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 .
Claim Objections
Claim 1 is objected to because of the following informalities: Line 4 reading “the detected first and second sounds” should read --the detected first sound and the detected second sound--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 7 reading “the first and second waveforms” should read --the first waveform and the second waveform--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 6-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitrosky et al. (USPGPub 2015/0174342).
Re Claim 1, Mitrosky teaches a real-time drug injection time duration measurement system (Mitrosky Fig. 1) comprising: a sound transducer (136) adapted to detect a first sound associated with drug delivery initiation and a second sound associated with drug delivery completion (Mitrosky ¶ 0020-0026), the sound transducer (136) further adapted to convert the detected first sound and the second sound into a first electronic waveform and a second electronic waveform, respectively (Mitrosky ¶ 0031); a waveform shaping circuit (212) operably coupled with the sound transducer (136), the waveform shaping circuit (212) adapted to convert the first waveform and the second waveform into a first pulse and a second pulse, respectively (Mitrosky ¶ 0031); a pulse clamping circuit (204) operably coupled with the waveform shaping circuit (208) (Mitrosky Fig. 4), the pulse clamping circuit (204) adapted to trigger upon receiving the first pulse and generate a regenerated pulse (Mitrosky ¶ 0031); and a timer operably coupled with the pulse clamping circuit (204), the timer adapted to initiate upon receiving the regenerated pulse and stop upon receiving a subsequent regenerated pulse via the pulse clamping circuit (Mitrosky ¶ 0031).
Re Claim 3, Mitrosky teaches wherein the pulse clamping circuit (204) is adapted to generate a pulse output having a designated width corresponding to a specified duration of time to prevent the timer from receiving the subsequent regenerated pulse until the specified duration of time has elapsed (Mitrosky ¶ 0024, 0026).
Re Claim 6, Mitrosky teaches wherein the specified duration of time has a longer duration than a duration of the first detected sound (Mitrosky ¶ 0020-0026, 0031).
Re Claim 7, Mitrosky teaches a method of measuring in real-time an injection time duration measurement for a drug delivery device (Mitrosky Fig. 1), the method comprising: detecting, via a sound transducer (136), a first sound associated with initiation of the drug delivery device (Mitrosky ¶ 0020-0026); converting the first detected sound into a first electronic waveform (Mitrosky ¶ 0031); converting, via a waveform shaping circuit (212) operably coupled with the sound transducer (136), the first waveform into a first pulse (Mitrosky ¶ 0031); triggering a pulse clamping circuit (204) operably coupled with the waveform shaping circuit (212) upon receiving the first pulse (Mitrosky ¶ 0031); generating, via the pulse clamping circuit (204), a regenerated pulse (Mitrosky ¶ 0031); initiating a timer operably coupled with the pulse clamping circuit (204) upon receiving the regenerated pulse; and terminating the timer upon receiving a subsequent regenerated pulse (Mitrosky ¶ 0031).
Re Claim 8, Mitrosky teaches the method further comprising the steps of: detecting, via the sound transducer (136), a second sound associated with completion of administration of the drug delivery device (Mitrosky ¶ 0020-0026); converting the second detected sound into a second electronic waveform (Mitrosky ¶ 0020-0026); converting the second waveform into a second pulse via the waveform shaping circuit (212) (Mitrosky ¶ 0031); and generating the subsequent regenerated pulse via the pulse clamping circuit (204) (Mitrosky ¶ 0031).
Re Claim 9, Mitrosky teaches wherein the regenerated pulse generated by the pulse
clamping circuit has a designated width corresponding to a specified duration of time to prevent the timer from receiving the subsequent regenerated pulse until the specified duration of time has elapsed (Mitrosky ¶ 0024, 0026).
Re Claim 12, Mitrosky teaches wherein the specified duration of time has a longer duration than a duration of the first detected sound (Mitrosky ¶ 0020-0026, 0031).
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, 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.
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mitrosky et al. (USPGPub 2015/0174342) in view of Streit et al. (USPGPub 2020/0023139).
Re Claim 2, Mitrosky teaches all of the limitations of Claim 1. Mitrosky fails to teach wherein the waveform shaping circuit is further adapted to filter high-pitched signals generated by the first electronic waveform and the second electronic waveform. Streit teaches a drug injection device comprising a waveform shaping circuit adapted to filter high-pitched signals for improving the clarity of data received during an injection (Streit ¶ 0013-0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the waveform shaping circuit of Mitrosky to filter high-pitched signals generated by the first electronic waveform and the second electronic waveform wherein Streit teaches filtering high-pitched signals for improving the clarity of data received during an injection (Streit ¶ 0013-0014).
Re Claim 13, Mitrosky teaches all of the limitations of Claim 7. Mitrosky fails to teach the method further comprising the step of filtering, via the waveform shaping circuit, at least one high-pitched signal generated by the first electronic waveform and/or the second electronic waveform. Streit teaches a drug injection device comprising a waveform shaping circuit adapted to filter high-pitched signals for improving the clarity of data received during an injection (Streit ¶ 0013-0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the waveform shaping circuit of Mitrosky to filter at least one high-pitched signal generated by the first electronic waveform and/or the second electronic waveform wherein Streit teaches filtering high-pitched signals for improving the clarity of data received during an injection (Streit ¶ 0013-0014).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mitrosky et al. (USPGPub 2015/0174342).
Re Claim 4, Mitrosky teaches all of the limitations of Claim 3. Mitrosky fails to teach wherein the specified duration of time is approximately 300 milliseconds. However, the duration of time is a product of the medical device and drug being injected. One of ordinary skill in the art at the effective filing date of the claimed invention was made would have considered the invention to have been obvious because the compositional proportions taught by Mitrosky overlap the instantly claimed proportions and therefore are considered to establish a prima facie case of obviousness. Therefore, it would have been obvious to one of ordinary skill in the art to select any ranges including the instantly claimed 300 milliseconds where the duration of time is a product of the medical device and drug being injected.
Re Claim 10, Mitrosky teaches all of the limitations of Claim 9. Mitrosky fails to teach wherein the specified duration of time of approximately 300 milliseconds. One of ordinary skill in the art at the effective filing date of the claimed invention was made would have considered the invention to have been obvious because the compositional proportions taught by Mitrosky overlap the instantly claimed proportions and therefore are considered to establish a prima facie case of obviousness. Therefore, it would have been obvious to one of ordinary skill in the art to select any ranges including the instantly claimed 300 milliseconds where the duration of time is a product of the medical device and drug being injected.
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mitrosky et al. (USPGPub 2015/0174342) in view of Shelton et al. (USPGPub 2023/0414294).
Re Claim 5, Mitrosky teaches all of the limitations of Claim 3. Mitrosky fails to teach wherein the pulse clamping circuit comprises a mono-stable vibrator adapted to selectively switch between a stable mode and a non-stable mode, wherein in the non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time. Shelton teaches a surgical device comprising a pulse clamping circuit (220000), the pulse clamping circuit (220000) comprises a mono-stable vibrator (220006) adapted to selectively switch between a stable mode and a non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time, wherein the mono-stable vibrator automatically switches to the stable mode after a predetermined time period (Shelton ¶ 0541-0551).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pulse clamping circuit of Mitrosky wherein the pulse clamping circuit comprises a mono-stable vibrator adapted to selectively switch between a stable mode and a non-stable mode, wherein in the non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time as disclosed by Shelton, wherein the mono-stable vibrator automatically switches to the stable mode after a predetermined time period (Shelton ¶ 0541-0551).
Re Claim 11, Mitrosky teaches all of the limitations of Claim 9. Mitrosky fails to teach wherein the step of triggering the pulse clamping circuit further comprises selectively switching, via a mono-stable vibrator, between a stable mode and a non-stable mode, wherein in the non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time. Shelton teaches a surgical device comprising a pulse clamping circuit (220000), the pulse clamping circuit (220000) comprises a mono-stable vibrator (220006), wherein triggering the pulse clamping circuit further comprises selectively switching, via a mono-stable vibrator, between a stable mode and a non-stable mode, wherein in the non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time, wherein the mono-stable vibrator automatically switches to the stable mode after a predetermined time period (Shelton ¶ 0541-0551).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pulse clamping circuit of Mitrosky wherein triggering the pulse clamping circuit further comprises selectively switching, via a mono-stable vibrator, between a stable mode and a non-stable mode, wherein in the non-stable mode, the pulse clamping circuit is non-responsive to subsequent inputs until completion of the specified duration of time as disclosed by Shelton, wherein the mono-stable vibrator automatically switches to the stable mode after a predetermined time period (Shelton ¶ 0541-0551).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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