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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 14-17, 19-21, and 24-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Keefe et al. (2017/0105746).
Regarding claim 14, O’Keefe et al. disclose a device (see at least figures 1, 2, 5, 13-16, 28, 56, and 69 and paragraphs [0160], [0165], [0193]-[0195], [0208]-[0212], and [0266]) for treating tissue, comprising: a needle (shaft 15 in combination with end effector 30; see paragraph [0160] where it is noted the end effector can be a needle) having a proximal section (20; see at least figure 2) and a distal section (25; see at least figure 2) wherein the distal section is more flexible than the proximal section (because of the slots in flex spine 80), the needle further including a plurality of channels (the combination of channels 235 and 145) extending within a wall thereof (see at least figure 5), each of the channels extending from a proximal end of the needle to a distal channel end within the distal section, the needle being configured to be inserted into a living body via an insertion instrument; a plurality of cables (220) with each of the cables being received within a corresponding one of the channels (see at least figure 13), a distal end of each of the cables being coupled to the distal channel end of the corresponding channel (see at least figures 15 and 17); and a handle (10) which, during use, remains outside the body, the handle including an actuator (315; see at least figures 28 and 69) coupled to the cables, operation of the actuator away from a neutral position placing at least one of the cables in tension to curve the distal section of the needle (see at least figure 56 and paragraphs [0165], [0208]-[0212], and [0266]).
Regarding claim 15, the needle is hollow and the channels extend through a length of the needle in the wall surrounding a lumen of the needle (see at least figure 15).
Regarding claim 16, the channels extend to a distal end of the needle (see at least figure 15).
Regarding claim 17, the needle includes a first pair of channels on a first side of the needle and a second pair of channels on a second side of the needle opposite the first side and wherein the device includes a first pair of cables extending through the first pair of channels and a second pair of cables extending through the second pair of channels, proximal ends of the cables of the first and second pairs of cables being connected to the actuator so that, when the actuator is operated in a first direction, the cables of the first pair of cables are tensioned and the cables of the second pair of cables are loosened so that the distal section of the needle is curved toward the first side of the needle (see at least figures 15-17).
Regarding claim 19, the distal section of the needle includes a plurality of cuts into a wall of the needle, a first portion of the cuts being arranged in a first group extending along the first side of the distal section of the needle (see at least figure 17).
Regarding claim 20, a second portion of the cuts are arranged in a second group extending along the second side of the distal section of the needle (see at least figure 17).
Regarding claim 21, the cuts of the first group are substantially similar in size and distribution along a length of the distal section of the needle to the cuts of the second group (see at least figure 17).
Regarding claim 24, the needle is configured so that, actuation of the actuator permits bending of the distal section of the needle only in a predefined plane (see at least paragraph [0266]).
Regarding claim 25, O’Keefe et al. disclose a device (see at least figures 1, 2, 5, 13-16, 28, 56, and 69 and paragraphs [0160], [0165], [0193]-[0195], [0208]-[0212], and [0266]) for treating tissue, comprising: a needle (shaft 15 in combination with end effector 30; see paragraph [0160] where it is noted the end effector can be a needle) having a flexible distal section (25; see at least figure 2), the needle including a plurality of channels (the combination of channels 235 and 145) extending within a wall thereof (see at least figure 5), each of the channels extending from a proximal end of the needle to a distal channel end within the distal section, the needle being configured to be inserted into a living body via an insertion instrument; a first cable (220) received within a first one of the channels (see at least figure 13 where four cables are present) with a distal end of the first cable coupled to the distal channel end of the first channel (see at least figures 15 and 17); and a second cable (220) received within a second one of the channels (see at least figure 13) with a distal end of the second cable coupled to the distal channel end of the second channel (see at least figures 15 and 17), the second cable being located on a second side of the needle opposite a first side of the needle on which the first cable is located (see at least figure 14 where the two outermost cables are on opposite sides of the needle), the first and second cables extending to a location that remains, during use of the device, outside a patient's body accessible to a user so that the user may tension the first cable to curve the distal section of the needle toward the first side (see at least figure 56 and paragraphs [0165], [0208]-[0212], and [0266]).
Regarding claim 26, O’Keefe et al. further discloses a handle (10) which, during use, remains outside the body, the handle including an actuator (315; see at least figures 28 and 69) coupled to the first and second cables, the actuator being configured so that operation of the actuator away from a neutral position in a first direction placing the first cable in tension to curve the distal section of the needle toward the first side of the needle and operation of the actuator away from a neutral position in a second direction placing the second cable in tension to curve the distal section of the needle toward the second side of the needle (see at least figure 56 and paragraphs [0165], [0208]-[0212], and [0266]).
Regarding claim 27, O’Keefe et al. disclose a method for treating tissue, comprising: inserting to a target site within a living body an insertion device (see at least figures 1, 2, 5, 13-16, 28, 56, and 69 and paragraphs [0160], [0165], [0193]-[0195], [0208]-[0212], and [0266]); inserting through the insertion device a needle (shaft 15 in combination with end effector 30; see paragraph [0160] where it is noted the end effector can be a needle) having a proximal section (20; see at least figure 2) and a distal section (25; see at least figure 2) wherein the distal section is more flexible than the proximal section (because of the slots in flex spine 80); extending the distal section of the needle distally out of the insertion device to enter a target anatomical structure (see at least paragraphs [0160], [0165], [0193]-[0195], [0208]-[0212], and [0266]); and tensioning at least one cable extending through a wall of the needle to pull the needle into a curved configuration within the target anatomical structure to achieve a desired orientation and positioning of the needle within the target anatomical structure (see at least figure 56 and paragraphs [0165], [0208]-[0212], and [0266]).
Regarding claim 28, O’Keefe et al. disclose further disclose operating a handle (10) to orient the needle so that, a plane within which the distal section of the needle curves is in the desired orientation relative to the target anatomical structure before tensioning the at least one cable (see at least figure 56 and paragraphs [0165], [0208]-[0212], and [0266]).
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 18, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over O’Keefe et al. (2017/0105746).
Regarding claim 18, O’Keefe et al. disclose the device substantially as described above with respect to claim 14, but fail to disclose the cables are formed of nitinol and are between 0.1 and 0.2mm in diameter. However, Examiner notes it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Examiner also notes 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. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the cables of O’Keefe et al. of the claimed material and dimensions.
Regarding claims 22 and 23, O’Keefe et al. disclose the device substantially as described above, but fail to disclose one of the spacing and size of the cuts varies along the length of the first group. However, Examiner notes the only two design options for said cuts would be to have the spacing and size constant along the length, or varied along the length. Examiner notes it has been held that absent persuasive evidence that the particular configuration of the claimed cutes is significant, a person of ordinary skill in the art would have found it obvious to shape the prior art cuts in the claimed shape/configuration. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, Examiner notes it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Finally, Examiner notes KSR, 550 U.S. at ___, 82 USPQ2d at 1396, rationale (E) recites “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is particularly applicable in this instance as noted above because there are only two possible configurations for the cuts (varied or constant size and spacing). Therefore, in totality of the case law recited above, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have varied the spacing and/or size of the cuts of O’Keefe et al. as claimed.
Claims 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over O’Keefe et al. (2017/0105746) in view of Wood et al. (2017/0238903).
Regarding claim 29, O’Keefe et al. disclose the device substantially as described above with respect to claim 27, but fail to disclose the target anatomical structure is a bile duct. However, Examiner notes Wood et al. disclose bile duct treatment (see at least paragraph [0055]) with a similar device to that of O’Keefe et al. Therefore, treatment at this target location is shown to be known before the effective filing date of the claimed invention. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the device of O’Keefe et al. to perform treatment in the bile duct per the teachings of Wood et al.
Regarding claim 30, O’Keefe et al. disclose the distal section of the needle includes a plurality of cuts into the wall of the needle (see at least figure 2), a first portion of the cuts being arranged in a first group extending along a first side of the distal section of the needle, further comprising supplying liquid (see at least paragraph [0160] where it is disclosed the needle can be an injection needle) to a lumen of the needle so that the liquid is supplied to the bile duct via the first group of cuts.
Regarding claim 31, O’Keefe et al. disclose a second portion of the cuts are arranged in a second group extending along a second side of the distal section of the needle and wherein a plane within which the distal section of the needle curves extends through midpoints of the cuts of the first and second groups of cuts (see at least figures 2 and 56).
Regarding claim 32, O’Keefe et al. disclose the at least one cable is tensioned by operating an actuator (315; see at least figures 28 and 69) of a handle (10) coupled to the needle.
Regarding claim 33, O’Keefe et al. disclose the actuator includes a ball joint between two sections of the handle (see at least figure 36 and paragraph [0211]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN J SEVERSON whose telephone number is (571)272-3142. The examiner can normally be reached Monday-Friday 6:00-4:00 central.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan J. Severson/Primary Examiner, Art Unit 3771
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