DETAILED ACTION
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) 1-12, 16-19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tah et al. (PG Pub. 2020/0196843).
Regarding Claim 1, Tah discloses a device (see system 100) for the removal of debris from a subject (see par. 30), wherein the device comprises at least one port and wherein the at least one port (see par. 13), comprises at least one fluid lumen (see lumen 108), at least one vacuum lumen (see working channel 110) and at least one optics lumen (see camera cable, par. 34).
Regarding Claim 2, Tah discloses wherein the at least one port comprises a fluid port (see port 116/242), a vacuum port (see port 118/218), and an optics port (see port 216), each of which independently and respectively houses the fluid lumen, vacuum lumen and optics lumen (see par. 28 and 48).
Regarding Claim 3, Tah discloses the debris comprises renal or urinary dust or stones, tissue, cells, bone, blood, clots, tumors, polyps, lesions, strictures, cysts, gallbladder or gallbladder stones, sludge or sand, or foreign bodies, such as debris caused by microbial infections, or combinations thereof (see par. 28).
Regarding Claim 4, Tah discloses the device further comprises a shaft (see shaft 106/206) and a handle (see handle 104/204).
Regarding Claim 5, Tah discloses the shaft includes a tip (see end cap 130) and the handle includes the ports (see Fig. 1 and 6) and at least one controller (see actuation mechanism, par. 30 or button, par. 31).
Regarding Claims 6-7, Tah discloses the device is connected to a vacuum source (see vacuum source 10) which is connected to the vacuum lumen (see par. 41).
Regarding Claim 8, Tah discloses the fluid port is capable of delivering fluid to the subject at the location of the debris (see par. 5 and 42).
Regarding Claims 9-10, Tah discloses wherein the optics lumen of the device is connected to a visualization apparatus (see camera 112; par. 34 and 37).
Regarding Claims 11, 16, the examiner considers if the ureteroscope is flexible, then the lumens within it are necessarily flexible (see par. 3).
Regarding Claim 12, the examiner considers anything can be thrown away and therefore, the device is disposable.
Regarding Claim 17, Tah discloses a fragmentation lumen (see internal first tube 220 par. 45).
Regarding Claims 18-19, Tah discloses wherein the fragmentation lumen is connected to a fragmentation device (see laser; par. 45).
Regarding Claim 21, see rejection of similarly worded Claim 1 above. Tah further discloses a. Inserting a device into the subject (see par. 40), b. Visualizing the debris with the optics lumen (see par. 30 and 39), c. Providing fluid with the fluid lumen to the cavity in the subject’s body where the debris is located (see par. 13 and 30), and d. removing the fluid in the cavity with the vacuum lumen, wherein the removal of the fluid results in the removal of the debris from the subject (see par. 28 and 30).
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) 13-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tah et al. (PG Pub. 2020/0196843) in view of Todd (PG Pub. 2017/0215854).
Regarding Claims 13-15, Tah does not elaborate on the dimensions of the shaft and handle. Todd discloses a similar system for removing debris wherein the shaft comprises a diameter of at least 7F and a length of about 40cm and the handle has a length of about 25cm (see par. 121). It would have been obvious to one of ordinary skill in the art at the time of the invention to use these dimensions because Todd teaches it provides the smallest feasible instrument for a micro invasive design (see par. 121).
Regarding Claim 20, Todd further discloses the device further comprises a pull wire (see guidewire, par. 61). It would have been obvious to one of ordinary skill in the art at the time of the invention o use a pull wire because Todd teaches it helps in the insertion process (see par. 61).
Conclusion
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/N.P/ Examiner, Art Unit 3792
/JAMES M KISH/ Supervisory Patent Examiner, Art Unit 3792