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 .
Specification
The disclosure is objected to because of the following informalities:
Throughout the specification, “intralumenal” should be corrected to “intraluminal” (note that the correct spelling is used once in published paragraph [0178]).
In the detailed description, figures 1G and 9 are not described/mentioned.
In the detailed description (published 0181), reference to figure 15 should be figure 15A.
Appropriate correction is required.
Claim Objections
Claims 1, 2, 5-8, 10, 12-14, and 18-20 are objected to because of the following informalities: In these claims, “intralumenal” should be corrected to “intraluminal”. Appropriate correction is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 10-17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hular et al (US Pub 2005/0261568).
Re claims 1, 14, 17, 19, 20: Hular discloses a system comprising:
a guiding sheath comprising a control handle with a pathway therein along a longitudinal axis and a catheter tube extending distally from the handle [0083, 0084, fig 6; see slideable sheath 630, shaft 640, and handle 610];
an intralumenal device comprising a shaft with a lumen configured to receive a second intralumenal device in communication with the pathway and with a predetermined geometry and configured to traverse through the handle and the catheter tube, and including a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath and the proximal portion configured to extend through the pathway of the control handle [0084-0086, fig 6; see the needle 620 that extends from the handle into the tube sheath]; and
a first emitter of an optical unit with a light source situated on the proximal portion of the first intralumenal device; and a sensor situated in the pathway of the control handle, configured to generate signals in response to the first emitter on the proximal portion of the first intralumenal device, the signals being representative of a position of the distal portion of the first intralumenal device, and the emitter including an optically-readable patter [0058, fig 3; see the emitting fiber and source on a proximal portion of the needle; 0096; see the color bar or encoder with an optically-readable pattern].
a sensor assembly disposed approximate the handle and configured to determine a parameter of the intralumenal device within the sheath to thereby determine a position of a distal end of the shaft, the parameter including a length of insertion or rotation of the intralumenal device, the assembly including an optical source and optical sensor to illuminate the pattern [0092, 0098, fig 6, claims 33 and 44; see the sensor 670 that determines an optical parameter such as length of insertion; 0096; see the color bar or encoder with an optically-readable pattern].
Re claims 2, 13: The system includes processor; and non-transitory computer readable medium with instructions thereon, that when executed by the processor, cause the system to: determine the length of insertion of the intralumenal device within the sheath and determine the position of the sensor marker; and determine the position of a distal end of the shaft based at least in part on the length of insertion of the intralumenal device within the sheath and the predetermined geometry of the shaft [0087-0090, 0092, 0098, 0099; see the processor that receives signals along with a memory device with controlling instructions for data analysis to determine the length of insertion and position of the distal end of the shaft; also see the visual marks that are recorded use a camera sensor].
Re claim 3: The sheath comprising a navigation sensor approximate a distal end of the catheter tube [0098; see the position sensor that is a navigation sensor].
Re claim 4: A distal portion of the catheter tube comprising a curvature, and a distal portion of the shaft comprising a pre-shaped curvature (fig 6; see the curvature of the needle 620 and shaft 640).
Re claim 5: A transseptal puncture kit comprising the sheath and the intralumenal device (fig 6; the sheath 630 and needle 620 together form a kit).
Re claim 6: The intralumenal device comprising a transseptal needle (fig 6; where the needle 620 is capable of transseptal use).
Re claim 10: The sensor assembly comprising a sensor array within the handle of the sheath and a sensor marker disposed on a proximal portion of the shaft of the intralumenal device, the sensor array being configured to determine a position of the sensor marker within the handle to thereby determine the position of a distal end of the shaft [0092, 0098, 0099; see the position sensors that comprise an array that determines an optical parameter such as length of insertion; also see the visual marks that are recorded use a camera sensor].
Re claim 11: The marker comprising a ferromagnetic material, and the sensor array comprising a plurality of magnetic sensors [0046; see the markings that are not limited to bar code but can be magnetic codes which indicates magnetic/ferromagnetic application].
Re claim 12: The sensor array comprising a plurality of sensors arranged linearly along a longitudinal axis and adjacent to a lumen within the handle, the lumen being configured to receive the shaft of the intralumenal device [0092, 0098, 0099; see the position sensors that comprise a linear array that determines an optical parameter such as length of insertion; also see the visual marks arranged linearly that are recorded use a camera sensor].
Re claim 15: The first emitter includes a magnetic member and the sensor includes a magnetic sensor [0046; see the markings that are not limited to bar code but can be magnetic codes which indicates magnetic emitter/sensor application].
Re claim 16: The first emitter includes an optically-readable pattern such that an optical signal is emitted when irradiated and the sensor includes an optical unit with at least an optical detector [0096; see the color bar or encoder with an optically-readable pattern].
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.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hular, as applied to claims 1 and 14, in view of Highsmith et al (US Pub 2021/0401483).
Re claims 7, 18: Hular discloses all features except that the intralumenal device comprising a dilator. However, Highsmith teaches of a transseptal procedure wherein a needle and/or dilator is used for the intervention [0049; see the dilator 150 and transseptal needle 110]. It would have been obvious to the skilled artisan to modify Hular, to incorporate a dilator as taught by Highsmith, in order to facilitate the transseptal procedure.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hular, as applied to claim 1, in view of Belson (US Pub 2007/0135803)
Re claims 8, 9: Hular discloses all features except that the intralumenal device further comprising an RFID circuit identification marker, and the handle further comprising an identification circuit configured to determine the predetermined geometry of the shaft based at least in part on the identification marker. However, Belson teaches an RFID circuit identification marker, and the handle further comprising an identification circuit configured to determine the predetermined geometry of the shaft based at least in part on the identification marker [0635; see the RFID tracking device used as an alternative to fiber optic tracking]. It would have been obvious to the skilled artisan to modify Hular, to use RFID tracking as taught by Belson, as such constitutes simple substitution with the well known tracking alternative.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797