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 .
Election/Restrictions
Applicant’s election of claims 1-12, 15, 17, 19-21, 23 and 26 (directed to Invention II) in the reply filed on 12 November 2025 is acknowledged. As such, claims 7-12, 14, 15 and 20 are also withdrawn from consideration as being directed to non-elected Invention I (Fig. 1). Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 18 and 26 are objected to because of the following informalities: at line 5 of claim 1, “and wherein” should apparently read –wherein--; and at line 6 of claim 1, “current stimulates the phrenic nerve” should apparently read –current is configured to stimulate the phrenic nerve--; at line 2 of claim 18, “least two layers” should apparently read –at least two layers--; at line 6 of claim 26, “supply” should apparently read –supplying--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “control unit” in claim 2 (the equivalent structures of which are identified in at least paragraph [0029] of the instant publication); and “trigger unit” in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) 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 2-6 and 18 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 2 at line 4 recites the limitation "the amplitude, pulse width, frequency and/or train duration". There is insufficient antecedent basis for this limitation in the claim.
Claim limitation “trigger unit” (claim 4) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
At line 2 of claim 18, it is unclear if “electrical components” includes any of the previously recited elements of the device or if “electrical components” are in addition to such.
Claim 18 at lines 2-3 recites “two layers of containment”. It is unclear if a layer of containment is an additional structure of the device as claimed, or if it is part of structures/limitations already recited.
At lines 3-4 of claim 18, it is unclear if “a primary layer of containment” is in addition to “two layers of containment” or part of the recited “two layers of containment”.
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)(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 1-3, 6, 17, 21 and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Prouza (U.S. Patent No. 11,266,850). Regarding claim 1, Prouza discloses a device for providing mechanical ventilation of a user, said device comprising:
at least two metallic (copper) coils (“energy delivery elements”) 2602 (Figs. 19a-23b and col. 10, lines 27-35 and 58-66), each coil configured to be placed adjacent to a phrenic nerve of the user (in the orientation shown in Fig. 26b and as described at col. 39, lines 57-67 – col. 40, lines 1-54; and col. 15, lines 41-48);
a stimulation unit for providing an electric current to the metallic coils (Fig. 3, col. 12, lines 46-53), and wherein the current is capable of stimulating the phrenic nerve to induce tetanic contractions of a diaphragm muscle of the user to regulate the user's breathing (stimulation of deep muscles such as the diaphragm - col. 20, lines 66-67 – col. 21, lines 1-7; also see col. 18, lines 17-22; pulses provided at appropriate position – col. 18, lines 35-38); and
a fluid compound for transferring heat away from the coils (col. 12, lines 7-9 and 46-53).
Regarding claim 2, the stimulation unit further comprises: a current pulse generator for supplying current pulses to each coil simultaneously (col. 39, lines 57-65), such that a time-varying magnetic field is induced on each coil (col. 2, lines 12-17) to stimulate the phrenic nerve (capable thereof - stimulation of deep muscles such as the diaphragm - col. 20, lines 66-67 – col. 21, lines 1-7); and a control unit for controlling one or more of the amplitude, pulse width, frequency and/or train duration of the current supplied to each coil (col. 6, lines 1-11; col. 37, lines 28-58; and Figs. 24, 27-29).
Regarding claim 3, the current pulse generator is configured to supply current pulses of up to 30 Hz frequency (col. 9, lines 39-47).
Regarding claim 6, the current pulse generator further comprises: one or more capacitors to store electrical energy for supply to the coils, said one or more capacitors connected to a transformer; and a thyristor/switching device 32, wherein the current from the one or more capacitors is discharged via the thyristor (col. 12, lines 54-64; col. 15, lines 32-40 and Figs. 4A-4B).
Regarding claim 17, the cooling compound comprises a cooling fluid that circulates through or around the coils to transfer heat from the coils to the cooling fluid (col. 12, lines 7-9; 21-37 and 46-53).
Regarding claim 21, each coil is made from a plurality of windings stacked in a plurality of layers (see Fig. 1), and wherein the layers are aligned and a shape of each layer forms a figure of eight pattern (col. 15, lines 41-52).
Regarding claim 23, Prouza teaches that the coils may correspond to various 3D bodies, such as a hemisphere, which would indicate the coil(s) as having a concave contour.
Claim Rejections - 35 USC § 103
18. 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.
19. 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.
20. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Prouza (U.S. Patent No. 11,266,850) in view of Biginton (GB2552004A). Regarding claim 18, Prouza discloses that the cooling fluid is electrically insulated from electrical components of the device by least two layers of containment (layers around the individual wires and insulated space between the individual, insulated wires – col.10, lines 27-39; and 58-67) and further that the device comprises an alarm/notification capability (col. 15, lines 6-20). However, Prouza fails to disclose wherein the alarm is triggered in an event of leakage of the fluid through a primary containment. Biginton teaches a magnetic stimulation device with a magnetic stimulation coil arrangement of adjacent coils, as likewise disclosed by Prouza, wherein first and second electrodes located in the housing/applicator of the device detect fluid leaks into the housing and the windings enclosed therein, wherein the windings are insulated (col. 9, lines 1-10) (as likewise disclosed by Prouza). Biginton further teaches that a change in impedance is indicative of a leak and therefore normal operation of the coil arrangement will be restricted via a control unit entering safety mode (col. 2, lines 10-30). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to a trigger/notification capability of restricted operation as taught by Biginton, in a portable magnetic stimulation containing a coolant fluid as suggested by Prouza, as Prouza recognizes the necessity of an alarm/notification capability (col. 15, lines 6-20), and Biginton teaches that such a notification/trigger capability would cease operation of a device in the event of a coolant fluid leak from around the coils (col. 2, lines 10-30 and col. 9, lines 1-10).
21. Claims 4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Prouza (U.S. Patent No. 11,266,850) in view of Simon et al. (U.S. Pub. No. 2019/0366076). Regarding claim 4, Prouza teaches that the stimulation unit further comprises a trigger unit capable of receiving a signal from an external ventilator unit (such as a sensor indicating movement of the patient col. 18, lines 54-67 – col. 19, lines 1-25), said signal providing data of a ventilation state of the ventilator unit (which is construed as movement data – col. 19, lines 1-5). While Prouza discloses that the unit is capable of generating synchronized pulses (col. 17, lines 1-11), Prouza fails to disclose that the pulses are synchronized with the sensor signal (128). Simon et al. (hereinafter Simon) teaches a portable device for transmitting impulses of energy to nerves/muscles of a patient (see Abstract, [0159] and [0219]), as likewise disclosed by Prouza, wherein an external unit is utilized to sense phases of the respiratory phase via movement and then provide stimulation during a selected phase of inspiration (which is construed as a synchronized manner) based on the sensed movement ([0218]-[0219]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to synchronize stimulation pulses as taught by Prouza, with sensed movement of a patient during a respiratory phase as suggested by Simon, as Prouza recognizes that movement of a patient affects placement of the magnetic stimulation, and Simon teaches that stimulation should synchronized with certain phases of patient movement, such as during the respiratory cycle([0218]-[0219]).
Regarding claim 26, Prouza teaches a method of stimulating a diaphragm muscle of a user to induce tetanic contractions (col. 20, lines 66-67 – col. 21, lines 1-7), said method comprising the steps of: aligning the coils of the device according to claim 1 such that each coil is placed adjacent to the diaphragm muscle (col. 20, lines 66-67 – col. 21, lines 1-7; and in the orientation shown in Fig. 26b and as described at col. 39, lines 57-67 – col. 40, lines 1-54; and col. 15, lines 41-48)); and supplying electrical pulses to said coils to induce tetanic contractions of the diaphragm muscle (stimulation of deep muscles such as the diaphragm - col. 20, lines 66-67 – col. 21, lines 1-7; also see col. 18, lines 17-22; pulses provided at appropriate position – col. 18, lines 35-38). However, Prouza fails to disclose explicitly that the stimulation of the diaphragm muscle involves stimulation of the phrenic nerve, such that each coil is placed adjacent to the phrenic nerve of the user. Simon teaches a portable device for transmitting impulses of energy to nerves/muscles of a patient (see Abstract, [0159] and [0219]), as likewise disclosed by Prouza, wherein stimulation of the diaphragm and phrenic nerve during inspiration phases effects regular diaphragm movement [0219]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to align coils placed adjacent to the diaphragm muscle, as taught by Prouza, adjacent the phrenic nerve as suggested by Simon, as the diaphragm muscle is where the phrenic nerve ends; the phrenic nerve controls movement of the diaphragm; and gradual stimulation of the phrenic nerve and diaphragm effects regular muscular movement of the diaphragm during the inspiration phase of the respiratory cycle ([0219] of Simon).
22. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Prouza (U.S. Patent No. 11,266,850) in view of Simon et al. (U.S. Pub. No. 2019/0366076) and further in view of Irazoqui et al. (U.S. Pub. No. 2019/0344076). Regarding claim 5, Prouza and Simon disclose the invention as claimed, see rejection supra; however the combination fails to disclose wherein the signal supplies the data at a frequency of at least 100 Hz. Irazoqui et al. (hereinafter Irazoqui) teaches a portable, personal-use device for providing magnetic stimulation to tissue of a patient ([0008]-[0010]) as likewise disclosed by Prouza and Simon, wherein external data signals are provided from remote units in order to facilitate wireless transmission of data to and from a stimulation unit/pulse generator ([0108]-[0109]). Irazoqui further indicates that the data signal may be applied at a frequency of at least 100 Hz to facilitate rapid data transmission from an external unit [0110]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to supply a data signal from the external sensing unit as taught by Poruza and Simon, at a frequency of at least 100 Hz as suggested by Irazoqui, as Poruza and Simon recognize that sensor data regulates/synchronizes with application of the stimulation device, and Irazoqui teaches that data supplied at a frequency of at least 100 Hz facilitates rapid transmission of data to and from a pulse generator [0110].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791