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 . Claims 1-23 are currently pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the electrodes (101/201) being in a tolerance fit relationship with the wiring member (102) must be shown or the feature(s) canceled from the claim (11) as the electrode never comes into contact with the walls of the wiring member the support does and the specification details that as being a distinct element). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 6 is objected to because of the following informalities: in line four “the adhesive sheet fixes fix a part” should be reworded for grammatical purposes. Appropriate correction is required.
Claims 1 and 18 both recite an electrode sheet in line two, the “including” does not have a colon after it so it’s unclear if the electrodes, wiring member, and sensor module are a part of the electrode sheet itself (which it is assumed to be in light of the original disclosure). Appropriate correction is required.
Claims 22-23 recite the “living-body-side” and though in a vacuum there is nothing wrong with this style, all of the other instances of “living body” lack the hyphen. It could be rewritten as the “living body side” and it would be more consistent with the other phrasings thought the other dependent claims, and is still supported.
Claim Interpretation
The phrase “meandering pattern” in claims 9-10 is being read as a winding or simply non-straight pattern/pathway. Meandering itself does not have an explicit shaping nor is there any special definition present in the original disclosure.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-12 and 22-23 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.
Claims 11-12 describe similar elements being fixed into “places” formed by covering with the wiring member a wall surface of a hole(s) made in the sheet member. The claims are convoluted and should be reworded as it is entirely unclear how the elements are structurally related. Even with the Figures 1-2 in mind, the claims are hard to read and are ultimately unclear as to how the elements are connected. The art rejection below is based on how the claims were possibly meant to be read, but even then it is a best guess.
Claims 22-23 both claim that the sensor module is disposed on a living-body side surface of the electrode sheet, however the electrode sheet already incorporates and is defined by the electrodes, wring member, and sensor module. The sheet itself is not a physical sheet or layer on its own according to independent claims 1 and 18, so it’s unclear how an element which already integral and a part of the sheet is on any side of the sheet. Additional clarity on the structural relationship between the elements would alleviate the issue.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4, 6, 8, and 22-23 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Each of these includes some variant of claiming an element is fixed, connected, or contacts the living body. The wording should be adjusted so that those elements are adapted or configured to contact, be fixed to, etc. to the living body. Claims 1 and 18 are acceptable with the “can be attached” however it is recommended it also be adjusted to “adapted to” or “configured to” as it would mean the same thing and would be consistent with the needed changes to the above rejected claims.
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 1-2, 4-5, 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker et al. US Publication 2008/0139953 (hereinafter Baker).
Regarding claim 1, Baker discloses an electrode device for a living body (abstract, Figures 1-2), the electrode device comprising: an electrode sheet including at least a pair of electrodes that receive a bioelectrical signal (404 which is a conductive member that electrically connects to a hydrogel 103, where either can technically be considered an electrode), a wiring member that transmits the bioelectrical signal received (412), a sensor module that externally outputs a signal relating to the bioelectrical signal (202 which includes circuits shown in Figure 5 on it, including a wireless antenna), and a connector that connects the bioelectrical signal to the sensor module (301-303 which are press fit electrical connectors connecting the wiring member and the electrodes to the processing circuitry); and an adhesive sheet that can be attached to a living body while covering the electrode sheet (105 which includes an adhesive layer).
Regarding claim 2, Baker discloses that the electrode sheet includes a sheet member that supports the electrodes, the wiring member, the sensor module, and the connector (101).
Regarding claim 4, Baker discloses that the electrode sheet includes at least a pair of conductive gels that are brought into contact with the living body (103) and receive the bioelectrical signal (103), and the electrodes are conductive members that receive the bioelectrical signal from the conductive gels (conductive member 404).
Regarding claim 5, Baker discloses that the sensor module wirelessly externally transmits the signal relating to the bioelectrical signal (518 coupled to 513 are an wireless antenna system).
Regarding claim 9, Baker discloses that the wiring member has a meandering pattern (traces 412 which have non-straight patterns; meandering is not clearly defined).
Claims 1-2, 4, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balda et al. US Publication 2021/0113109 (hereinafter Balda).
Regarding claims 1 and 14, Balda discloses an electrode device for a living body (Figures 1-2), the electrode device comprising: an electrode sheet including: at least a pair of electrodes that receive a bioelectrical signal (electrodes 128, could also be 130 depending on the interpretation), a wiring member that transmits the bioelectrical signal received (104 which is a receiver connected to a wire 135, see Figure 6), a sensor module that externally outputs a signal relating to the bioelectrical signal (103, see also [0044]), and a connector that connects the bioelectrical signal to the sensor module (126), wherein the connector (126) is inserted into and fixed to a hole in the wiring member (wiring element 104 as per [0048]); and an adhesive sheet that can be attached to a living body while covering the electrode sheet (131 of Figure 9).
Regarding claim 2, Balda discloses that the electrode sheet includes a sheet member that supports the electrodes, the wiring member, the sensor module, and the connector (117).
Regarding claim 4, Balda discloses that the electrode sheet includes at least a pair of conductive gels that are brought into contact with the living body (130) and receive the bioelectrical signal (130), and the electrodes are conductive members that receive the bioelectrical signal from the conductive gels (conductive member 128).
Regarding claim 11, Balda discloses, as best understood, that the electrodes are (128 snaps into connector 126), by fit tolerance of "transition fit" or "tight fit", fixed into places formed by covering with the wiring member a wall surface of holes made in the sheet member (sheet member 117 includes holes and walls in 119 to house the wiring member 104, all of the elements are friction fit together).
Regarding claim 12, Balda discloses, as best understood, that the connector is, by fit tolerance of "transition fit" or "tight fit" (128 snaps into 104 by means of a friction fit), fixed at locations formed by covering with the wiring member a wall surface of a hole made in the sheet member (Figure 6 which has walls at 119 of sheet member 117 that houses wiring member 104 to fix 128 within it).
Regarding claim 13, Balda discloses that each of the electrodes (128) is fixed so as to be held between the wiring member (104) and the adhesive sheet (131) and have a projection thereof exposed from a hole in the wiring member (128 starts below the adhesive sheet 131 and includes a projection that extends into connector 128 as well as into 104, all of which are fixed into place).
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 non-obviousness.
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.
Claims 1-3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek et al. US Publication 2008/0275327 (hereinafter Faarbaek) in view of Baker.
Regarding claim 1, Faarbaek discloses an electrode device for a living body (abstract, Figures 19-20), the electrode device comprising: an electrode sheet including: at least a pair of electrodes that receive a bioelectrical signal (elements 14-15 and [0161]-[0162] which details electrodes, needle or planar), a wiring member that transmits the bioelectrical signal received (traces mentioned at [0222]), a sensor module that externally outputs a signal relating to the bioelectrical signal (processor 13 which can be coupled to an antenna 12), and an adhesive sheet that can be attached to a living body while covering the electrode sheet (sheet 5).
Baker teaches a similar monitoring device that includes a connector that connects the bioelectrical signal to the sensor module (301-303 which are press fit electrical connectors connecting the wiring member 412 and the electrodes 404 to the processing circuitry located at 202 and Figure 5). Given that some type of connector would have had to have been present between the electrode and the processing circuitry of Faarbaek, it would have been obvious to the skilled before the effective filing date to utilize the connector as taught by Baker with the device of Faarbaek as predictable results would have ensued (connecting the electrodes to the processing circuits).
Regarding claim 2, Faarbaek discloses that the electrode sheet includes a sheet member that supports the electrodes, the wiring member, the sensor module, and the connector ([0136] which details a printed circuit board, the alternate interpretation can simply be element 7 which is flat and can be considered a sheet member that supports the above mentioned components).
Regarding claim 3, Faarbaek discloses that the electrodes are needle-shaped members that are brought into contact with the living body and receive the bioelectrical signal ([0148]).
Regarding claim 22, Faarbaek discloses, as best understood (see 112 second above), that the sensor module is disposed on a living-body-side surface of the electrode sheet (Figure 19 where the sensor module 12-13 sits within housing 7 which is located on the skin-facing side of sheet 5).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek in view of Baker and in further view of Carim US Publication 2005/0015134 (hereinafter Carim).
Regarding claim 6, Faarbaek discloses a sensor module as mentioned above and even mentions that in lieu of a wireless system, it can be used in a wired configuration for external outputting the obtained signal ([215]), however it’s still silent as to what that could look like. Carim teaches an electrode that utilizes a wired output that is connected to and fixed by the adhesive sheet (90, 98) that can fix said wire to the living body (Figures 1-2). It would have been obvious to the skilled artisan before the effective filing date to utilize the wired connection as taught by Carim with the electrode of Faarbaek as the two output types are known art recognized equivalents.
Claims 7-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek in view of Baker and in further view of Libbus et al. US Publication 2009/0076364 (hereinafter Libbus).
Regarding claims 7-8 and 15, Faarbaek discloses the electrodes (14-15) and that they can sense and provide electrotherapy ([0001] EMG, and [0164] stimulation; where it should be noted these electrodes are fully capable of performing the claimed intended use without any additional structural modifications), but is silent on there being more than the two electrodes present (both claims require a minimum of four electrodes) and that the adhesive sheet is porous.
Libbus teaches an adhesive sensing patch that includes electrodes (112 A-D) and that the adhesive sheet is porous ([0031]). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional electrodes and porous adhesive sheet as taught by Libbus with the device of Faarbaek in order to allow the adhesive to be more comfortable (breathable), and in order to allow for additional sensing (both quantity and type) to take place with the additional electrodes (see also duplication of parts, MPEP 2144.04-VI:B).
Claims 9-10 is rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Gallego et al. US Publication 2014/0031663 (hereinafter Gallego).
Regarding claims 9-10, Baker discloses that the wiring member has a meandering pattern (as mentioned above), but is silent on the sheet member having a slit for the meandering pattern. Gallego teaches an ECG monitoring device that includes a wiring member with a meandering patter (18), where the sheet member includes a slit disposed at any location of the meandering pattern ([0069] which explicitly details a “meandering pattern” and is placed within the cutout of the sheet 121). The same concept can be applied to traces where grooves are made in the layer for said traces. Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the slit for the wiring member as taught by Gallego with the device of Baker in order to aid in the longevity and mechanical stress on the wiring member.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek in view of Baker and in further view of Keightley et al. US Patent 7,993,167 (hereinafter Keightley).
Regarding claims 16-17, Faarbaek discloses an adhesive sheet (element 5) but is silent on the attached material. Keightley teaches a shielded electrode device that includes the top cover having a metal foil attached thereto (column 2 lines 23-30 which details that either conductive paint/ink or a conductive metal foil can be utilized in the top most layer). Therefore, it would have been obvious top the skilled artisan before the effective filing date to utilize the additional material as taught by Keightley with the device of Faarbaek and Baker in order to protect the signal and components from electromagnetic interference as is known in the art.
Claims 18-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek in view of Baker and in further view of Palasz US Publication 2018/0051194 (hereinafter Palasz).
Regarding claims 18-19, Faarbaek discloses an electrode device for a living body (abstract, Figures 19-20), the electrode device comprising: an electrode sheet including: at least a pair of electrodes that receive a bioelectrical signal (elements 14-15 and [0161]-[0162] which details electrodes, needle or planar), a wiring member that transmits the bioelectrical signal received (traces mentioned at [0222]), a sensor module that outputs a signal relating to the bioelectrical signal to an exterior (processor 13 which can be coupled to an antenna 12), and though Faarbaek would need some trace/wire/conductive via to go from the electrode through the circuit board to reach the processing circuitry in 13, no exact mention of such a known feature was disclosed.
Baker teaches a similar monitoring device that includes a connector that connects the bioelectrical signal to the sensor module (301-303 which are press fit electrical connectors connecting the wiring member 412 and the electrodes 404 to the processing circuitry located at 202 and Figure 5). Given that some type of connector would have had to have been present between the electrode and the processing circuitry of Faarbaek, it would have been obvious to the skilled before the effective filing date to utilize the connector as taught by Baker with the device of Faarbaek as predictable results would have ensued (connecting the electrodes to the processing circuits).
Faarbaek teaches a covering for the electrode sheet (element 5) and a release liner (film of claim 19), but is silent on it being made of a photocurable resin (various pressure sensitive adhesives and thermoplastics are mentioned but those do not inherently have to be UV curing resins, though that material is detailed as being known for encapsulating the circuits as per [0133]). Palasz teaches a process for making a UV curable adhesive that can be attached to a living body with the photocurable resin being applied to a PET film (see [0034]-[0035][0071] abstract and mentions in [0061] these can be utilized in medical tapes and adhesives). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the material choice for the sheet as taught by Palasz with the device of Faarbaek as predictable results would have ensued (maintaining precise geometry after curing, faster manufacturing, and higher cohesive strength over the adhesives suggested by Faarbaek).
Regarding claim 20, Faarbaek as modified by Palasz discloses that the photocurable resin (of Palasz, rendered obvious above) can separately attach the electrodes and the sensor module to the living body (the device can be broken into more than one unit as per [0215] and claim 58). It would have been obvious to the skilled artisan before the effective filing date to utilize the material choice for the sheet as taught by Palasz with the device of Faarbaek as predictable results would have ensued (maintaining precise geometry after curing, faster manufacturing, and higher cohesive strength over the adhesives suggested by Faarbaek).
Regarding claim 21, Faarbaek discloses that a part or all of the electrodes are used as electrodes for electrotherapy (there is no change to the electrode structure itself nor is there details on a processor configured to perform this task, as such, the electrodes of Faarbaek mentioned above at 14-15 are fully capable of performing this intended use without any additional structural modifications).
Regarding claim 23, Faarbaek discloses, as best understood (see 112 second above), that the sensor module is disposed on a living-body-side surface of the electrode sheet (Figure 19 where the sensor module 12-13 sits within housing 7 which is located on the skin-facing side of sheet 5).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Faarbaek in view of Baker and Palasz, and in further view of Banet et al. US Publication 2008/0114220 (hereinafter Banet).
Regarding claim 20, in a second interpretation of the claim, Faarbaek as modified by Palasz discloses that the photocurable resin (of Palasz, rendered obvious above) and includes electrodes but not detached electrodes. Banet teaches an ECG monitoring patch that includes an electrode device (Figure 1) with an adhesive for attaching to a living body (25) but then also includes separately attachable electrodes (60 as per Figure 5B) that are also attached by an adhesive (75 of Figure 4A). The adhesive of Palasz would be applied to the other instances of adhesive in Banet in the above resultant combination. It would have been obvious to the skilled artisan before the effective filing date to utilize the additional, separate electrodes as taught by Banet with the device of Faarbaek in order to allow for additional sensing types increasing the device’s versatility (such as multi-lead ECG).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/B.M.A/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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