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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second thermoplastic outer tube of claim 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2010/132560 (Bunch) (provided by the applicant).
In Re claim 1 in Figure 1C Bunch discloses a medical device comprising: a tubular liner (26) defining a working channel (working lumen 18) capable of receiving an accessory instrument; a braided tube (36) surrounding and contacting the tubular liner; and an outer tube (58) surrounding and contacting the braided tube.
In Re claim 7 Bunch discloses a braided tube (36) surrounding one lumen (18) which comprises a working channel.
In Re claim 14 Bunch discloses a handle (66) and an end cap (therapeutic device 130).
In Re claim 15 Bunch discloses a handle including steering components and a port, and an end cap including an exit port, an imager, and lighting (Paragraph 33, ports are inherently indicated by the necessary access to lumen 18).
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) 6, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bunch.
In Re claim 6 Bunch discloses a tubular liner including only one layer (26) comprising polyethylene (Paragraph 36), but fails to disclose a molecular weight of at least 200 kilodaltons.
It would have been obvious to one of ordinary skill in the art to manufacture the Bunch apparatus such that the inner layer has a molecular weight of at least 200 kilodaltons, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In Re claim 8 Bunch discloses a braided tube including metal wires (Paragraph 41), but fails to disclose the adjacent windings of the braided tube contacting one another. It would have been an obvious matter of design choice to use any known type of braided tube structure to manufacture the Bunch apparatus, including a braided tube having adjacent windings in contact with each other.
In Re claim 12 Bunch discloses a device consisting essential of the tubular liner (18), a reinforcement tube (60) and the outer tube (58 in Figure 1E), but fails to disclose the configuration in which the reinforcement tube is a braided tube. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to construct an embodiment of Bunch consisting essentially of the tubular liner, the braided tube as the reinforcement tube, and the outer tube, since the substitution of one known element for another known element to achieve predictable results requires only ordinary skill in the art.
Claim(s) 2 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bunch in view of WO 2019/018736 (Chan) (provided by the applicant).
In Re claim 2 Bunch discloses many limitations, but fails to disclose the tubular liner comprising inner and outer layers.
Chan discloses a medical device shaft comprising an inner liner which further comprises an inner layer (630) and an outer layer (639) which is used to adhere the inner layer to a reinforcing layer (Paragraph 98).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the Bunch apparatus by using an inner liner comprising an inner and outer layer, in order to provide adhesion between the inner liner and the reinforcing layer.
In Re claim 16 Bunch discloses a medical device shaft comprising a tubular liner (26), a braided tube of metal wires (36) surrounding only one lumen (18), and a thermoplastic outer tube (58), but fails to disclose the inner layer comprising a polyethylene layer and a tie layer.
Chan discloses a medical device shaft comprising an inner liner which further comprises an inner layer (630) and an outer layer (639) which is used to adhere the inner layer to a reinforcing layer (Paragraph 98). Chan discloses polyethylene for some of the liner components (Paragraph 98).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the Bunch apparatus by using an inner liner comprising an inner and outer layer, in order to provide adhesion between the inner liner and the reinforcing layer. Furthermore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to manufacture the inner layer of the inner liner from polyethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 3-5, 9-11, 13, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bunch in view of Chan and in further view of US PGPub 2009/0227962 (Eversull).
In Re claim 3 Bunch in view of Chan discloses many limitations, including an outer layer of the inner liner comprising acid-modified polyethylene (paragraph 99), but fails to explicitly disclose the inner layer comprising polyethylene, and further fails to disclose extruding the inner and outer layer. Chan discloses polyethylene for some of the liner components (Paragraph 98).
Eversull discloses a medical device shaft which is formed by extrusion of the component layers (Paragraph 95).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to manufacture the inner layer of the inner liner from polyethylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Furthermore, it would have been obvious, in light of the teaching of Eversull, to form the inner and outer layers by extrusion, in order to provide a commonly known method of manufacture for the medical device shaft of Bunch as modified by Chan.
In Re claim 4 it would have been obvious to one of ordinary skill in the art to manufacture the Bunch apparatus such that the inner layer has a molecular weight of at least 200 kilodaltons, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In Re claim 5 Chan discloses the outer layer adhering the inner layer to a braided tube layer (Paragraphs 98 and 99.
In Re claim 9 Bunch discloses a thermoplastic (Paragraph 43) tube comprising multiple lumens (27, 28), but fails to explicitly disclose extruded thermoplastic.
Eversull discloses a medical device shaft which is formed by extrusion of the component layers (Paragraph 95).
Therefore, it would have been obvious, in light of the teaching of Eversull, to form the inner and outer layers by extrusion, in order to provide a commonly known method of manufacture for the medical device shaft of Bunch as modified by Chan.
In Re claim 10 it would have been an obvious matter of design choice to manufacture the Bunch apparatus with lumens for any commonly known function of the medical device shaft, including steering, irrigation, and the positioning of electronic components.
In Re claim 11 Bunch discloses many limitations, but fails to disclose the lumens being surrounded by only the outer tube (lumens are surrounded by a layer 27). However, it would have been an obvious matter of design choice to construct the additional lumens without the layer 27, in order to save on material and manufacturing costs in circumstances where the extra layer is not needed.
In Re claim 13 Bunch in in view of Chan discloses many limitations, but fails to disclose the manufacture of the medical device shaft by extruding the various components onto a mandrel.
Eversull discloses a medical device shaft which is manufactured by extrusion (Paragraph 95) onto a mandrel (Paragraph 97).
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to manufacture the medical device shaft by extruding the components parts onto a mandrel, as taught by Eversull, in order to provide a method to manufacture the Bunch in view of Chan medical device shaft.
Bunch in view of Chan and Eversull performs the method of claims 18-20
Allowable Subject Matter
Claim 17 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON KAROL NIESZ whose telephone number is (571)270-3920. The examiner can normally be reached M-F 9-5 EST.
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, Craig Schneider can be reached at 571 272 3607. 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.
/JASON K NIESZ/Primary Examiner, Art Unit 3753
