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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11567028. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are narrower and meet the limitations of this application’s broader claims. In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the patented claims to include a ZIF coupler since it would provide the predictable results of a conventional coupling mechanism to connect the electrodes to a measuring device. Note that the patented method claims provide the structure for this application’s device claims.
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 1-3, 5-14, and 16-20 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, line 4, “screen-printed on…” is vague and sounds more like a method step than a structural limitation. It is unclear what structural limitation this phrases imparts to the sensing device, the array of electrodes, and/or the adhesive film. Similarly, claim 12 uses this language and is vague.
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.
NOTE that for the rejections below, the claims contain a product-by-process limitation of “screen-printed on…” the film. The determination of patentability of the claims are 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). The structure implied by the process step in the claims was considered when assessing the patentability of the claims over the prior art, but it was unclear what structural limitations this imparted to the product besides appearing to provide a thin or flexible electrode.
Claims 1, 3, 5-7, 9, 12, 14, 16, and 18 are rejected under 35 U.S.C. 102a1 as being anticipated by McPeck et al (2013/0172721). McPeck discloses the claimed limitations as follows:
--an adhesive film formed with a plurality of openings having a first side and second side (e.g. figure 3, elements 30, 32, 34, para. 42, etc.), where the first side is attachable to a skin (e.g. figure 7, etc.)
--an array of dry electrodes on the second side of the film (e.g. figures 2, 3, element 20 which is a dry electrode that is printed on the second side 30 of the film, para 37, etc. to provide a thin electrode), each having a sensing portion exposed by an opening of the plurality of openings (e.g. figure 3 at element 20, para. 42, etc.)./ Note that the electrodes are dry electrodes as the claims do not preclude putting additional elements/gels on the electrodes.
For claims: 3/14, double sided adhesive film (e.g. para. 42, elements 30, 32, 34, etc.) ; 5/6/16 ZIF electrical coupler (e.g. figure 2, element 22); 7 measuring device (e.g. paras. 27, 37, etc.); 9/18 EEG (paras. 27, 37, etc.).
Claims 1, 3, 5, 7-12, 14, and 16-20 are rejected under 35 U.S.C. 102a1 as being anticipated by Guillory et al (2008/0146958). Guillory discloses the claimed limitations as follows:
--an adhesive film formed with a plurality of openings having a first side and second side (e.g. figures 8, 9, element 51 with holes 54, para. 40, etc.), where the first side is attachable to a skin (e.g. figures 3, 6, etc.)
--an array of dry electrodes (e.g. paras. 42, 59, element 12, etc.) on the second side of the film (e.g. paras. 45, 59, element 61, figure 9, providing thin, flexible structure), each having a sensing portion exposed by an opening of the plurality of openings (e.g. figure 8, etc.).
For claims: 3/14, double sided adhesive film (e.g. para. 40, etc.); 5/16 electrical coupler (e.g. paras. 44, 47, wires leading from the electrodes to the monitor, figure 7, from element 12 to element 31, etc.); and 7-11, and 17-20 of EMG, EEG, ECG and EOG (e.g. paras. 43, 48, etc.).
Claims 1, 3, 5-8, 12, 14, 16, and 17 are rejected under 35 U.S.C. 102a1 as being anticipated by Bennett et al (6233472). Bennett discloses the claimed limitations as follows:
--an adhesive film formed with a plurality of openings (e.g. element 32, with holes 38, figures 4, 5, 7, etc.) having a first side and second side, where the first side is attachable to a skin (e.g. figure 9, etc.)
--an array of dry electrodes on the second side of the film (e.g. element 12/30, screen printed, col. 6, lines 18-20; col. 10, lines 4-14, etc.), each having a sensing portion exposed by an opening of the plurality of openings (e.g. figure 7, etc.). Note that Bennett states the device does not require any wetting and/or that it can be packaged with any electrolytic medium (e.g. col. 11, lines 34-35).
For claims: 3/14, double sided adhesive film, the adhesive is for adhesion on both sides onto both the flexible layer 24/electrodes, and the detachable pad 42 (e.g. col. 10, lines 64-67, etc.); 5/6/16 ZIF (e.g. col. 9, lines 66, etc.); 7/8/17 measuring device being EMG (e.g. col. 11, line 55 to col. 12, line 39, etc.).
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McPeck, Guillory, or Bennett. McPeck, Guillory, and Bennett disclose the claimed invention except for the use of conductive carbon ink electrodes. 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 McPeck, Guillory, or Bennett, with the use of conductive carbon ink electrodes, as is well known and common knowledge in the art (MPEP 2144I, 2144.03) since it would provide the predictable results of flexible, conventional electrodes that are known to not easily corrode and still provide electrical conductivity when bent.
Claims 9-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett. Bennett discloses the claimed invention and that the device and method are meant to monitor differential electrical states in various parts of a living animal (e.g. col. 5, lines 35-40), but then goes on to discuss one example such as EMG monitoring. Bennett does not disclose the specifics of monitoring other areas and electrical states in the various parts of the body, such as EEG, ECG, or EOG. 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 Bennett, with the use of monitoring other various electrical signals from the body, such as EEG, ECG, or EOG, as is well known and common knowledge in the art (MPEP 2144I, 2144.03), since it would provide the predictable results of allowing the physician to monitor multiple physiological parameters of the patient, such as the heart, brain, and eyeball, to better determine the patient’s condition during surgery or when in the hospital to know if the patient is in distress or not.
Response to Arguments
Applicant’s arguments with respect to the claims 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
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.
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.
/George R Evanisko/Primary Examiner, Art Unit 3792 9/4/26
Prosecution Insights