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 .
Status of Claims
Claims 1-25 are currently pending and under consideration.
Claim Objections
Claims 15 is objected to because of the following informalities:
In claim 15, “The transient electrode of claim 1 being configured as a percutaneous lead.” is grammatically incorrect. Applicant is recommended to amend claim 15 to --The transient electrode of claim 1, wherein the transient electrode is configured as a percutaneous lead.--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The breadth of the claims and the nature of the invention
Claims 8 and 9 are dependent from claim 1, which is directed to a transient electrode, “wherein the entire electrode biodegrades.” Claim 8 is directed to “transient electrode with metal layer, wherein the metal layer comprises a bioinert material” and claim 9 is directed to the interlayer comprising “titanium.”
The state of the prior art, the level of one of ordinary skill, and the level of predictability in the art
The current state of art recognizes bioinert material to be crucial in biomedical engineering for their ability to interact minimally with biological tissues, minimizing adverse reactions such as inflammation and rejection (Introduction section of Costa, “Introduction to Bioinert Materials: Properties and Application”, Bioceram Dev Appl, 14 (2024): 262). These materials are designed to maintain stability and functionality within the body over extended periods, making them ideal for a wide range of medical devices and implants (Introduction section of Costa). They are resistant to degradation and corrosion in biological environments (Introduction section of Costa). Further, titanium is art-recognized metal that is widely used in implants due to its bionert properties (Dean, US 7,702,380, Col. 7, line 65-Co. 8, line 18). As such, bioinert metals would not be expected to biodegrade when being implanted or within biological environments based on current state of art in the field of biomaterials.
The amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure
As-filed specification does not provide any working examples of how bioinert materials can be degraded when used as part of the claimed invention of transient. In light of art-recognized material properties of bioinert materials as discussed above, "undue experimentation" would have been needed to use bioinert material in the claimed transient electrode and meet the recited feature of allowing the entire transient electrode to be degraded. Therefore, the claimed transient electrode of claims 8 and 9 of having bioinert metal layer was not described in the specification in such a way as to enable one skilled in the art to meet the recited function where the entire transient electrode would be capable of degraded.
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 8 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.
In claim 8, the limitation of “bioinert material” appears inconsistent with the inclusion of materials such as magnesium, zinc, and iron, which may be understood in the art as biodegradable, bioresorbable, or bioactive rather than bioinert ([0048] of US 2008/0195170 A1).
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 1-7, 12-15, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et. al, (US 20170020402 A1, published 01/26/2017, hereinafter known as Rogers).
Regarding claims 1-3, Rogers discloses a transient electrode comprising (“implantable and bioresorbable sensor” [0133]):
an electrically non-conductive core substrate (substrate 20, as shown in annotated Fig. 1A below, [0133], it is commonly understood in the art that the core substrate should be non-conductive if it is supporting an electronic device to control the flow of electric current);
a continuous, electrically-conductive metal layer that envelops at least a portion of the core substrate (“electronic device may have semiconductor and/or metallic components, in this case illustrated as Si-nanomembrane (Si-NM) and positioned adjacent to a cavity disposed in the substrate…adjacent refers to at least a portion of the distal end of the Si-NM that extends over the cavity”, as shown in annotated Fig. 1A below [0133]);
an interlayer that is disposed between the core substrate and the metal layer to promote adhesion between the core substrate and the metal layer (“electronic device may form a sensor, including a pressure sensor having a cavity covered by a deformable layer”, as shown in annotated Fig. 1A below [0133]); and
a barrier layer that at least partially envelops the metal layer (“barrier layer may be used to assist in achieved a desired controlled operational lifetime”, reference number 40 in Fig. 1C, [0133]);
wherein the entire electrode biodegrades and is rendered non-functional after a period of time in vivo (”the thicker the layer, the longer time for sufficient dissolution so as to result in sensor non-function and corresponding bioresorption…the magnesium coils, electrodes, interconnects and silicon resistors dissolve fully after 14 days” [0040] & [0165]).
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Regarding claim 4, Rogers discloses the transient electrode as described in claim 1, wherein the continuous, electrically-conductive metal layer completely envelops the core substrate (“bioresorbable sensor has a substrate…an encapsulation layer may surround all of the sensor” [0133] & [0135]).
Regarding claim 5, Rogers discloses the transient electrode as described in claim 1, wherein at least a portion of a surface of the electrically non-conductive core substrate is modified or treated to improve bond strength with the metal layer and/or the barrier layer (“sensors may include Si on PLGA substrates with Si bottom substrate, and Si-NMs bonded on Si bottom structure…fabrication involved integration of silicon-based, piezoresistive sensing elements onto substrates of PLGA, bonded over cavities etched into the surfaces of nanoporous Si (np-Si) substrates” [0103] & [0153]).
Regarding claim 6, Rogers discloses the transient electrode as described in claim 1, wherein the electrically non-conductive core substrate is a bioresorbable suture (“subgaleal closure utilizing interrupted resorbable sutures sealed the surgical site with all device components fully implanted” [0216]).
Regarding claim 7, Rogers discloses the transient electrode as described in claim 1, wherein the bioresorbable suture comprises polyglactin (“modified roman sandal technique using a 3/0 VICRYL RAPIDE (polyglactin 910) suture secured the sensor” [0277]).
Regarding claim 12, Rogers discloses the transient electrode as described in claim 1, wherein the barrier layer covers less than the entirety of the metal layer (“the invention includes implantable devices having partially…encapsulated inorganic semiconductor components and/or electrodes”, if the encapsulating layer is referred to as the barrier layer, and the semiconductor/metallic components are referred to as the metal layer, than a partial encapsulation of the semiconductor/metallic layer can be interpreted as the barrier layer covering less than the metal layer, [0117]).
Regarding claim 13, Rogers discloses the transient electrode as described in claim 1, including one or more discrete, geometrically-defined regions that are surrounded, but not covered by, the barrier layer (“an encapsulation layer may surround part of the sensor” [0135]).
Regarding claim 14, Rogers discloses the transient electrode as described in claim 1, wherein the period of time is less than about 5 years (“the magnesium coils, electrodes, interconnects and silicon resistors dissolve fully after 14 days” [0165]).
Regarding claim 15, Rogers discloses the transient electrode as described in claim 1 being configured as a percutaneous lead (“tested 6 controls and 6 rats with implanted percutaneous wires” [0214]).
Regarding claim 19, Rogers discloses a system comprising:
the transient electrode of claim 1 (described above by Rogers in claim 1); and
a power source in electrical communication with the transient electrode (“external reader wirelessly delivers power for operating the logic chip and provides the small currents needed to assess the response of the sensors…that can be recorded and transmitted to the external reader” [0163]).
Regarding claim 20, Rogers discloses the transient electrode as described in claim 19, wherein an electrical signal is delivered from the power source to the transient electrode via one or more of a hard-wired connection, a wireless connection, capacitive coupling, and Faradaic coupling (“external reader wirelessly delivers power for operating the logic chip and provides the small currents needed to assess the response of the sensors…that can be recorded and transmitted to the external reader” [0163]).
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 (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 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 10-11, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of Franke et. al, (US 20190357847 A1, published 11/28/2019, hereinafter known as Franke).
Regarding claim 10, Rogers discloses the transient electrode as described in claim 1.
Rogers doesn’t disclose wherein the barrier layer comprises a material selected from the group consisting of polyacetylene, polypyrrole, polythiophene, poly(3,4-ethylenedioxythiophene), graphene, and combinations thereof.
However, Franke teaches a cured electrode comprising a mixture comprising conductive elements and a carrier which, upon injection into a body, cures from a liquid phase at a first time to a biocompatible solid phase at a second time at or on a target tissue within the body (Abstract). Another material which can be used as a conductive element is poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (“PEDOT:PSS”) [0321].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of poly(3,4-ethylenedioxythiophene) of Franke with the transient electrode of Rogers because PEDOT is a biocompatible conductive polymer (Franke, [0321]).
Regarding claim 11, Rogers discloses the transient electrode as described in claim 1.
Rogers doesn’t disclose wherein the barrier layer is made of one or a combination of materials that is/are electrically-insulative and provide(s) mechanical stability to the metal layer.
However, Franke teaches the resulting insulating PEG cured electrode may be used to restrict electrical current flow from certain areas [0179]. Additives for the PEG hydrogel may also be varied…other preservatives may be added to help stabilize the conductive element suspension or resuspension [0194].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of insulative and stabilizing materials of Franke with the transient electrode of Rogers because this provides more control over the electrical flow of the electrode.
Regarding claim 22, Rogers discloses a method (“provided are various methods of using the sensors described herein” [0056]) for temporary neuromodulation of a target nervous tissue in a subject (“the operational lifetime may be selected between a range of days to months, such as 1 day to 4 months” since the electrode is bioresorbable and the operational lifetime eventually ends, the modulation of the tissue is thus temporary, [0112]), the method comprising:
advancing the transient electrode (as described in claim 1) into electrical contact with the target nervous tissue (“implantable and bioresorbable sensor may be configured to adhere to a tissue” [0049]);
for a period of time until the transient electrode completely biodegrades and is rendered non-functional (”the thicker the layer, the longer time for sufficient dissolution so as to result in sensor non-function and corresponding bioresorption…the magnesium coils, electrodes, interconnects and silicon resistors dissolve fully after 14 days” [0040] & [0165]).
Rogers doesn’t disclose delivering a therapy signal to the target nervous tissue via the transient electrode.
However, Franke teaches a Transcutaneous Electrical Neural Stimulation (TENS) system…TENS is often used for rehabilitation purposes or to provide non-invasive neuromodulation [0154]. The cured electrode provides a means to deliver a therapy to reversibly stimulate or block neural tissue of the sympathetic chain or ganglia [0505].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of neuromodulation and delivering a therapy of Franke with the transient electrode of Rogers because this widens the scope of diseases and disorders that can be treated by the resorbable electrode.
Regarding claim 23, Rogers discloses the transient electrode as described in claim 22, wherein the therapy signal is delivered to target nervous tissue that has experienced a crushing injury, nervous tissue that has experienced a partial disruption in action potential propagation, nervous tissue that has experienced a complete disruption in action potential propagation, or a combination thereof (“these features will be useful in diagnosing and treating a diverse range of medical conditions, from acute traumatic injuries such as extremity compartment syndrome, to chronic medical diseases such as diabetes”, it is well known in the art that many chronic medical diseases such as diabetes affects action potential propagation [0150]).
Regarding claim 24, Rogers discloses the transient electrode as described in claim 22, wherein the transient electrode as described in claim 1, wherein the subject is suffering from post-surgical and/or post-traumatic pain (“one specific application is for the treatment of traumatic brain injury” [0130]).
Regarding claim 25, Rogers discloses a method for temporary recording of electrical activity in a target nervous tissue in a subject (“changes in resistance associated with changes in pressure and temperature register as voltages that can be recorded and transmitted” [0163]), the method comprising:
advancing the transient electrode (as described in claim 1) into electrical contact with the target nervous tissue (“implantable and bioresorbable sensor may be configured to adhere to a tissue” [0049]);
until the transient electrode completely biodegrades and is rendered non-functional (”the thicker the layer, the longer time for sufficient dissolution so as to result in sensor non-function and corresponding bioresorption…the magnesium coils, electrodes, interconnects and silicon resistors dissolve fully after 14 days” [0040] & [0165]).
Rogers doesn’t disclose recording, by the transient electrode, the electrical activity of the target nervous tissue for a period of time.
However, Franke teaches tissue impedances were measured with a LCR meter using a 1 kHz sinusoid by recording the impedance between two stainless steel wire probes inserted in animal tissue [0537].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the recording of a nerve’s electrical activity of Franke with the transient electrode of Rogers because this allows for measurements to be transmitted to users or healthcare professionals that can result in a more proper assessment of treatment.
Claims 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers in view of McLaughlin et. al, (US 20180126155 A1, published 05/10/2018, hereinafter known as McLaughlin).
Regarding claim 16, Rogers discloses the transient electrode as described in claim 1.
Rogers doesn’t disclose wherein all or only a portion of a surface of the metal layer is microcracked.
However, McLaughlin teaches an electrode array system includes a unitary body forming a plurality of apertures, and a plurality of continuous conductive elements at least partially encapsulated within the unitary body (Abstract). Thin-film continuous conductive elements are inherently brittle and fracture upon flexure and strain…the thin-conductors absorb the tensile forces and, frequently, fracture over time [0034].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the microcracking of the metal layer of McLaughlin with the transient electrode of Rogers because it relieves stress that could lead to more serious issues in the metal layer.
Regarding claim 21, Rogers discloses the transient electrode as described in claim 1.
Rogers doesn’t disclose wherein the power source is a pulse generator.
However, McLaughlin teaches an implantable pulse generator generates therapeutic pulses or waveforms for delivery through a therapy array/electrode array [0031].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a pulse generator of McLaughlin with the transient electrode of Rogers because the pulse generator provides the electric pulse for the therapy.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers.
Regarding claim 17, Rogers discloses the transient electrode as described in claim 1 having an impedance of about 2 Ohms to about 2000 Ohms (impedance of the bioresorbable electrode is shown in Fig. 37A below, with an impedance of around 1 Ohm).
Paragraph [0076] of the specification discloses the appropriate ranges that apply to the claimed invention in impedance of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of impedance is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range(s) of impedance provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of impedance by normal optimization procedures known in the neuromodulation arts.
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Regarding claim 18, Rogers discloses the transient electrode as described in claim 1 having an impedance of less than about 200 Ohms (impedance of the bioresorbable electrode is shown in Fig. 37A above, with an impedance of around 1 Ohm).
Paragraph [0076] of the specification discloses the appropriate ranges that apply to the claimed invention in impedance of the applicant’s printed publication. However, the specification does not disclose that the specifically claimed range(s) of impedance is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Because Applicants fail to disclose that the claimed range(s) of impedance provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art recognizes stimulation duration is a result effective variable, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of impedance by normal optimization procedures known in the neuromodulation arts.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ek et. al, (US 20140323948 A1, published 10/30/2014) teaches a medical microelectrodes for implantation [0030], which would include an elongate electrode body including a tip section, a main body section and, optionally, a coupling section (Abstract). The electrically conducting layer on a non-conducting core consists or comprises a metal of high electrical conductivity, such as silver, gold and or a suitable metal alloy, e.g. platinum-iridium [0041].
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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