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:
In the detailed description, figures 1G and 9 are not described/mentioned.
Appropriate correction is required.
Claim Objections
Claims 10 and 12 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 § 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 2-4, 8, and 10-13 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.
In claim 2, in the ‘determine the position’ step, it is unclear whether the limitation is intended to be different that what is in claim 20, which determines a distal position of the intraluminal device. In claim 20, the shaft is part of the sheath, while the shaft that was in now-canceled claim 1 had a shaft that was part of the intraluminal device.
In claims 3 and 4, ‘the catheter tube’ lacks antecedence.
In claims 4, 8, 10, 12, and 13, it is unclear whether the ‘shaft’ is intended because the shaft in claim 20 is part of the sheath, while the shaft in now-canceled claim 1 was part of the intraluminal device.
In claim 10, ‘the sensor assembly’ lacks antecedence.
In claims 10, 11, and 13, it is unclear whether the sensor marker is intended to be set forth as claim 20 already sets forth an optical sensor, as these claims originally depended from claim 1 which did not set forth an optical sensor.
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 2-6, 10-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hular et al (US Pub 2005/0261568 -previously cited) in view of Ninni et al (US Pub 2022/0202500 -cited by applicant).
Re claims 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 intraluminal device comprising a shaft with a lumen configured to receive a second intraluminal 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 intraluminal 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 intraluminal device when the first emitter is in the pathway of the handle, the signals being representative of a position of the proximal portion of the first intraluminal 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 intraluminal 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 intraluminal 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].
Hular discloses all features including a memory to store probe calibration parameters and that the distal tip position is determined as a depth of the needle [0098, 0099], but does not disclose a memory to store geometries or a predetermined geometry of the first intraluminal device including a relative geometry between the distal portion and the proximal portion of the first intraluminal device and non-transitory computer readable medium with instructions thereon, that when executed by a processor, cause the system to process the signals according to the relative geometry to determine the position of the distal portion of the first intraluminal device based on the position of the proximal portion of the first intraluminal device. However, Ninni teaches of intraluminal navigation including a memory to store geometries or a predetermined geometry of the first intraluminal device including a relative geometry between the distal portion and the proximal portion of the first intraluminal device and non-transitory computer readable medium with instructions thereon, that when executed by a processor, cause the system to process the signals according to the relative geometry to determine the position of the distal portion of the first intraluminal device based on the position of the proximal portion of the first intraluminal device [0051, 0052; see the intraluminal device shape that is stored as an initial shape and the software that determines the a current shape to match the initial shape, thereby determining the position of the distal portion of the device based on the position of the proximal portion to which it is connected according to the relative geometry].
Re claims 2, 13: Hular discloses the system includes a 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 intraluminal 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 intraluminal 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: Hular discloses 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: Hular discloses 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: Hular discloses a transseptal puncture kit comprising the sheath and the intraluminal device (fig 6; the sheath 630 and needle 620 together form a kit).
Re claim 6: Hular discloses the intraluminal device comprising a transseptal needle (fig 6; where the needle 620 is capable of transseptal use).
Re claim 10: Hular discloses 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 intraluminal 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: Hular discloses 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: Hular discloses 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 intraluminal 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: Hular discloses 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: Hular discloses he 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].
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hular/Ninni, as applied to claims 1 and 14, in view of Highsmith et al (US Pub 2021/0401483 -previously cited).
Re claims 7, 18: Hular/Ninni discloses all features except that the intraluminal 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/Ninni, 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/Ninni, as applied to claim 1, in view of Belson (US Pub 2007/0135803 -cited by applicant)
Re claims 8, 9: Hular/Ninni discloses all features except that the intraluminal 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/Ninni, to use RFID tracking as taught by Belson, as such constitutes simple substitution with the well known tracking alternative.
Response to Arguments
Applicant’s arguments with respect to claims 2-20 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. As Hular does not disclose that a memory stores any predetermined geometry, it is noted that Hular is found to disclose position sensing of one portion of the device to determine the position of another portion of the device, contrary to Applicant assertions. In particular, Hular discloses that the sheath that has the color coded bar retracts, and this position sensing is used to determine the depth of the needle which is another portion of the device.
The claim objections and specification objections are withdrawn due to amendments, except in regard to one issue with the specification that does not appear to be addressed.
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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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, Christopher Koharski can be reached at 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
Prosecution Insights