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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Applicant filed amended claims on July 15, 2026 and addressed all previous 35 U.S.C. 112(b) rejections and all objections to the specification, drawings, abstract, and claims set forth in the Non-Final Office Action mailed April 16, 2026. These previous rejections and objections have been withdrawn. Rejections under U.S.C. 101, 102, & 103, and double patenting rejections are addressed below. Applicant’s amendment to claim 1 necessitated a new grounds of rejection in view of previously cited reference to Freeman as set forth below, specifically, Fig. 3C and ¶55 which discusses detecting the use state of how the device cover is placed, and outputting different content before and after detecting that use state.
Response to Arguments
Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive.
35 U.S.C. 101 Subject Matter Eligibility
Applicant submits that amended claim 1 is eligible at Step 2A, Prong 1 at least because claim 1 does not recite mental processes and does not recite a method of organizing human activity.
Applicant argues that claim 1 contains limitations that cannot practically be performed in the human mind. Specifically, the features "a controller...configured to detect a change in the use state in a period between a start up event of the defibrillator and an event involving the defibrillator detecting that a pair of pads of the defibrillator are attached to a skin of a subject, wherein during the period, the controller is configured to output a first content of the guidance, the first content comprising a series of audio output, and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance" could not, as a practical matter, be performed entirely in a human's mind, even if aided with pen and paper due to the complex electrical signal processing of the detection of use state of a defibrillator and outputting different contents of guidance upon further detecting a change in the use state, and thus are not directed to a mental process. However, someone skilled in the use of a defibrillator could visually observe a user operating the defibrillator and determine, in their mind, the use state of the defibrillator based on those observation, then speak guidance to the operator. As stated in the Non-Final Office Action mailed April 16, 2026, the limitation of performing this abstract idea by a computer processor amounts to no more than mere instructions to apply the exception using a generic computer component.
“Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." … (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").” - MPEP 2106.04(a)(2) III
“An example of a case in which a computer was used as a tool to perform a mental process is Mortgage Grader, 811 F.3d. at 1324, 117 USPQ2d at 1699. The patentee in Mortgage Grader claimed a computer-implemented system for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The interface prompts a borrower to enter personal information, which the grading module uses to calculate the borrower’s credit grading, and allows the borrower to identify and compare loan packages in the database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at 1695. The Federal Circuit determined that these claims were directed to the concept of "anonymous loan shopping", which was a concept that could be "performed by humans without a computer." 811 F.3d. at 1324, 117 USPQ2d at 1699. Another example is Berkheimer v. HP, Inc., 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in which the patentee claimed methods for parsing and evaluating data using a computer processing system. The Federal Circuit determined that these claims were directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform the processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53.” - MPEP 2106(a)(2) III(C)(3)
Applicant argues that amended claim 1 includes features that do not fall within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people. Specifically, applicant argues that the activities of claim 1 are directed to actions performed by the controller and that none of these activities are directed to fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people. Therefore, amended claim 1 is not directed to a method of organizing human.
The mere implementation of an abstract idea by a generic computer is addressed in the Non-Final Office Action mailed April 16, 2026 and addressed again above. Examiner notes that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions. (MPEP 2106(a)(2) II(C)). The limitation of providing audible guidance is, for example, equivalent to a skilled user providing verbal instruction or teaching to another user of the defibrillator.
Applicant submits that the amended claims are eligible at Step 2A, Prong 2 even if it is assumed the claims recites an abstract idea because the combination of recitations in amended claim 1 integrates any purported abstract idea into a practical solution.
Applicant argues that the claims constitutes an Improvement to a Technical Field on the basis that a defibrillator that "enables even an operator who is unfamiliar with the use of the defibrillator to use the defibrillator more reliably and with a more accurate operation procedure, thus improving the healthcare industry." See id., paragraph [0005].
However, the main claim element that "enables even an operator who is unfamiliar with the use of the defibrillator to use the defibrillator more reliably and with a more accurate operation procedure, thus improving the healthcare industry" is no more than providing instructions which, as explained above, is an abstract idea. “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field -MPEP 2106.05(a).
The defibrillator is described at a high level of generality and the only claimed element that implements the steps of the claims is the controller, which constitutes nothing more than a generic computer component. No other elements of a defibrillator perform any steps of the claims. Only the controller performs the abstract idea of making determinations based on observations and outputting pre-set guidance. Courts have indicated that mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, (or in this case outputting guidance based on observations) may not be sufficient to show an improvement in computer-functionality. (See MPEP 2106.05(a)(I). Therefore, even taken together, this reads as a generic computer performing generic computer functions to implement the abstract idea.
Applicant argues that claim 1 constitutes a Particular Machine. MPEP suggests three main relevant factors to consider in determining whether a machine recited in a claim provides significantly more: I. the particularity or generality of the elements of the machine or apparatus, II. whether the machine or apparatus implements the steps of the method, and III. whether its involvement is extra-solution activity or a field-of-use (MPEP 2106.05(b)). As mentioned above, the only structural element that is claimed as part of the defibrillator is the controller. Only the controller performs the steps of the claim, and those steps do not involve delivering defibrillation. In fact, other than being directed to a defibrillator, the steps as claimed could operate entirely separate from a defibrillator, as it does not perform any steps of defibrillation; for example: this device as claimed could be used with neuromuscular stimulators, cardiac monitors that do not perform defibrillation, electroencephalogram and electromyogram devices, or another computer in communication with such a device. This suggests that the claimed device is no more than a computer which implements the abstract idea, and the nominal claim of a defibrillator is no more than an object on which the method operates. Neither electrode pads nor optical sensors referenced in the claims are actually claimed as part of the defibrillator device, and even if they were, these components serve no claimed function beyond the insignificant extra-solution activity of data gathering. Therefore, the device as claimed does not constitute a particular machine. Further, even if the claimed device did constitute a particular machine, it would still be well understood, routine, and conventional under step 2B as discussed below.
“It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine.” - MPEP 2106.05(b)(I)
“Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more.” - MPEP 2106.05(b)(II)
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more… mere [data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.” - MPEP 2106.05(b)(III)
Applicant submits that amended claims are eligible at Step 2B, even if it is assume that they are ineligible under the preceding steps.
Applicant submits that the additional elements of claim 1 are not well- understood, routine, conventional activities previously known to the industry. See MPEP 2106.05(d). As described in paragraph [0040] of the specification, "in the AED in the related art, the guidance from step S13 onwards is repeated until it is detected that the two electrode pads are attached to the subject. Therefore, for example, even in a situation in which the first electrode pad has been attached, that is, in a situation in which the electrode pad has already been taken out from the bag, guidance is output to prompt the operator to remove the bag of the electrode pad from the lid portion or to take out the electrode pad from the bag." That is conventionally, such unnecessary output that can confuse the operator and is provided to the operator.
However, the outputting of guidance is one of the claimed abstract ideas, not an additional element. Further, the only additional structural element claimed in the amended claims is the defibrillator comprising a controller. With no claimed additional elements other than a controller (which reads on computer processor), the claim as a whole amounts to nothing more than a generic computer performing generic computer functions merely used to implement an abstract idea which, as stated in the office action mailed on April 16, 2026, is well-understood, routine, conventional activity under Berkheimer Option 2 (see MPEP 2106.05(d)(II). See rejection below for additional detail.
The objection under 35 U.S.C 101 is maintained.
Double Patenting
In the office action mailed on April 16, 2026 claims 1-9 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/729,387 to Kuno in view of Freeman US 2005/0251213. On Aug-4 2026 Application No. 18/729,387 was issued as US Patent No. 12697499. Those rejections have been edited to reflect applicant’s claim amendments and the current claims of US Patent No. 12697499 and is presented above.
At the applicants request the rejection of the claims for obviousness-type double patenting is held in abeyance until resolution of all other objections and rejections
Patentability over Freeman
Regarding claim 1: claim 1 has been amended to recite in part "a controller configured to:... output guidance of a use method of the defibrillator, according to the detected use state, wherein the controller is configured to detect a change in the use state in a period... wherein during the period, the controller is configured to output a first content of the guidance, the first content comprising a series of audio output, and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance."
Applicant argues that that audio prompts 122 and, 124, and 126 as depicted in Fig. 6A and described in [61-64] of Freeman (US 2005/0251213) depict sequential guidance rather than guidance that changes based on use state. It should be noted that the office action mailed on April 16, 2026 refers to Fig. 6A-6E, not to Fig. 6A alone. In [0058], Freeman explains that FIG. 6A illustrates, in flow chart form, the default graphical and audio prompts without including responsive feedback prompts by the device that provide more detailed instructions depending on whether particular sequences have been successfully completed by the caregiver. However, Fig.s 6B-6E provide flowcharts of more detailed responsive feedback prompts. In Fig. 6D for example, after prompts #19-22 have been delivered (a first guidance) the defibrillator detects whether or not the use state is “Pad still on left liner.” If yes, the defibrillator issues prompt #23 (second guidance A), and if no, the defibrillator issues prompt #26-30 (second guidance B). This reads on outputting a first guidance then outputting a second guidance with a content based on a change in use state. Further, see the new grounds of rejection set forth below in reference to Freeman ¶55 and Fig. 3C.
Regarding claims 2-3: Applicant argues that Freeman does not teach changing the content of guidance before and after checking the use state at FIG. 6D because, as shown in FIG. 6D, Freeman teaches that all prompts are provided sequentially. However, in the example in Fig. 6D, only prompts #19-22 are delivered sequentially, prompts #23 & #26-30 are delivered based on a change in use state. Further, although the applicant argues that the defibrillator provides prompts 19-22 before it checks if pad is still on left liner to output either prompt #23 or prompts #26-30, even if there is a change in the use state at a time during prompts #19-22, independent claim 1, on which claims 2 and 3 depend, requires “the controller is configured to output a first content of the guidance, the first content comprising a series of audio output, and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance.” Prompts #19-22 read on a first content of the guidance and prompt #23 or prompts #26-30 read on a second content of a guidance. Claim 1 requires that the first content of the guidance be output before the second content of the guidance is output after the controller detects a change in use state. Therefore, even though prompts #19-22 are delivered sequentially, this still reads on the limitations of claims 1-3.
Regarding claim 6: Applicant did not challenge Kanemoto et al. (US 2017/0296804) but did argue that claim 6 would be allowable if their argument regarding claim 1 is found persuasive on the basis of the dependency of claim 6 on independent claim 1 and because of the additional limitations added by claim 6. This argument is not found persuasive for the same reasons as claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites the following limitations which are identified by the examiner as encompassing an abstract idea:
“detect a use state of a defibrillator by an operator”;
“output guidance of a use method of the defibrillator, according to the detected use state”
“detect a change in the use state in a period before a timing at which a pair of pads of the defibrillator are attached to a skin of a subject from a timing at which the defibrillator is started up”
MPEP 2106.04(a)(2)(III): The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.
MPEP 2106.04(a)(2)(II): The sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions.
The above limitations are identified as a mental process, and/or a method of organizing human activity because they reflect a mental process of a medical professional observing an operational state of a defibrillator based on the attachment status of defibrillator pads and issuing instructions for its use.
This judicial exception is not integrated into a practical application because although the claim recites additional elements: “defibrillator comprising a controller” used to perform the abstract steps identified in Step 2A, Prong 1 section above, the USPGPub. version of instant specification discloses the following:
"[0029] In a case where the AED 1 is started up, the controller 103 reads and executes the program or the like that is stored in the memory 104, and controls the various operations of the AED 1. More specifically, the controller 103 can include an output controller 131, a power supply controller 132, a detection unit 133, and an electrode pad controller 134."
Therefore, “controller” reads on computer processor, is recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of providing performing the abstract idea steps identified in Step 2A, Prong 1. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component.
Recitation of the defibrillator itself is also an additional element, but similarly is described only at a high level and serves to nominally tie the claimed abstract idea to a technical field, or field of use but does not integrate the abstract idea into a practical application.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraph [0029] does not provide any indication that the controller is anything other than generic, off-the-shelf computer components. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
For these reasons, there is no inventive concept in the claim and thus it is ineligible. as discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component.
Recitation of the defibrillator itself is also an additional element, but similarly is described only at a high level and serves to nominally tie the claimed abstract idea to a technical field, or field of use but does not integrate the abstract idea into a practical application.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraph [0029] does not provide any indication that the controller is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2. The use of control circuitry in an AED is well understood, routine and conventional in the art as evidenced by Marenco et al. (Improving Survival from Sudden Cardiac Arrest: The Role of the Automated External Defibrillator, 2001. Pg 1194, Results section ¶1).
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
Dependent claims 2-7 further limit the abstract idea already indicated in independent claim 1 and they are ineligible for the same reasons provided for claim 1 above.
Dependent claims 8 and 9, further recites an “optical sensor.” However, “optical sensor” is not part of the defibrillator. The detected signal is being used by the controller, which is the only part of the defibrillator, in assessing the configuration/state of the pads. This is considered extra-solution activity and therefore does not integrate the abstract idea into a practical application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, & 8 of US Patent No. 12697499 to Kuno & Miyachi (hereinafter Kuno) in view of Freeman (PGPub US 2005/0251213).
With respect to instant claim 1-4
Instant claims, application 18/974,356
US Patent No. 12697499
Differences
Claim 1
A defibrillator comprising: a controller
Claim 1
An automated external defibrillator … the automated external defibrillator comprising: …a processor;
configured to: detect a use state of a defibrillator by an operator;
Claim 6
the automated external defibrillator determines whether the pair of electrode pads are attached to the subject or not based on an impedance value between the pair of electrode pads
output guidance of a use method of the defibrillator, according to the detected use state
Claim 8
An output portion that audibly or visually presents first guidance for prompting an operator to perform the defibrillation process
according to the detected use state
wherein the controller is configured to detect a change in the use state in a period between a start up event of the defibrillator and an event involving the defibrillator detecting that a pair of pads of the defibrillator are attached to a skin of a subject
Claim 1
receiving a physiological signal of the subject through an electrode pad; determining whether the defibrillation process is necessary or not, based on the physiological signal; and determining whether the electrode pad is attached to the subject and a predetermined operation has been performed on the automated external defibrillator or not
Claim 6
the automated external defibrillator determines whether the pair of electrode pads are attached to the subject or not
wherein during the period, the controller is configured to output a first content of the guidance, the first content comprising a series of audio output
wherein during the period, the controller is configured to output a first content of the guidance, the first content comprising a series of audio output
upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance.
upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance.
Claim 2
defibrillator according to claim 1,
As claim 1
wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper
wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper
Claim 3
The defibrillator according to claim 2
As claim 2
wherein the controller is configured to change a content of the guidance before and after the controller detects that at least one of the pair of pads is peeled off from the release paper.
wherein the controller is configured to change a content of the guidance before and after the controller detects that at least one of the pair of pads is peeled off from the release paper.
Claim 4
The defibrillator according to claim 2
As claim 2
wherein the controller is further configured to detect that the pair of pads are attached to the skin of the subject,
Claim 1
determining whether the electrode pad is attached to the subject;
and in a case where the controller does not detect that the pair of pads are attached to the skin of the subject before a predetermined time elapses after the controller detects that at least one of the pair of pads is peeled off from the release paper,
the controller is configured to output the guidance to prompt an operator to check a connection state of the defibrillator and each of the pair of pads.
and in a case where the controller does not detect that the pair of pads are attached to the skin of the subject before a predetermined time elapses after the controller detects that at least one of the pair of pads is peeled off from the release paper,
the controller is configured to output the guidance to prompt an operator to check a connection state of the defibrillator and each of the pair of pads.
Therefore, the claims in US Patent No. 12697499 recite all of instant claims 1-4, excepting for “output guidance… according to the detected use state”, “output a first content of the guidance, the first content comprising a series of audio output and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance”, “the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper”, “the controller is configured to change a content of the guidance before and after the controller detects that at least one of the pair of pads is peeled off from the release paper”, and “in a case where the controller does not detect that the pair of pads are attached to the skin of the subject before a predetermined time elapses after the controller detects that at least one of the pair of pads is peeled off from the release paper, the controller is configured to output the guidance to prompt an operator to check a connection state of the defibrillator and each of the pair of pads”.
Attention is brought to the Freeman reference, which show in Figs. 7A-7B a list of the prompts that are delivered, based on device use state, according to the flowchart in Figs. 6A-E (output guidance… according to the detected use state). For example, in FIG. 6D Freeman shows a flowchart for prompting related to retrieval and application of electrodes ([0074]). These audio prompts include a first content (#19-22 for example), and a second content delivered after a change in use state of the device (prompts #23 & #26-30 for example). Which prompt or prompts are delivered is determined based on the use state, as indicated in the flow charts (output a first content of the guidance, the first content comprising a series of audio output and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance).
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Freeman further teaches that when it has been determined that an electrode 212, 214 has been removed from the liner 216 (detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper), the processor means 20 proceeds to the next state ([0074) and alters the guidance before and after that use state illustrated by the flowchart in Fig. 6D which shows 3 sets of prompts: #19-22 used before the use state check, #23 used if the use state “pad is still on the liner” is detected, and #26-30 used if the use state “pad is not still on the liner” is detected (change a content of the guidance before and after the controller detects that at least one of the pair of pads is peeled off from the release paper). If electrode contact is lost at any time (as determined by the impedance data received from the electrode assembly), this will result in an appropriate audio prompt, such as "check electrodes" and illumination of the LED adjacent graphic 46 ([0072]) (in a case where the controller does not detect that the pair of pads are attached to the skin of the subject before a predetermined time elapses after the controller detects that at least one of the pair of pads is peeled off from the release paper, the controller is configured to output the guidance to prompt an operator to check a connection state of the defibrillator and each of the pair of pads.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the outputting of a first content of guidance, outputting a second content of guidance based on a upon detecting the change in the use state, the detection of a pad peeled off of release paper, the alteration of guidance based on a change in use state based on the pad being peeled off of the release paper, and issuing guidance to check the connection state and pad if the device does not detect the electrodes being attached to the subject as disclosed by Freeman to the device claimed by US Patent No. 12697499 for the purpose of “assisting caregivers in delivering therapy to a patient,” as stated by Freeman ([0001]).
With respect to instant claim 5-7
Instant claims, application 18/974,356
US Patent No. 12697499
Differences
Claim 5
The defibrillator according to claim 1,
As claim 1
wherein the controller is configured to detect the change in the use state, based on an impedance between the pair of pads.
Claim 6
the automated external defibrillator determines whether the pair of electrode pads are attached to the subject or not, based on an impedance value between the pair of electrodes
Claim 6
The defibrillator according to claim 5
As claim 5
wherein, in a case where the impedance becomes equal to or greater than a threshold value or in a case where the impedance rises by a predetermined value or more from a reference value, the controller determines that at least one of the pair of pads is peeled off from a release paper.
wherein, in a case where the impedance becomes equal to or greater than a threshold value or in a case where the impedance rises by a predetermined value or more from a reference value, the controller determines that at least one of the pair of pads is peeled off from a release paper.
Claim 7
The defibrillator according to claim 5
As claim 5
wherein, in a case where the impedance becomes equal to or less than a threshold value or in a case where the impedance decreases by a predetermined value or more from a reference value, the controller determines that the pair of pads is attached to the subject.
wherein, in a case where the impedance becomes equal to or less than a threshold value or in a case where the impedance decreases by a predetermined value or more from a reference value, the controller determines that the pair of pads is attached to the subject.
Therefore, the claims in US Patent No. 12697499 recite all of instant claim 5-7, excepting for “in a case where the impedance becomes equal to or greater than a threshold value or in a case where the impedance rises by a predetermined value or more from a reference value, the controller determines that at least one of the pair of pads is peeled off from a release paper” and “in a case where the impedance becomes equal to or less than a threshold value or in a case where the impedance decreases by a predetermined value or more from a reference value, the controller determines that the pair of pads is attached to the subject”.
Attention is brought to the Freeman reference, which teaches evaluating whether or not “an impedance measured between the electrodes that is significantly outside the normal physiological range” and that impedance outside this range may result from insufficient electrical contact with the patient's skin ([0074]). Detecting whether a value is or in not within a range requires determining whether the value is above or below the limits of the range, which are predetermined values (in a case where the impedance becomes equal to or less than a threshold value or in a case where the impedance decreases by a predetermined value or more from a reference value, the controller determines that the pair of pads is attached to the subject). As stated above, Freeman also teaches detecting the release of a pad from a liner as a use state by means of measuring impedance, (e.g. "Attach Electrodes" if the initial prompts on the unit have been delivered and the impedance remains greater than some specified threshold) ([0012]) (where the impedance becomes equal to or greater than a threshold value or in a case where the impedance rises by a predetermined value or more from a reference value, the controller determines that at least one of the pair of pads is peeled off from a release paper).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the comparison of impedance to reference value, determination of pads being removed from release paper, and determination of pads being attached to a subject as disclosed by Freeman to the device claimed by US Patent No. for the purpose of “assisting caregivers in delivering therapy to a patient,” as stated by Freeman ([0001]).
With respect to instant claim 8 & 9
Instant claims, application 18/974,356
US Patent No. 12697499
Differences
Claim 8
The defibrillator according to claim 1
As claim 1
wherein the controller is configured to detect the change in the use state, based on a measurement value obtained by an optical sensor attached to each of the pair of pads.
wherein the controller is configured to detect the change in the use state, based on a measurement value obtained by an optical sensor attached to each of the pair of pads.
Claim 9
The defibrillator according to claim 8
As claim 8
wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper or that the pads are taken out from a bag, based on the measurement value obtained by the optical sensor.
wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper or that the pads are taken out from a bag, based on the
Therefore, the claims in US Patent No. 12697499 recite all of instant claim 8 & 9, excepting for “wherein the controller is configured to detect the change in the use state, based on a measurement value obtained by an optical sensor attached to each of the pair of pads” and “wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper or that the pads are taken out from a bag, based on the measurement value obtained by the optical sensor”.
Attention is brought to the Freeman reference, which teaches the use of an optical sensor to detect a change in use state when the electrodes are taken out of a bag (When the package photosensor 210 detects light above a certain threshold, it is known that the electrodes have been removed from the storage area 222 or pouch 16 ([0074]) (wherein the controller is configured to detect the change in the use state, based on a measurement value obtained by an optical sensor attached to each of the pair of pads and wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper or that the pads are taken out from a bag, based on the measurement value obtained by the optical sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the use of an optical sensor to determine the change of use state of removing the electrodes from a bag as disclosed by Freeman to the device claimed by US Patent No. 12697499 for the purpose of “assisting caregivers in delivering therapy to a patient,” as stated by Freeman ([0001]).
In the office action mailed on April 16, 2026, the above rejection was presented as a provisional rejection based on copending Application No. 18/729,387. On Aug-4, 2026 Application No. 18/729,387 was issued as US Patent No. 12697499. The rejection has been updated to reflect the applicant’s amendments and the claims of issued US Patent No. 12697499. This is a non-provisional rejection based on an issued US Patent.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. PGPUB No. 2005/0251213 to Freeman, hereinafter "Freeman".
Regarding claim 1, Freeman discloses a defibrillator (¶[0042] defibrillator element 10) comprising: a controller (¶¶[0043-0044] circuitry and software, processor) configured to:
detect a use state of a defibrillator by an operator (Fig. 6A-6E flowchart illustrates decision points which test the use state of the defibrillator comprising whether one or more steps in a protocol has been completed successfully in ¶[0043], it is noted that “use state” is interpreted by the examiner to comprise the device status such as on, electrodes deployed, packaging removed, electrodes attached, electrodes attached properly, shockable rhythm present, etc.); and output guidance of a use method of the defibrillator according to the detected use state (Fig. 7A-B, table of provided prompts which comprise guidance for a user in using the device), wherein the controller is configured to detect a change in the use state (¶[0043] the steps in a protocol each comprise a use state, and completion of a step of the protocol yields a change in the use state, see flowcharts in Figs. 6A-E to see additional changes in use state) between a start up event of the defibrillator and an event involving the defibrillator detecting that a pair of pads of the defibrillator are attached to a skin of a subject (each of the steps in Fig. 6A-6D up to “analyze rhythm” are changes in use state of the device between device start up and electrodes attached to skin of a subject, see [0059-0065]), wherein during the period, the controller is configured to output a first content of the guidance, the first content comprising a series of audio output (prompt #4-6 in Fig. 6C), and upon detecting the change in the use state at any timing during the period, the controller is further configured to output a second content of the guidance (prompt #7, #8, & #9-12 in Fig. 6C and “Referring to FIG. 6c, if the processing means 20 detects that the cover is upside down 153, it will cause an audible prompt 151 to be delivered to the user that is more detailed than the original prompt. The processing means 20 will also slow down the rate of speech of the audio prompts. If the cover is still upside down after a predetermined period of time, the processing means 20 will deliver an even more detailed message on how to properly place the cover” in ¶55).
Regarding claims 2 and 3, Freeman discloses the defibrillator according to claim 1 wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper to which each of the pair of pads is attached (FIG. 6d shows the flowchart for prompting related to retrieval and application of electrodes ¶74; this chart includes separate steps for “Pad still on Left liner?” and “Pad still on Right liner?”), and wherein the controller is configured to change a content of the guidance before and after the controller detects that at least one of the pair of pads is peeled off from the release paper (FIG. 6d shows prompts #19-22 given before checking the use state, prompt #23 given if the Left electrode is still on the liner after the use state is checked, and prompts #26-30 given if the Left electrode is not still on the liner).
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Regarding claim 4, Freeman discloses the defibrillator according to claim 2, wherein the controller is configured to detect that the pair of pads are attached to the skin of the subject (If it has been determined that both electrodes 212, 214 are applied to the patient 218 but there is an impedance measured between the electrodes that is significantly outside the normal physiological range then it is very possible that the user has applied the electrodes to the patient without removing the patient's shirt. Surprisingly, this is not uncommon in real situations with users; a patient's shirt will have been only partially removed when electrodes are applied resulting in insufficient electrical contact with the patient's skin. ¶72) and, in a case where the controller does not detect that the pair of pads are attached to the skin of the subject before a predetermined time elapses after the controller detects that at least one of the pair of pads is peeled off from the release paper the controller is configured to output the guidance to prompt an operator to check a connection state of the defibrillator and each of the pair of pads (If electrode contact is lost at any time (as determined by the impedance data received from the electrode assembly), this will result in an appropriate audio prompt, such as "check electrodes" and illumination of the LED adjacent graphic 46 ¶72).
Regarding claim 5- 7, Freeman discloses the defibrillator according to claim 1, wherein the controller is configured to detect the change in the use state, based on an impedance between the pair of pads (If electrode contact is lost at any time (as determined by the impedance data received from the electrode assembly) ¶72) wherein, in a case where the impedance becomes equal to or greater than a threshold value or in a case where the impedance rises by a predetermined value or more from a reference value, the controller determines that at least one of the pair of pads is peeled off from a release paper (an impedance measured between the electrodes that is significantly outside the normal physiological range ¶74 and Fig 6D including the use state checks “Pad still on Left liner?” and “Pad still on Right liner?”. It should be noted that Freeman does not explicitly recite the use of impedance to determine the release of a pad from a liner, but the BRI of claim 6 does not explicitly require a causal relationship between the increased impedance and the detection of at least one pad being released.), in a case where the impedance becomes equal to or less than a threshold value or in a case where the impedance decreases by a predetermined value or more from a reference value, the controller determines that the pair of pads is attached to the subject (If it has been determined that both electrodes 212, 214 are applied to the patient 218 but there is an impedance measured between the electrodes that is significantly outside the normal physiological range then it is very possible that the user has applied the electrodes to the patient without removing the patient's shirt.).
Regarding claims 8 & 9, Freeman discloses a defibrillator according to claim 1, wherein the controller is configured to detect the change in the use state, based on a measurement value obtained by an optical sensor attached to each of the pair of pads (a package photosensor 210 is provided on the outer face of the electrode backing 220. Detection that the electrode 208 is sealed in the storage area is determined by the photosensor output being below a threshold ¶74) wherein the controller is configured to detect, as the change in the use state, that at least one of the pair of pads is peeled off from a release paper, based on the measurement value obtained by the optical sensor (When an electrode 212, 214 is removed from the liner 216 the background level of the signal increases due to ambient light while the synchronous portion decreases because there is little if any of the photoemitter light reflected back into the photosensor; this condition describes when an electrode 212, 214 is removed from the liner 216 ¶74).
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Kanemoto et al. (U.S. Patent Application Publication No. 20170296804 (herein after referred to as Kanemoto).
Regarding claim 6, Freeman discloses the defibrillator according to claim 5.
In case Applicant disagrees with the examiner’s BRI in interpreting claim 6 as above, rejected under 35 U.S.C. § 102 as anticipated by Freeman, attention is drawn to the Kanemoto reference.
Kanemoto teaches wherein, in a case where the impedance becomes equal to or greater than a threshold value (Table 1), the controller determines that at least one pair of pads is peeled off from a release paper (¶[0031] and ¶[0034] the pads are activated for sensing when the paper is peeled from the surface, in combination with Table 1, ¶[0045]: “In the case where R is higher than RH (R>RH), it is possible to detect that the defibrillation pad has not yet been attached or an attachment failure occurs.”)
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the impedance measurement taught by Kanemoto for the purpose of determining the use state of electrode pads to the defibrillator taught by Freeman as method of determining the use state of the electrodes for the purpose of checking whether the electrode pads have been used as stated by Kanemoto (¶17).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM P ADAMS whose telephone number is (571)270-0136. The examiner can normally be reached 9am-6pm M-Th.
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/W.P.A./ Examiner, Art Unit 3792
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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