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) 1-25 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).
Regarding claims 1 and 18, 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.
Regarding claims 2 and 19, Krolik teaches that the ultrasound transducer is directed at an inner surface of the medical balloon (see Figs. 25, 27A and 27B).
Regarding claims 3 and 20, Krolik teaches opposing ultrasound tranducers (3046, in particular any diametrically opposed pair of transducers).
Regarding claims 4 and 21, 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 claims 5 and 22, Krolik teaches (via the transducer positioning in Figs. 25, 27A-27B) determining a radial diameter of the balloon.
Regarding claims 6 and 23, 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 claims 9 and 24, 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 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).
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).
Regarding claims 17 and 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).
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 24 January 2026