DETAILED ACTION
This action is pursuant to the claims filed on January 31, 2024. Claims 1-11 are pending. A first action on the merits of claims 1-11 is as follows.
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 . 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Paragraph [0041]: “Such placement of the five electrodes 3, 4, 5, 6, 7 corresponds to the electrode placement provided by the EASI™ method (https://www.theonlinelearningcenter.com/Assets/PMDCBT/PIIC_Fundamentals_1.0/shell/viewer/swfs/assets/downloads/easi.pdf)...”
Appropriate correction is required.
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 2 and 5 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, ln. 5 recites “optionally placed on a right flank of a patient, below the sixth rib of said patient”, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 is rejected by virtue of its dependency on claim 2.
Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 nonobviousness.
Claims 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (hereinafter ‘Hyde’, U.S. PGPub. No. 2017/0000370), and further in view of Dower (Dower, U.S. Pat. No. 4,850,370).
In regards to independent claim 1 and claims 3-4, Hyde discloses a diagnostic device (an electrocardiogram system as shown in Fig. 4) for acquiring a twelve-lead electrocardiogram of a patient ([0022]: EKG system is configured to detect at least two electrical potentials; [0071]: the system can be configured for a standard 5 lead EKG system, the EASITM lead system and to provide an interpolated 12 lead EKG cardiac monitoring system), wherein said diagnostic device comprises:
a first glove, or right glove (Fig. 4, [0088]: “first glove 402A (e.g., a right-handed glove)”),
a second glove, or left glove (Fig. 4, [0088]: “second glove 402B (e.g., a left-handed glove”),
wherein said first glove, or right glove, and said second glove, or left glove, are configured to be worn in the hands of an operator, or user, and intended, in use, to be placed at a portion of a patient’s chest to acquire an electrocardiogram of said patient ([0097]-[0098]: the at least one glove is positioned against a first surface of a subject which includes the chest; the respective surfaces can correspond to five of the V1-V6 standard chest electrode placement or the six precordial lead locations);
said first glove, or right glove and said second glove, or left glove, comprising a plurality of electrodes (each of the gloves 402A and 402B comprises at least one electrode 404 in Fig. 4, [0088]) configured to detect at least three cardiac signals, corresponding to three cardiac leads ([0097]-[0098]: the at least one glove is positioned against a first surface of a subject which includes the chest; the respective surfaces can correspond to five of the V1-V6 standard chest electrode placement or the six precordial lead locations; [0071]: note that the system can be configured for a standard 5 lead EKG system, the EASITM lead system and interpolated to provide an interpolated 12 lead EKG cardiac monitoring system),
wherein each of said plurality of electrodes is disposed at an end portion of said first glove, or right glove, and/or of said second glove or left glove (electrodes 404 are disposed along the distal end of each of the finger sheath of the gloves 402A and 402B in Fig. 4),
the diagnostic device further comprising a processing unit ([0092]: controller 406 in Fig. 4; note that while Fig. 4 shows the controller being remote from gloves 402A and 402B, para. [0092] explains that a portion of the controller 406 can be located in the first glove 402A or the second glove 402B; this particular arrangement of providing portions of the controller such as a control electrical circuit 116 is further explained in [0044]-[0046]) configured to receive and process said at least three cardiac signals to obtain a twelve-lead electrocardiogram ([0071]: the system can be configured for a standard 5 lead EKG system, the EASITM lead system and interpolated to provide an interpolated 12 lead EKG cardiac monitoring system; [0093]-[0094]: the report generated by the processor can include one or more graphical representations 534 which includes the 12 lead ECG information).
However, Hyde does not disclose wherein said first glove, or right glove, and said second glove, or left glove, comprise a total of five electrodes, wherein said first glove, or right glove, comprises two electrodes and wherein said second glove, or left glove, comprises three electrodes and the positions of the given electrodes along the gloves claimed in claim 4.
Dower teaches 1) a conventional 12-lead electrocardiogram (ECG) involves the placement of 10 lead electrodes (one of which is a ground or reference electrode) at selected points on a surface of a subject’s body while 2) an interpolated 12-lead electrocardiogram can be derived by measuring and processing voltages sensed by only 5 electrodes (one of which is a ground electrode, col. 3, ln. 54-60). Given that Dower explains that the 12-lead ECG using 10 lead electrodes is more costly due to a higher number of electrodes (col 2, ln. 15-19) and Hyde contemplates a standard EASI lead system to interpolate 12-lead ECG, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the number of electrodes along the gloves of Hyde to reduce to only 5 electrodes, as taught by Dowers as doing so reduces the overall cost of the apparatus and manufacturing time while providing accurate simulation of conventional 12-lead electrocardiograms and vectorgrams (col. 3, ln. 46-51).
Furthermore, Dower explains where the EASI electrodes should be positioned along the subject so that the 5 electrodes can be used to derive an accurate 12-lead ECG information (col. 4, ln. 5-12: “The 4 electrode positions that are fundamental in the use of the present invention consist of electrode position E of the Frank lead system, electrode position A of the Frank lead system, an electrode position S over the upper end of the sternum (manubrium sterni), and electrode position I of the Frank lead system. (Such E, A, S and I electrodes are from time-to-time collectively referred to herein as the "EASI" electrodes.)”; see Figs. 1-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the positions of the first electrode, second electrode, third electrode, fourth electrode and fifth electrode along the two gloves of Hyde/Dower combination to correspond with the well-established EASI electrode positions when the two gloves are positioned against the subject as claimed in claims 4/3/1, as rearranging of parts, specifically the five electrodes along the two gloves, involve routine skill in the art and a predictable result of electrodes corresponding to the EASI system would ensue.
In regard to claims 2, in view of the combination in claim 1 above, the examiner notes that claim 2 merely recites an intended use limitation with the plurality of electrodes of the first and second gloves intended to be placed along specific parts of the patient as claimed. The examiner further notes that these positions are known EASI lead system positions as shown in exemplary Fig. 4 of Dower. Therefore, the examiner is in the position that the plurality of electrodes of the gloves of Hyde/Dower combination are capable of being positioned as recited in the claim 2.
In regard to claim 5, in view of the combination in claim 1 above, the examiner notes that claim 5 recites configuring the diagnostic device to measuring cardiac signals between specific electrodes which is known in the EASI lead system to obtain a 12 lead ECG (col. 4, ln. 13-18: “It has been found that 12-lead electrocardiographic signals and xyz vectorcardiographic signals can be derived by measuring and, with suitable signal processing means, combining and scaling the voltages present between first, second and third selected pairs of the EASI electrodes.”). Therefore, the examiner is in the position that the plurality of electrodes of the gloves are capable of being positioned as recited in the claim and to derive a 12 lead ECG based upon the EASI lead system.
In regards to claim 6, Hyde/Dower combination further discloses wherein said electrodes are contact electrodes ([0027]: electrode is in contact with a surface of subject via a gel).
In regards to claim 8, Hyde/Dower combination further discloses wherein the processing unit comprises an electronic unit configured to receive said at least three cardiac signals detected by said plurality of electrodes ([0092]: controller 406 in Fig. 4; note that while Fig. 4 shows the controller being remote from gloves 402A and 402B, para. [0092] explains that a portion of the controller 406 can be located in the first glove 402A or the second glove 402B; this particular arrangement of providing portions of the controller such as a control electrical circuit 116 is further explained in [0044]-[0046]), and a portable device operatively associated with said electronic unit configured to process said at least three cardiac signals to obtain a twelve-lead electrocardiogram ([0067]: a remote device configured to display, store, or further process information; [0093]-[0094]: the report generated by the processor can include one or more graphical representations 534 which include the 12 lead cardiac signals).
In regard to claims 9-10, Hyde further discloses wherein said first glove, or right glove, and said second glove, or left glove, are connected to each other and to the electronic unit ([0023]: the electrodes 130 are connected to the controller 140 via electrical connections 125). However, it is silent as to the connection via a shielded cable. The concept of using cables to bundle a plurality of electrical connections to connect to a processor or electronic unit is old and notoriously well known, and is capable of instant and unquestionable demonstration as being well-known, to one of ordinary skilled in the art as evidenced by Zimmerman et al. (U.S. Pat. No. 4, 988,981, col. 4, ln. 53-64: a shieled cable 13 which connects glove 12 to an interface circuit 14 is preferably a flat ribbon cable). In addition, the concept of providing a ribbon cable which is in the form of a printed circuit board and to provide a shield for minimizing noise are also routine and known in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to bundle the plurality of electrical connections of Hyde/Dower combination into a single cable such as a ribbon cable in a form of a printed circuit, and to shield the cable as doing so reduces the number of wires and a shield reduces noise introduced to the wires.
In regards to claim 11, Hyde further discloses wherein the portable device is further configured to graphically represent the acquired twelve-lead electrocardiogram ([0093]-[0094]: the report generated by the processor can include one or more graphical representations 534 which include the 12 lead cardiac signals).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hyde and Dower as applied to claim 1 above, and further in view of Volpe et al. (hereinafter ‘Volpe’, U.S. PGPub. No. 2019/0282115).
In regards to claim 7, Hyde discloses the invention substantially as claimed in claim 1 and discussed above.
However, Hyde does not disclose that the electrodes are capacitive electrodes.
Volpe teaches the use of contact and/or capacitive electrodes along a garment to measure ECG information ([0086]: The ECG electrodes 322 can monitor a patient's ECG information. For example, the ECG electrodes 322 can be galvanic (e.g., conductive) and/or capacitive electrodes configured to measure changes in a patient's electrophysiology to measure the patient's ECG information). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the contact electrodes of Hyde/Dower combination with capacitive electrodes as taught by Volpe since the equivalence of contact and non-contact electrodes for their use in a wearable monitoring device art and the selection of any one of these known equivalents to measure ECG signals would be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 1/21/2026