DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The Applicant should note that the large number of references in the attached information disclosure statement (IDS) have been considered by the Examiner in the same manner as other documents in Office search files are considered by the Examiner while conducting a search of the prior art in a proper field of search (See MPEP 609.05(b)). The Applicant is requested to point out any particular references in the IDSs which they believe may be of particular relevance to the instant claimed invention in response to this office action (see suggestion 13 of MPEP 2004).
Also, it is noted that only those references that have been properly supplied in proper IDS format have been considered. In particular, 37 CFR 1.98(a)(1) requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-10 and 17-10 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.
Claim 7 recites “the output signal being associated with the trigger condition in response to detecting the trigger condition” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “an output configured to be detected by a user holding the hand-held device” of claim 7, lines 1-2. If they are the same, consistent terminology should be used. If they are different, there is insufficient antecedent basis for “the output signal” in the claim, it is not clear where this output signal comes from, and it is not clear what “associated with the trigger condition in response to detecting the trigger condition” is intended convey since the trigger condition itself cannot be a consequence of detecting the trigger condition.
Claims 8-10 are rejected by virtue of their dependence from claim 7.
Claim 17 recites “the output signal being associated with the trigger condition in response to detecting the trigger condition” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “an output configured to be detected by a user holding the hand-held device” of claim 17, lines 1-2. If they are the same, consistent terminology should be used. If they are different, there is insufficient antecedent basis for “the output signal” in the claim, it is not clear where this output signal comes from, and it is not clear what “associated with the trigger condition in response to detecting the trigger condition” is intended convey since the trigger condition itself cannot be a consequence of detecting the trigger condition.
Claims 18-20 are rejected by virtue of their dependence from claim 17.
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.
Claims 1-3, 6-13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/084182 (Willand 2019)(previously cited), in view of U.S. Patent Application Publication No. 2003/0088185 (Prass), and further in view of U.S. Patent No. 8,731,657 (Shambayati).
Willand 2019 teaches a method of operating a hand-held electrical stimulation device (FIG. 2A of Willand 2019), the method comprising: applying an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Willand 2019 also teaches that, when an electrode is properly placed in contact with neural tissue, the electrode-tissue impedance will be smaller than the impedance when the electrode is not in contact with tissue (paragraph 0156 of Willand 2019). The impedance in such circumstance is typically less than 10 kOhm (e.g., 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-9, 9- 10, 3-8, 1-10, 4-8 KOhm, impedances between the foregoing ranges, etc.)(paragraph 0156 of Willand 2019). Resistances exceeding a threshold value (e.g., 10 kOhm) can be an indication of improper placement of the electrode and the system is configured of recognizing values exceeding such a threshold (paragraph 0156 of Willand 2019).
Prass teaches that duration of time can be used to determine if the probe is in going into or determining a position (that is, “Whether the predetermined operations are initiated or completed depends upon the duration of continuous tissue contact…if the duration [of] continuous tissue contact is less than a preselected period of approximately one or two seconds, the controller will maintain the operational status of the nerve Integrity monitor in the ‘search’ mode”, paragraph 0150 of Prass). However, “if the duration of continuous tissue contact exceeds the preselected time period, the stimulator or controller may alert the surgeon with an indicator tone and controller will automatically change the operational status of the nerve integrity monitor to a quantitative assessment mode and provide a preprogrammed sequence of quantitative assessment stimulus pulses” (paragraph 0150 of Prass). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor the duration of continuous tissue contact and automatically operate the qualitative assessment mode of the device of Willand 2019 when the duration exceeds a preselected period of time, as suggested by Prass, since it ensures contact and automates the process.
Willand 2019 teaches that the system is configured to periodically detect the impedance during the continuous application of electrical stimulation. If relatively high impedance is detected (e.g., high compared to a threshold level or upper limit), the system can be designed and otherwise configured to pause the application of continuous electrical stimulation and enable an indicator 118 on the housing 114 to alert the operator. In other arrangements, the system is configured to terminate (e.g., automatically stop) the stimulus output and/or prompt the user. The indicator comprises a visual indicator, an auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication (paragraph 0157 of Willand 2019).
Shambayati teaches that a very small stimulus current is sent through the electrode at regular intervals for contact detection (col. 7, lines 18-35 of Shambayati). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a very small stimulus current (smaller than the operational current) to periodically detect the impedance for contact detection during operation of the probe of Willand 2019 since it confirms electrode contact. With respect to the amount of the very small stimulus current, such an amount is suggested by Shambayati as being smaller than the operational current and Willand 2019 suggests that the contact detection is determined during operation. From these teachings, the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current would depend upon the level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the level of certainty required for electrode contact. As such, the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current are results-effective variables that would have been optimized through routine experimentation based on the level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the level of certainty required for electrode contact. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current so as to obtain the desired level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the desired level of certainty required for electrode contact.
With respect to claim 1, the combination teaches or suggests a method of operating a hand-held electrical stimulation device (FIG. 2A of Willand 2019), the method comprising:
detecting a trigger condition associated with a predefined tetanic burst stimulation (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
automatically applying an electrical tetanic burst signal to an electrode system of the hand-held device, in response to the detecting of the trigger condition, to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019 which is automatically activated when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass);
wherein detecting the trigger condition comprises detecting continuous contact between the electrode system and tissue for at least a predefined duration of time (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
wherein during a detection waveform phase of the electrical tetanic burst signal, a sub-threshold electrical signal is provided to the electrode system to confirm the trigger condition, wherein the sub-threshold electrical signal does not generate an action potential (the very small stimulus current of Shambayati optimized in amount and its temporal application relative to the temporal application of the operational stimulus of Willand 2019).
With respect to claims 2-3 and 12-13, Prass teaches that a suitable duration of time to determined electrode contact can be one or two seconds when can be used to determine if the probe is in going into or determining a position (paragraph 0150 of Prass). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use one or two seconds as a duration of time for determining electrode contact since a duration of time is required and Prass teaches such durations of time. Thus, the combination teaches or suggests “wherein the predefined duration of time is at least 0.1 seconds” (claim 2), “wherein the predefined duration of time is at least 0.5 seconds” (claim 3), “wherein the predefined duration of time is at least 0.1 seconds” (claim 12), and “wherein the predefined duration of time is at least 0.5 seconds” (claim 13).
With respect to claim 6, the combination teaches or suggests that the electrical tetanic burst signal has a frequency of 20 Hz (The frequency range may include 15-20 Hz or 20-30 Hz or any frequencies within the these ranges; paragraphs 0249-0250 of Willand 2019).
With respect to claim 7, the combination teaches or suggests generating an output configured to be detected by a user holding the hand-held device, the output signal being associated with the trigger condition in response to detecting the trigger condition (the visual indicator, the auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication; paragraph 0157 of Willand 2019).
With respect to claims 8, 10, 18, and 20, Willand 2019 teaches that the system is configured to periodically detect the impedance during the continuous application of electrical stimulation. If relatively high impedance is detected (e.g., high compared to a threshold level or upper limit), the system can be designed and otherwise configured to pause the application of continuous electrical stimulation and enable an indicator 118 on the housing 114 to alert the operator. In other arrangements, the system is configured to terminate (e.g., automatically stop) the stimulus output and/or prompt the user. The indicator comprises a visual indicator, an auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication (paragraph 0157 of Willand 2019). Willand 2019 also teaches that a haptic feedback indicator is also a suitable indicator for reporting proper conditions for application of operational stimulus current (paragraphs 0010, 0020, 0233-0234, and 0242 of Willand 2019). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a haptic feedback indicator in addition to the visual indicator for informing the user of electrode contact since Willand 2019 teaches that any other type of indicator can be used in addition to visual indication and Willand 2019 teaches one such type of indicator. Thus, the combination teaches or suggests “wherein the output comprises a haptic output” (claim 8), “wherein the output comprises a haptic output and a visual output” (claim 10), “wherein the output comprises a haptic output” (claim 18), and “wherein the output comprises a haptic output and a visual output” (claim 20).
With respect to claim 9, the combination teaches or suggests that the output comprises a visual output (the visual indicator; paragraph 0157 of Willand 2019).
With respect to claim 11, the combination teaches or suggests a method of operating a hand-held electrical stimulation device, the method comprising:
detecting a trigger condition associated with a predefined tetanic burst stimulation, wherein the trigger condition comprises continuous contact between an electrode system of the hand-held device and tissue for at least a predefined duration of time (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
applying an electrical tetanic burst signal to the electrode system in response to the detecting of the trigger condition, to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019 which is automatically activated when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
providing a sub-threshold electrical signal to the electrode system during a detection waveform phase to confirm the trigger condition, wherein the sub-threshold electrical signal does not generate an action potential (providing the very small stimulus current of Shambayati optimized in amount and its temporal application relative to the temporal application of the operational stimulus of Willand 2019).
With respect to claim 16, the combination teaches or suggests that the electrical tetanic burst signal has a frequency of 20 Hz (The frequency range may include 15-20 Hz or 20-30 Hz or any frequencies within the these ranges; paragraphs 0249-0250 of Willand 2019).
With respect to claim 17, the combination teaches or suggests generating an output configured to be detected by a user holding the hand-held device, the output signal being associated with the trigger condition in response to detecting the trigger condition (the visual indicator, the auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication; paragraph 0157 of Willand 2019).
With respect to claim 19, the combination teaches or suggests that the output comprises a visual output (the visual indicator; paragraph 0157 of Willand 2019).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Willand 2019, in view of Prass, and further in view of Shambayati, and further in view of WO 2023/137142 (Mooney).
Willand 2019 teaches the application of an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Mooney teaches that a pulse width of 2 milliseconds and a train duration of 1 second can be used in such an application (paragraph 00232 of Mooney). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pulse width of 2 milliseconds and a train duration of 1 second in the application of an electrical tetanic burst signal since pulse width and train duration are required and Mooney teaches such parameters and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 4, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the train duration of 1 second of Mooney).
With respect to claim 5, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the pulse width of 2 milliseconds of Mooney).
With respect to claim 14, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the train duration of 1 second of Mooney).
With respect to claim 15, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the pulse width of 2 milliseconds of Mooney).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Willand 2019, in view of Prass, and further in view of Shambayati, and further in view of U.S. Patent Application Publication No. 2018/0326220 (Kaula).
Willand 2019 teaches the application of an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Kaula teaches that the pulse width of tonic pulses in a range between about 1 microsecond and about 10,000 microseconds can be used in such an application (paragraph 0129 of Kaula). Thus, Kaula teaches that the pulse width can be subject to optimization based on physiology, user preferences, and the condition of the patient. As such, the pulse width is a results-effective variable that would have been optimized through routine experimentation based on physiology, user preferences, and the condition of the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the pulse width, using the range of Kaula as a starting point, so as to obtain the desired result based on physiology, user preferences, and the condition of the patient.
With respect to claim 4, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the optimization using the ranges of Kaula as a starting point; further, “about 10,000 microseconds” is close to the claimed range, which makes the value obvious (MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”)).
With respect to claim 5, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the optimization using the ranges of Kaula as a starting point; further, “about 1 microsecond and about 10,000 microsecond” is overlapping the claimed range, which makes the value obvious (MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”)).
With respect to claim 14, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the optimization using the ranges of Kaula as a starting point; further “about 10,000 microseconds” is close to the claimed range, which makes the value obvious (MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”)).
With respect to claim 15, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the optimization using the ranges of Kaula as a starting point; further, “about 1 microsecond and about 10,000 microsecond” is overlapping the claimed range, which makes the value obvious (MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”)).
Response to Arguments
The Applicant's arguments filed 11/26/2025 have been fully considered.
Specification
In view of the amendments to the abstract filed on 11/26/2025, the objections to the abstract are withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph that were necessitated by the claim amendments filed on 11/26/2025.
Prior art rejection
The Applicant’s arguments with respect to the rejections of claims 1-20 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection that were necessitated by the claim amendments filed on 11/26/2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791