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 .
Acknowledgment
Claims 1, 4, 35, 47, 51 are amended and filed on 10/14/2025.
Claims 96-97 are newly added.
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.
Claim(s) 1-4, 6, 8-11, 14, 35-37, 39, 44-47, 50-53, 56, 89-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (US. 20110060229A1) (“Hulvershorn”) in view of Sparks et al. (US. 20040171983A1) (“Sparks”) and further in view of Kuhn et al. (US. 20030200812A1) (“Kuhn ”).
Re Claim 1, Hulvershorn discloses a device for monitoring fluid properties (100, Figs. 1-9, ¶0063, ¶0078), the device comprising: a) an inner housing (Fig. 1a-1b house of 140 which a portion of the housing that contains lumens 132, 130, 144, 146, Fig. 1b) comprising a first lumen (132 and 130, Fig. 1b) with a proximal opening (close to 116) and a distal opening (close to 114, Fig. 1a) permanently affixed to or releasably affixable to a hypodermic needle (20, ¶0063) having a second lumen (lumen of the needle, ¶0063), wherein the first and second lumens are fluidically connected via the distal opening (Fig. 1a, ¶0063), and a pressure sensor (144 and 146) operatively coupled to the first lumen or the second lumen to measure fluid pressure in the first or second lumen (Fig. 1b, ¶0064, ¶0069, ¶0078) and capable to measure a pressure waveform (¶0075, ¶0088); and a circuitry (160, 170, Fig. 1a-1b) electrically configured to process pressure waveform data collected by the pressure sensor (¶0064) and provide an indicator signal thereof (180, ¶0064), and further it disclose that the house can be a single piece or multiple pieces engaged to form the house (¶0145), but it fails to disclose an outer housing containing the circuitry and comprising a channel or groove, wherein the inner housing is releasably mated within the channel or groove of the outer housing to electrically connect the pressure sensor and the circuitry, wherein the device as a whole is sized to be held by a single hand of a clinical during monitory of the fluid properties.
However, Sparks discloses a device (Fig. 1-2) and wherein the inner housing (118a) comprising a pressure sensor (120, ¶0024, ¶0033), an outer housing (118b Fig. 2) containing the circuitry (circuitry 122, and battery 142, ¶0024) and wherein the inner housing is releasably mated with the outer housing (releasably plugged, ¶0024) to electrically connect the pressure sensor and the circuitry (¶0024), wherein the device as a whole is sized to be held by a single hand of a clinical during monitory of the fluid properties (¶0012) and further it discloses that the two housing are connecting in any suitable manner (¶0024).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hulvershorn to include an outer housing containing the circuitry and wherein the inner housing is releasably mated with the outer housing to electrically connect the pressure sensor and the circuitry, wherein the device as a whole is sized to be held by a single hand of a clinical during monitory of the fluid properties as taught by Sparks for the purpose of using a preferable housings that can be releasably attached and recuse a house that contain electrical elements and discarded other fluid contaminated house portion (Sparks, ¶0024).
The Hulvershorn in view of Sparks fails to disclose that the outer housing comprising a channel or groove and wherein the inner housing is releasably mated within the channel or groove of the outer housing.
However, Kuhn discloses a device (Fig. 1-2) and wherein the housing comprises an inner housing (40) and outer housing (12) that has a channel or groove (42, ¶0052) and wherein the inner housing is releasably mated within the channel or groove of the outer housing (¶0052, wherein 44 is snapped toward the groove 42).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the modified Hulvershorn so that the outer housing comprising a channel or groove and wherein the inner housing is releasably mated within the channel or groove of the outer housing as taught by Kuhn for the purpose of engaging and disengaging the housings as desired (Kuhn, ¶00052).
Re Claim 2, Hulvershorn discloses wherein the hypodermic needle further comprises a catheter releasably connected the needle (¶0019, Syringe 50 can be replace with catheter).
Re Claim 3, Hulvershorn discloses further comprising a fluid conducting source fluidically connected to the proximal opening of the first lumen (¶0019, Syringe 50).
Re Claim 4, Hulvershorn discloses further comprising circuitry configured to collect, store, and/or transmit data collected by the pressure sensor (¶0064, ¶0076-¶0078, processor 160 or remote wireless monitoring ¶0181).
Re Claim 6, Hulvershorn discloses wherein the pressure sensor is an inductive, resistive, piezoelectric, or capacitive transducer (¶0069, such as piezoelectric).
Re Claim 8, Hulvershorn discloses further comprising an indicator actuated by the indicator signal (¶0080, screen 182 or the LEDS 184 or speaker 186, Fig. 1c).
Re Claim 9, Hulvershorn discloses further comprising a fluid content sensor (150) operatively coupled to the first or second lumen (¶0071).
Re Claim 10, Hulvershorn discloses wherein the fluid content sensor comprises an optical sensor or an electrical sensor, or wherein the fluid content sensor is a blood sensor operatively coupled to the lumen to determine the presence or amount of blood in the first or second lumen (¶0069, ¶0071, 150, 152 detect the content of the red blood cells base on hemoglobin, ¶0059).
Re Claim 11, Hulvershorn discloses wherein the optical sensor comprises a light detector and a light source (¶0069, ¶0071).
Re Claim 14, Hulvershorn discloses wherein the indicator is an audible, visual, or tactile indicator, or wherein the device transmits the indicator signal externally (¶0064, ¶0080, speaker).
Re Claim 35, Hulvershorn discloses a kit (Figs. 1-9, ¶0019, ¶0063, ¶0103) comprising: a) an inner housing (Fig. 1a and housing of 140, a portion of the housing that includes the lumens 132, 130, Fig. 1b and the sensors can be inserted inside the needle shaft 20, Fig. 4a) comprising a first lumen (lumen for 210) with a proximal opening (close to 208) and distal opening (close to 204) and a pressure sensor (210) operatively connected to the first lumen to measure fluid pressure in the first lumen (¶0104) and capable to measure a pressure waveform (¶0168); and b) further discloses a portion of housing (a portion of the housing 110 that include the circuit, Fig. 1a) containing circuitry electrically configured to process pressure waveform data collected by the pressure sensor and provide an indicator signal thereof (¶0105 wherein the 200 can be connected to 100, ¶0108-¶109), but it fails to disclose an outer housing containing circuitry and comprising a channel or groove and wherein the inner housing releasably mates with the outer housing to provide electrical connectivity between the pressure sensor and the circuitry, wherein the inner housing being mated to the outer housing is sized as a whole to be held by a single hand of a clinician during measuring of fluid pressure.
However, Sparks discloses a device (Fig. 1-2) and wherein the inner housing (118a) comprising a pressure sensor (120, ¶0024, ¶0033), an outer housing (118b Fig. 2) containing the circuitry (circuitry 122, and battery 142, ¶0024) and wherein the inner housing is releasably mated with the outer housing (releasably plugged, ¶0024) to electrically connect the pressure sensor and the circuitry (¶0024), wherein the device as a whole is sized to be held by a single hand of a clinical during monitory of the fluid properties (¶0012) and further it discloses that the two housing are connecting in any suitable manner (¶0024).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hulvershorn to include an outer housing containing circuitry and wherein the inner housing releasably mates with the outer housing to provide electrical connectivity between the pressure sensor and the circuitry, wherein the inner housing being mated to the outer housing is sized as a whole to be held by a single hand of a clinician during measuring of fluid pressure.as taught by Sparks for the purpose of using a preferable housings that can be releasably attached and recuse a house that contain electrical elements and discarded other fluid contaminated house portion (Sparks, ¶0024).
The Hulvershorn in view of Sparks fails to disclose that the outer housing comprising a channel or groove and wherein the inner housing is releasably mates within the channel or groove of the outer housing.
However, Kuhn discloses a device (Fig. 1-2) and wherein the housing comprises an inner housing (40) and outer housing (12) that has a channel or groove (42, ¶0052) and wherein the inner housing is releasably mated within the channel or groove of the outer housing (¶0052, wherein 44 is snapped toward the groove 42).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the modified Hulvershorn so that the outer housing comprising a channel or groove and wherein the inner housing is releasably mates within the channel or groove of the outer housing as taught by Kuhn for the purpose of engaging and disengaging the housings as desired (Kuhn, ¶00052).
Re Claim 36, Hulvershorn discloses wherein the pressure sensor is an inductive, resistive, piezoelectric, or capacitive transducer (¶0104, optical sensor).
Re Claim 37, Hulvershorn discloses wherein the inner housing further comprises a hypodermic needle (20) having a second lumen (lumen of the needle) so that the first and second lumens are fluidically connected via the distal opening (¶0104), or wherein the inner housing further comprises the fluid content sensor operatively connected to the first lumen.
Re Claim 39, Hulvershorn discloses wherein the hypodermic needle further comprises a catheter releasably connected to the needle (¶0019, Syringe 50 can be replace with catheter or syringe with catheter).
Re Claim 44, Hulvershorn discloses wherein the inner or outer housing further comprises an indicator actuated by the indicator signal (182, 184, 186, Fig.1c).
Re Claim 45, Hulvershorn discloses wherein the indicator comprises a visual, tactile, and/or audible indicator (182, 184 are visual, 186 is audible, Fig.1c, ¶0080).
Re Claim 46, Hulvershorn discloses wherein the circuitry transmits the indicator signal externally (speaker can be send externally).
Re Claim 47, Hulvershorn discloses wherein the circuitry is configured to collect, store, and/or transmit the pressure waveform data collected by the pressure sensor (¶0064).
Re Claim 50, Hulvershorn discloses further comprising a fluid conducting source fluidically connectable to the proximal opening of the first lumen (syringe 50, Fig. 1a) or further comprising a hypodermic needle having a second lumen and being connectable to the first lumen via the distal opening.
Re Claim 51, Hulvershorn discloses a method for measuring pressure during a medical procedure (¶0161, Figs. 1-9, ¶0063), the method comprising: a) providing a device of claim 1 (see claim 1); b) inserting the hypodermic needle into a site of the medical procedure (¶0073, ¶0161); and c) measuring the pressure in the first lumen or the second lumen during the medical procedure via the pressure sensor to produce data, wherein the circuitry analyzes the data and generates an indicator signal representative of the pressure (182, or 184, or 186, ¶0064, ¶0080) and wherein the pressure measured is from a pressure waveform (¶0075, ¶0088).
Re Claim 52, Hulvershorn discloses wherein the indicator signal is generated when the pressure is above or below a threshold pressure (¶0082, ¶0175).
Re Claim 53, Hulvershorn discloses wherein the pressure measured is a combination of the pulsatile pressure waveform and an opening injection pressure (¶0078, ¶0080, ¶0088).
Re Claim 56, Hulvershorn discloses wherein the medical procedure is an epidural nerve block (¶0161, ¶0173).
Re Claim 89, Hulvershorn discloses circuitry capable to measure opening injection pressure (¶0078, ¶0172, Fig. 1a).
Re Claim 90, Hulvershorn discloses wherein the fluid content sensor is a blood sensor operatively coupled to the first lumen to measure the presence or amount of blood in the first lumen or wherein the fluid content sensor comprises an optical sensor or an electrical sensor (¶0069, ¶0071, 150, 152 detect the content of the red blood cells base on hemoglobin).
Re Claim 91, Hulvershorn discloses wherein the optical sensor comprises a light detector and a light source (¶0069, ¶0071, 150, 152).
Re Claim 92, Hulvershorn discloses wherein the pressure waveform is pulsatile (¶0059 pulsatility pressure measure and ¶0069 has a peak and wavelength).
Re Claim 93, Hulvershorn discloses wherein the pressure waveform is pulsatile (¶0059 pulsatility pressure measure and ¶0069 has a peak and wavelength).
Re Claim 94, Hulvershorn fails to discloses wherein the inner housing is slidably and releasably mated within the channel or groove of the outer housing.
However, Kuhn discloses a device (Fig. 1-2) and wherein the housing comprises an inner housing (40) and outer housing (12) that has a channel or groove (42, ¶0052) and wherein the inner housing is slidably and releasably mated within the channel or groove of the outer housing (¶0052, wherein 44 is snapped toward the groove 42).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the modified Hulvershorn so that the inner housing is slidably and releasably mated within the channel or groove of the outer housing as taught by Kuhn for the purpose of engaging and disengaging the housings as desired (Kuhn, ¶00052).
Re Claim 95, Hulvershorn fails to discloses wherein the inner housing slidably and releasably mates within the channel or groove of the outer housing.
However, Kuhn discloses a device (Fig. 1-2) and wherein the housing comprises an inner housing (40) and outer housing (12) that has a channel or groove (42, ¶0052) and wherein the inner housing is slidably and releasably mated within the channel or groove of the outer housing (¶0052, wherein 44 is snapped toward the groove 42).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the modified Hulvershorn so that the inner housing is slidably and releasably mated within the channel or groove of the outer housing as taught by Kuhn for the purpose of engaging and disengaging the housings as desired (Kuhn, ¶00052).
Re Claim 96, Hulvershorn fails to discloses wherein the outer housing further comprises a power supply to power the circuitry.
However, Sparks discloses a device (Fig. 1-2) and wherein the inner housing (118a) comprising a pressure sensor (120, ¶0024, ¶0033), an outer housing (118b Fig. 2) containing a power supply ( battery 142, ¶0024) to power the circuitry (¶0024).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hulvershorn so that the outer housing further comprises a power supply to power the circuitry as taught by Sparks for the purpose of using a preferable housings that can be releasably attached and recuse a house that contain electrical elements and discarded other fluid contaminated house portion (Sparks, ¶0024).
Re Claim 97, Hulvershorn fails to discloses wherein the outer housing further comprises a power supply to power the circuitry.
However, Sparks discloses a device (Fig. 1-2) and wherein the inner housing (118a) comprising a pressure sensor (120, ¶0024, ¶0033), an outer housing (118b Fig. 2) containing a power supply ( battery 142, ¶0024) to power the circuitry (¶0024).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hulvershorn so that the outer housing further comprises a power supply to power the circuitry as taught by Sparks for the purpose of using a preferable housings that can be releasably attached and recuse a house that contain electrical elements and discarded other fluid contaminated house portion (Sparks, ¶0024).
Response to Arguments
Applicant’s arguments, see remarks filed 10/14/2025, with respect to the rejection(s) of claim(s) 1, 35 under 103 and with regards to the newly added limitations have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Hulvershorn in view of Sparks and Kuhn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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