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 .
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.
Election/Restrictions
Applicant's election with traverse of Invention I, drawn to an oxygen measurement device that measures oxygen in a patient’s urine of claims 1-11 in the reply filed on 6/23/26 is acknowledged. The traversal is on the ground(s) (1) that the two sets of claims define overlapping subject matter and (2) that there is no examination burden. This is not found persuasive because (1) MPEP 806.05 defines that “overlapping in scope” (i.e., “mutually exclusive”) means “if a first invention would not infringe a second invention, and the second invention would not infringe the first invention,” which is true of the instant claim set as evidenced by the claim language that was recited in para 2 if the restriction requirement dated 4/23/26 and (2) the examination burden is due to the groupings have acquired a separate status in the art in view of their different classification; the grouping have acquired a separate status in the art due to their recognized divergent subject matter; and/or the grouping require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 12-19 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/23/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claim 5, the claim term “the axial extent of the urethral catheter” (line 2) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2010/0286559 to Paz et al. (hereinafter “Paz”) in view of U.S. Patent Application Publication No. 2017/0055906 to Bremer and U.S. Patent Application Publication No. 2017/0157298 to Diemeer.
For claim 1, Paz discloses an oxygen measurement device that measures oxygen in a patient's urine (Abstract), the oxygen measurement device being comprised of a urethral catheter (Examiner’s Note: made up of the elements it comprises) (also see 102, Fig. 1A, para [0115]), the urethral catheter comprising:
an elongated shaft (unlabeled, but as can be seen in Fig. 1A) possessing a distal portion that is positionable in a bladder of the patient (unlabeled, but as can be seen in Fig. 1A, the distal portion of 102 being positionable in bladder 111), the elongated shaft being comprised of a wall (unlabeled wall of 102, as can be seen in Fig. 1A) surrounding a urethral catheter lumen (unlabeled lumen of 102, as can be seen in Fig. 1A) that extends from a distal end of the elongated shaft to a proximal end of the elongated shaft (see Fig. 1A), the elongated shaft including a urethral catheter port (unlabeled, but as can be seen on the distal end of 102 inside of 111 of Fig. 1A) that passes through the wall of the elongated shaft and communicates with the urethral catheter lumen to permit urine in the patient's bladder to enter the urethral catheter lumen by way of the urethral catheter port when the distal portion of the elongated shaft is positioned in the patient's bladder (as can be seen in Fig. 1);
a hub (108, optionally in conjunction with 120) (Fig. 1A) (para [0115]) provided at the proximal end of the elongated shaft (as can be seen in Fig. 1A), the hub being comprised of a wall (unlabeled wall of 108, as can be seen in Fig. 1A) that surrounds a hub lumen (unlabeled lumen of 108, as can be seen in Fig. 1A) extending throughout the hub (as can be seen in Fig. 1A), the hub having a proximal end (proximal end of 108 and optionally 120);
the urethral catheter lumen and the hub lumen communicating with one another to define a urine lumen having an axial extent extending through the elongated shaft (as can be seen in Fig. 1A) and the hub so that urine entering the urethral catheter port flows along the urine lumen toward the proximal end of the hub (as can be seen in Fig. 1A);
a sensor (110) (Fig. 1A) (para [0120]) that detects oxygen in the urine flowing in the urine lumen (para [0124] and [0155]), he sensor being mounted in the wall of the hub (as can be seen in Fig. 1A) and the sensor being exposed to the urine lumen so that the urine flowing in the urine lumen contacts the sensor (see Fig. 1A) (also see para [0128] and [0192]).
Paz further discloses that the monitoring may further include a chromatographic device or a spectroscopic device (see para [0130]), but does not explicitly disclose the sensor comprising phosphor supported on a base, the base being mounted in the wall of the hub and the phosphor being exposed to the lumen in the urine lumen so that the urine circulating in the urine lumen contacts the phosphor.
However, Bremer teaches a sensor comprising a phosphor supported on a base (Examiner’s Note: the “phosphor” construed in view of para [0042] of Applicant’s specification as originally filed) (para [0601]) and that the sensor may have an adhesive system that makes it attachable (Abstract).
It would have been obvious to a skilled artisan to modify Paz to include the sensor comprising phosphor supported on a base, the base being mounted in the wall of the hub and the phosphor being exposed to the lumen in the urine lumen so that the urine circulating in the urine lumen contacts the phosphor, in view of the teachings of Bremer, because such a modification would be the simple substitution of the type of oxygen sensor being used that would lead to the predictable result of being able to monitor oxygen levels. Paz appears to be ready for such a modification since Paz already contemplates chromatographic/spectroscopic devices and a phosphor is a fluorescent or phosphorescent substance. Additionally, Bremer teachings of making it attachable via an adhesive are congruent with attaching it at the wall location where Paz’s oxygen sensor(s) is/are already located.
Paz and Bremer do not expressly disclose the elongated shaft being made of a shaft material having an oxygen gas permeation rate; and a gas barrier layer extending along at least a portion of the axial extent of the urine lumen and being made of a material having an oxygen gas permeation rate less than the oxygen gas permeation rate of the shaft material to suppress gas permeation into the urine lumen and to suppress a change in an amount of oxygen in the urine flowing in the urine lumen, the gas barrier layer being located distal of the base.
However, Diemeer teaches the elongated shaft being made of a shaft material having an oxygen gas permeation rate (Examiner’s Note: construed in view of para [0027] of Applicant’s specification as originally filed) (para [0083]); and a gas barrier layer extending along at least a portion of the axial extent of the urine lumen and being made of a material having an oxygen gas permeation rate less than the oxygen gas permeation rate of the shaft material to suppress gas permeation into the urine lumen and to suppress a change in an amount of oxygen in the urine flowing in the urine lumen (Examiner’s Note: construed in view of para [0096] of Applicant’s specification as originally filed) (para [0065], [0067], and [0071]-[0072]), the gas barrier layer being located distal of the base (para [0083].
It would have been obvious to a skilled artisan to modify Paz to include the elongated shaft being made of a shaft material having an oxygen gas permeation rate; and a gas barrier layer extending along at least a portion of the axial extent of the urine lumen and being made of a material having an oxygen gas permeation rate less than the oxygen gas permeation rate of the shaft material to suppress gas permeation into the urine lumen and to suppress a change in an amount of oxygen in the urine flowing in the urine lumen, the gas barrier layer being located distal of the base, in view of the teachings of Diemeer, for the obvious advantage of improving scratch resistance of the catheter (see para [0072] of Diemeer).
For claim 2, Paz, as modified, further discloses wherein the shaft has an inner surface facing toward the urethral catheter lumen (as can be seen in Fig. 1A), the gas barrier layer being provided on and covering the inner surface of the shaft so that the gas barrier layer contacts the urine flowing in the urethral catheter lumen (see para [0024] and [0060] of Diemeer).
For claim 3, Paz, as modified, further discloses wherein the shaft is comprised of a shaft wall having an outer surface facing outwardly and an inner surface facing toward the urethral catheter lumen (as can be seen in Fig. 1A), the gas barrier layer being embedded in the shaft wall so that the gas barrier layer is between the inner surface of the shaft wall and the outer surface of the shaft wall (see para [0013], [0015], and [0117] of Diemeer) (alternatively, see para [0071] of Diemeer).
For claim 4, Paz does not expressly disclose wherein the oxygen measurement device comprises a cable connector, the cable connector including a housing that is attachable to and detachable from the hub, the cable connector also including an optical fiber in the housing that is optically connectable to the sensor when the housing is connected to the hub.
However, Bremer teaches a cable connecter (103) (also see “connector,” para [0187]) (also see para [0601]) comprised of a housing (“[s]ensor 110 of Fig. 1A is housed in sensor assembly 110A, which also houses transducer 111 and at least one waveguide 119 (see Fig. 2B) in a sensor subassembly with a connector 103 for connecting to controller 120…,” para [0185]) configured to be attached to and detached from a hub (4302 and/or 4310) (Fig. 43A) (para [0605]-[0607]), the cable connector also including an optical fiber provided in the housing (“optical fiber,” para [0187]) (also see para [0601]) that is optically connectable (Examiner’s Note: functional language, i.e., capable of) a sensor when the housing is connected to the hub (“…sensing element is optically interrogated with visible light,” para [0187]) (also see para [0601] and [0605]-[0607]).
It would have been obvious to a skilled artisan to modify Paz wherein the oxygen measurement device comprises a cable connector, the cable connector including a housing that is attachable to and detachable from the hub, the cable connector also including an optical fiber in the housing that is optically connectable to the sensor when the housing is connected to the hub, in view of the teachings of Bremer, because such a modification would be the simple substitution of the type of oxygen sensor being used that would lead to the predictable result of being able to monitor oxygen levels. Paz appears to be ready for such a modification since Paz already contemplates chromatographic/spectroscopic devices and a phosphor is a fluorescent or phosphorescent substance.
For claim 5, Paz, as modified, further discloses wherein the gas barrier layer extends over an entirety of the axial extent of the urethral catheter lumen (see para [0083] of Diemeer).
For claim 6, Paz, as modified, further discloses wherein the gas barrier layer extends from the urine lumen of the hub toward the distal end of the shaft (see para [0083] of Diemeer).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Bremer and Diemeer, and further in view of U.S. Patent Application Publication No. 2008/0103408 to Denton et al. (hereinafter “Denton”).
For claim 7, Paz, as modified, further disclose wherein the gas barrier layer extending from the urine lumen of the hub toward the distal end of the shaft (see para [0083] of Diemeer).
Paz, Bremer, and Diemeer do not expressly disclose wherein the urethral catheter comprises an expandable balloon that is expandable upon introducing fluid into the balloon and that is positioned proximal of the urethral catheter port.
However, Denton teaches an outwardly expandable balloon (125) that is expandable upon introducing fluid into the balloon (para [0027]) and that is positioned proximal of the urethral catheter port (133 or 143) (see Fig. 1).
It would have been obvious to a skilled artisan to modify Paz wherein the urethral catheter comprises an expandable balloon that is expandable upon introducing fluid into the balloon and that is positioned proximal of the urethral catheter port, in view of the teachings of Denton, for the obvious advantage of restraining/resisting inadvertent removal of the catheter from placement inside the patient.
Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Bremer and Diemeer, and further in view of WO 02/13899 to Evans et al. (hereinafter “Evans”).
For claim 8, Paz, Bremer, and Diemeer do not expressly disclose wherein the urethral catheter lumen possesses a rectangular cross-sectional shape.
However, Evans teaches a catheter lumen possessing a rectangular cross-sectional shape (see Fig. 1A).
It would have been obvious to a skilled artisan to modify Paz wherein the urethral catheter lumen possesses a rectangular cross-sectional shape, in view of the teachings of Evans, for the obvious advantage of optimizing wall thickness with material and shape to avoid wall collapse and make the catheter highly kink resistant (see Abstract of Evans).
For claim 9, Paz and Bremer do not expressly disclose wherein the gas barrier layer possesses a rectangular cross-sectional shape.
However, Diemeer teaches that the gas barrier layer covalently bonds the inner wall of the lumen of the catheter as the “polymer substrate” (para [0015]).
Additionally, Evans teaches that the walls of the lumen of the catheter can have a rectangular cross-sectional shape (see Fig. 1A).
It would have been obvious to a skilled artisan to modify Paz wherein the gas barrier layer possesses a rectangular cross-sectional shape, in view of the teachings of Diemeer and Evans, because changes in shape have been held to be a matter of design choice to a skilled artisan. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, matching the shape of the lumen of the catheter allows for the greatest area for fluid to flow.
For claim 11, Paz and Bremer do not expressly disclose wherein the gas barrier layer possesses a rectangular cross-sectional shape.
However, Diemeer teaches that the gas barrier layer covalently bonds the inner wall of the lumen of the catheter as the “polymer substrate” (para [0015]).
Additionally, Evans teaches that the walls of the lumen of the catheter can have a rectangular cross-sectional shape (see Fig. 1A).
It would have been obvious to a skilled artisan to modify Paz wherein the gas barrier layer possesses a rectangular cross-sectional shape, in view of the teachings of Diemeer and Evans, because changes in shape have been held to be a matter of design choice to a skilled artisan. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, matching the shape of the lumen of the catheter allows for the greatest area for fluid to flow.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Bremer, Diemeer, and Evans, and further in view of U.S. Patent Application Publication No. 2016/0263294 to Anzai.
For claim 10, Paz, Bremer, Diemeer, and Evans do not expressly disclose wherein the gas barrier layer possess a circular cross-sectional shape.
However, Anzai teaches wherein a gas barrier layer (i.e., coating) maintains is circular cross-sectional shape (para [0106]).
It would have been obvious to a skilled artisan to modify Paz wherein the gas barrier layer possess a circular cross-sectional shape, in view of the teachings of Anzai, because changes in shape have been held to be a matter of design choice to a skilled artisan. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, maintaining a circular cross-sectional shape while Paz is already modified to have its urethral catheter lumen possess a rectangular cross-sectional shape (since claim 10 depends from claim 8) would result in a “strong cast film” (see para [0106 of Anzai) that would add to the integrity of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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