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 § 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.
Claims 3, 20 and 25 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.
Regarding claims 3 and 20, these claims recite a first orientation “generally opposing” a second orientation. This limitation is unclear, as it is not clear what orientations are or are not generally opposing. This is due to the vague nature of “generally”. This limitation will be interpreted as including at least facing opposite directions and facing each other.
Regarding claim 25, there is insufficient antecedent basis for the limitation of “the inflation fluid”.
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) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/013536 to Krolik et al. (Krolik hereinafter, copy provided herewith) in view of US Pre-Grant Publication 2016/0260958 to Weir et al. (Weir) and US Pre-Grant Publication 2010/0113939 to Mashimo et al. (Mashimo).
Regarding claims 1, Krolik teaches a balloon assembly (see Figs. 25, 27A, 27B) and method, including a first catheter (as illustrated, see paragraph 36) extending distally, an inflatable medical balloon (see paragraph 103, “balloon”), and at least one ultrasound transducer (2842 or 3046). Krolik does not teach a handle. Weir teaches another catheter assembly generally, and particularly teaches a handle (e.g. 1175) for controlling a catheter balloon inflation device (1160, see paragraph 119). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a handle to the catheter and balloon assembly of Krolik in order to control inflation therein. Krolik also does not teach a reservoir, pump, and a sensor data unit configured as claimed. Mashimo teaches another balloon catheter generally, and particularly teaches a reservoir (20), a pump (22) arranged to inflate a medical balloon (32, see paragraph 25). Finally, Mashimo teaches that the dilation is controlled by feedback including the volume sensing (paragraph 38) to thereby control the pump. Mashimo teaches that this reduces damage from the catheter to the biological lumen (paragraph 2). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pump, reservoir, and sensor data unit as taught by Mashimo in order to use the balloon assembly of Krolik with reduced possibility of damage to a patient.
Regarding claim 2, Krolik teaches that the ultrasound transducer is directed at an inner surface of the medical balloon (see Figs. 25, 27A and 27B).
Regarding claim 3, Krolik teaches opposing ultrasound tranducers (3046, in particular any diametrically opposed pair of transducers).
Regarding claim 4, Krolik teaches a sensor data unit (see e.g. paragraph 101, “data analysis hardware”), and further teaches determination of diameter indication (see e.g. paragraph 85, 128) and display of diameter indication (see Fig. 24, “RESULTS DISPLAY”: “Annulus Diameter”).
Regarding claim 5, Krolik teaches (via the transducer positioning in Figs. 25, 27A-27B) determining a radial diameter of the balloon.
Regarding claim 6, Krolik teaches determining a surface topography of the inflatable medical balloon (paragraphs 104, 126 – “map” and “3D ultrasound image”).
Regarding claim 7, Krolik teaches determining a protrusion depth (Fig. 24, “RESULTS DISPLAY”: “Protrusions”).
Regarding claim 8, Krolik teaches providing a map of the internal topography, which will implicitly include all information regarding that topography including height-diameter aspect ratio of the protrusions. See also Figs. 33A-B.
Regarding claim 9, as best understood by the examiner, recoil is used by the applicant as a difference in diameter. This information is again included in a complete map of the internal topography.
Regarding claim 10, Krolik teaches determination and output of an indication of a determined orientation (paragraph 136).
Regarding claim 11, Krolik teaches selection of a valve, which implicitly includes a determination of viability of that valve (see paragraph 136).
Regarding claim 12, while Krolik does not explicitly teach providing a heart valve, it is directed to selecting a heart valve for implantation in a patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a heart valve with the catheter and balloon assembly of Krolik in order to implant such a valve into a patient. Thus provided, due to the selection of a valve of a size compatible with the implantation location as measured by the balloon, such a valve would be positionable on the balloon so as to be responsive thereto.
Regarding claim 13, Krolik teaches the limitations of previous claim 1 as discussed above. Krolik further teaches a sensor position member (3149) and a sensor (3146) thereon. Krolik teaches that the position member is arranged to contact the outer surface of the balloon (paragraph 107) and that multiple such are provided (Fig. 28B) forming an intermittent sleeve around the balloon..
Regarding claim 14, Krolik further teaches sensor position members (3149) and sensors (3146) thereon. Krolik teaches that the position member is arranged to contact the outer surface of the balloon (paragraph 107) and that a force map is generated (in order to determine compliance, paragraphs 69, 101) and output (paragraph 102).
Regarding claim 15, Krolik teaches a sensor (2320) which is at least radially within a depression (A’).
Regarding claim 16, Krolik teaches force sensors (3146) juxtaposed with the balloon and a sensor data unit (data analysis hardware) arranged to output determined force data (paragraphs 101-102).
Claim(s) 18-20, 22, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik in view of Weir and Mashimo, and further in view of US Pre-Grant Publication 2016/0067465 to Gerrans et al. (Gerrans).
Regarding claims 1, Krolik teaches a balloon assembly (see Figs. 25, 27A, 27B) and method, including a first catheter (as illustrated, see paragraph 36) extending distally, an inflatable medical balloon (see paragraph 103, “balloon”), and at least one ultrasound transducer (2842 or 3046). Additionally, Krolik teaches determining a surface topography of the inflatable medical balloon (paragraphs 104, 126 – “map” and “3D ultrasound image”) as well as a sensor data unit (see e.g. paragraph 101, “data analysis hardware”), and further teaches determination of diameter indication (see e.g. paragraph 85, 128) and display of diameter indication (see Fig. 24, “RESULTS DISPLAY”: “Annulus Diameter”).. Krolik does not teach a handle. Weir teaches another catheter assembly generally, and particularly teaches a handle (e.g. 1175) for controlling a catheter balloon inflation device (1160, see paragraph 119). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a handle to the catheter and balloon assembly of Krolik in order to control inflation therein. Krolik also does not teach a reservoir, pump, and a sensor data unit configured as claimed. Mashimo teaches another balloon catheter generally, and particularly teaches a reservoir (20), a pump (22) arranged to inflate a medical balloon (32, see paragraph 25). Finally, Mashimo teaches that the dilation is controlled by feedback including the volume sensing (paragraph 38) to thereby control the pump. Mashimo teaches that this reduces damage from the catheter to the biological lumen (paragraph 2). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pump, reservoir, and sensor data unit as taught by Mashimo in order to use the balloon assembly of Krolik with reduced possibility of damage to a patient. Krolik does not teach determination and output of density indication. Gerrans teaches another medical balloon system generally and particularly teaches measuring biological material density in order to provide safer treatment (see e.g. paragraph 101). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to measure and output density as taught by Gerrans in order to provide safer treatment.
Regarding claim 19, Krolik teaches that the ultrasound transducer is directed at an inner surface of the medical balloon (see Figs. 25, 27A and 27B).
Regarding claim 20, Krolik teaches opposing ultrasound tranducers (3046, in particular any diametrically opposed pair of transducers).
Regarding claim 22, Krolik teaches (via the transducer positioning in Figs. 25, 27A-27B) determining a radial diameter of the balloon.
Regarding claim 24, Krolik teaches providing a map of the internal topography, which will implicitly include all information regarding that topography including height-diameter aspect ratio of the protrusions. See also Figs. 33A-B. Since, as best understood by the examiner, recoil is used by the applicant as a difference in diameter. This information is again included in a complete map of the internal topography.
Regarding claim 25, Krolik teaches a reservoir (1165) containing a predetermined volume of inflation fluid (see e.g. paragraph 123) and a pump (1100) arranged to generate flow into the balloon and operable to adjust the flow in response to the transducer (via human operation).
Allowable Subject Matter
Claim 26 is 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: the limitations of a four-dimensional map including surface topography and tissue density indication as in claim 26 are not shown in or fairly suggested by the prior art of record in combination with the remaining limitations of the claim and parent claim 18.
Response to Arguments
Applicant’s arguments, see page 7, filed 27 July 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 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 in view of Mashimo and Gerrans as discussed above.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 27 September 2026
