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
Applicant’s election without traverse of group I claims 1-9 in the reply filed on 11/10/2025 is acknowledged.
Claims 10-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
The present claims under considerations are claims 1-9 and 22-32.
Examiner’s Note: All reference to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2022/0409116 A1.
Claim Rejections - 35 USC § 112(b)
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 9, 23, 27, 30-32 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 9 recites “a conductive third coating positioned over the second coating” but the limitation “the second coating” lacks sufficient antecedent basis. It is thus unclear if the “third” coating is applied to the first coating of claim 1 or some other coating. For the purposes of this examination, this claim will be interpreted as being dependent from claim 8 such that the third coating is applied to the second coating introduced in claim 8.
Claim 23 recites “the shaft has a base portion and a tapered portion” but it is unclear if the “tapered portion” is the same as, related to, a subset of, or different from “a tapered tip” of claim 1. For the purposes of this examination, “a tapered portion” will be interpreted as referring to the tapered tip of claim 1.
Claim 27 recites “wherein the shaft has a stiffness sufficient to maintain straightness when inserted into muscle tissue while having a gauge between 25 and 32, such that the stiffness is reduced relative to an equivalent uncoated needle of larger diameter” but it is unclear what this limitation is meant to convey as “stiffness sufficient to maintain straightness when inserted into muscle tissue” is not a particular, measurable parameter and the limitation “straightness” appears to be a relative term of degree since it is unclear what level of deflection satisfies “straightness”. Additionally, the limitation “such that the stiffness is reduced relative to an equivalent uncoated needle of larger diameter” is unclear as it is unclear what this “equivalent uncoated needle” comprises. It is unclear if the limitation is meant to convey that the stiffness of the electrode is lower than the stiffness of a thicker needle comprised of the same material as the core shaft. If so, it would seem that such a reduction in stiffness, assuming there is no change in the cross sectional shape of the needle, is inherent to the material properties of the device (i.e. a tungsten needle with a thinner cross section will be less “stiff” than one with a thicker cross section). It is unclear how these limitations are meant to further limit the claimed electrode and thus this claim has not been rejected over the prior art as it is unclear what teachings would anticipate these limitations.
Claim 28 recites “wherein the first coating has a dielectric thickness selected to reduce electrical capacitance of the electrode below a capacitance value of an uncoated conductive shaft of equivalent geometry” but it is unclear what this limitation is meant to convey as the presence of any electrically insulative coating achieves the recited effect. It is unclear if there is a requisite degree of reduction which is used to select the thickness or if any reduction of capacitance ,which is inherently produced by an insulative coating, it acceptable. For the purposes of this examination, the limitation will be interpreted as being inherently taught by the present of any insulative coating.
Claim 30 recites “a hub having a polymeric body molded around the exposed conductive material”, but it is unclear if this “hub” is the same as, relate to, or different from the “hub” of claim 1. For the purposes of this examination, the limitation will be interpreted as further limiting the construction of the hub of claim 1.
Claim 31 recites “a boat-hull configuration” but it is unclear what configuration this limitation is meant to convey. For the purposes of this examination, any configuration having three sides which converge to a point will be considered a “boat-hull configuration.
Claim 32 recites “wherein the first coating, second coating, and any third coating collectively provide a surface friction reduction of at least 50 percent relative to a conventional PTFE-coated electromyography needle of comparable size” but the meets and bounds of this limitation are unclear because it is unclear what level or coefficient of friction “a conventional PTFE-coated electromyography needle of comparable size” has and thus it is unclear what a 50% reduction in this unknown value entails. Additionally, it is unclear what “any third coating” is meant to refer to and what the meets and bounds of this limitation entail. It is further unclear what “collectively provide a surface friction reduction” is meant to convey as it would seem that the second coating completely covers the first coating. It is unclear if this limitation is meant to convey that there is some form of interaction between the coatings that alters the surface friction of the outermost coating of the electrode. It is unclear how these limitations are meant to further limit the claimed electrode and thus this claim has not been rejected over the prior art as it is unclear what teachings would anticipate these limitations.
Claim Rejections - 35 USC § 112(a)
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 1, 9, and 32 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the cylindrical shaft consists of a conductive material” but the specification does not appear to support the claimed scope of any and all known conductive materials being used for the shaft. In particular, the specification only provides the examples of conductive metals tungsten and stainless steel. The specification does not appear to contemplate the use of other non-metallic conductive materials such as doped polymers.
Claim 1 recites “a first coating that is electrically insulative” but the specification does not appear to support the full scope of the claim language. The specification appears to be directed towards the use of DLC coatings adapted to be electrically insulative such as is described in paragraphs 0063-0065 and additive materials/coating to be applied with the DLC coatings like those described in paragraphs 0078 and 0087. The specification does not appear to fully support the claimed scope of any and all possible insulative coatings.
Claim 9 recites “a conductive third coating positioned over the second coating”. As described in the 35 USC 112(b) rejections above, claim 9 is interpreted as being dependent from claim 8. Claim 8 indicates that he second coating may include silicone oil. The specification does not appear to support the application of a third conductive coating to a coating of silicone oil. Rather the third conductive coating appears to only be applied to the metallization layer of metal sulfides as described in Fig. 3A. The second layer being silicone oil appears to be directed to a separate, mutually exclusive embodiment than the embodiment claimed in claim 9.
Claim 32 recites “wherein the first coating, second coating, and any third coating collectively provide a surface friction reduction of at least 50 percent relative to a conventional PTFE-coated electromyography needle of comparable size” but the specification does not support such a reduction in friction to a PTFE-coated EMG needle and further does not describe what such a conventional PTFE-coated EMG needle entails or what friction levels it possesses. Paragraph 0065 recites a reduction of the coefficient of friction of up to 50% but does not recite that the reduction is compared to conventional PTFE-coated needle.
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 1-2, 6-7, and 28-30 rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt.
Regarding claim 1, Carr discloses an electrode configured for use for use in electromyography procedures (Abstract), comprising:
a cylindrical shaft having a first end and a second end, wherein the cylindrical shaft consists of a conductive material (Paragraph 0027: the inner core may be tungsten which is conductive. A first and second end of a cylinder are implicitly taught; Fig. 2B the shaft appears to be cylindrical);
a first coating that is electrically insulative and is configured to encase an entirety of the conductive material (Paragraph 0027: the insulating layer; Fig. 1 reference 106);
a tapered tip defined by an angled surface and positioned at the first end of the shaft, wherein the tip comprises a portion of the cylindrical shaft having a first portion of the first coating removed therefrom to thereby expose a first length of conductive material that was positioned under the removed first portion of first coating and form the angled surface (Paragraph 0028: the tip portion may be slanted, narrowed, beveled, and/or faceted; Fig. 1 references 104 and 106: the insulating coating does not cover the tapered tip of the inner core).
Carr fails to further disclose the electrode comprising: a hub positioned at the second end of the shaft, wherein the hub is positioned on a portion of the cylindrical shaft having a second portion of the first coating removed therefrom to thereby expose a second length of conductive material that was positioned under the removed second portion of first coating, and wherein the hub is configured to electrically couple a lead wire to the second length of conductive material at the second end.
Nesbitt teaches a coated electromyography needle including an anti-microbial, electrically insulative coating applied to non-tip portion of an electrode of the electromyography needle (Abstract). Thus Nesbitt falls within the same field of endeavor as Applicant’s invention.
Nesbit teaches a hub positioned at the second end of the shaft, wherein the hub is positioned on a portion of the cylindrical shaft having a second portion of the first coating removed therefrom to thereby expose a second length of conductive material that was positioned under the removed second portion of first coating, and wherein the hub is configured to electrically couple a lead wire to the second length of conductive material at the second end (Paragraphs 0011-0012: the hub on the proximal end includes wires or connectors for attaching the electrode to an electric signal measuring device; Fig. 1 references 106 and 116: the coating (116) does not extend into the hub portion and the elongate body (106) is exposed to allow for electrical connection).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the electrode of Carr to include the hub assembly with an uncoated proximal end of the electrode to permit electrical communication with measurement equipment as taught by Nesbit because such a configuration allows the EMG needle electrode to send signals to a measurement device and protects the uncoated core from interference or damage.
Regarding claim 2, modified Carr teaches the electrode of claim 1. Modified Carr further teaches the electrode wherein the conductive material comprises tungsten or stainless steel (Paragraph 0027: the inner core may be tungsten).
Regarding claim 6, modified Carr teaches the electrode of claim 1. Modified Carr further teaches the electrode wherein the tapered tip comprises at least two bevels (Fig. 1: the point is formed by two angles surfaces or bevels).
Regarding claim 7, modified Carr teaches the electrode of claim 1. Modified Carr further teaches the electrode wherein the cylindrical shaft and tapered tip have a first portion and a second portion (Fig. 1, the first portion is the cylinder before the beginning of the bevel to form the tip, the second portion is the tip beginning at the bevel), wherein the first portion is of a first length and has a substantially uniform diameter (Fig. 1: the first portion has a length and substantially uniform diameter), wherein the second portion is of a second length and has a tapered surface, and wherein the tip comprises the second portion (Fig. 1: the second portion begins as the bevel to form the tip and thus comprises the tip and is tapered to a point).
Regarding claim 28, modified Carr teaches the electrode of claim 1. Modified Carr further teaches the electrode wherein the first coating has a dielectric thickness selected to reduce electrical capacitance of the electrode below a capacitance value of an uncoated conductive shaft of equivalent geometry (Paragraph 0027: the inner core is coated with an insulating layer. Such a coating reduces the capacitance of the inner core as compared to an uncoated shaft. It is noted that any insulative coating achieves the claimed effect since it adds distance from the core shaft and the surrounding environment. Such a property is noted by Applicant’s specification paragraph 0063 which recites “As is known, capacitance is equal to permittivity×area/distance. Therefore capacitance drops as thickness of the insulative coating or sheath 110 on the needle 100 increases”).
Regarding claim 29, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the first coating further comprises an antimicrobial additive selected from titanium-nitride-silver (TiNAg), silver, or silver chloride.
Nesbitt teaches an electrically insulative first coating which may include antimicrobial additives including silver particles, silver compounds, and other additives (Paragraphs 0019-0021).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the antimicrobial additives taught by Nesbitt into the electrode of modified Carr with the first coating because such additives provide the benefit of having antimicrobial properties which may be beneficial to reduce infection risk of the patient since the first coating is exposed at the tip of modified Carr.
Regarding claim 30, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the second end further comprises a lead wire mechanically secured by a hub having a polymeric body molded around the exposed conductive material.
Nesbitt teaches a hub secured to a proximal end of the electrode to serve as a handle and to allow for electrical connection to a wire to connect to an electronic signal measuring and recording instrument. The hub may be formed of molded plastic (Paragraphs 0004, 0011 and 0027).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the electrode of Carr to include the hub assembly with an uncoated proximal end of the electrode to permit electrical communication with measurement equipment as taught by Nesbit because such a configuration allows the EMG needle electrode to send signals to a measurement device and protects the uncoated core and electrical connection from interference or damage.
Claims 3 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 1 above and further in view of Mumford US Patent Application Publication Number US 2005/0261602 A1 hereinafter Mumford
Regarding claim 3, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the conductive material has a thickness ranging from 25 to 32 gauge.
Mumford teaches needles having more than one electrode and which are particularly suited for use in electromyography (Abstract). Thus Mumford falls within the same field of endeavor as Applicant’s invention.
Mumford teaches a concentric EMG electrode with an outer dimeter ranging from approximately 0.3mm (approximately 30 gauge) to 0.65mm (approximately 23 gauge) (paragraph 0014).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the electrode of modified Carr to have an outer diameter within the range taught by Mumford because such a configuration is a simple substitution of one known element (the gauge of Carr) for another (the gauge of Mumford) with no surprising technical effect. It is further noted that the particular diameter or gauge of the needle is a matter of routine optimization and experimentation to optimize the physical properties and/or form factor of the needle to a desired use case. In particular, the gauge may be altered based on the required rigidity, the particular materials used for construction, intended puncture site, importance of patient comfort for the procedure in which the needle is used, age and/or size of the patient, as well as manufacturing limitations. No surprising technical effect or evidence of criticality of the claimed gauge range has not been set forth in the specification and thus the claimed gauge range of the EMG electrode is considered to be an obvious variation of modified Carr since the particular gauge of the needle may be optimized.
Regarding claims 22 and 23, modified Carr teaches the electrode of claim 1. Modified Carr further teaches the electrode wherein the shaft has a base portion and a tapered portion (Fig. 1 the base portion is considered the cylindrical shaft up until the start of the bevel, the tapered portion starts at the bevel and extends to the tip of the needle).
Modified Carr fails to further disclose the electrode wherein the tapered tip has a length ranging from 0.1 mm to 1 mm measured along a longitudinal axis of the shaft, or wherein the tapered portion forms an angle between 10 degrees and 20 degrees relative to the longitudinal axis of the shaft.
Mumford teaches an EMG needle with a tip having an angle from about between 5 to 25 degrees and wherein the distance from the tip point to the outer conductor formed on the shaft of the needle is between 0.2mm and 10mm (Paragraph 0053).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the tip angles taught by Mumford in the electrode of modified Carr because altering the tip angle is a simple substitution of one known element (the tip angles of Carr) for another (the tip angle of Mumford) with no surprising technical effect. If is further noted that the particular length of the tapered tip is a dependent upon the angle formed by the tip. For an electrode with an outer diameter of 0.3mm (approximately 30 gauge) a 20 degree tip results in a tapered portion of 0.85mm in length. Thus the claimed length of the tapered portion is considered to be taught by modified Carr as described above. Furthermore, the particular length of the tapered portion is considered to be a matter of routine optimization and experimentation and is driven by the gauge and tip angle of the needle.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 1 above and further in view of Ellman US Patent Number US 5695495 A hereinafter Ellman
Regarding claim 4, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the first coating has a minimum thickness of 20 microns.
Ellman teaches an electrode for use in an electrosurgical procedure for treating varicose veins. In a preferred embodiment, the electrode is characterized by a bare active sharpened tip portion at the end of a needle-shaped member capable of penetrating the vein of a patient. The vein-tissue damage is effected with the bare tip and the adjacent portions of the needle are made insulating to prevent accidental burns to the patient and to allow the physician to use these insulated parts to help position and guide the active tip portion during the surgical procedure (Abstract). Thus, Ellman is reasonably pertinent to the problem at hand.
Ellman teaches the application of an electrically insulative coating to a needle electrode. Ellman teaches that the thickness of the coating is preferably in the range of 0.0007 to 0.0013 inches or 17.78 to 33.02 microns (Col 3 lines 41-61).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the thickness range of the electrically insulative coating taught by Ellman into the electrode of modified Carr because modified Carr does not set forth a particular thickness range for the insulative coating and Ellman teaches that the above range may be suitable for a Teflon coating. Furthermore, it would seem that the exact thickness of the coating is a matter of routine optimization and experimentation and based on the required degree of electrical insulation, the particular insulating material being utilized, and other application specific parameters which may be optimized to a particular use case.
Claims 5 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 1 above and further in view of McCullagh US Patent Application Publication Number US 2007/0260234 A1 hereinafter McCullagh.
Regarding claim 5, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the first coating comprises at least one biocompatible diamond-like carbon (DLC) material.
McCullagh teaches an RF ablation device comprises an electrode including a DLC coating deposited on at least a portion thereof. A method of forming an RF ablation device, comprises forming a DLC coating on a portion of a metallic electrode (Abstract). Thus, McCullagh is reasonably pertinent to the problem at hand.
McCullagh teaches that diamond-like coatings are coatings whose properties may be significantly modified by varying the composition of the precursor gases used, the deposition time, and other parameters to achieve a coating having specific desired properties. The coating may be adapted to a particular use case and the thickness of the coating may also be adapted to achieve specific desired properties. In some cases the coating may be approximately 0.02mm, or 20 microns, in thickness (Paragraph 0021). McCullagh teaches that DLC coatings have lubricating properties and reduce sticking to tissue (Paragraph 0022). DLC coating may be configured to have a variety of properties including being electrically insulative (Paragraph 0027).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the use of DLC coatings as taught by McCullagh into the device of modified Carr because McCullagh teaches that these coatings are highly adaptable to achieve the properties most desirable for a particular use (Paragraphs 0021-0022 and 0027), and would thus allow modified Carr to adapt the coatings for specific use cases.
Regarding claims 25 and 26, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the first coating comprises a fluorinated or hydrogenated diamond-like carbon (DLC) compound adapted to reduce friction and insertion force, or wherein the first coating comprises a dopant selected from nitrogen, fluorine, or hydrogen adapted to modify at least one of hardness, conductivity, or coefficient of friction of the coating.
McCullagh teaches that diamond-like coatings are coatings whose properties may be significantly modified by varying the composition of the precursor gases used, the deposition time, and other parameters to achieve a coating having specific desired properties. McCullagh teaches that adding hydrogen to the gas mixture, or hydrogen doping, may be used to remove graphite. McCullagh teaches embodiments using hydrogen and nitrogen doped carrier gas (C:H:N). The coating may be adapted to a particular use case and the thickness of the coating may also be adapted to achieve specific desired properties. In some cases the coating may be approximately 0.02mm, or 20 microns, in thickness (Paragraph 0021). McCullagh teaches that DLC coatings have lubricating properties and reduce sticking to tissue (Paragraph 0022). DLC coating may be configured to have a variety of properties including being electrically insulative (Paragraph 0027).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the hydrogen and nitrogen doped DLC coating taught by McCullagh into the electrode of modified Carr as the first coating because McCullagh teaches that these coatings are highly adaptable to achieve the properties most desirable for a particular use (Paragraphs 0021-0022 and 0027), and would thus allow modified Carr to adapt the coatings for specific use cases while achieving desirable properties such as electrical insulation and high lubricity.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 7 above and further in view of Iddan US Patent Application Publication Number US 2017/0265745 A1 hereinafter Iddan in view of Lu US Patent Application Publication Number US 2020/0054273 A1 hereinafter Lu
Regarding claim 8, modified Carr teaches the electrode of claim 7. Modified Carr further teaches the electrode further comprising: a second coating positioned over the first coating (Fig. 1 reference 102; Paragraph 0027: the outer cannula, or coating, may comprise stainless steel or other materials and forms an outer electrode).
Modified Carr fails to further teach the electrode wherein the second coating is at least one of molybdenum disulfide, tungsten disulfide or silicone oil.
Iddan teaches a biopsy access tube, tools and/or methods, and, more particularly, but not exclusively, to tools and/or methods for sharing an access tube (Paragraph 0003). Thus Iddan is reasonably pertinent to the problem at hand.
Iddan teaches that molybdenum disulfide is biocompatible as it may be used to cover a cannula to protect the patient (Paragraph 0107).
Lu teaches nanomaterial epidermal sensors which may be optically transparent and may be used to measure an electrocardiogram (ECG), an electroencephalogram (EEG) or an electromyogram (EMG) (Abstract). Thus Lu is reasonably pertinent to the problem at hand.
Lu teaches that molybdenum disulfide may be conductive and mechanically robust (paragraph 0031)
Thus Iddan and Lu teach material properties of molybdenum disulfide which indicate that it is conductive and suitable for use in invasive devices.
It would have been obvious to one of ordinary skill in the art to construct the electrode of modified Carr such that the outer cannula comprises a layer of molybdenum disulfide because Carr explicitly contemplates the cannula being comprised of materials other than stainless steel (Carr: paragraph 0027 “The outer cannula may comprise stainless steel among other materials”) and Iddan and Lu teach that molybdenum disulfide has suitable material properties, that is being electrically conductive, biocompatible, and mechanically robust, to serve as the outer cannula of modified Carr. Thus, constructing the outer cannula of modified Carr using a layer molybdenum disulfide is a simple substitution of one known element for another with no surprising technical effect.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt in view of Iddan US Patent Application Publication Number US 2017/0265745 A1 hereinafter Iddan in view of Lu US Patent Application Publication Number US 2020/0054273 A1 hereinafter Lu as applied to claim 8 above and further in view of McCullagh US Patent Application Publication Number US 2007/0260234 A1 hereinafter McCullagh
Regarding claim 9, modified Carr teaches the electrode of claim 8 (as interpreted in light of the above presented 35 USC 112(b) rejection). Modified Carr fails to further teach the electrode further comprising: a conductive third coating positioned over the second coating, wherein the third coating comprises a doped diamond-like carbon material.
McCullagh teaches that diamond-like coatings are coatings whose properties may be significantly modified by varying the composition of the precursor gases used, the deposition time, and other parameters to achieve a coating having specific desired properties, including electrical conductivity. The coating may be adapted to a particular use case and the thickness of the coating may also be adapted to achieve specific desired properties. In some cases the coating may be approximately 0.02mm, or 20 microns, in thickness (Paragraph 0021). McCullagh teaches that DLC coatings have lubricating properties and reduce sticking to tissue (Paragraph 0022).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to add an outer coating of doped DLC as taught by McCullagh into the device of modified Carr because McCullagh teaches that these coatings have lubricating effect and their particular material properties are highly configurable. Thus adding a doped DLC coating as taught by McCullagh on top of the outer cannula of modified Carr would result in a needle that has reduced friction when penetrating the user’s tissue (McCullagh: paragraph 0022: lubricating qualities) resulting in more comfortable use while not altering the function of the outer cannula since the doped DLC coating may be adapted to be electrically conductive (McCullagh: paragraph 0021: may be made electrically conductive) and would thus still allow the outer cannula to conduct electrical signals as intended.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 1 above and further in view of McCullagh US Patent Application Publication Number US 2007/0260234 A1 hereinafter McCullagh in view of JP1 the machine English translation of Japanese Patent Application Publication Number JP H08510829 A hereinafter JP1.
Regarding claim 24, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the first coating is deposited by a vacuum plasma deposition process that comprises a plasma-assisted chemical vapor deposition cycle repeated a plurality of times to achieve the desired thickness.
McCullagh teaches that diamond-like coatings are coatings whose properties may be significantly modified by varying the composition of the precursor gases used, the deposition time, and other parameters to achieve a coating having specific desired properties. The coating may be adapted to a particular use case and the thickness of the coating may also be adapted to achieve specific desired properties. In some cases the coating may be approximately 0.02mm, or 20 microns, in thickness (Paragraph 0021). McCullagh teaches that DLC coatings have lubricating properties and reduce sticking to tissue (Paragraph 0022). DLC coating may be configured to have a variety of properties including being electrically insulative (Paragraph 0027).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the use of DLC coatings as taught by McCullagh into the device of modified Carr to use as the first coating because McCullagh teaches that these coatings are highly adaptable to achieve the properties most desirable for a particular use (Paragraphs 0021-0022 and 0027), and would thus allow modified Carr to adapt the coatings for specific use cases.
Modified Carr in view of McCullagh fails to further teach the electrode wherein the first coating is deposited by a vacuum plasma deposition process that comprises a plasma-assisted chemical vapor deposition cycle repeated a plurality of times to achieve the desired thickness.
JP1 teaches a probe which may be coated with DLC coatings (Abstract; Page 9). Thus, JP1 is reasonably pertinent to the problem at hand.
JP1 teaches that DLC coatings may be applied using conventional techniques including plasma enhanced chemical vapor deposition (PECVD). The coatings may be modified with other materials to achieve desired properties of the coating. The coatings may additionally be applied in layers to achieve desired properties and the coatings may vary in thickness (Page 9). Thus, JP1 teaches that PECVD is a conventional application process for DLC and that DLC may be applied in layers to achieve desired material properties which includes a desired thickness of a coating.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to apply the first coating comprising DLC of modified Carr in view of McCullagh using PECVD as taught by JP1 because such a deposition process is conventional and is a simple substitution of one known element (the application process of McCullagh) for another known element (PECVD) with no surprising technical effect. Additionally, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to apply the DLC in a plurality of layers, or repeat the deposition process a plurality of times, to achieve a desired thickness as taught by JP1 because such a process is a simple substitution of one known process (depositing the DLC coating a single time) for another known process (repeated depositions) with no surprising technical effect.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Carr US Patent Application Publication Number US 2013/0237795 A1 hereinafter Carr in view of Nesbitt US Patent Application Publication Number US 2016/0235327 A1 hereinafter Nesbitt as applied to claim 1 above and further in view of Das US Patent Application Publication Number US 2004/0143218 A1 hereinafter Das.
Regarding claim 31, modified Carr teaches the electrode of claim 1. Modified Carr fails to further teach the electrode wherein the tapered tip has three bevels comprising a front bevel and two rear bevels arranged in a boat-hull configuration to define a penetrating point.
Das teaches an introducer needle for an infusion set or the like includes a solid tip portion with a plurality of intersecting wedge surfaces that converge toward a common insertion point. Preferably, the common insertion point is coincident with a central axis of the introducer needle. The tip portion also includes a plurality of cutting edges formed at intersections of the wedge surfaces (Abstract). Thus, Das is reasonably pertinent to the problem at hand.
Das teaches a needle with a tip having three bevels to form a penetrating point. The penetrating point is formed by the intersection of a first, second, and third wedge face (Paragraph 0020; Fig 2 references 48 and 46).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configured the tapered tip of modified Carr to be constructed in the same manner as the tapered tip of Das because such a construction is a simple substitution of one known element (the needle tip of Carr) for another known element (the needle tip of Das) with no surprising technical effect.
Claims 27 and 32 are not rejected over the prior art, as described in the above presented 35 USC 112(b) rejections, the meets and bounds of these claims are unclear and it is unclear what teachings would serve to anticipate them.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. 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.
/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791