DETAILED ACTION
This Office Action is responsive to the Amendment filed 8 June 2026. Claims 24,
27-37 and 40-44 are now pending. The Examiner acknowledges the amendments to
claims 24, 27-37 and 40-43, as well as the cancellation of claims 26, 26, 38 and 39 and
the addition of claim 44.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “230” has been used to designate both “EEPROM” and “support structure”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“identifier” in claim 24, the corresponding structure of which is found to be “EEPROM”; and
“controller” in claims 31, 33, 35 and 37 (which is “configured to control operation of the induction device”), the corresponding structure of which is found to be disclosed at paragraph [0032].
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 24, 27-37 and 40-44 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 24 at lines 8-9 recites “a coil arrangement including one or more coils…”. It is unclear what “arrangement” implies structurally in this limitation as the claim then recites “one or more coils” however one coil would not appear to constitute an arrangement which would appear to implies a plurality of coils to fit the definition of “arrangement”.
Claims 27 and 43 recite “the digital data storage comprises an identifier memory included in the identifier”. Since, “identifier” in claim 24 is being construed as “EEPROM” per the interpretation under 35 U.S.C. 112(f) as indicated above, it is unclear, in light of the specification, how EEPROM could further include “identifier memory”. Claim 29 would also be indefinite for similar reasons.
Claim 28 at line 3 recites the limitation "the individual induction device". There is insufficient antecedent basis for this limitation in the claim.
Claim 40 at line 3 recites the limitation "the coil arrangements". There is insufficient antecedent basis for this limitation in the claim.
Claim 40 at line 3 recites “the coil arrangements is arranged to individually stimulate the Phrenic nerve”. It is unclear what “individually stimulate” means in this recitation.
At line 1 of claim 41, it is unclear if “life time data representing an operating lifetime…” is the same as or different than “lifetime data representing an operating lifetime…” recited at lines 20-21 of claim 24.
Claim 43 at line 4 recites the limitation "the individual induction device". There is insufficient antecedent basis for this limitation in the claim.
At line 5 of claim 43, it is unclear if “an identifier memory” is the same as or different than “an identifier memory” recited at line 2 of claim 43.
Claim 44 at lines 3-4 recites the limitation "the evaluated support structure data of the identified individual patient". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment to that recitation in lines 3-4 is -- the evaluated support structure data--.
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.
Claims 24, 27-29, 31-37 and 40-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Errico et al. (U.S. Pub. No. 2019/0111255). Regarding claim 24, Errico et al. (hereinafter Errico) teaches a stimulation arrangement for stimulating a phrenic nerve [0285] of a patient for activating a diaphragm of the patient (Figs. 1C, 6 and 8; [0092] and [0285]), the stimulation arrangement comprising:
an induction device with an electro-magnetic field generator (magnetic coil 340) and a support structure (Figs. 1C, 3A-3C and 7; [0108]-[0109], [0066], [0164]), and
a digital data storage comprising one or more non-transitory computer readable storage medium [0308],
wherein:
the electro-magnetic field generator of the induction device comprises a coil arrangement including one or more coils (magnetic coil 340) configured to generate a spatial electro-magnetic field having a targeted shape ([0066], [0074], [0108]-[0109], [0114], [0117]),
the coil arrangement of the electro-magnetic field generator of the induction device is coupled to the support structure of the induction device ([0164], Figs. 3A-3C and 7),
the support structure of the induction device is configured to be positioned at the patient such that the coil arrangement of the electro-magnetic field generator of the induction device is arranged to stimulate the phrenic nerve [0285] of the patient by generating the spatial electro-magnetic field (Figs. 6-8; [0108], [0111], [0114], [0117] and [0163]-[0164]),
the induction device comprises an identifier (flash memory) configured to identify the induction device (“medical device” 108/208) (see Figs. 12C, 14-15; ([0268]-[0269], [0303] and [0305]),
and the stimulation arrangement is configured to store use data representing a use of the stimulation arrangement in the digital data storage ([0308] – “…program the storage medium…”; also see [0146]-[0147]), and to store the lifetime data representing an operating lifetime of the induction device in the digital data storage ([0313] – “For example, there can be about 10, 31, or 93 (or less or more) days or uses of therapy as prescribed by a medical service provider…; and [0296] – “the processor 104 tracks such use and can take an action when a predetermined threshold is satisfied or not satisfied, such as via the logic stored via the memory 106. For example, the logic tracks a use of the medical device 108 and when a number of uses, as programmed in advance, satisfies or does not satisfy the predetermined threshold, then the processor 104 can take an action”; and [0311] – “the processor 104 instructs the output device of the system 100A to communicate with the storage medium in order to deactivate the storage medium, as disclosed herein, such as via deleting the content from the storage medium, reformatting the card, or others. As per block 508, the processor 104 tracks usage of the medical device 108 in order to be compliant with the content of the storage medium as read by the input device 110. For example, if the content mandates 1 use during 24 hours for 1 week, then the processor 104 track time, data”; also see [0146]-[0147]).
Regarding claim 27, and in view of its indefinite nature, the digital data storage comprises an identifier memory (e.g., flash memory) included in an identifier member (construed as a tag/barcode) ([0268]-[0269], [0303] and [0305]).
Regarding claim 28, and in view of its indefinite nature, the identifier memory of the digital data storage of the identifier member (tag/barcode) stores unique identifying data representing the induction device ([0268]-[0269] and [0303]).
Regarding claim 29, and in view of its indefinite nature, the electrically erasable programmable read-only memory (flash memory as indicated above with respect to claim 27) comprises identifier memory of the digital data storage.
Regarding claim 31, the stimulation arrangement further comprises a controller 330 configured to control operation of the induction device (Fig. 1C; [0108] and [0112]).
Regarding claim 32, the digital data storage comprises a controller memory included in the controller (controller 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]).
Regarding claim 33, the controller is configured to obtain an identification information from the identifier ([0112] and [0305]).
Regarding claim 34, the stimulation arrangement is configured to assign an identification information of the identifier to an individual therapy (such as prescribing a defined number of doses – [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 35, the stimulation arrangement further comprises a controller configured to control operation of the induction device (controller 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]), wherein the controller is configured to operate the induction device in accordance with the individual therapy assigned to the identification information (such as the defined number of doses - [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 36, the stimulation arrangement is configured to assign an identification information of the identifier to an individual therapy (such as prescribing a defined number of doses – [0009], [0140], [0303], [0313] and [0322]).
Regarding claim 37, the stimulation arrangement further comprises a controller configured to control operation of the induction device (controller 330 comprises a CPU and computer memories for the storage and retrieval of data [0112]), wherein the controller is configured to operate the induction device in accordance with the individual patient assigned to the identification information ([0303]-[0304]).
Regarding claim 40, and in view of its indefinite nature, the support structure of the induction device is configured to be individually adapted to the patient (via tightening of support collar 78 with a strap 79) such that the coil arrangement is arranged to individually stimulate the phrenic nerve of the patient (Fig. 7; [0285] and [0163]-[0164]).
Regarding claim 41, the stimulation arrangement is configured to store life time data representing an operating life time of the induction device in the digital data storage (as indicated above with respect to claim 24) and configured to store support structure data representing an individual adaptation of the support structure of the induction device of an individual patient in the digital data storage (the stimulation arrangement is also configured to store various types of data [0268]).
Regarding claim 42, absent any further description of a “blocking configuration,” the support structure of the induction device has a blocking configuration to block the stimulator 30 from touching the patient’s neck (see Fig. 7 and [0164]) when being individually adapted to a child.
Regarding claim 43, and in view of its indefinite nature, the identifier is an electrically erasable programmable read-only memory which comprises an identifier memory (see claim 29) and the identification information is unique identifying data stored in the identifier memory ([0268]-[0269] and [0303]).
Regarding claim 44, the stimulation arrangement is configured to evaluate the support structure data to identify the individual patient and to automatically adapt the support structure in accordance with the evaluated support structure data ([0174]: “the stimulator itself may modulate the amplitude of the stimulation in order to make such compensations” and [0180]).
Allowable Subject Matter
Claim 30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments filed 8 June 2026 with respect to the objections to the Drawings have been fully considered, and the objection above remains with respect to character “230” being used to designate both “EEPROM” and “support structure”. Such objection was not addressed nor resolved.
Applicant’s arguments filed 8 June 2026 with respect to the objection to the Specification have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 8 June 2026 with respect to the claim objections have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 8 June 2026 with respect to the interpretation of the claims under 35 U.S.C. 112(f) have been fully considered. While the claims were amended such that certain limitations are no longer interpreted under 112(f), “identifier” and “controller” are now interpreted under 35 U.S.C. 112(f) with their corresponding structures described.
Applicant’s arguments filed 8 June 2026 with respect to the rejection of claims 24-43 under 35 U.S.C. 112(b) have been fully considered, however new grounds of rejection are presented above in light of the amendments.
Applicant’s arguments filed 8 June 2026 with respect to the rejection of claim 38 under 35 U.S.C. 112(d) have been fully considered and are persuasive in light of its cancellation.
Applicant’s arguments filed 8 June 2026 with respect to the rejection of claims 24-43 under 35 U.S.C. 102(a)(1) citing Errico (‘255) have been fully considered and are not persuasive. Regarding claim 24, Applicant contends that “Although Errico identifies the phrenic nerve as one of several anatomical structures present in a neck cross-section, Errico does so only in the context of describing nearby anatomy for vagus nerve stimulation. See Errico at 0165. The mere identification of the phrenic nerve as an anatomical structure near the vagus nerve is not a disclosure of a stimulation arrangement configured to stimulate the Phrenic nerve, much less a disclosure of stimulating the Phrenic nerve for activating the diaphragm of the patient.” Applicant further states that Errico’s support structures are described in the context of positioning a stimulator for vagus nerve stimulation. However, this argument is not persuasive. Applicant’s attention is drawn to [0285] for the new limitation of “the coil arrangement…arranged to stimulate the Phrenic nerve” where Errico teaches that the medical device…can be configured to…treat a medical condition…with..output of an energy…to various nerves of human body…” which “include nerves, such as….phrenic nerve…”.
Applicant further contends that “Errico also does not disclose shaping the spatial electro-magnetic field to have the claimed targeted shape. Rather, Errico describes vagus nerve stimulation and general magnetic stimulation.”. However, this argument is not persuasive. First, the claim does not further define any particular shape of the field. A spatial electromagnetic field is created in or around the nerves as disclosed by Errico [0091]-[0092], and considered to be “targeted” in order to reach the nerve requiring stimulation by the electromagnetic energy, and due to various parameters of the stimulator such as frequency, amplitude and pulse width ([0086] and [0164]).
Applicant further contends that Errico does not disclose “storing lifetime data representing an operating lifetime of the induction device in the digital data storage…the data representing an operating lifetime of the induction device in the digital data storage” as “The Office appears to rely on Errico's disclosure of prescribed days or uses of therapy, usage tracking, and deactivation of a device or storage medium after a prescribed threshold is reached” and that such disclosure is materially different from the
claimed lifetime data representing an operating lifetime of the induction device as prescribed therapy duration, number of permitted uses, or refill data does not disclose storing such operating-lifetime data of the induction device. However, this argument is not persuasive. Applicant’s attention is directed to [0296], where it is disclosed by Errico that logic/memory tracks the number of uses of the medical device, which can be for “…a day, a week, a month, a year) or a number of single uses regardless of any time limit” which is being construed as “an operating lifetime” of the induction device, absent any further limitation of what constitutes “an operating lifetime”. In view of the foregoing, the rejection of claims 24, 27-29, 31-37 and 40-44 under 35 U.S.C. 102(a)(1) citing Errico (‘255) has been maintained.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Pub. No. 2002/0188332; and U.S. Pub. No. 2011/0230702.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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