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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/869,866, filed on 11/27/2024.
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 nonobviousness.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hung (US 20200054226 A1) in view of Toth (US 20150351690 A1), Ichimura (US 20180104855 A1), and Rogers (US 20120165759 A1).
Regarding claim 1, Hung teaches a biological sensor, comprising: a sensor body configured to obtain biological information (Fig 1; [abstract] The electrical signal is processed by the electric circuit, and the corresponding heart rhythm information is acquired and recorded); an electrode having adhesiveness ([0042] The enforcement layer 23 is under the water-proof film 22 and the electrodes 30, and provided with an adhesive layer on the upper and lower parts of the enforcement layer 23 for upward sticking the water-proof film 22 and the electrodes 30, and at the same time, downward sticking the second adhesive layer 28. The primary effect of the enforcement layer 23 is to enhance mechanical strength of the electrodes 30) and connected to the sensor body (Fig 3; [0025] Further, each electrode 30 is electrically connected to the electric circuit 50, and configured under the water-proof case 10. Also, the electric circuit 50 is provided with at least two circuit elements, and at least one exposing region of the upper part of each electrode 30 under the water-proof case 10 is connected to the at least two circuit elements to form an electrical connection); a first layer member including a housing space in which the sensor body is housed ([0039] The above upper release layer 21 has a middle opening, which surrounds the water-proof case 10. In other words, the water-proof case 10 can insert into the middle opening) ([0040] The water-proof film 22 is sticky and attached to the skin to form a closed system such that external water and vapor is unable to enter the space between the water-proof film 22 and the skin so as to prolong the attaching period), the electrode being disposed on a lower surface of the first layer member ([0041] The at least two electrodes 30 are provided under the water-proof film 22 and in the water-proof case 10, and electrically connected to the electrical circuit 50); and a second layer member that is attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body (Fig 3; [0042] The enforcement layer 23 is under the water-proof film 22 and the electrodes 30, and provided with an adhesive layer on the upper and lower parts of the enforcement layer 23 for upward sticking the water-proof film 22 and the electrodes 30, and at the same time, downward sticking the second adhesive layer 28).
Hung fails to fully teach wherein a thickness of the electrode is 15 µm or more, an area of the electrode is from 2.0 cm^2 through 5.0 cm^2, and a tack force of the electrode is 60 gf/Ф5 mm or more, and in a bottom view, a covering percentage of the electrode with respect to the first layer member is from 40% through 90%.
However, Toth teaches wherein a thickness of the electrode is 15 µm or more ([0098] In aspects, the patch may be provided with a characteristic thickness, of less than 50 micrometer (um), less than 25 um, less than 12 um, less than 8 um, less than 4 um, or the like), an area of the electrode is from 2.0 cm^2 through 5.0 cm^2 ([0211] In aspects, an electrode including one or more features in accordance with the present disclosure may be dimensioned with an area of less than 4 centimeter (cm).sup.2, less than 1 cm.sup.2, less than 0.5 cm.sup.2, less than 0.25 cm.sup.2). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hung to include wherein a thickness of the electrode is 15 µm or more, an area of the electrode is from 2.0 cm^2 through 5.0 cm^2. Doing so allows for the device to have a comfortable thickness and for the electrodes to take up substantial area for accurate sensing results.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a thickness of the electrode is 15 µm or more, an area of the electrode is from 2.0 cm^2 through 5.0 cm^2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further, Ichimura teaches a tack force of the electrode is 60 gf/Ф5 mm or more ([0035] A probe tack of an adhesive sheet sample is measured by a method in accordance with ASTM D 2979 using an NS probe tack tester (manufactured by Nichiban Co., Ltd.) under conditions of a columnar probe diameter of 5 mm, a pressing pressure of 100 gf/cm.sup.2, contact time of one second, and a peeling rate of 10 mm/sec. Non-covered surfaces easily cause blocking. Therefore, a probe tack value of the adhesive sheet sample is preferably from 0.5 to 7.5 N/5 mmφ. The probe tack value is more preferably from 0.5 to 6.5 N/5 mmφ), and still more preferably from 0.5 to 6.0 N/5 mmφ) (Conversion for 1 N = 101.97 gram-force. Therefore, the conversion of the range of 0.5 to 6.5 N/5mmφ to gf/5mmφ taught by Ichimura is equal to a range of ~ 50.985 to 662.805 gf/5mmφ which overlaps the claimed range of 60 or more). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hung to include a tack force of the electrode is 60 gf/Ф5 mm or more. Doing so allows for the electrode to have substantial stickiness to adhere to the user while still being able to be removed in a comfortable way.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Hung to include a tack force of the electrode is 60 gf/Ф5 mm or more as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Furthermore, Rogers teaches in a bottom view, a covering percentage of the electrode with respect to the first layer member is from 40% through 90% ([0049] In certain embodiments, a flexible or stretchable electronic circuit supported by an external surface of a suture or a flexible or stretchable substrate covers a percentage of the external surface of the suture or the flexible or stretchable substrate, for example a percentage selected over the range of 1% to 100%, optionally for some applications selected over the range of 10% to 100%, optionally for some embodiments selected over the range of 10% to 60% and optionally for some applications selected over the range of 40% to 100%). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hung to include in a bottom view, a covering percentage of the electrode with respect to the first layer member is from 40% through 90%. Doing so allows the electrodes to take up substantial area for accurate sensing results.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include in a bottom view, a covering percentage of the electrode with respect to the first layer member is from 40% through 90%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, Hung teaches the biological sensor according to claim 1, wherein the first layer member includes a first base including a through-hole at a position corresponding to the housing space ([0039] The above upper release layer 21 has a middle opening, which surrounds the water-proof case 10. In other words, the water-proof case 10 can insert into the middle opening), and a first adhesive layer that is provided at a surface of the first base ([0040] The water-proof film 22 is under the upper release layer 21 and the water-proof foam layer FL, and outward extends from the internal to the external of the water-proof case 10. The water-proof film 22 is sticky and attached to the skin to form a closed system such that external water and vapor is unable to enter the space between the water-proof film 22 and the skin so as to prolong the attaching period), the surface of the first base facing a living body (Fig 3; release layer 21 and water-proof film 22), and to which the electrode is attached ([0041] The at least two electrodes 30 are provided under the water-proof film 22 and in the water-proof case 10, and electrically connected to the electrical circuit 50), and the electrode is attached to a surface of the first adhesive layer ([0042] The electrodes 30, and provided with an adhesive layer on the upper and lower parts of the enforcement layer 23 for upward sticking the water-proof film 22 and the electrodes 30, and at the same time), the surface of the first adhesive layer facing the second layer member (Fig 3; the water-proof film 22 and enforcement layer 23).
Regarding claim 3, Hung teaches the biological sensor according to claim 1, wherein the second layer member includes a second adhesive layer at a surface opposite to the first layer member ([0042] The enforcement layer 23 is under the water-proof film 22 and the electrodes 30, and provided with an adhesive layer on the upper and lower parts of the enforcement layer 23 for upward sticking the water-proof film 22 and the electrodes 30, and at the same time, downward sticking the second adhesive layer 28).
Regarding claim 4, Hung teaches the biological sensor according to claim 1, wherein an attachment surface to a living body is formed by the first layer member (Fig 3; water-proof film 22), the electrode (Fig 3; electrodes 31), and the second layer member (Fig 3; enforcement layer 23).
Regarding claim 5, Hung teaches the biological sensor according to claim 2, wherein an attachment surface to a living body is formed by the first layer member (Fig 3; water-proof film 22), the electrode (Fig 3; electrodes 31), and the second layer member (Fig 3; enforcement layer 23).
Regarding claim 6, Hung teaches the biological sensor according to claim 3, wherein an attachment surface to a living body is formed by the first layer member (Fig 3; water-proof film 22), the electrode (Fig 3; electrodes 31), and the second layer member (Fig 3; enforcement layer 23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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