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 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 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Guziak et al. (USPGPUB 2007/0028698 - applicant cited) in view of Eggers et al. (USPN 5,928,155) and evidenced by Burnett (USPGPUB 2022/0095978). In regard to claim 1, Guziak discloses a measurement device (Figs. 1-22 and associated descriptions) comprising: a processing device (MEMS device, abstract; elements 160/1260, Figs. 1-2 and 12-14 and associated descriptions; element 1220 and processing, [0049]; [0052]); a catheter (elements 102/1202, Figs. 1-2 and 12 and associated descriptions); a tip portion (elements 120/1220, Figs. 1 and 12 and associated descriptions) disposed at a distal end of the catheter an end near elements 158/1208, Figs. 2 and 12 and associated descriptions), wherein: the tip portion receives the distal end of the catheter (Figs. 1-2 and 12 and associated descriptions); a diaphragm film assembly is coupled to the tip portion at an opposite end that receives the distal end of the catheter (diaphragms 150/1250, Figs. 1-2 and 12 and associated descriptions) wherein the diaphragm film assembly is configured to flexibly move between a plurality of positions based on an applied pressure that displaces the diaphragm film assembly ([0011-0012]; Figs. 1-2 and 12 and associated descriptions), and a sensor assembly communicatively coupled to the processing device (elements 160/1260/1262 and associated electronic elements, Figs. 1-2, 4 and 12 and associated descriptions), the sensor assembly is configured to measure the applied pressure displacing the diaphragm film assembly (elements 160/1260/1262 and associated electronic elements, Figs. 1-2, 4 and 12 and associated descriptions) and the processing device comprises additional sense function (temperature, chemical, & biological), [0049]).
Guziak does not specifically discloses to determine a concentration of ammonia currently in a fluid at the tip portion.
Eggers teaches an catheter system (Figs. 22-26 and associated descriptions) comprises ammonia concentration sensing elements (elements 524/578/580/586, Figs. 22-26 and associated descriptions; Col 28 lines 39-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tip portion of the device (Guziak) to incorporate the ammonia concentration sensing elements and associated functions as taught by Eggers, since both devices are catheter systems and one of ordinary skill in the art would have recognized that an analyte sensor can be disposed near the pressure sensing element at the end portion of an catheter, as evidenced by Burnett, which describes a pressure sensing membrane and analyte sensor can be disposed at a distal portion of a catheter (analyte sensor 50 and pressure sensing membrane 39, Figs. 5 and 6 and associated descriptions; [0015]; [0085-0086]). The rationale would have been to obtain more information of the fluid.
In regard to claim 9, Guziak as modified by Eggers discloses the tip portion further comprises: a cavity (cavity 138 or the cavity for holding elements 1260/1262, Figs. 1-2 and 12 and associated descriptions of Guziak) extending between a first end portion (the end facing the catheter 120/1202, Figs. 1-2 and 12 and associated descriptions of Guziak) and a second end portion (the other end near elements 134/1232, Figs. 1-2 and 12 and associated descriptions of Guziak); and the sensor assembly is positioned within the cavity of the tip portion (elements 160/1260/1262 and associated electronic elements, Figs. 1-2, 4 and 12 and associated descriptions of Guziak).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Guziak and Eggers as applied to claims 1 and 9 above, and further in view of Teo (USPGPUB 2013/0109980). In regard to claims 10-11, Guziak as modified by Eggers discloses all the claimed limitations except a handle, the catheter extending from the handle such that the tip portion is positioned opposite of the handle and wherein the handle further comprises: a display portion configured to display the applied pressure and the concentration of ammonia in the fluid currently at the tip portion.
Teo teaches a vascular pressure measuring catheter system (Figs. 1-8 and associated descriptions) comprises a handle (element 810, Fig. 8 and associated descriptions), a catheter extending from the handle such that a tip portion is positioned opposite of the handle (the catheter connected to the handle, Fig. 8 and associated descriptions) and wherein the handle further comprises: a display portion (display on the handle 810, Fig. 8 and associated descriptions) configured to display the result of processed parameter(s) (abstract), waveforms ([0036]) and/or both waveforms and numerical results ([0092])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device (Guziak as modified by Eggers) to incorporate the handle and display and associated configurations/functions as taught by Teo, since both devices are pressure sensing catheter systems and one of ordinary skill in the art would have recognized that a handle coupled to a catheter facilitates the user to insert and position the catheter at the desired location and a display facilitates providing the detected information to a user. The rationale would have been to provide better manipulation of the catheter device and visualization of the results.
In regard to claim 12, Guziak as modified by Eggers and Teo discloses a combination measurement device (referring to claims 1 and 9 above) comprising: a processing device (referring to claim 1 above), a handle (referring to claims 1 and 10 above); a catheter extending from the handle (referring to claims 1 and 10 above); and a tip portion disposed at a distal end of the catheter such that the tip portion is positioned opposite of the handle (referring to claims 1 and 9-10 above), wherein: the tip portion includes a first end portion, an opposite second end portion, and a cavity extending therebetween (referring to claims 1 and 9 above), the first end portion receives the distal end of the catheter (referring to claim 1 above); a sensor assembly positioned within the cavity of the tip portion (referring to claim 1 above); and a diaphragm film assembly coupled to the tip portion and communicatively coupled to the sensor assembly (referring to claim 1 above), the diaphragm film assembly configured to flexibly move between a plurality of positions based on an applied pressure that displaces the diaphragm film assembly (referring to claim 1 above), wherein the sensor assembly is configured to measure the applied pressure displacing the diaphragm film assembly (referring to claim 1 above) and the processing device is configured to determine a concentration of ammonia currently in a fluid at the tip portion (referring to claim 1 above).
Allowable Subject Matter
Claims 19-20 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior arts of record does not teach or suggest “detecting, with a sensor assembly, an amount of a deflection currently occurring in a diaphragm film assembly positioned at a tip portion of a catheter, the amount of the deflection changes a capacitance measured by the sensor assembly, the diaphragm film assembly is communicatively coupled to the sensor assembly; detecting, with a processing device, a change in a resistance of diaphragm film assembly; displaying, on a display portion communicatively coupled to the sensor assembly and to the processing device, the amount of the deflection currently occurring and the change in the resistance of diaphragm film assembly, wherein the change in the resistance of diaphragm film assembly is indicative of a change in the concentration of ammonia and an amount of deflection currently occurring in the diaphragm film assembly is indicative of the pressure”, in combination with the other claimed elements/ steps.
Claims 2-8 and 13-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: in regard to claims 2 and 13, the prior arts of record does not teach or suggest “the diaphragm film assembly further comprises: a first layer film member; a second layer film member, and a plurality of electrodes positioned between the first layer film member and the second layer film member and communicatively coupled to the second layer film member”, in combination with the other claimed elements/ steps.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Urion et al. (USPN 5,566,680) teaches a pressure catheter system (Figs. 1-14) comprises a handle (element 104, Figs. 14a-b) and a catheter extending from the handle (element 50, Figs. 14a-b) connected to the catheter tip (connected at end 80 with element 52, Figs. 14a-b), wherein a pressure sensor is disposed at the tip portion (elements 20, Figs. 9-11) and the handle facilitates movement of catheter by the user and eases the procedure by which catheter is inserted and positioned (Col 13 lines 1-9).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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