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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/2026 has been entered.
Response to Arguments
Applicant's arguments with respect to the 35 USC 112 rejections filed 1/20/2026 have been fully considered but they are not persuasive. As noted in the Final Rejection dated 10/17/2025, the cited portions of the Applicant’s specification (par. [0041-0044, 0056]) only mentions a desired result distinguishing perfusing and non-perusing arrhythmias using blood oxygen saturation without any details regarding how his determination is actually made. In other words, how does the processor use the blood oxygen saturation readings to distinguish perfusing from non-perfusing rhythms? Without these details, the specification fails to provide written description support for the claimed algorithm. As noted in MPEP §2161.01, “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)”.
Upon review of the current claim amendments, the Examiner has withdrawn the previously applied rejections in favor of a 35 USC 102 rejection with respect to the previously cited Webster. Webster does no use the exact terms “perfusing” and “non-perfusing” but does disclose identifying VF (which is a non-perfusing rhythm) and also false positives of VF (which would include perfusing rhythms where a patient is conscious and able to respond to prompts), see rejection below.
Additionally, a new rejection is made under 35 USC 10 with respect to Sullivan in that Sullivan likewise discloses distinguishing VF (a non-perfusing rhythm) from rhythms that don’t need to be treated (perfusing ones). Webster is relied upon here for prompting blood oxygen readings from an interface, which Sullivan does not disclose.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
When dealing with computer implemented functional limitations, MPEP §2161.01 states: “…claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Claim 1 currently claims the processor implemented step of “determine whether the person is experiencing perfusing arrhythmia or non-perfusing arrythmia” in response to a measured blood oxygen saturation level and information indicative of the cardiac condition received from the monitoring component. Applicant’s specification only discusses perfusing and non-perfusing arrythmias in three paragraphs (par. [0041, 0042 and 0062] as referenced from PGPUB 2023/0277100, which is the publication of the repent application). Par. [0041] states, “In some embodiments, determining whether a rhythm is shockable may be further aided by the blood oxygen saturation level (e.g., blood flow, which may provide blood perfusion information)… Along with heart rate and QRS width, blood oxygen saturation level (i.e., perfusion information) may aid in determinations related to shockable/non-perfusing heart rate ranges.” Par. [0042] states, “For example, blood oxygen saturation level information may help detect non-perfusing cardiac arrest (e.g., heart failure condition).” Par. [0062] states “Because in these embodiments the oximetry sensor would not require an action from the patient (i.e., passive), the oximetry sensor may provide additional information as to whether the non-responsive person (e.g., unconscious) may be experiencing a perfusing or non-perfusing arrhythmia and determine its response based on the additional oximetry information”. In each instance, the specification states perfusing/non-perfusing arrhythmias can be determined but does not set forth any particular steps/algorithms/criterion etc. that indicate how the processor distinguishes between perfusing and non-perfusing arrhythmia. Applicant has claimed an intended result without the requisite level of details in the specification indicating how the result is actually achieved.
Claims 2-9 and 21 are rejected due to their dependence on Claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Webster (PGPUB 2021/0252277).
Regarding Claims 1, 6-8, Webster discloses a wearable medical device comprising a support structure 102 to be worn by a patent; a monitoring component 106 configured to be coupled to the support structure 102, the monitoring component 106 configured to sense one or more physiological parameters of the person and provide information indicative of a cardiac condition (Fig. 1; par. [0045, 0046, 0051]); an integrated pulse oximeter/interactive device in which a user, once prompted to take a measurement, can insert a finger on an interactive surface of the blood oxygen sensor to take an oxygen reading (par. [0037, 0039]); a processor in the monitor (par. [0034]) configured to cause the prompt to be issued to a user to take a blood oxygen saturation measurement when a potential cardiac event is detected (par. [0039]). Webster discloses the cardiac data and blood oxygen saturation data is then used to determine whether treatment needs to be delivered to the patient (par. [0039]). Specifically, the blood oxygen in conjunction with others sensing data received from monitoring component 106 to determine the occurrence of VF or sustained VT (non-perfusing rhythms in which blood flow stops or is greatly diminished thus resulting in low blood oxygen values which would lead a person to becoming immobile or unconscious) or the lack thereof (a person can respond to a prompt and thus indicate the person is conscious and the identification of VF or sustained VT is indicated as a false positive which equates to a state of a patient having a perfusing rhythm, such as a normal sinus rhythm, bradycardia, etc. in which blood is flowing sufficiently to allow oxygen saturation to be at a level that keeps a patient conscious and mobile, see par. [0040, 0043-0052, 0072]).
Regarding Claim 4, Webster discloses the monitoring component includes ECG electrodes 112 connected thereto (par. [0045]).
Regarding Claim 5, Webster discloses the monitoring component includes therapy electrodes 110 connected thereto (par. [0045]).
In regard to Claim 9, Webster discloses the oxygen sensor 116 can be on the shoulder strap of the support structure (Fig. 1; par. [0037, 0046]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Webster (PGPUB 2021/0252277) in view of Marriot et al. (2023/0172499). Webster discloses all of the claimed invention except for a reflective oxygenation sensor. However, Marriot, in the same field of endeavor of health monitoring with wearable devices, discloses reflective sensors are typical and provide the advantage of being less intrusive and more portable (par. [0082]). Therefore 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 device in Webster to include a reflective sensor, as taught and suggested by Marriot, for the purpose of being less intrusive and more portable.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Webster (PGPUB 2021/0252277) in view of Lu et al. (2020/0282224). Webster discloses all of the claimed invention except for sensing blood flow parameters and blood flow trends. However, in the same field of endeavor of wearable cardioverter defibrillator systems, Lu discloses including blood flow parameters/trends for the purpose of aiding in the detection of whether a patient needs a shock or not (par. [0033]). Therefore 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 device in Webster to include blood flow sensors, as taught and suggested by Lu, for the purpose of aiding in the detection of whether a patient needs a shock or not.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Webster (PGPUB 2021/0252277) in view of Huang et al. (2015/0051473). Wester discloses all of the claimed invention except for ensuring proper contact between the sensors and the skin of a patient. However, Huang, in the same filed of endeavor of patient monitoring and concerned with the common problem of proper sensor contact with a patient’s skin, discloses detecting sensor contact with the skin and issuing an audible alert or prompt for a user to hold the sensor on the skin when improper contact is detected (par. [0051]) for the purpose of ensuring proper functionality of the sensor. Therefore 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 device in Webster to include monitoring sensor contact and issuing a prompt to hold the sensor on the skin when contact is lost, as taught and suggested by Huang, for the purpose of ensuring proper functionality of the sensor.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan (PGPUB 2018/0280710) in view of Webster (PGPUB 2021/0252277) .
Regarding Claims 1, 6-8, Sullivan discloses a wearable medical device comprising a support structure 170 to be worn by a patent; a monitoring component 180 configured to be coupled to the support structure 170, the monitoring component 180 configured to sense one or more physiological parameters of the person and provide information indicative of a cardiac condition (Fig. 1; par. [0025-0028]); an integrated pulse oximeter 501 (Fig. 5, par. [0067-0058]); a processor communicatively coupled to the sensing components of the monitoring component 180 (Fig. 1, 2; par. [0044]) and discloses that alerts can be communicated via a user interface controlled by the processor and a cancel alert can be provided (par. [0031]). Sullivan further discloses the cardiac data and blood oxygen saturation data (par. [0033, 0067]) is then used to determine the presence of a non-perusing rhythm that needs shock treatment (such as VF, par. [0045]) and thus conversely discloses perfusing rhythms are present when VF/a shockable rhythm is not detected (such as a normal sinus rhythm or baseline state). Sullivan is silent regarding prompting for a user to obtain a blood oxygen saturation measurement. However, Webster discloses incorporating a prompt to take a blood oxygen measurement for the purpose of confirming an indication of a non-perfusing rhythm such as VF while also testing to see if the determination is a false positive and a user is instead experiencing a perfusing arrhythmia (par. [0040]). Therefore 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 device in the Sullivan reference to include prompting a pulse oximeter measurement, as taught and suggested by Webster, for the purpose of confirming an indication of a non-perfusing rhythm such as VF while also testing to see if the determination is a false positive and a user is instead experiencing a perfusing arrhythmia.
Regarding Claim 4, Sullivan discloses the monitoring component includes ECG electrodes 112 connected thereto (Fig. 1; par. [0045]).
Regarding Claim 5, Sullivan discloses the monitoring component includes therapy electrodes 110 connected thereto (Fig. 1; par. [0045]).
In regard to Claim 9, Sullivan discloses the oxygen sensor can be on the shoulder strap of the support structure (Fig. 1; par. [0037]).
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796