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
Claims 8-14 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 5/9/25.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 15, and 21-23 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.
In claim 1, “at least one electrode comprising at least one of a therapy electrode or a monitoring electrode” and the language of the last paragraph make the claim vague and seem to conflict between the two. Since the claim uses “at least one”, it could have only a therapy electrode, only a monitoring electrode, or both. However, the last paragraph indicates that the therapy electrode is used, and also appears to indicate the monitoring electrode is used to detect/sense the medical condition. If a therapy electrode is used in the claim, then does the sensing/detecting need to be performed in the claim or prior art? If a monitoring electrode is used in the claim, does the last paragraph need to be accomplished in the claim of delivery of therapy? The examiner has interpreted the claim of needing one of a therapy electrode or a monitoring electrode since “at least one” electrode is claimed.
In claim 1, in the next to last paragraph, “wherein a duration of the application of the portion of conductive ink on the patient’s skin is based on a determined medical condition” is vague, relative, and appears to be more like a method step than a structural limitation. The claim is drawn to a structure, but this phrase seems to indicate the step of an application of the portion to the body, and someone determining the medical condition and how long the duration of the conductive ink should be on the body. Also no element has been set forth to determine the duration (note that the last paragraph “detects” the condition, and does not determine it). In addition, the duration is relative and can be anything from instantaneous to a permanent tattoo, and therefore any prior art that has a conductive ink portion meets the limitations of the claim.
In claim 6, “further comprising a wearable medical device” is vague as it is unclear if this is in addition to the wearable garment set forth in claim 1, or further defining the wearable garment of claim 1 (and if so, what is the additional limitation of claim 6), or is the same element as set forth in claim 1 (which the claim should then be canceled).
In claim 15, “while being in contact with the patient’s skin” is vague and sounds like there is a connection to the patient’s body. Apparatus claims should use functional language to claim a connection, such as “configured to be in contact with the patient’s skin”.
Claims 21-23 are vague and are more like method steps than structural limitations. The claims state the ink “is temporarily applied to the patient’s skin”, but since the claims are drawn to an apparatus, it is unclear what structural limitation is being further recited. In addition, apparatus claims cannot claim connection to the body and it is suggested to use functional language such as “configured to be temporarily applied…”.
In claim 21, “wherein the duration of temporary application is reduced based on…patient” is vague and relative as it is unclear how the duration of the portion of the conductive ink is reduced. Claim 1 already has the duration based on the medical condition, so how does claim 21 reduce this duration? Are multiple different inks being used? And if claim 1 bases the duration of the condition, then wouldn’t they already take into account the reduced duration?
In claim 22, “wherein the portion of conductive in is further applied…application” is vague and is directed more to a method step than a structural limitation. In addition, it is unclear how the original “portion of conductive ink” is “further applied”. Is it stripped off then used again? Or is a new conductive ink used?
In claim 23, “using a transfer paper” is vague, inferentially included, and more like a method step. It is unclear if a method step is being recited (i.e. “using” a transfer paper), or if the transfer paper is part of the system (and therefore needs to be positively recited first before use), or if this is an intended use/functional recitation.
The structural limitations of claims 21-23 could not be determined.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-7, 15, and 21-23 are rejected under 35 U.S.C. 102(a1) as anticipated by Bradley et al (4576170) or, in the alternative, under 35 U.S.C. 103 as obvious over Bradley et al in view of Radivojevic et al (2019/0167196). Bradley discloses:
--a wearable garment cardioverter defibrillator (e.g. figures 1-3, col. 3, lines 10-25, col. 7, lines 55-65, claim 9, etc.) configured to detect a medical condition to deliver therapy through the therapy electrode (e.g. col. 6, lines 5-43, col. 3, lines 47-65, claim 8-12, etc.)
--that has at least one electrode being a therapy electrode (e.g. wire mesh 56, col. 4, lines 17-39, etc.). Note also that Bradley discloses other electrodes such as monitoring electrodes (e.g. figure 3, elements 19-21, etc.), that the claims do not state that all of the electrodes are connected to the portion of conductive ink, and/or that Bradley’s therapy electrode can also be considered a “monitoring electrode” configured to sense signals from the patient’s body as the therapy electrode 56 is a conductive piece of material that is capable of sensing signals (the claim does not contain any structure to receive signals from the monitoring electrode).
--conductive paint/ink in paint form that is painted on (e.g. col 6, lines 25-32, etc.) that provides a low contact resistance, and therefore reduces electrical impedance and improves conductivity at the electrode-skin interface (e.g. col. 4, lines 17-39, etc.).
--the conductive ink/paint includes metallic material as it is SC20 from Micro-Circuits, a silver paint (e.g. col. 4, lines 20-25, see as evidence, EP 0312077, page 4, line 3—in the alternative, see the 103 rejection below), and the paint allows the adhesion of the patient’s skin to the electrode as the electrode can be taped to the paint, or another layer of paint can be placed over the electrode to hold it in place (e.g. col. 4, lines 25-30, col. 6, lines 25-35, etc.).
--As to the claim limitation of a duration of application based on a determined medical condition, Bradley does perform this as he recognizes that the conductive ink/paint needs to be applied semi-permanently or for an extended period of time based on the patient’s heart condition to cardiovert/defibrillate the patient’s heart. Note that this limitation is a more like a method step than a structural limitation, no structural element has been set forth to determine this duration, and it is a relative amount of time.
--The claims state that the conductive ink is in “paint form” and as Bradley provides a conductive paint that is painted on, and functions as a tattoo as it leaves a mark on the skin, he does meet the limitations of the claims of the conductive ink/paint being a tattoo and also being applied in paint form (in the alternative, see the 103 rejection below).
In the alternative, Radivojevic teaches the use of a conductive ink having metallic material (e.g. paras. 71, 10, 11, 25, 58, etc.) so as to allow adhesion of an electrode to the skin (e.g. paras. 21, 66, etc.), the ink can be above or below the skin as a tattoo (e.g. figure 3, paras. 74-77, etc.), applied to the skin with a paper backing (e.g. para. 85, etc.; and therefore both a tattoo and decalcomania), and as it is an ink, it is capable of being directly painted on the skin, where it is decided to apply it temporary or permanent (e.g. paras. 74-77, 84 etc.) in order to measure the patient’s body parameters, and therefore based on a determined condition, in order to provide a way for wearable electrodes to make good conductive contact with the patient’s skin. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Bradely, with the conductive ink having metallic material so as to allow adhesion of an electrode to the skin, the ink can be above or below the skin as a tattoo or applied to the skin with a paper backing (e.g. para. 85, etc.; and therefore both a tattoo and decalcomania), and as it is an ink, it is capable of being directly painted on the skin, as taught by Radivojevic, since it would provide the predictable results of allowing a physician or user to easily apply the conductive ink to the patient’s body so that the electrodes are properly placed on the patient’s body at the correct position and allow good conductive contact and secure connection between the electrode and the patient’s skin.
Note for claims 21-23, it is not clear what structural limitations are being claimed. However, Bradley discloses the use of temporary application of the ink/paint, that his ink/paint can be reapplied, and Bradley meets the intended use recitations of claim 23 as his paint/ink can be applied to transfer paper to apply the ink/paint temporarily to the skin. Similarly, as discussed above, Radivojevic discloses these same limitations.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/ Primary Examiner, Art Unit 3792 12/3/25