The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant's communication of 7/31/2025. Currently claims 1-12, 14, 16-18, 21-23 are pending and rejected below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bresnaham et al (US 6,117,105).
Bresnaham discloses a catheter system and a catheter (as in figures 1-30), comprising: a first elongate, substantially tubular primary aortic lumen (100) having proximal and distal ends and comprising at least one opening at the distal end; at least one elongate substantially tubular supplemental aortic lumen (163/134 or opening at end of the device) constructed to extend substantially past the distal aortic opening (as shown in figures 2-4); and at least one aortic balloon (120) in operational communication with the at least one supplemental lumen so as to be inflated by way of that supplemental aortic lumen (inflation lumen of 120).
Concerning the claim language of “lumen is sized to position the balloon in the descending aorta of the patient without the balloon passing an aortic arch of the patient” examiner is of the position that the structures and the associated functions of those structures thereof of Bresnaham would be capable of performing those functions as the prior art can be used/constructed and arranged in a way as to not extend into the descending aorta or passing an aortic arch. Examiner is of the position that this is an apparatus type claim and the prior art would be capable of the associated functions and intended uses as in the claim limitations.
Concerning claim language of wherein the aortic balloon is fixedly positioned on the at least one supplemental aortic lumen at a location spaced proximally from the distal end of the primary aortic lumen such that, when the distal end of the aortic catheter is advanced from a femoral arterial access, the aortic balloon is located in the descending aorta of the patient without the aortic balloon passing an aortic arch of the patient examiner is of the position that this is an intended use and placement of the device and the catheter system of Bresnaham would be fully capable of this intended use and placement since the user and practitioner could only allow the device to be deployed in the decending aorta and not passing an aortic arch (from a femoral arterial access) depending on the route and length of how the user deploys the device (further see figure 29).
Concerning claim 2, 4 and the pressure sensor arranged to measure pressure in the aorta or inferior vena cava (see root pressure port and disclosure of column 8 lines 60-65).
Concerning claim 3 and it is examiners position that this “vena cava” catheter contains the same structures as the above “aortic” catheter as disclosed in Bresnaham. Further it is examiners position that Bresnaham contemplates the use of a “vena cava” catheter (see paragraphs at column 15, lines 1-20; column 11 lines 30-45).
Concerning claim 5 and the control unit (see column 11 lines 13-25).
Concerning claim 6 and providing blood see (column 3 lines 40-45).
Concerning claim 7 and the inflation and deflation of at least one of the aortic balloon or the venous balloon can be controlled by the pressure sensor (it is examiners position that the information provided by the monitoring of pressure of lumen 118 would allow for the balloon to be inflated or deflated in response to that pressure information) Further it is unclear how a sensor could "control" something. Examiner is reading the claim limitations on the terms "controlled" and "sensor" in the broadest reasonable reading of the terms in order to know invoke a 112 issue.
Concerning claim 8 and the cardiopulmonary resuscitation catheter system for use in a patient to permit isolation of a portion of the vascular system of the patient, the system comprising:. a resuscitation catheter (as in figure 1 for example) comprising: an elongate catheter shaft defining a first elongate, substantially tubular primary lumen (100) having proximal and distal ends and comprising at least one opening at the distal end; and at least one balloon (120) in operational communication with the elongate catheter shaft and constructed and arranged so as to be inflated; and a control unit comprising an air pump in hermetic communication with the at least one balloon (column 11, lines 15-30 discussion of connection to a syringe or balloon inflation device), wherein the elongate catheter shaft is constructed and arranged to be disposed within the vena cava of the patient, the control unit is constructed and arranged to inflate the at least one balloon to a specified pressure (see column 11 lines 13-25)., and the pressure sensor is constructed and arranged to measure pressure in the aorta or inferior vena cava of the patient such that the inflation and deflation of the at least one balloon can be controlled by the control unit (see root pressure port and disclosure of column 8 lines 60-65).
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.
Claims 9-12, 14, 16-19, 21-23 is/are rejected under 35 U.S.C. 103 as being obvious over Bresnaham et al (US 6,117,105) in view of Schwamm (US 2004/0127813 A1).
Concerning claim 9 see previously identified claimed elements as described in the rejection above. Concerning claim 9 and at least one elongate substantially tubular supplemental lumen (163/134 or opening at end of the device). Concerning the at least one balloon (120) comprises a circumferential balloon disposed outside the primary lumen and is constructed and arranged to be inflated in the descending aorta of the patient (see figure 15 near 120). Concerning the control unit is constructed and arranged to inflate and deflate the first balloon and / or second balloon in response to changes in blood pressure (see discussion of hemostatis valve in various embodiment or paragraphs at column 14 lines 45-62).
Concerning the language of “fixedly positioned to the elongate catheter shaft so as to be inflated in the descending aorta of the patient”, examiner is of the position that this is an intended use and placement of the device and the catheter system of Bresnaham would be fully capable of this intended use and placement since the user and practitioner could only allow the device to be deployed in the decending aorta and not passing an aortic arch (from a femoral arterial access) depending on the route and length of how the user deploys the device (further see figure 29).
Bresnaham discloses the claimed invention except for the control unit “automatically inflate and deflate the first balloon or second balloon in response to changes in blood pressure”. Schwamm teaches that it is known to use the control unit “automatically inflate and deflate the first balloon or second balloon in response to changes in blood pressure” as set forth in paragraphs [0020]-[0022] to provide [motivational statement]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bresnaham with the control unit “automatically inflate and deflate the first balloon or second balloon in response to changes in blood pressure”as taught by Schamm, since such a modification would provide the system with the control unit “automatically inflate and deflate the first balloon or second balloon in response to changes in blood pressure” for providing a patient safe automated balloon inflation operation while easing the use of the device for a physician. Further it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192 (CCPA 1958). This control unit would provide automatic control over something that would have been done by an attending physician.
Concerning the claim language of the “…the at least one opening is constructed to be disposed near the roots of the left subclavian artery, left common artery, or innominate artery when the at least one balloon is inflated..”. Examiner is of the position that the catheter system of the prior art would be “near the roots of one of those anataomical structures based on the size and shape of the prior art of record.
Concerning claim 10 and at least one elongate substantially tubular supplemental lumen is constructed and arranged to be disposed within the primary lumen (see figures 4 or 14).
Concerning claim 11 and the at least one balloon (120) is in operational communication with the at least one elongate substantially tubular supplemental lumen and inflated by way of the supplemental lumen (see discussion of hemostatis valve in various embodiment or paragraphs at column 14 lines 45-62).
Concerning claim 12 and a pressure sensor in operational communication with the control unit (see root pressure port and disclosure of column 8 lines 60-65).
Concerning claim 14 and the second balloon is constructed and arranged to be passed into the ventricular cavity of the patient and inflated (see figure 15 near 122).
Concerning claim 16 and at least one valve in operational communication with the at least one balloon and at least one supplemental lumen, wherein the at least one valve is constructed and arranged to allow passage of fluid or gas into the at least one balloon for inflation and deflation (again see discussion of hemostatis valve in various embodiment or paragraphs at column 14 lines 45-62)
Concerning claim 17 and the catheter is constructed and arranged to be disposed within the vena cava of the patient (see paragraphs at column 11 lines 30-45).
Concerning claim 18 and a cardiopulmonary resuscitation system, comprising: a. an elongate, tubular catheter constructed and arranged to be inserted through the aortic valve of the patient comprising: an elongate primary lumen (100), comprising: a proximal primary lumen end; a distal primary lumen end; and at least one opening at the distal primary lumen end; at least one elongate supplemental lumen (163/134 or opening at end of the device) disposed within the primary lumen, the supplemental lumen comprising: a proximal supplemental lumen end; and a distal supplemental lumen end; a first balloon (120) disposed outside the primary lumen and adapted for inflation; and a second balloon (122) in operational communication with the supplemental lumen; and b. an external control unit (see column 11 lines 13-25). Further concerning the control unit and the automatically regulating see the obvious modification with Schwamm as in claim 9 above. Concerning the claim language of the “…the at least one opening is constructed to be disposed near the roots of the left subclavian artery, left common artery, or innominate artery when the at least one balloon is inflated..”. Examiner is of the position that the catheter system of the prior art would be “near the roots of one of those anataomical structures based on the size and shape of the prior art of record.
Concerning the language of “wherein the first elongate, tubular catheter is constructed and arranged for:positioning the opening within the descending aorta of the patient without passing over an aortic arch of the patient; andinflating the first balloon within the descending aorta of the patient via the external control unit.”, examiner is of the position that this is an intended use and placement of the device and the catheter system of Bresnaham would be fully capable of this intended use and placement since the user and practitioner could only allow the device to be deployed in the descending aorta and not passing an aortic arch (from a femoral arterial access) depending on the route and length of how the user deploys the device (further see figure 29).
Concerning claim 19 and the elongate, tubular catheter is constructed and arranged for: a. positioning the opening within the descending aorta of the patient; b. inflating the first balloon within the descending aorta of the patient via the external control unit; and c. inflating the second balloon distally of the right and left coronary arteries of the patient (see figures 15 and 25-30).
Concerning the tubular catheter is further constructed and arranged for regulating the inflation of the first balloon and second balloon in response to changes in blood pressured measured by a pressure sensor (see column 11 lines 13-25).
Concerning claim 21 and the second elongate catheter examiner is of the position that a guidewire, supplemental lumen, or second duplicate catheter of the prior art, would read on the “second elongate catheter” claim limitation as in claim 21.
Concerning claim 22 it is examiner’s position that the devices of the prior art and the associated structures thereof would be fully able and capable of entering through the jugular vein or the femoral vein. Both of these locations are well known to a PHOSITA as means for intravascular medical operations concerning the heart. The prior art is constructed in a way and configuration that this entering through a jugular or femoral vein is possible and known.
Concerning claim 23 it is examiner’s position that the devices of the prior art and the associated structures thereof would be fully able and capable of entering through the jugular vein or the femoral vein. Both of these locations are well known to a PHOSITA as means for intravascular medical operations concerning the heart. The prior art is constructed in a way and configuration that this entering through a jugular or femoral vein is possible and known.
Response to Arguments
Applicant's arguments filed 7/31/2025 have been fully considered but they are not persuasive. As explained in the rejections above examiner is of the position that the prior art of record teaches the claim limitations, and in particular the newly added claim limitations above. Examiner has addressed the newly added claim language in the rejection above.
The elements disclosed in the prior art of record are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
Again, it is recommended applicant amend the claims to greater define structures over the prior art of record and any obvious modification thereof.
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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached on M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783