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: The first paragraph should include the priority information.
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 1, 8, 11, 14-18, and 20 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 1, lines 13-14, ‘the sensor wire’ lacks antecedence.
In claim 8, it is unclear which ‘the wire’ is referring to.
In claim 11, line 2, ‘deflect to catheter’ is unclear.
In claims 14-17, ‘the braided wire’ lacks antecedence.
In claim 17, ‘the sensor wire’ lacks antecedence.
In claim 18, line 5, ‘the electromagnetic field’ lacks antecedence.
In claim 18, lines 13-14, and in claim 20, ‘the distal end portion of the catheter’ lacks antecedence (previously ‘an end portion of the tubular structure’ and ‘a distal portion’ are set forth).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: ‘tracking system’ in claim 1 with support in published [0016].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Chan et al (US Pub 2020/0222666 -cited by applicant as WO 2019/018736).
Re claims 1, 9 ,18: Chan discloses a catheter navigation system comprising:
an electromagnetic field generator configured to generate an electromagnetic field [0048; see the externally generated EM field];
a deflectable catheter [0053] including:
a tubular structure configured to receive and guide a surgical tool (figs 6A,B; see lumen wall layer 630, tie layer 639 and axial support structure 624 wherein a tool can be received in lumen 611);
a sensor disposed around an end portion of the tubular structure and configured to sense the electromagnetic field [0048, fig 2; see sensor 220 to detect EM field];
a pull wire assembly coupled to the end portion of the tubular structure and configured to cause a distal portion of the tubular structure to deflect when the pull wire assembly is operated [0093, 0110, 0111, figs 6A,B and 9; see control elements 612 and control ring 910 for steering control]; and
a coil disposed around a portion of the tubular structure configured to restrain the pull wire [0096, fig 6A,B; see reinforcement layer 632 that is a coil or see steel braided band];
a tracking system electrically coupled to the electromagnetic field generator and the sensor wire, the tracking system configured to determine a location of the sensor wire based on the electromagnetic field sensed by the sensor wire [0048; see the tracking system that determines location of the sensor based on the EM field]; and
and a handle assembly including: a handle; and a manipulator coupled to the pull wire and enabling a user to deflect the distal end portion of the catheter [0031-0033; see master assembly 106 that has a handle and manipulator to control the pull wire].
Re claims 2, 10, 11: The pull wire assembly includes a pull ring fixedly coupled to the end portion of the tubular structure and a pull wire coupled for engaging the pull ring [0069, 0110-0113; see the control ring 910 and pull wire 940].
Re claims 3, 12: The sensor is positioned distal from the pull ring (fig 2A and 9; see pull ring 910 proximal to at least a portion of the sensor 220).
Re claims 4, 5, 13, 14: The system further includes braided wire disposed around a portion of the tubular structure and wherein the coil is disposed around the braided wire and the pull wire [0096, figs 6A,B; see layer 632 or the steel braided band (corresponding to the coil and braided wire) that is disposed around the tubular structure].
Re claims 6, 8, 15, 17: The pull wire assembly further includes a lumen disposed between the coil and the braided wire, and configured to receive the pull wire and the catheter further includes a lumen disposed between the coil and the braided wire, and configured to receive the wire (fig 6A,B; see the lumen spacing between the coil and braided wire that receives the pull wire 612).
Re claims 7, 16: The sensor includes a wire disposed along a portion of the length of the catheter between the braided wire and the coil [0068; see the lumen for electrical wiring for the sensor].
Re claim 19: The assembly includes a second tubular structure enclosing the catheter [0096; see the outer band that is a tubular structure around the catheter].
Re claim 20: The manipulator includes a slider having detents that engage with a locking member to maintain the distal end portion of the catheter in a deflected state [0031-0033; see the links that comprise a slider structure that may be locked thereby including a locking member portion]
Conclusion
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