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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, drawn to a system including an implant device.
Group II, claim(s) 13-24, drawn to a method of using an implant device.
Group III, claim(s) 25-28, drawn to a system including an external computing device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Inventions I-III lack unity of invention because even though the inventions of these groups require the technical feature of processing circuitry configured to receive electrical signals from a plurality of free tissue grafts surgically attached to nerves of a subject, wherein the signals are received through a plurality of bipolar electrode pairs each having a positive and negative electrode that are implanted inside the free tissue grafts and in electrical communication with the free tissue grafts,
the grafts being surgically attached to the subject so that they are entirely surrounded by and in direct contact with non-grafted tissue of the subject, and being autografts harvested from the subject, devascularized and deinnervated before being surgically attached,
wherein the processing circuitry is further configured to process the received electrical signal, generate processed signal date and wirelessly transmit the signal data to a prosthetic controller,
wherein the nerves have reinnervated the grafts subsequent to being attached to the nerves,
the electrical signals from the grafts have a voltage amplitude of greater than or equal to 150 mV, and
the prosthetic controller is configured to control a prosthetic device based on the processed signal data which is transferred from the circuitry to the device,
this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chestek et al. (US 20160143751 A1). Chestek et al. discloses processing circuitry (22) configured to receive electrical signals (Abstract) from a plurality of free tissue grafts (Abstract; Figure 1, item 10) surgically attached to nerves of a subject (Figure 1; [0043]),
wherein the signals are received through a plurality of bipolar electrode pairs each having a positive and negative electrode that are implanted inside the free tissue grafts and in electrical communication with the free tissue grafts ([0095] the implanted electrodes can be bipolar. Bipolar electrode pairs are understood to inherently have positive and negative electrodes); Figure 1 shows a plurality of grafts, and shows how the electrodes 14 can be implanted therein),
the grafts being surgically attached to the subject so that they are entirely surrounded by and in direct contact with non-grafted tissue of the subject (Figure 3), and being autografts harvested from the subject ([0035]), devascularized and deinnervated before being surgically attached ([0035], [0044]),
wherein the processing circuitry is further configured to process the received electrical signals ([0048]), generate processed signal data ([0053]) and wirelessly transmit the signal data to a prosthetic controller ([0048], [0053], [0054]),
wherein the nerves have reinnervated the grafts subsequent to being attached to the nerves (Abstract, [0036]),
the electrical signals from the grafts have a voltage amplitude of greater than or equal to 150 mV ([0008], [0036]), and
the prosthetic controller is configured to control a prosthetic device based on the processed signal data which is transferred from the circuitry to the device ([0057], [0048]).
During a telephone conversation with Michael Doerr on 08/07/26 a provisional election was made without traverse to prosecute the invention of invention I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1, 4-5, 8, 11 are objected to because of the following informalities:
Claim 1 is objected to for claiming the plurality of free tissue grafts are attached to a plurality of nerves, when it is unclear how multiple grafts are attached to multiple nerves all at the same time. The specification appears to indicate that there is only one graft attached to one nerve, making this further unclear.
Further, the claim states “each having a positive electrode and a negative electrode” but it is unclear from the language of the claim what has the positive/negative electrode (the electrical signals, the free tissue grafts, the nerves, or the electrode pairs).
Further, the claim is objected to for claiming “the processes signal data” when it is believed this should read “processed” signal data.
The claim is further objected to for claiming “wherein the nerves have reinnervated the plurality of free tissue grafts subsequent to…being surgically attached to the nerves” but it is believed this should indicate that the nerves are capable of reinnervating the tissue grafts, or “wherein subsequent to the grafts being attached to the nerves, the grafts are capable of/can be reinnervated”. With the current wording, it appears that the nerves of the subject might be positively claimed, which would result in a 101 rejection.
Claim 4 is objected to for claiming “wireless transmit” when it is believed this should read “wirelessly transmit” for proper grammar.
Claim 5 is objected to for referring to “a patient” when it is unclear how, if at all, this relates to the previously claimed “subject” from claim 1. It is believed these might actually intend to refer to the same element within the claim, but clarification is required.
Claim 8 is objected to for claiming the Bal Seal connector is configured to seal the implant device, but it is unclear what it means to seal a device. The Examiner understands something can be sealed against something, or sealed from something, or sealed itself, but the context of this claim makes it unclear what it means to “seal” the implant device.
Further, the claim refers to the implant device “20” and it is unclear whether this is a typographical error.
The claim is further unclear for claiming the seal occurs once the two connectors are inserted, but it is unclear what happens if the connectors are not inserted. It appears the claim gives a conditional statement, without explaining the alternative.
Claim 11 is objected to for referring to “a time period” but it is unclear how, if at all, this relates to the previously claimed “consecutive time periods”.
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 1-12 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming the system comprises “an implant device having processing circuitry” and then claiming various things the circuitry is configured to do. However, it is unclear whether or not any of the elements described within the circuitry’s capabilities are being positively claimed as part of the “system” or “implant device”. It appears none of the elements is actually positively claimed, but the Examiner wishes for clarification. The description/specification describes all these elements, and so the system could potentially include all the claimed elements. However, as presently worded, the system only appears to have circuitry. The Examiner requests clarification within the language of the claim which makes it clear what the parts of the system actually are, and what are not positively claimed, but are merely parts of functional recitations. The Examiner believes the Applicant intends all the elements from the claim to be positively claimed, so for the purposes of examination these will be interpreted as part of the system, but clarification within the language of the claim is required.
Claim 7 is indefinite for claiming the electrode pairs are “connected to the implant device” but claim 1 has apparently claimed the electrode pairs as being a part of the implant device, making it unclear how the pairs can be attached to something they are described as being a part of.
Remaining claims are rejected for depending on a rejected claim.
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 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.
Claim(s) 1-3, 9-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chestek et al. (US 20160143751 A1), hereinafter known as Chestek.
Regarding claim 1 Chestek discloses a system (Abstract) comprising:
an implant device (20) having processing circuitry (64, 22) configured to receive electrical signals (Abstract) from a plurality of free tissue grafts (Abstract; Figure 1, item 10) surgically attached to nerves of a subject (Figure 1; [0043]),
wherein the signals are received through a plurality of bipolar electrode pairs each having a positive and negative electrode that are implanted inside the free tissue grafts and in electrical communication with the free tissue grafts ([0095] the implanted electrodes can be bipolar. Bipolar electrode pairs are understood to inherently have positive and negative electrodes); Figure 1 shows a plurality of grafts, and shows how the electrodes 14 can be implanted therein; [0059] multiple nerve signals are received from multiple muscle grafts, and any of the grafts can include either the electrode 14, wire lattice 17, or wire 18b.),
the grafts being surgically attached to the subject so that they are entirely surrounded by and in direct contact with non-grafted tissue of the subject (Figure 3), and being autografts harvested from the subject ([0035]), devascularized and deinnervated before being surgically attached ([0035], [0044]),
wherein the processing circuitry is further configured to process the received electrical signals ([0048]), generate processed signal data ([0053]) and wirelessly transmit the signal data to a prosthetic controller ([0048], [0053], [0054]),
wherein the nerves have reinnervated the grafts subsequent to being attached to the nerves (Abstract, [0036]),
the electrical signals from the grafts have a voltage amplitude of greater than or equal to 150 mV (specification [0199] “about” corresponds to 10-15% range) ([0008], [0036]), and
the prosthetic controller is configured to control a prosthetic device based on the processed signal data which is transferred from the circuitry to the device ([0057], [0048]).
Regarding claim 2 Chestek discloses the system of claim 1 substantially as is claimed,
wherein Chestek further discloses the processing circuitry is configured to apply a bandpass filter to the received electrical signals and to sample the filtered electrical signals ([0060]).
Regarding claim 3 Chestek discloses the system of claim 2 substantially as is claimed,
wherein Chestek further discloses the bandpass filter is a 100-500 Hz bandpass filter ([0060]) and the processing circuitry is configured to sample the filtered electrical signals at a sample rate of 1 kHz ([0060]).
Regarding claim 9 Chestek discloses the system of claim 1 substantially as is claimed,
wherein Chestek further discloses the prosthetic device includes at least one pressure sensor ([0052]-[0053]), and
the prosthetic controller is configured to receive at least one pressure signal from the sensor (it is considered inherent, or alternatively obvious, for the prosthetic controller to receive the pressure sensors before communicating them to the implant device as is disclosed by [0053], since the controller would need to receive the signals before sending them onward) and communicate the pressure signal to the implant device ([0053]), and
wherein the processing circuitry is further configured to receive the pressure signal and generate and transmit at least one stimulation signal to the electrode pairs to stimulate the nerves of the subject through the free tissue grafts attached thereto ([0053]).
Regarding claim 10 Chestek discloses the system of claim 9 substantially as is claimed,
wherein Chestek further discloses the processing circuitry of the implant device is configured to alternate the receiving of the electrical signal sand the generation/transmission of the stimulation signal during consecutive time periods ([0048] the circuitry 22 monitors the electrical signals from the nerves and controls flexion/extension of the hand based on the signals; [0066] nerve input circuitry can use a one-of-two classifier (like a Naïve Bayes classifier or regression analysis) to determine whether the signal data over a predetermined time period segment indicates flexion/extension; [0074] the circuitry can predict whether the data indicates flexion or extension every 25 ms so the circuitry can monitor and decode the nerve signal data and send corresponding commands to operate the limb; indicating every 25 ms the signals are alternating between the receiving, processing, and sending.).
Regarding claim 11 Chestek discloses the system of claim 10 substantially as is claimed,
wherein Chestek further discloses the processing circuitry is configured to generate commands to control the prosthetic device based on the received electrical signals ([0053]) and generate an estimated command to control the prosthetic device during a time period when at least one stimulation signal is generated and transmitted to the electrode pairs ([0054] a calibration process receives training and calibration data from the implant and communicates estimated operation parameters; [0074] the circuitry can accordingly determine or predict whether the nerve signal data for a given time period segment (e.g. 25 ms) corresponds to or is indicating a flexion/extension movement. The circuitry also sends commands to the limb every 25 ms based on the classification of the current/most recent sample group so the circuitry continuously monitors and decodes the data and sends commands; [0078] training data is obtained through a calibration process which is used to estimate operational parameters used by the processing circuitry to control the hand. Estimated parameters are then downloaded to circuitry to make real-time estimations of finger velocity to drive the hand.).
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chestek as is applied above in view of Lock et al. (US 20140032462 A1) hereinafter known as Lock.
Regarding claim 4 Chestek discloses the system of claim 3 substantially as is claimed,
wherein Chestek further discloses the sampled electrical signals being wirelessly transmitted to the prosthetic controller as the processed signal data ([0054]),
but is silent with regards to the data being a calculated mean absolute value.
However, regarding claim 4 Lock teaches wherein systems for controlling prosthetic devices includes calculating a mean absolute value of EMG data ([0023]). Chestek and Lock are involved in the same field of endeavor, namely prosthetic control algorithms. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Chestek so that any defining feature of the data is extracted, including a mean absolute value as is taught by Lock, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E), and since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of any known signal feature extraction known within prosthetic control is understood to be obvious to try and use.
Claims 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chestek as is applied above in view of Henke et al. (US 20150065789 A1) hereinafter known as Henke.
Regarding claim 5 Chestek discloses the system of claim 1 substantially as is claimed,
but is silent with regards to the implant device including protection to provide the implant device from surge voltages during an electrostatic discharge event during implantation.
However, regarding claim 5 Henke teaches wherein devices in connect with the nervous system of a patient can include protection circuitry to protect the implant device from surge voltages during an electrostatic discharge event during implantation ([0167]). Chestek and Henke are involved in the same field of endeavor, namely implantable electronics. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Chestek so that there is surge protection within the implant as is taught by Henke in order to improve patient safety by preventing against accidental shock.
Regarding claim 6 the Chestek Henke Combination teaches the system of claim 5 substantially as is claimed,
wherein Henke further teaches the protection circuitry include at least one resistor and at least one diode ([0174]).
Claims 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chestek as is applied above in view of Kast et al. (US 6895276 B2) hereinafter known as Kast.
Regarding claim 7 Chestek discloses the system of claim 1 substantially as is claimed,
wherein Chestek further discloses the electrode pairs include a first set of electrode pairs and a second set of electrode pairs ([0059] multiple nerve signals are received from multiple muscle grafts, and any of the grafts can include either the electrode 14, wire lattice 17, or wire 18b. Figure 1 shows how there can be three grafts 10, indicating the presence of three electrodes as well. See also [0095] the implanted electrodes can be bipolar pairs.),
but is silent with regards to the pairs being connected to the implant device with multi-contact connectors each having a pair of contacts associated with each pair,
and the implant device including a header with ports to receive the two multi-contact connectors.
However, regarding claim 7 Kast teaches that implantable electrode devices (Abstract) with bipolar electrode leads (Column 1 lines 59-62) have multi-contact connectors associated with the bipolar electrode (Column 1 lines 62-65),
and wherein the implantable device includes a header (Column 2 lines 11 and 15), with ports configured to receive the multi-contact connectors (Column 2 lines 20-23). Chestek and Kast are involved in the same field of endeavor, namely implantable electrical simulation devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Chestek so that the electrode pairs connect to the implant via multi-contact connectors and the implant having a header with ports for the connectors as is taught by Kast in order to provide the necessary structure for the bipolar electrodes of Chestek to connect to the implant 20 as is described in Chestek.
Regarding claim 8 the Chestek Kast Combination teaches the system of claim 7 substantially as is claimed,
wherein Kast further teaches the first and second ports each include a Bal Seal connector configured to seal the implant device once the multi-contact connectors are inserted into the ports (Column 8 lines 23-34).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chestek as is applied above in view of Gittis et al. (WO 2021146557 A1) hereinafter known as Gittis.
Regarding claim 12 Chestek discloses the system of claim 9 substantially as is claimed,
but is silent with regards to the processing circuitry estimating an artifact within the stimulation signal and subtracting the artifact from the stimulation signals.
However, regarding claim 12 Gittis teaches an electrical stimulation system which estimates an artifact within an electrical signal generated by a stimulating signal and subtracts it from the electrical signal ([0051]). Chestek and Gittis are involved in the same field of endeavor, namely stimulation nerves of a patient. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Chestek so that the artifact is estimated and subtracted from the stimulation signals as is taught by Gittis in order to allow for a method of examining nerve firing rates without the presence of artifacts, thus easing signal interpretation and illustration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
Prosecution Insights