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 Objections
Claim 16 is objected to because of the following informalities: at lines 2-3, “performing grating” should be changed to --perform grating--. 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 1-12 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.
Claim 1 recites the limitation “ a sheath configured to slide over the elongate shaft to alternatively cover and cover the textured scraping body.”, which is unclear. It is not clear whether the claim is describing the sheath covering and uncovering the textured scraping body or if the sheath can only cover and not uncover the textured scraping body.
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.
(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, 2, 4, 7, 8, 10, and 13-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Carson et al. (US 20230404551 A1), hereinafter “Carson”.
Regarding claim 1, Carson teaches a ductal sampling device comprising: an elongate shaft comprising: a proximal end portion; and a distal end portion comprising a textured scraping body ([0008]); and a sheath configured to slide over the elongate shaft to alternatively cover and cover the textured scraping body ([0045]).
Regarding claim 2, Carson teaches an endoscope comprising: an insertion section having a working channel in which the elongate shaft can be disposed (Figure 15, [0008]); and an imaging device configured to view the textured scraping body when extended from the working channel; and a duodenoscope configured to receive the endoscope ([0067]).
Regarding claim 4, Carson teaches the textured scraping body comprising: a plurality of rows of cutting elements configured to slice or abrade tissue ([0045]); and internal storage space configured to receive tissue from the plurality of rows of cutting elements ([0047]).
Regarding claim 7, Carson teaches an embodiment with a longitudinal lumen extending within the elongate shaft to define at least a portion of the internal storage space (Figure 7 element 132, [0047]); a slit extending along at least a portion of the elongate shaft (Figure 4A element 108, [0048]); and a paddle configured to slide along the longitudinal lumen ((Figure 7 element 118, [0047]). Carson also teaches an embodiment which includes a hand grip that extends from the paddle through the slit (Figure 7 element 118).
Regarding claim 8, Carson teaches a longitudinal lumen extending within the elongate shaft to define at least a portion of the internal storage space; and a fluid injection or suction system connected to the longitudinal lumen (Claim 8, figure 8 element 132, [0057]).
Regarding claim 10, Carson teaches a pull wire attached to the distal end portion to deflect the textured scraping body, wherein the pull wire is configured to induce bending or bulging of the textured scraping body ([0047]).
Regarding claim 13, Carson teaches a method of collecting biological matter using a ductal sampling device, the method comprising: inserting the ductal sampling device into anatomy of a patient; guiding a textured scraping body of the ductal sampling device to a target tissue; grating the textured scraping body against the target tissue; and collecting biological matter from the target tissue with the textured scraping body ([0009]).
Regarding claim 14, Carson teaches viewing the target tissue and the textured scraping body with an endoscope from which the ductal sampling device extends ([0067]).
Regarding claim 15, Carson teaches grating the textured scraping body against the target tissue comprises slicing portions of the target tissue using teeth of the textured scraping body; and collecting biological matter from the target tissue with the textured scraping body comprises capturing portions of the target tissue within pockets of the textured scraping body ([0047]).
Regarding claim 16, Carson teaches retracting a sheath to expose the textured scraping body to the target tissue to performing grating of the target tissue; and extending the sheath to trap grated target tissue between the textured scraping body and the sheath ([0050]).
Regarding claim 17, Carson teaches pulling an activator to induce bending of the textured scraping body to expose a scraping edge, wherein pulling the activator comprises pulling a pull wire extending within an insertion shaft connected to the textured scraping body or pulling an insertion sheath configured to surround the textured scraping body ([0047], [0067]).
Regarding claim 18, Carson teaches activating a fluid system to remove collected biological matter from the textured scraping body ([0050], [0051], [0057]).
Claim Rejections - 35 USC § 103
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 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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Intintoli et al. (US 20190298321 A1), hereinafter ”Intintoli”.
Regarding claim 5, Carson teaches all of the elements discussed above, as well as the internal storage space comprising: a plurality of pockets recessed within the elongate shaft ([0050]) and a plurality of radially extending passages extending from each of the plurality of pockets; and a lumen extending axially through the elongate shaft connecting to the plurality of radially extending passages (Figure 8, elements 132 and 134, [0050]). Carson does not teach that each of the plurality of pockets comprises an annular pocket circumscribing the elongate shaft. Intintoli teaches a biopsy device having a plurality of annular pockets circumscribing the elongate shaft (Figures 22C and 22D element 355, [0194]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson with annular pockets similar to those of Intintoli to scrape and collect tissue from the biopsy site.
Regarding claim 6, Carson teaches all of the elements discussed above. Carson further teaches each of the cutting elements comprises an axially projecting edge that overhangs one of the plurality of pockets, each axially projecting edge comprises: a tab projecting at an angle outward from the elongate shaft to form: a cutting edge; and an opening in the elongate shaft connecting to the lumen (Figure 4A, figure 4B. figure 8 element 134, [0050]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Intintoli further in view of Tam et al. (US 20220240908 A1), hereinafter “Tam”.
Regarding claim 3, Carson teaches all of the elements of the current invention discussed above except the elongate shaft further comprising: an atraumatic tip disposed distal of the textured scraping body, wherein the atraumatic tip comprises an elongate flexible cap; and a handpiece connected to the proximal end portion; and the sheath comprises an actuator to facilitate sliding of the sheath along the elongate shaft, wherein the actuator comprises a knob. Intintoli teaches an atraumatic tip disposed distal of the textured scraping body, wherein the atraumatic tip comprises an elongate flexible cap ([0021], [0052], and figure 22I); and a handpiece connected to the proximal end portion (figure 24E element 1664). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson with elements similar to those of Intintoli such as an atraumatic tip comprising a flexible cap to prevent the operational elements from contacting and unintentionally damaging body tissue and a handpiece for the user to operate the device.
Carson and Intintoli disclose all elements of the current invention as discussed above except a sheath comprising an actuator wherein the actuator comprises a knob. Tam teaches a sampling system including a sheath comprising an actuator wherein the actuator comprises a knob ([0007]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson, as modified with Intintoli, with an actuator comprising a knob similar to that of Tam, to allow for safe and reliable sheath actuation with a greater degree of control over the actuation.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Ogawa et al. (US 20140187939 A1), hereinafter “Ogawa”. Regarding claim 9, Carson teaches all of the elements as discussed above except that the textured scraping body comprises a plurality of flexible linkages formed in the elongate shaft, wherein each of the plurality of flexible linkages comprises a shaped body positioned within an opposing shaped cut-out. Ogawa teaches a treatment instrument with having a sample collection portion and a plurality of flexible linkages used to collect tissue samples (Figure 2, [0023], [0024], [0027]). This design enables easy and reliable tissue collection, and allows for a larger amount of tissue to be collected ([0041, [0042]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson with flexible linkages similar to those in Ogawa in order to make tissue sample collection easier and more reliable, and to increase the volume of tissue collected.
Claim 11 is rejected under 35 U.S.C 103 as being unpatentable over Carson in view of Inoue et al. (US 20230148849 A1), hereinafter “Inoue”. Regarding claim 11, Carson teaches all of the elements as discussed above except that the elongate shaft includes pre-curvature at the textured scraping body. Inoue teaches an endoscope with a bent section ([004], [0081]). The bent section allows for navigation of the anatomy ([0131]) and would also allow for the scraping body to collect more tissue. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson with a pre-curved, bent section similar to that of Inoue in order to more effectively navigate the anatomy and collect more tissue samples.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Elfman et al. (US 20160045190 A1), hereinafter “Elfman”. Regarding claim 12, Carson teaches all of the elements as discussed above except that a break-away section located between the elongate shaft and the textured scraping body. Elfman teaches a biopsy device with a frangible link designed to break under a certain load, which allows for sample collection ([0035]). it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the device of Carson with a frangible link similar to that of Elfman to collect tissue samples from within the device lumen.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Carroll (US 5961458 A), hereinafter “Carroll”. Regarding claim 19, Carson teaches all of the elements discussed above except severing the textured scraping body from an insertion shaft to facilitate removal of collected biological matter from the textured scraping body. Carroll teaches a probe for removing tissue including a disposable sheath, which can be removed from the device (Column 3, line 24-25) along with the tissue samples which can be stored in the sheath (Column 3, line 22-23). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the sheath of Carson with the disposable sheath of Carroll to make it easier to remove tissue samples.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Ogawa. Regarding claim 20, Carson teaches all of the elements as discussed above except flexing the textured scraping body along a plurality of interconnected scraping linkages. Ogawa teaches a treatment instrument with having a sample collection portion and a flexible textured scraping body with a plurality of interconnected scraping linkages ([0023], [0024], [0027]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the sheath of Carson with flexible, interconnected linkages similar to those of Ogawa to be able to collect a larger volume of tissue samples.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
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/CHARLES A MARMOR II/ Supervisory Patent Examiner
Art Unit 3791
/EMILY R UCHITEL/Examiner, Art Unit 3791
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