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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
Content of Specification
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it does not provide an accurate description of the invention as claimed. The claimed invention relates to both a device and method of using that device, wherein the device comprises an adhesive film and screen-printed dry electrodes. By contrast, the abstract presently on file describes a method relying on coated electrodes, the array of electrodes being at least partially coated by a polymer. The instant specification presents coated electrodes as an alternative to dry electrodes, which are understood to be absent coatings or gels (e.g., paragraphs [0061], [0064]).
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).
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 1-20 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.
The claims as presented recite that an array of dry electrodes are screen printed directly onto the second side of an adhesive film (e.g., claims 1, 12). The Specification does not provide sufficient written description of this construction. As described in at least paragraphs [0016], [0018], [0019], [0063], [0084], [0092], [0093], [0112], and [0113], in every contemplated fabrication method, the electrodes are not printed or screen-printed onto the adhesive film, but instead are printed onto a flexible substrate material which may then be attached to a double-sided adhesive film comprising a plurality of openings for exposing a sensing portion of the electrode. This can be confirmed in Figs. 3A-F, which show the pattern 42 being printed onto a work substrate 44 and then transferred to flexible substrate 46, which is then covered with/attached to the adhesive film 14 already comprising openings 20. In Figs. 4A-F, the electrodes are screen-printed onto a temporary tattoo sheet equivalent to the flexible substrate, which is then attached to the passivation layer equivalent to the adhesive film 14. In neither iteration are the electrodes disclosed as being printed directly onto adhesive film 14 or a passivation layer, or sufficiently described to suggest that they would be capable of being so printed directly to the adhesive layer.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 4 and 15 only recite the limitation “wherein the electrodes are dry” which is already a requirement of independent claims 1 and 12 from which they respectively depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
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, 2, 4, 5, 7-10, 12, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 2013/0041235 A1, hereinafter Rogers’235) in view of Bouton et al. (US 2015/0306373 A1, hereinafter Bouton’373).
It is first noted that the limitation that the electrodes are screen-printed is being interpreted as a product-by-process limitation. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020).
Regarding claims 1, 4, 12 and 15, Rogers’235 discloses a method of measuring signals from a skin (e.g. abstract; paragraphs [0033], [0034], [0088], [0099]), the method comprising: placing on the skin a sensing device (ibid.) having an array (e.g. Fig. 46, 50a, 55, 56) of dry electrodes printed on a film (e.g. paragraphs [0045], [0051], [0067], [0157]; [0445] - “The present skin-mounted electronic devices do not require a conductive gel”; [0456]; [0533] - “EES configured for measuring ECG, EMG and EEG, in conformal, skin-mounted modes without conductive gels”; [0665] refers explicitly to dry electrodes without conductive gels to record signals on skin through direct electrode-skin contact) that is adhesive (e.g., paragraph [0181], [0218]), and collecting signals from said sensing device (e.g. paragraphs [0015], [0033], [0034], [0099]); wherein said electrodes are on a second side of said film and said first side is attached to the skin (e.g. Figs. 30a, 50a-b), and wherein said film comprises a plurality of openings to expose a sensing portion of each electrode to the surface (e.g. paragraphs [0031], [0042], [0050], [0076], [0450]).
Further regarding claims 1 and 12, and regarding claims 2 and 13, Rogers’235 discloses the invention substantially as claimed including use of transfer printing or contact printing for patterning of the electrodes as cited, but does not expressly disclose where the electrodes specifically comprises a conductive carbon ink or that the transfer printing technique specifically includes screen-printing. Rogers’235 discloses wherein the printed electrodes can comprise a metal layer among other semiconductor or dielectric layers (e.g. [0065], [0067], [0087]) and at [0228] specifically differentiates the electrode/conducting layers from the semiconductor components. Thus, although it is acknowledged that Rogers’235 states that the presence of carbon can be seen as an undesirable impurity in a semiconductor material (e.g. paragraphs [0227], [0252]), the electrodes are stated as comprising a metal layer and not a semiconductor material, and as such this disclosure is not seen as limiting with regard to the metal electrodes disclosed. In the same field of endeavor, Bouton’373 teaches that it is known to create a flexible textile-based sensing/recording device in which the electrode are printed using silk-screen technology using conductive silver/carbon-based ink as an alternate equivalent to other contemplated nanostructure inks or other construction methods using conductive threads (e.g. paragraphs [0018], [0077], [0096]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Rogers’235, with use of screen-printing carbon nanotubes in the conductive ink as taught by either Bouton’373, since such a modification would provide the predictable results of improving the electroconductive properties of the resultant textile electrodes since carbon nanotubes provide improved conductivity even when the textile is stretched/deformed.
Regarding claims 5 and 16, Rogers’235 discloses the device comprising an electrical coupler configured for connecting said electrodes to a measuring device (e.g., Figs. 55, 60; paragraphs [0290], [0316], [0384], [0389]).
Regarding claims 7-10 and 17-19, Rogers’235 discloses the device comprising said measuring device wherein that device is configured to measure one of EMG, EEG, or ECG signals (e.g. paragraphs [0015], [0034], [0444], [0448], [0451]).
Claims 3 and 14 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over Rogers’235 in view of Bouton’373 as applied to claim 1 above, and further in view of Guillory et al. (US 2008/0146958 A1, hereinafter Guillory’958).
Regarding claims 3 and 14, Rogers’235 as modified discloses the invention substantially as claimed and cited above, but does not expressly disclose wherein the film is a double-sided tape. In the same problem-solving area, Guillory’958 teaches that it is known to use an adhesive film which can be double-sided to allow the adhesive layer to adhere both to the underlying device layer (i.e. the electrode layer) as well as the subject’s skin (e.g. paragraphs [0040], [0045], [0083]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Rogers’235, with use of a double-sided cover layer as taught by Guillory’958, since such a modification would provide the predictable results of allowing the device to be adhered to the user’s skin with the electrode layer being held close to the skin.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers’235 in view of Bouton’373 as applied to claim 1 above, and further in view of Lappalainen et al. (US 2015/0238106 A1, hereinafter Lappalainen’106).
Regarding claim 6, Rogers’235 as modified discloses the invention substantially as claimed including an electrical coupler (e.g., Figs. 55, 60; paragraphs [0290], [0316], [0384], [0389]), but does not expressly disclose wherein the coupler is a zero-insertion-force (ZIF coupler). In the same problem-solving area, Lappalainen’106 teaches that it is known to use ZIF-type quick coupling to attach conductor lines between electrodes and a measuring device to, in addition to providing quicker coupling, ensure MRI compatibility of a device, since ZIF couplings are easy and quick to remove and reattach as set forth in paragraphs [0022], [0033], [0047]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rogers’235, with a ZIF coupler as taught by Lappalainen’105, since such a modification would provide the predictable results of providing quicker disconnection and reattachment between the electrodes and the upstream device, which also improves the MRI compatibility of the overall arrangement by allowing easier disconnection of the upstream device.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers’235 in view of Bouton’373 as applied to claim 1 above, and further in view of one of Tarler (US 7,206,630 B1, hereinafter Tarler’630) or Varadan et al. (US 2013/0211208 A1, hereinafter Varadan’208).
Regarding claims 11 and 20, Rogers’235 as modified discloses the invention substantially as claimed, but does not expressly disclose wherein the sensed signals are EOG signals. In the same field of endeavor, Tarler’630 teaches that it is known to use wireless electrode patches utilizing dry electrodes to collect physiological signals from a subject, and wherein the same type of patch electrode can be utilized in a variety of applications including ECG, EEG, EMG (as taught by Rogers’235) as well as EOG (e.g. column 5, lines 39-50). Likewise, in the same field of endeavor, Varadan’208 teaches that it is known to use dry electrode textile sensors to collect physiological signals not limited to ECG, EMG, EEG (as taught by Rogers’235) and EOG to provide a more comprehensive medical status of a person (e.g. paragraph [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Rogers’235, with collection of EOG signals as taught by Tarler’630, since such a modification would provide the predictable results of providing a more diverse utility of the Rogers’235 device for collecting a wider range of physiological signals and providing a more comprehensive medical status of a person.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2015/0306373 to Bouton et al.; US 2008/0127978 and US 2007/0249952 each to Rubin et al.; US 2017/0354372 A1 to Varadan et al.; US 2015/0370320 A1 to Connor; US 2010/0198038 A1 to Nagata et al.; US 7,206,630 B1 to Tarler; and US 6,687,523 B1 to Jayaramen et al. are each considered to disclose substantial portions of the invention as claimed, and could alternatively serve as the basis of an obviousness rejection. For the sake of compact prosecution only one line of rejection is presented above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER A FLORY whose telephone number is (571)270-5305. The examiner can normally be reached Monday, Tuesday, and Thursday, 8:30am-4:30pm (PST).
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, Benjamin Klein can be reached at (571) 270-5213. 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.
/CHRISTOPHER A FLORY/Primary Examiner, Art Unit 3792 14 November 2025