement within at least one movement parameter (as can be seen in Figs. 17-21), said sensor control and monitoring unit connected to the patient movement monitor and the work station display (as can be seen in Fig. 23); wherein the sensor control and monitoring unit processes the movement data to generate a real time (“real time,” para [0076]) (also see para [0087] and [0153]) graphic data output providing a graphical display feedback (“…data can be graphically displayed…,” para [0076]) to the patient movement monitor to the patient showing processed movement data in real time (“real time,” para [0076]) (also see para [0087] and [0153]) of relative patient movement depicting a movement threshold that meets acceptable movement parameters for the medical procedure (as can be seen in Figs. 17-21), both said patient movement monitor and work station display displaying the real time graphic data output (para [0289]).
U.S. Patent Application Publication No. 2014/0266771 to Chau et al. discloses averaging pitch data for boring and drilling devices (para [0010]-[0011]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791