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 .
Election/Restrictions
The election of species is withdrawn. Claims 1-20 are examined on the merits.
Claim Objections
Claim 8 is objected to because of the following informalities:
On line 5 of claim 8, “to object cut by the cutting unit to enter the discharge lumen by way of the open distal end to cause the object cut by the cutting unit to enter the discharge lumen by way of the open distal end” appears to be a repetitive limitation.
Appropriate correction is required.
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, 2, 7, 11, 13-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terumo Kabushiki Kaisha (WO2019/188918; hereafter Terumo).
In regard to claim 1, Terumo discloses a medical device (10) that discharges an object from a biological body lumen, the medical device comprising: a shaft (20) that includes a rotatable part (shaft 20 is rotatable to rotate cutter 40) having a proximal portion and a distal portion, the shaft including a discharge lumen (21) having an open distal end, the discharge lumen extending from the open distal end to a proximal portion of the discharge lumen (“discharge” is functional”; the structure is a lumen); a cutting unit (40) fixed to the distal portion of the rotatable part (see Fig. 3); a motor (62) connected to the rotatable part to rotate the rotatable part and the cutting part so that during use of the medical device when the motor is operated, the cutting unit is rotated to cut the object; a suction producer (12) in fluid communication with the discharge lumen (via 27) so that operation of the suction producer during use of the medical device produces suction in the discharge lumen that causes the object cut by the cutting unit to enter the discharge lumen by way of the open distal end; a discharge passage (any portion of the suction lumen proximal of 27 including proximal portions of 31) that communicates with the proximal portion of the discharge lumen (via 27); and a mixing unit (11) that supplies fluid or a moving body to the discharge passage during use of the medical device.
In regard to claim 2, Terumo discloses wherein the discharge passage includes a first passage (proximal portion of 31), a second passage (35) and a third passage (65), the first passage having a distal end connected to the proximal portion of the lumen and having an opposite proximal end, the second passage having a distal end downstream of the proximal end of the first passage with respect to a direction of flow of the object and having an opposite proximal end connected to the mixing unit, the third passage having a distal end connected to the mixing unit and having an opposite proximal end, the distal end of the third passage being downstream of the proximal end of the second passage so that the mixing unit is positioned between the proximal end of the second passage and the distal end of the third passage (see Fig. 1).
In regard to claim 7, Terumo discloses wherein the suction producer (12) includes a pump (12 can be a pump), the pump being in fluid communication with the second passage to pump the object toward the proximal end of the second passage (see Fig. 1).
In regard to claim 11, Terumo discloses a medical device (10) that discharges an object from a biological body lumen, the medical device comprising: a shaft (30) that extends from a proximal side toward a distal side and includes a discharge lumen (portion of 31 distal of 27) through which the object can pass to the proximal side; a discharge passage (any portion of the suction lumen proximal of 27 including proximal portions of 31) that communicates with a proximal portion of the discharge lumen; and a mixing unit (any portion including 27, 11, 64 that supplies fluid to the device) that supplies, to the discharge passage during operation of the medical device, fluid or a moving body movable in the discharge passage (portion of injected saline solution is directed via to the discharge passage to avoid thrombus).
In regard to claim 13, Terumo discloses further comprising: a pump (11; in this interpretation 11 would not need to be considered part of the mixing unit) coupled to the discharge passage and operable to send the object and bodily fluid toward a discharge side together with the fluid or moving body supplied at the mixing unit.
In regard to claim 14, Terumo discloses wherein the mixing unit is disposed on the discharge side of the pump (see Fig. 1).
In regard to claim 16, Terumo discloses wherein the pump (12) has a structure that intermittently reduces pressure inside the discharge lumen and sends the fluid toward the discharge side (turning the pump on and off could accomplish this functional limitation).
In regard to claim 20, Terumo discloses, wherein the moving body includes air (the moving body is functionally recited and also recited in the alternative).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Terumo in view of Deville et al. (US 2020/0093503; hereafter Deville).
Terumo fails to disclose the translucent or transparent material set forth in claim 12. Deville teaches at paragraph [0210] that it is known in the art of discharge passages to use the claimed material (translucent material) to manufacture discharge passage. In view of the teaching of Deville, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select translucent material as the specific type of plastic from which to manufacture the discharge passage of Terumo, because it amounts to selection of a known material based on its known suitability for the purpose.
Claim(s) 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Terumo in view of Look et al. (US 2015/0327875; hereafter Look).
In regard to claims 8 and 15, Terumo discloses, further comprising: an operation unit (60) that is coupled to a proximal portion of the shaft and discloses wherein the mixing unit (any portion including 27, 11, 64 that supplies fluid to the device) is disposed inside the operation unit (see Fig. 2) but Terumo does not disclose that the operation unit contains the pump. Both claims require the pump to be inside the operation unit which Terumo does not disclose.
In a similar art, Loisel discloses an operation unit (12) that includes a pump (26) within the operation unit (12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Terumo with the features of Look in order to provide a handle with the pump positioned within the handle to improve maneuverability of the handle and system as a whole.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Terumo in view of Minskoff (US 2017/0274125).
In regard to claims 17-18, Terumo fails to expressly disclose wherein the mixing unit includes a check valve and wherein the check valve is openable in response to the pressure reduced by the pump.
In a similar art, Minskoff discloses a mixing unit including a check valve (2116) and wherein the check valve (2116) is openable in response to the pressure reduced by the pump (see par. [0275]-[0290]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Terumo with the common feature of a check valve as disclosed by Minskoff in order to provide a predictable result of improved fluid control.
Allowable Subject Matter
Claims 3-6 and 19 are 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.
Claim 9-10 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 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, Michael Tsai can be reached at 571-270-5246. 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.
THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights