DETAILED ACTION
Response to Amendment
Acknowledgements
The 112f interpretation is no longer invoked as the applicant has amended claim 7 to recite structural limitations. The 112b rejection is withdrawn as a result.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosengart et al. (US 6,508,802; hereafter Rosengart) in view of Fung et al. (US 2012/0095434; hereafter Fung) and further in view of Davies (US 2008/0208184).
In regard to claim 1, Rosengart discloses a method for delivering therapeutic injectates to a heart comprising: introducing at least one intrusion needle (56) through a chest wall; positioning the at least one intrusion needle (56) adjacent a heart of a treatment subject via use of at least one cardiac mapping technique; inserting at least one probing device (64) through the at least one intrusion needle to locate at least one injection site on the heart of the treatment subject (see col. 7, line 59- col. 8, line 23); introducing at least one secondary needle (20) for intrusion into the myocardium; and injecting a therapeutic injectate via the at least one secondary needle when movement of a heart of the treatment subject causes the heart to engage the at least one secondary needle (see col. 7, lines 34-38; the heart is beating so the beat of the heart is involved in the injection); and wherein delivery of the therapeutic agent occurs without performing thoracotomy while the heart is on-beat (see col. 7, lines 12-24).
Rosengart fails to explicitly disclose inserting the intrusion needle via use of at least one cardiac mapping technique as is recited in claim 1.
In a similar art, Fung discloses a sheath (902) that is inserted into a subject (930) at a location beneath the sternum (922). Once the sheath (902) has been inserted, the curved region (906) may be adjusted in order to bring the distal portion (908) close to the surface of the heart (920). For example, the distal portion (908) may be navigated underneath the ribs (928) towards the heart (920). Once the distal portion (908) of the sheath (902) is in a desired location, e.g., an anterior and/or slightly lateral side of the heart, the curved region (906) may be locked to retain the curvature of the curved region. The location of the distal portion (908) may be monitored using any suitable imaging modality, for example, ultrasound, fluoroscopy, and the like (see par. [0043]).
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 method/device of Rosengart with the cardiac mapping technique of Fung in order to provide the predictable result of providing a means for locating and guiding a distal tip of a needle/cannula.
The combination fails to teach wherein the therapeutic injectate is injected only when such contact is made and when the heart is enlarged during ventricular diastole as is now recited in claim 1.
In a similar art, Davies discloses a method of perforating the heart comprising a user positioning an energy delivery device 212 and timing the delivery of energy such that the beating motion of the heart forces the pericardium against perforation device 200, thereby causing perforation device 200 to advance into the pericardium. For example, the user may deliver energy during diastole, such that the heart expands towards the device, rather than physically advancing the device through the pericardium. See par. [0052]. This teaching corresponds to perforating the heart only when contact is made and when the heart is enlarged during ventricular diastole and is disclosed an alternative to physically moving the perforator to heart wall. Rosengart already teaches to inject upon perforation into the heart.
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 combination with the teachings of Davies to position the perforator in a position such that the heart causes the perforation to provide an art-recognized means for accessing an interior portion of the heart.
In regard to claim 4, Rosengart discloses wherein the secondary needle (20) engages the myocardium orthogonally to minimize unintended tissue injury during a cardiac cycle (see Fig. 6; the needle 20 is inserted orthogonally into the heart tissue 72; the injury limitation is a functional limitation; the proper technique will result in non-injury).
In regard to claim 5, Rosengart discloses wherein positioning of the secondary needle (20) is adjusted via a control system (15; the barrel is effectively a handle that is used to guide the needle 20 into the body) that can position the secondary needle prior to, and after an injection into the myocardium during sequential injections (15 is engageable at any time during the injection).
In regard to claim 6, Rosengart discloses wherein the injection occurs when the heart of the treatment subject is enlarged during the cardiac cycle (the injection occurs during the beating of the heart including the diastole and systole).
In regard to claim 7, Davies teaches wherein an control system including software configured to process real-time ECG signals (“computer-controlled device”; see col. 6, lines 6-8) determines time points for injection, volume to deliver, initiation, and stoppage of the injection (Davies further teaches using electrocardiogram to measure cardiac cycle (see at least par. [0051]-[0053]).
In regard to claim 8, Rosengart discloses wherein a hydrodynamic system employing a precision pump controls injectate delivery (15 is a syringe).
In regard to claim 9, Rosengart discloses wherein the at least one injection occurs at an infarct area of the heart (see col. 3, lines 27-47).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rosengart and Fung and further in view of Pflueger et al. (US 5,304,115; hereafter Pflueger).
The combination fails to teach wherein the at least one probing device is a fiber angioscope producing real time images that are analyzed by an operator or controller software to detect or locate the site of injection on the myocardium as is recited in claim 2.
In a similar art, Pflueger discloses (see FIGS. 16 and 16a) an angioscope 70 comprising a flexible catheter body 72 having a first lumen 74, a second lumen 76 and a third lumen 78 extending longitudinally therethrough. The second lumen 76 contains a plurality of optical fibers extending longitudinally therethrough and providing optical image transmission to the angioscopic device 82 mounted on the proximal end thereof. An attendant TV monitor 84 is provided for optimal viewing of the procedure. The optical fibers 77 within second lumen 76 may comprise light transmitting fibers which function to transmit light from a proximal light source to the distal tip of the catheter 72 and image return fibers which serve to transmit the optical image from the distal tip of the catheter 72 to the angioscopy device 82.
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 combination with the fiber angioscope device of Pflueger in order to provide real-time images inside the treating area of the patient. Since Pflueger at least discloses attendant TV monitor 84 the system is configured to be analyzed by an operator or controller software to detect or locate the site of injection on the myocardium.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rosengart and Fung and further in view of Ozaki (US 2015/0209079).
The combination fails to teach wherein the at least one probing device is a conductive probe that measures bio-impedance of the myocardium to detect or locate the site of injection on the myocardium.
In a similar art, Ozaki discloses (see FIG. 12) an electrode for measuring the bioelectrical impedance, serving as biological information, may be provided as the sensor 13. Because the bioelectrical impedance differs between when the body tissue or the pericardium A is in contact with the electrode and when the electrode is disposed in a space inside the pericardial cavity E, the relative movement mode can be automatically switched to the protection mode upon detection of a change in bioelectrical impedance, similarly to the case of the pressure.
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 combination with the bio-impedance electrode of Ozaki in order to provide a device which can use impedance of the heart to trigger actuation of the device. Since Ozaki discloses an electrode for measuring bioelectrical impedance, the system is capable of performing the detecting or locating function.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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 at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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