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 .
Response to Amendment
This Office action is responsive to the preliminary amendment filed January 16, 2025. As directed by the amendment, claims 1 and 6 have been amended.
Claims 1-10 are presently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Independent claim 1 in line 5 recites in part “…a first sensor component positioned outside of the artificially-created cavity…”, in line 12-13, “… a second sensor component positioned within the artificially-created body tissue cavity …”, each of these limitations amounts to positively recitation of encompasses a part of a living organism, i.e., an artificial-created cavity in living tissue. It is suggested to insert the term/phrase “adapted to be” or “configured to be” between the word “component” and “positioned”, so as to overcome this rejection or any other phrase that would avoid positive recitation of the artificial-created cavity in living tissue in relation to the first and second sensor .
Independent claim 6 recites similar limitations that are rejected under this Statue for substantially similar rationale as noted above. Dependent claims 4-5 and 7-10 are likewise rejected, because they include all limitations and deficiencies thereof of the independent claim1 or 6.
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.
Claims 1-2, 4-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Gavaert et al., US 20160310115 A1 (“Gavaert”) in view of Applicant cited Saini WO 2016063190 A1.
Regarding claim 1, Gevaert discloses a device for continuously monitoring a physiological condition of a wearer having an artificially-created cavity in living body tissue (a self-monitoring device with wearable sensors measuring the created cavity temperature (physiological condition) within an artificial cavity; abstract; [0027]), the artificially-created cavity being bounded by a first hole in body tissue and a second hole in body tissue opposite the first hole (the artificially created cavity in living tissues having at least two holes where the first hole is opposite the second hole; figure 2; [0039]), the device comprising:
a body piercing device post, the body piercing device post being configured for insertion and to be worn in the artificially-created cavity, said body piercing device post being dimensioned to be inserted through at least the first hole of the body tissue and into the artificially-created body tissue cavity, the body piercing device post containing a second sensor component positioned within the artificially-created body tissue cavity and providing a second signal which is a measurement of a second physiological condition of the wearer continuously or periodically using specified time intervals (temperature sensor 103 is part of the body piercing post, the post is inserted to be worn in the artificially-created cavity through at least the first hole of the body tissue, as shown in figures 5 and the temperature sensing occurs periodically using specified time intervals; figures 1, 5; [0035]);
a transmitter configured to wirelessly transmit said first and second measurements continuously or periodically to a remote receiver for recording (a transmitter for sending a temperature measurement signal wirelessly to a remote receiver for recording; paragraphs [0032-0033], [0039], [0073-0075]; claim 2), the transmitter being located within the central body such that in use ii is located outside of the artificially-created cavity (the transmitter 101 is in the central body and is located outside of the artificially-created cavity; figure 1); and
the device further comprising at least one power supply that powers said first and second sensors and said transmitter (miniature battery 104 for complete operation of the wireless sensor nodes and transmitter; paragraphs [0036], [0038]).
Gevaert fails to disclose a central body having a first sensor component positioned outside of the artificially-created cavity at a location adjacent to a skin surface of the wearer, the first sensor providing a first signal which is a measurement of a first physiological condition of the wearer continuously or periodically using specified time intervals.
Saini discloses a central body having a first sensor component positioned outside of the artificially-created cavity at a location adjacent to a skin surface of the wearer, the first sensor providing a first signal which is a measurement of a first physiological condition of the wearer continuously or periodically using specified time intervals (the printed circuit board 11O is in the central body and contains one or more sensors adjacent to the skin surface of the wearer, providing a physiological parameter measurement on a continuous basis; [0030]; claim 1; figure 1).
It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the central body of Gevaert to include a sensor component, as taught by Saini, in order to have a second sensing element to measure a second physiological feature that would be more accurately measured outside of the body cavity. Additionally or alternatively, it is now well settled “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” (In re Kerkhoven, 626 F2d 846, 205 USPQ 1069, CCPA 1980). Therefore, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the second sensor component positioned within the artificially-created body tissue cavity as cited in Gavaert with a first sensor component positioned outside of the artificially-created cavity as disclosed in Saini, because both systems are used for the same purpose of providing a physiological parameter measurement for monitoring condition of the wearer and such a combination would have yielded a predictable result of collecting more data associated with the wearer, for more accurate analysis of the physiological condition of the wearer.
Regarding claim 2, Gevaert in view of Saini discloses the sensing device of claim 1. Modified Gevaert discloses the second sensor measures temperature of the wearer (temperature sensor 103; [0035]). Gevaert fails to disclose wherein the first sensor measures blood oxygenation of the wearer. Saini discloses wherein the first sensor measures blood oxygenation of the wearer (the earring is a device which can acquire physiological parameters like blood oxygen level; abstract; [0028]). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the second sensor of modified Gevaert to measure blood oxygenation of the wearer, as taught by Saini, for additional benefit of monitoring and/or assessing lung function or shortness of breath that the wearer may experience, which is of diagnosis interest.
Regarding claim 4, Gevaert in view of Saini discloses the sensing device of claim 1. Modified Gevaert fails to disclose wherein the first sensor measures blood oxygenation of the wearer and the second sensor measures glucose levels of the wearer. Saini discloses wherein the first sensor measures blood oxygenation of the wearer and the second sensor measures glucose levels of the wearer (one or more sensors that can acquire physiological parameters like blood oxygen levels and glucose levels; abstract; [0028]; claim 1). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the first and second sensors of modified Gevaert to measure blood oxygenation and glucose levels respectively, as taught by Saini, in order to measure physiological parameters that are associated with diabetes.
Regarding claim 5, Gevaert in view of Saini discloses the sensing device of claim 1. Modified Gevaert further discloses wherein the sensor is removeable by the wearer (the earring has a backing that allows it to be removed, as shown in figure 5).
Regarding claim 6, Gevaert discloses a device for continuously monitoring a physiological condition of a wearer having an artificially-created cavity in living body tissue (a self-monitoring device with wearable sensors measuring the created cavity temperature (physiological condition) within an artificial cavity; abstract; [0027]), the artificially-created cavity being bounded by a first hole in body tissue and a second hole in body tissue opposite the first hole (the artificially created cavity in living tissues having at least two holes where the first hole is opposite the second hole; figure 2; [0039]), the device comprising:
a sleeved tube for receiving a body piercing device post extending through the artificially-created cavity, the sleeved tube including an extending portion which substantially surrounds the post and passes into the artificially-created cavity (the earring has a backing (sleeved tube) for receiving the body piercing device post that extends through the artificially created body cavity; figure 5),
the extending portion containing a second sensor component positioned within the artificially-created body tissue cavity and providing a second signal which is a measurement of a second physiological condition of the wearer continuously or periodically using specified time intervals (temperature sensor 103 is part of the body piercing post, the post is inserted to be worn in the artificially-created cavity through at least the first hole of the body tissue, as shown in figures 5 and the temperature sensing occurs periodically using specified time intervals; figures 1, 5; [0035]);
a transmitter configured to wirelessly transmit said first and second measurements continuously or periodically to a remote receiver for recording (a transmitter for sending a temperature measurement signal wirelessly to a remote receiver for recording; paragraphs [0032-0033], [0039], [0073-0075]; claim 2), the transmitter being located within the central body such that in use it is located outside of the artificially-created cavity (the transmitter 101 is in the central body and is located outside of the artificially-created cavity; figure 1); and
the device further comprising at least one power supply that powers said first and second sensors and said transmitter (miniature battery 104 for complete operation of the wireless sensor nodes and transmitter; paragraphs [0036]. [0038]).
Gevaert fails to disclose a central body having a first sensor component positioned outside of the artificially-created cavity at a location adjacent to a skin surface of the wearer, the first sensor providing a first signal which is a measurement of a first physiological condition of the wearer continuously or periodically using specified time intervals.
Saini discloses a central body having a first sensor component positioned outside of the artificially-created cavity at a location adjacent to a skin surface of the wearer, the first sensor providing a first signal which is a measurement of a first physiological condition of the wearer continuously or periodically using specified time intervals (the printed circuit board 110 is in the central body and contains one or more sensors adjacent to the skin surface of the wearer, providing a physiological parameter measurement on a continuous basis; [0030]; claim 1; figure 1).
It would have been obvious to one of ordinary skill in the art at the lime the invention, to have modified the central body of Gevaert to include a sensor component, as taught by Saini, in order to have a second sensing element to measure a second physiological feature that would be more accurately measured outside of the body cavity. Additionally or alternatively, it is now well settled “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” (In re Kerkhoven, 626 F2d 846, 205 USPQ 1069, CCPA 1980). Therefore, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the second sensor component positioned within the artificially-created body tissue cavity as cited in Gavaert with a first sensor component positioned outside of the artificially-created cavity as disclosed in Saini, because both systems are used for the same purpose of providing a physiological parameter measurement for monitoring condition of the wearer and such a combination would have yielded a predictable result of collecting more data associated with the wearer, for more accurate analysis of the physiological condition of the wearer.
Regarding claim 7, Gevaert in view of Saini discloses the sensing device of claim 6. Modified Gevaert discloses the second sensor measures temperature of the wearer (temperature sensor 103; [0035]). Gevaert fails to disclose wherein the first sensor measures blood oxygenation of the wearer. Saini discloses wherein the first sensor measures blood oxygenation of the wearer (the earring is a device which can acquire physiological parameters like blood oxygen level; abstract; [0028]). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the second sensor of modified Gevaert to measure blood oxygenation of the wearer, as taught by Saini, for additional benefit of monitoring and/or assessing the lung function or shortness of breath that the wearer may experience, which is of diagnosis interest.
Regarding claim 9, Gevaert in view of Saini discloses the sensing device of claim 6. Gevaert fails to disclose wherein the first sensor measures blood oxygenation of the wearer and the second sensor measures glucose levels of the wearer. Saini discloses wherein the first sensor measures blood oxygenation of the wearer and the second sensor measures glucose levels of the wearer (one or more sensors that can acquire physiological parameters like blood oxygen levels and glucose levels; abstract; [0028]; claim 1). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the first and second sensors of modified Gevaert to measure blood oxygenation and glucose levels respectively, as taught by Saini, in order to measure physiological parameters that are associated with diabetes.
Regarding claim 10, Gevaert in view of Saini discloses the sensing device of claim 6. Modified Gevaert further discloses wherein the sensor is removeable by the wearer (the earring has a backing that allows it to be removed, as shown in figure 5).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gavaert in view of Saini as applied to claim 1 or 6 above, and further in view of Applicant cited Kumar et al., WO 02/078783 A2 (“Kumar”).
Regarding claim 3, Gevaert in view of Saini discloses the sensing device of claim 1. Modified Gevaert further discloses the second sensor measures temperature of the wearer (temperature sensor 103; [0035]). Modified Gevaert fails to disclose wherein the first sensor measures blood pressure of the wearer. Kumar discloses wherein the first sensor measures blood pressure of the wearer (earrings that monitor physiological activity such as blood pressure; page 9, 8-17). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the first sensor of modified Gevaert to be a blood pressure sensor, as taught by Kumar, in order to monitor the wearers' blood pressure to track their overall health and be able to track issues with blood pressure to help healthcare providers better treat their patients.
Regarding claim 8, Gevaert in view of Saini discloses the sensing device of claim 6. Gevaert further discloses the second sensor measures temperature of the wearer (temperature sensor 103; [0035]). Modified Gevaert fails to disclose wherein the first sensor measures blood pressure of the wearer. Kumar discloses wherein the first sensor measures blood pressure of the wearer (earrings that monitor physiological activity such as blood pressure; page 9, 8-17). It would have been obvious to one of ordinary skill in the art at the time of filing the claimed invention, to have modified the first sensor of modified Gevaert to be a blood pressure sensor, as taught by Kumar, in order to monitor the wearers' blood pressure to track their overall health and be able to track issues with blood pressure to help healthcare providers better treat their patients.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2015/0250418 A1 to Ashby, see abstract, Figs. 1-6, earing or body piercing with sensor for continuously monitoring a physiological condition of a wearer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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