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 .
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
Abstract: “System comprises…and a stimulation”. The Examiner believes Applicant intended this to read “and a stimulation unit”.
Page 1 of the specification reads “Complex is a system consisting of a pulses generation unit…”; and “The disadvantage of the solutions mentioned above is that they do not provide the possibility of data exchange with systems for lungs artificial ventilation…and that they do not consider initiation and support of the rhythmic respiratory movement with activation of relevant critics in the spinal cord”
Page 3 states : “…due to non-invasive or minimally invasive neurostimulation (hereinafter referred to as : system; system ‘Neurolungs”; complex or complex “Neurolungs”).
There are numerous other unclear and awkwardly worded sections that need to be addressed. Above are just a few exemplary parts of the specification to highlight the issue at hand.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 states “…to an output of EMG unit” and should read “to an output of the EMG unit”. Likewise, Claim 1 states “and an output of algorithmic unit” and should read “and an output of the algorithmic unit”. Additionally, Claim 1 states “from the sensors of EMG unit…” and should read “of the EMG unit”. 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: “the communication unit…capable of receiving data on parameters…and of transmitting data…”; “a data processing, storage and management unit is associated with ensuring a receipt and transmission of data…”; “the algorithmic unit is configured to synchronize data received from the sensors…”; “the pulse generation unit is configured to generate pulses to stimulate…with different pulse parameters for each muscle type” in claim 1.
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. Applicant has not attributed any specific structure to the “communication unit”; “data processing storage and management unit”; or the “pulse generation unit”. For purposes of examination, these units will be interpreted as any structure capable of the claimed function. For instance, the “communication unit” will be interpreted as any structure capable of receiving and transmitting data; the “data processing storage and management unit” will be interpreted as any structure capable ensuring receipt and transmission of data, such as a CPU or processor; and the “pulse generation unit” will be interpreted as any device capable of delivering adjustable stimulation parameters (different parameters for each muscle type). Applicant states the “algorithmic unit” is software, see par. [0066] of PGPUB 20230233782, which is the publication of the present application.
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 1-4 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.
Regarding Claim 1, the limitations “the communication unit…capable of receiving data on parameters…and of transmitting data…”; “a data processing, storage and management unit is associated with ensuring a receipt and transmission of data…”; and “the pulse generation unit is configured to generate pulses to stimulate…with different pulse parameters for each muscle type”” 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. Applicant’s specification only repeats the word “units” and does not define these units as any particular structures 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.
Claim 1 states “a communication unit connected to a ventilator” and then later recites “wherein the communication unit is connected to a ventilator…”. This repeats a limitation already in the claim and, by the use of “a ventilator” twice in the claim, Applicant appears to be claiming two separate ventilators connected to the communication unit, which does not have antecedent support in the originally filed specification. If Applicant intends to only have one ventilator, the Examiner suggests amending the claim to read “wherein the communication unit is connected to the ventilator through a communication interface…”. However, as currently presented, the metes and bounds of claim 1 are unclear.
Claim 1 states “a volume of the air entering the lungs”. There is insufficient antecedent basis for “the air” and “the lungs”. The Examiner suggests amending the claim to read “a volume of air entering the lungs of a patient” or some variant thereof.
Claim 1 further states “a human-machine interface unit” and then later claims “a human-machine interface unit including…” which essentially claims two separate human-interface units (similar to the ventilator mentioned above). If Applicant intends for only one human-machine interface unit, the Examiner suggests amending the claim to read “the human-machine interface unit including a data input means…”. However, as currently presented, the metes and bounds of claim 1 are unclear.
Claim 1 recites “a data processing, storage and management unit” and then later claims “a data processing, storage and management unit is associated with …”. This is the same issue as with the human-machine interface unit as discussed above. The Examiner suggests amending the claim to read “the data processing, storage and management unit is associated with…”.
Claim 1 recites “a stimulation (EMG unit)”. It appears Applicant is calling an EMG unit (which is commonly and well-known as a sensing unit) a stimulation device. EMG units do not provide stimulus energy and instead detect electrical energy from the muscles of a patient. Applicant is using a term counter to its plain and ordinary meaning and has not re-defined EMG as meaning a stimulation unit. The metes and bounds are unclear. For the purposes of examination, the Examiner will interpret the claim as having a stimulation unit (the previously claimed pulse generation unit) and an EMG detection unit.
Claim 1 recites “from the sensors of EMG unit”. There is insufficient antecedent basis for this phrase. The EMG unit has not previously been claimed as having sensors and therefore “the sensors of EMG unit” is not clearly referring to any previously claimed combination of structures.
Claim 1 states “…to an output data transmitted to a pulse generation unit”. However, Applicant has already previously claimed a pulse generation unit. It is unclear if this is the same unit or a different unit. If it is the same unit, the Examiner suggests amending the claim to read “transmitted to the pulse generation unit”.
Claim 1 recites “to stimulate the intercostal muscles, diaphragm…”. There is insufficient antecedent support for “the intercostal muscles…”.
Claim 2 recites “…a mode of oepriaotn of stimulating electrodes” It is unclear if these electrodes are the same or different from “stimulation electrodes” in Claim 1.
Claim 3 states “from a unit of electromyography electrodes and stimulation”. It is unclear if there are multiple sets of EMG electrodes or just one due to the previous claiming of “a unit of electromyography electrodes”. The Examiner suggests amending the claim to read “from the unit of electromyography electrodes…”. Also, “stimulation” is not a structure but an action. Appropriate correction/clarification is respectfully requested.
Claim 4 is rejected as being dependent on indefinite claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Meyyappan et al. (PGPUB 2020/0164207).
The Examiner notes the following rejection is made with the best understanding of the claimed invention in light of the numerous 112b issues in the claim as highlighted previously in this action.
Regarding Claim 1, Meyyappan discloses a neurostimulation system that interfaces with a ventilation system to aid in breathing (Abstract). The system comprises a communication unit (I/O interface)connected to a ventilator 32 through breath sensor 50 (see Fig. 1, 4); a human-machine interface, such as user input devices 86 (par. [0147]; Fig. 4); a data processing, storage and management unit such as controller 60 that controls all functions of the device, which includes the transmission and receipt of data (Fig. 4; par. [0143]); an algorithmic unit, such as signal processor 80, that receives sensed data (such as EMG data), processes it and transmits it to pulse generation unit 70 that in turn uses the data to control stimulation (Fig. 4; par. [0142, 0146]); and EMG sensor with sensing electrodes 48 (par. [0038, 0113, 0124]). Meyyappan further discloses receiving data from sensors at the communications interface, the data including amount of carbon dioxide, and amount of oxygen, volume of air in the lungs and inspiratory and expiratory frequency (par. [0124, 146, 149]). With respect to the pulse generation unit and it being “configured to generate pulses to stimulate the intercostal muscles, diaphragm, abdominal muscles, cervical and thoracic spinal cord with different pulse parameters for each muscle type”, the Examiner notes this is an intended use recitation of the pulse generation unit. Applicant has not claimed any particular structure that is configured or adapted to connect to these various muscle groups (such as electrodes connected to the pulse generation unit) or any other structural means for targeting these various muscle groups. Instead, Applicant is claiming a pulse generation unit that has the capability of delivering adjustable/different stimulation parameters. Meyyappan discloses a pulse generation unit that is configured to deliver different sets of pulse parameters over time in order to change the level of breathing assistance the stimulation unit provides to the muscles of the patient’s body (par. [0130-0138]).
In regards to Claim 2, Meyyappan discloses the data processing, storage and management unit receives programmable parameters characterizing the operation of the stimulating electrodes (par. [0042], “The controller in some embodiments is programmed to: receive input data indicative of one or more aspects of the therapy plan”; par. [0044], “the controller is further programmed to maintain synchrony of the delivery of the stimulation signal with the ventilator breath cycle.”).
With regards to Claim 3, Meyyappan discloses controlling stimulation with the pulse generation unit 70 based on sensed signals received from the EMG sensor (par. [0124, 0129]).
In regards to Claim 4, Meyyappan discloses the pulse generation unit contains device settings (routines for operating the decision making algorithms, see par. [0150-0158]), statistical parameters (trend data, see par. [0174]) and operating mode parameters (programmable stimulation settings. See par. [0130]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Thakkar et al. (2019/0175908); Jung (2016/0287877); Tehrani et al. (2011/0288609); Dimarco et al. (2010/0185253); .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796