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
The disclosure is objected to because of the following informalities:
Page 6, in paragraph 0032 the language “each remote unit s receives controller energy 2”. The s should be removed and appears to be a typographical error. The word “energy” should also be removed in that element 2 is the controller.
Page 6 paragraph 0035 recites “IC medium contact”. The acronym IC is not labeled and it is unclear what applicant intends IC to be.
Page 9, paragraph 0043 recite “polarity. the load”, the period is misplaced.
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:
energy emission module in claim 1
data emission/reception module (of the controller) in claim 1
energy recovery module in claim 1
data emission/reception module (of the remote unit) 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, they 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the coupling capacitor (claim 1, line 9), coupling capacitor (claim 1, line12), load balancing module comprising a buffer capacitor (claim 15), IC medium contact of the controller (claim 18) and intra-body medium contact (claim 19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim 14 is objected to because lines 3-4 recite “the intra-body medium”, this language lacks proper antecedent basis and should recite “an intra-body medium”.
Appropriate correction is required.
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 11-22 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 11, line 2 recites “distributed elements comprising:” based on how the claim is written it is unclear what applicant intends the distributed elements to be. The distributed elements could be the controller, energy emission module, data emission/reception module, remote unit, energy recovery module, data emission-reception module, wire bus, common reference wire, energy wire and data wire or some other combination. It is assumed that the distributed elements are the controller, remote unit and wire bus. However this language is indefinite and confusing.
Claim 1 recites “an energy wire connected via a coupling capacitor to the energy emitting module of the controller; and connected directly to the energy recovery modules of the at least one remote unit.” The remote unit appears to only have one energy recovery module, this language is not understood in light of the specification and drawings.
Claim 18 recites “measuring by the controller a voltage between the common reference wire and an IC medium contact of the controller.” It is unclear what an IC medium contact is or how it is “of the controller”. This is assumed to be an impedance measurement. Further, it is unclear how a voltage or impedance is measure in that no circuitry for impedance is disclosed.
Claim 19 recites “injecting by an intra-body medium contact”, it is unclear what an intra-body medium contact is or how the device “injects” current, there is no circuit disclosed. This is assumed to be impedance.
The claim limitations found in claim 1 including: 1) energy emission module, 2) data emission/reception module, 3) energy recovery module, and 4) data emission/reception module invoke 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. There is no disclosure as to what these specific modules are our could be. The energy emissions module is based on the current source according to paragraph 0041 however it is not disclosed what this is or could be. The data emission/reception module and energy recovery module are not described as to what components they are or could be. There is no disclosure as to what structures these could be.
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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Min et a. US 2015/0265841 in view of DeShazo et al. US 2021/0244948.
Regarding claim 11 as understood: Min discloses a stimulation system 100 (figure 1) which is an implanted spinal cord stimulator (paragraph 0007) comprising:
distributed elements comprising:
a controller 140 (figure 2) which includes a signal generator (paragraph 0036; the signal generator is considered to be an energy emission module) and a data emission/reception module 218/210 (figure 2); and
a remote unit 150 (figure 2) including an energy recovery module 256 (figure 2) and a data emission/reception module 264/254 (figure 2);
a wire bus 108a/108b (figure 2) connecting the distributed elements; the bus comprising:
a common reference wire 108b connecting all the distribution elements (paragraph 0043);
an energy wire 108a connected to the energy emitting module 206 (this is connected via wire 108a, figure 2), the energy wire 108a is also connected to the energy recovery module 256 (figure 2) in the remote unit; and
a data wire 108a connected to each of the data emission/reception modules and all of the distributed elements (figure 2; wire 108a delivers communication signals, power signals and stimulation pulses, paragraph 0042).
However, Min does not specifically disclose coupling capacitors. DeShazo however teaches of a similar stimulation device which includes coupling capacitors between output circuits (paragraph 0042). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Min to include coupling capacitors, as taught by DeShazo, in order to use DC blocking and block errant DC and also serve as a passive charge balancing component.
Regarding claim 12 as understood: Min discloses that the remote unit is for stimulation via electrodes 112d-112f (paragraphs 0033 and 0035).
Regarding claim 13 as understood: Min discloses, in figure 5, two stimulation units 4052 and 404. Min paragraphs 0057 discloses that the electronics can perform sensing functions during sensing operations (paragraph 0057). It would be obvious to one of ordinary skill in the art at the time the invention was filed to modify Min figure 2 to include multiple stimulation units, which can also be sensing units, as taught by Min figure 5, in order to deliver stimulation and sense physiological states.
Regarding claim 14 as understood: Min discloses that the remote unit 150 (figure 2) can include sensing from the electrodes (paragraph 0057); the electrodes are implanted and considered to be in contact with the body.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Min et a. US 2015/0265841 in view of DeShazo et al. US 2021/0244948 and further in view of Bulkes et al. US 2010/0280568.
Regarding claim 15 as understood: Min/DeShazo discloses the claimed invention however Min/DeShazo dies not specifically disclose a buffer capacitor. Bulkes however teaches of using a buffer capacitor (paragraph 0054). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Min/DeShazo to include a buffer capacitor, as taught by Bulkes, in order to allow a minimal drop in voltage between charging pulses.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Min et a. US 2015/0265841 in view of DeShazo et al. US 2021/0244948 and further in view of Astrom US 2018/0185651.
Regarding claims 18-20 as understood: Min discloses switch circuits 212/258 (figure 2) however Min/DeShazo does not disclose measuring impedance from an electrode to the controller, which is considered to be an electrode on the controller. Astrom however teaches of measuring impedance from a reference electrode by (paragraph 0042) in which the electrodes are operatively switched to measure impedance (paragraph 0088). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Min/DeShazo to include switching the electrodes to measure impedance of the electrode, as taught by Astrom, in order to determine tissue impedance.
Claims 16, 17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Min et a. US 2015/0265841 in view of DeShazo et al. US 2021/0244948 and further in view of Mishra et al. US 2014/0188189.
Regarding claims 16 and 21 as understood: Min/DeShazo discloses the claimed invention however Min/DeShazo does not disclose a spare wire to transmit data. Mishra however teaches of a sets of wires, each set includes a redundant wire (paragraph 0028). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Min/DeShazo to include redundant wires, as taught by Mishara, in order to transmit signals once a problem is detected in the primary wires.
Regarding claim 17 and 22: Min/DeShazo/Mishra discloses the claimed invention however Min/DeShazo/Mishra does not disclose a switch which is open to perform normal function and closed to utilize the redundant wire. Switches are common in the art and it would be obvious to one of ordinary skill in the art to include a switch to switch between the normal wire and the redundant wire in order to either use the normal or redundant wire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H 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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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796