DETAILED ACTION
Specification
The abstract of the disclosure is objected to because “substrat” should be “substrate”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: “substrat” in [0007] should be “substrate”.
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 1-10 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 that one of the plurality of wire electrodes in the invasion section is at least partially wound around each of other ones of the plurality of wire electrodes in the invasion section in a spiral manner. There is no support for such a feature in the original disclosure. The original disclosure provides support for two winding geometries – the first being one where all the wires are wound around each other (e.g. Fig. 8) and the second where multiple electrodes are spirally wound around the invasion section of a central wire electrode (e.g. Fig. 9). What is being recited is the reverse of what’s disclosed with respect to Fig. 9 – one in which a single electrode is wound around each of the other ones of the plurality of wire electrodes in the invasion section.
Claim 9 recites that the distal end of the electrically conductive core of the one of the plurality of wire electrodes is flush with the distal end of the electrically conductive core of each of the other ones of the plurality of wire electrodes. There is no support for such a feature in the original disclosure. The only instance of the specifications use of “flush” is when it describes a surface treatment to the distal end of each conductive core so as to have the configuration of being flush with its own corresponding insulating sheath ([0029] of the printed publication). That is not the same as what’s being recited, as it describes a relationship between the core and it's own sheath, not a relationship between one core to another.
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 1-10 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.
As to claim 1, the claim recites that the plurality of gold fingers are “located at the same level.”. It is unclear what the applicant means by “level”. While the disclosure provides support for having gold fingers that are provided on the same side of the substrate, that is not the same as being “located on the same level”, whether it means that they share the identical amount of elevation or whatever positional element it is based on. Moreover, when a single electrode is wound around each of the plurality of wire electrodes, the single electrode cannot, inherently, be on the same level, since it must occupy space that is above/below the other electrodes as it is wound around them. For purposes of interpretation, it will be understood that they are located at the same side of the substrate.
In addition, claim 1 recites “a plurality of wire electrodes, wherein each of the plurality wire electrodes comprises an electrically conductive core and an insulating sheath,” and thereafter refers throughout in the singular to “the insulating sheath”, “the electrically conductive core”, “the substrate section”, “a proximal end,” and “a distal end”. It is unclear whether these singular recitations are distributive and required of every one of the plurality of wire electrodes or directed to a single one of the plurality of wire electrodes. This lack of clarity is compounded as in one instance, the applicant specifies that “one of the plurality of wire electrodes” is “wound around each of the other ones of the plurality” and the fact that the previous iteration of claims used to recite “each said” element, implying that it was a deliberate decision to make such an amendment. Furthermore, the final clause now states that “the electrically conductive core in the substrate section is electrically connected to a corresponding one of the plurality of gold fingers”, which implies a one-to-one mapping across a plurality, but the antecedent is a single core in a single substrate section. In this case, it cannot be determined whether the claim requires each of the plurality of cores to be connected to its own respective gold finger, or only one such connection. This issues gets further compounded in the dependent claims. Clarification is required.
Claim 8 recites that “the electrically conductive core has a main portion which extends between the proximal end and the distal end, and which is covered by the insulating sheath”. Claim 1 already requires that the insulating sheath “substantially covers the electrically conductive core while exposing a proximal end and a distal end”. It is unclear whether this “main end” is referring to the same portion defined in claim 1, or if it’s some other portion.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-6, and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2007/0213611) in view of Brauker et al. (US 2006/0270923) and Say et al. (USP #6,175,752).
As to claim 1, Simpson teaches an invasive multi-electrode electrochemical sensor ([0153], [0335]), comprising: a plurality of wire electrodes, wherein each of the plurality wire electrodes comprises an electrically conductive core ([0160]) and an insulating sheath ([0164]), the insulating sheath substantially covers the electrically conductive core while exposing a proximal end and a distal end of the electrically conductive core ([0165], [0096]), the plurality of wire electrodes each has a non-invasion section ([0071] – ex vivo terminus) and an invasion section ([0136] – in vivo portion), the proximal end and the distal end of the electrically conductive core are respectively located at the non-invasion section and the invasion section ([0331] – the first end, front end, or in vivo portion versus second end, the ex vivo portion, or back end), and one of the plurality of wire electrodes in the invasion section is at least partially wound around each of other ones of the plurality of wire electrodes in the invasion section in a spiral manner ([0324] – helically wound; various configurations such as Fig. 1B, 7C, 9B, 11C).
Simpson does not directly teach a substrate, the substrate sections provided on the substrate, the invasion extends outward from an edge of the substrate, and a plurality of gold fingers provided on the substrate, wherein the electrically conductive core in the substrate section is electrically connected to a corresponding one of the plurality of gold fingers, at least a part of the plurality of gold fingers is printed on the substrate by screen printing, and the plurality of gold fingers are located at the same level.
However, Simpson, incorporates by reference, the teachings of Braucker ([0209], [0269]). Braucker in turn, incorporates by reference the teachings of Say in ([0147], [0184], [0264]). Say teaches a continuous in vivo analyte sensor (col. 2 lines 13-22) wherein the sensor is formed with a substrate (50), substrate sections provided on the substrate (col. 7 lines 14-25), and a plurality of gold fingers (49) provided on the substrate (col. 14 lines 39-60) and screen-printed at the same level (col. 10 lines 8-30)
Accordingly, it would have been obvious to modify Simpson, which incorporates the teachings of Braucker, which in turn, incorporates the teachings of Say, to utilize a planar sensor substrate structure as it would be obvious to try.
As to claim 2, the above combination teaches the proximal end is electrically connected to the corresponding one of the plurality of gold fingers (Say – col. 14 lines 10-23).
As to claim 4, the above combination teaches a diameter of the electrically conductive core is less than or equal to 25 µm (Brauker – [0173] – wire with a diameter of about 0.001 or less inches, which is roughly 25.4 µm or less).
As to claim 5, the above combination teaches a diameter of the electrically conductive core is greater than 25 µm and less than 1000 µm (Brauker – [0173] – wire with a diameter of about 0.001 or less inches, which is roughly 25.4 µm or less, to about 0.010 inches or more, which is roughly 254 µm).
As to claim 6, the above combination teaches a diameter of the electrically conductive core is greater than or equal to 1000 µm (Brauker – [0173] – wire with a diameter of about 0.010 inches or more, which is roughly 254 µm).
As to claim 8, the above combination teaches the electrically conductive core has a main portion which extends between the proximal end and the distal end, and which is covered by the insulating sheath (Brauker – [0176]), wherein the main portion has a first part which is connected to the proximal end (Say – col. 9 lines 10-20), and a second part which extends spirally between the first part and the distal end, wherein the first part of the electrically conductive core is in the substrate section, wherein the second part of the electrically conductive core is in the invasion section (Brauker – [0177], [0182]), and wherein the second part is covered by the insulating sheath (Brauker - [0177]) such that the electrically conductive core of the one of the plurality of wire electrodes is prevented from being in direct electrical connection with the electrically conductive core of each of the other one of the plurality of wire electrodes (Simpson – [0129]).
As to claim 9, the above combination teaches the distal end of the electrically conductive core of the one of the plurality of wire electrodes is flush with the distal end of the electrically conductive core of each of the other ones of the plurality of wire electrodes (Brauker – [0179]).
As to claim 10, the above combination teaches the plurality of wire electrodes and the plurality of gold fingers are located at the same side of the substrate (Say – col. 12 lines 22-37, col. 15 lines 17-26).
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2007/0213611), Brauker et al. (US 2006/0270923), and Say et al. (USP #6,175,752), and further in view of Shah et al. (WO 2004/030514).
As to claim 3, the above combination does not necessarily teach the proximal end is welded to the corresponding one of the plurality of gold fingers. Shah teaches that the wires can in the conductive element may be welded, soldered, or otherwise attached to the circuit pads ([0068]). It would have been obvious to modify the above combination with Shah to utilize one of the established ways to make electrical connections between components as it would be obvious to try.
As to claim 7, the above combination does not necessarily teach a cover plate provided on the substrate such that the substrate section is at least partially fixed between the cover plate and the substrate. Shah teaches a cover plate (lid 38) that is on top of the substrate (Fig. 2B, [0051]). It would have been obvious to modify the above combination with Shah to utilize a cover plate to provide environmental protection or to provide strain relief of the connected portions to impart additional structural integrity to the device.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/9/26
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