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 .
Response to Amendment
Claims 1-17 and 19-21 are pending in the application. Claim 18 has been canceled. Claim 21 is new. Claims 1-3, 12, 13, 16, 17, 19, and 20 have been amended.
Terminal Disclaimer
The terminal disclaimer filed on 12/23/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,957,365 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 1, 3-5, 7-9, 11, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Deville et al. (US 10,531,883 B1) (“Deville”).
Regarding claim 1, Deville discloses (Figures 25-41) a device configured to convert a constant suction force to a periodic suction force, the device comprising: a housing (401, 552) configured to receive a portion of a vacuum tube (426) and a portion of a vent tube (446); a rotatable cam comprising an exterior surface that forms a body (430, 450, 460); a first plunger (421) coupled to the body (430, 450, 460) of the rotatable cam; and a second plunger (441) coupled to the same body of the rotatable cam as the first plunger, wherein the rotatable cam is configured to cause the first plunger to periodically compress the vacuum tube and to cause the second plunger to periodically compress the vent tube (Column 30, lines 3-15).
Deville fails to disclose the rotatable cam comprises an exterior surface that forms a single body. However, Deville discloses the vacuum and vent cams (430, 450) are fixed rotationally to the cam shaft (Column 29, lines 19-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rotatable cam (vacuum cam, vent cam, and cam shaft) disclosed by Deville to be formed as a single body, since it has been held that the use of a one piece construction instead of multiple parts rigidly secured together as a single unit would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). See MPEP § 2144.04.
Regarding claim 3, Deville teaches (Figures 31-36) that the single body of the rotatable cam comprises a cylindrical body (460) defining a first circumferential groove on the exterior surface (at 452) configured to receive a first portion of the first plunger (421) and a second circumferential groove (at 452) on the exterior surface configured to receive a first portion of the second plunger (441), wherein rotation of the cylindrical body causes a second portion of the first plunger to periodically compress the vacuum tube and causes a second portion of the second plunger to periodically compress the vent tube (Figures 31 and 32).
Regarding claim 4, Deville teaches (Figures 31 and 32) the first groove comprises a first proximal groove portion and a first distal groove portion, wherein the second groove comprises a second proximal groove portion and a second distal groove portion, and wherein: the first proximal groove portion biases the first plunger away from the vacuum tube (Figure 31), the first distal groove portion biases the first plunger to hold the vacuum tube closed (Figure 32), the second proximal groove portion biases the second plunger away from the vent tube, and the second distal groove portion biases the second plunger to hold the vent tube closed (Column 30, line 61 – Column 33, line 2).
Regarding claim 5, Deville teaches (Figures 31 and 32) that the first plunger (421) and the second plunger (441) are linear, and wherein the rotatable cam is configured to rotate to cause the first plunger to periodically compress the vacuum tube away from the cam, and wherein the cam is configured to rotate to cause the second plunger to periodically compress the vent tube away from the rotatable cam (Column 30, line 61 – Column 33, line 2).
Regarding claim 7, Deville teaches that the housing comprises: a user-interface control panel; and control circuitry configured to control a speed of rotation of the rotatable cam, wherein the control circuitry is configured to receive user input via the user-interface control panel and control the speed of rotation of the rotatable cam based on the user input (Column 14, line 58 – Column 15, line 8; Column 28, line 62 – Column 29, line 18; Column 32, line 43 – Column 33, line 2).
Regarding claim 8, Deville teaches that in response to receiving user input indicative of a request to pause the rotation of the rotatable cam, the control circuitry is configured to select a time at which to pause the rotation of the rotatable cam such that the vacuum tube or the vent tube remains compressed or uncompressed while the rotation of the rotatable cam is paused (Column 33, lines 25-51; Column 6, lines 11-37).
Regarding claim 9, Deville teaches that the housing comprises control circuitry configured to control a speed of rotation of the rotatable cam, wherein the control circuitry is configured to cause the rotatable cam to rotate at a frequency of between about 1.5 Hz and about 15 Hz (Column 32, line 43 - Column 33, line 2; Column 33, lines 52-61).
Regarding claim 11, Deville teaches (Figure 35) that the vacuum tube and the vent tube are configured to fluidically couple to a catheter (410), and wherein rotation of the rotatable cam is configured to establish the periodic suction force within a lumen of the catheter via the vacuum tube and the vent tube.
Regarding claim 12, Deville teaches that the rotatable cam has only the single body (as modified in claim 1; Column 29, lines 19-20), the first and second plungers (421, 441) being coupled to the single body.
Regarding claim 14, Deville teaches (Figures 25-41) a system comprising: a vacuum source (80); the vacuum tube (426) configured to be coupled to the vacuum source; the vent tube (446); the device of claim 1 (see rejection of claim 1 above); a motor (510) configured to rotate the rotatable cam of the device of claim 1; and control circuitry configured to control the motor to control the rotation of the rotatable cam (Column 14, line 58 - Column 15, line 8; Column 28, line 62 - Column 29, line 18; Column 32, line 43 - Column 33, line 2).
Regarding claim 15, Deville teaches (Figure 35) an aspiration catheter (410) fluidically coupled to the vacuum tube and to the vent tube, wherein the vacuum tube is configured to connect a lumen of the catheter to the vacuum source to establish a suction force in the lumen of the catheter.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Deville et al. (US 10,531,883 B1) (“Deville”) in view of Felix et al. (US 4,941,872) (“Felix”).
Regarding claim 6, Deville teaches that the first plunger and the second plunger (421, 441) are pill-shaped, and wherein the rotatable cam is configured to rotate to cause the first plunger to periodically compress the vacuum tube toward the cam, and wherein the cam is configured to rotate to cause the second plunger to periodically compress the vent tube toward the cam (Figures 31 and 32). Deville fails to teach that the first plunger and the second plunger are hook-shaped. However, Deville teaches that the first plunger and the second plunger can be formed in any shape to provide the function of closing off the tubes (Column 30, lines 12-15).
Felix teaches a surgical irrigation and suction device comprising a plunger in the form of a hook (88) that pinches a tube (38) between ribs (84, 86). Felix teaches that this arrangement results in a drip-proof, leak-proof valve (Column 5, lines 60-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first plunger and the second plunger to have a hook shape, as taught by Felix. Deville teaches that the first plunger and the second plunger can be formed in any shape to provide the function of closing off the tubes (Column 30, lines 12-15) and Felix teaches that a hooked configuration results in a drip-proof, leak-proof arrangement (Felix, Column 5, lines 60-63).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Deville et al. (US 10,531,883 B1) (“Deville”) in view of Anton (US 2017/0296712 A1).
Regarding claim 10, Deville teaches (Figure 34) a motor (510) mechanically coupled to the rotatable cam. However, Deville fails to teach a removable battery configured to power the motor to rotate the cam.
Anton teaches an analogous suction device comprising a motor (508), a controller (510), and a removable or rechargeable battery (512) electrically coupled to the motor and the controller (paragraph 0051).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Deville to comprise a removable battery configured to power the motor to rotate the cam, as taught by Anton. This modification would provide a known power source to electrically couple to the motor to allow the device to function (Anton, paragraph 0051).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Deville et al. (US 10,531,883 B1) (“Deville”) in view of Nash et al. (US 2004/0059284 A1) (“Nash”).
Regarding claims 19 and 20, Deville discloses (Figures 25-41) an aspiration system, comprising: an aspiration tube (426); a motorized pulsator (400) coupled to the aspiration tube, wherein the pulsator is operable to open and close the aspiration tube to flow of liquid through the tube, and wherein the pulsator comprises a cam comprising an exterior surface that forms a cam body (430, 450, 460) coupled to both a first plunger (421) and a second plunger (441), the first and second plungers being configured to close and open the aspiration tube (426) and a vent tube (446), respectively, via external compression of the tubes, and release of such compression (Column 30, lines 3-15); an aspiration catheter (410) connected to the aspiration tube, wherein the aspiration catheter is configured for insertion into a blood vessel of a patient; and a vent tube (446), wherein the aspiration catheter is connected to the aspiration tube and the vent tube, and wherein the pulsator is operable to open or close the vent tube to flow of fluid through the tube (Column 30, lines 3-15).
Deville fails to explicitly disclose a sterile field, and the aspiration tube, vent tube, and pulsator located in the sterile field. Deville also fails to disclose the exterior surface forms a single cam body. However, Deville discloses the vacuum and vent cams (430, 450) are fixed rotationally to the cam shaft (Column 29, lines 19-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rotatable cam (vacuum cam, vent cam, and cam shaft) disclosed by Deville to be formed as a single body, since it has been held that the use of a one piece construction instead of multiple parts rigidly secured together as a single unit would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). See MPEP § 2144.04.
Nash teaches (Figures 1-6B) an infusion/aspiration pumping system that has a reduced size to allow the entire device to be placed within the confines of the sterile field of the operating room, thereby enabling a physician to personally monitor and/or control the system (paragraphs 0029 and 0038).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration system disclosed by Deville to comprise a sterile field, and a size such that the aspiration tube, vent tube, and motorized pulsator are located in the sterile field, as taught by Nash. This modification would enable a physician to personally monitor and/or control the system within the confines of the sterile field of the operating room (Nash, paragraphs 0029 and 0038).
Regarding claim 21, Deville as modified by Nash teaches that the single cam body comprises a cylindrical body (460) defining a first circumferential groove (at 452) on the exterior surface configured to receive a first portion of the first plunger (421) and a second circumferential groove (at 452) on the exterior surface configured to receive a first portion of the second plunger (441), wherein rotation of the cylindrical body causes a second portion of the first plunger to periodically compress the vacuum tube and causes a second portion of the second plunger to periodically compress the vent tube (Figures 31 and 32).
Allowable Subject Matter
Claims 2 and 13 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.
The following is a statement of reasons for the indication of allowable subject matter: Claims 2 and 13 were indicated allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in the previous Office Action.
Claims 16 and 17 are allowed.
The following is an examiner’s statement of reasons for allowance: Claim 16 has been amended to recite that the rotatable cam comprises a groove configured to receive a first portion of the first plunger and a first portion of the second plunger. This limitation, in combination with the other limitations in claim 16, is not disclosed or suggested in the prior art of record. Deville fails to disclose or suggest a groove that receives both a first portion of the first plunger and a first portion of the second plunger.
Claim 17 is dependent on claim 16, thus is also allowable over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-12, 14, 15, and 19-21 have been considered but are not persuasive. The Applicant has argued that claims 1 and 19 as amended distinguish over the prior art because the vacuum cam (430), vent cam (450), and cam shaft (460) are formed by separate exterior surfaces. Deville discloses the vacuum and vent cams (430, 450) are fixed rotationally to the cam shaft (Column 29, lines 19-20). The Examiner does not agree that the amended claims distinguish over the Deville reference, because modifying multiple parts that are rigidly secured together (vacuum cam, vent cam, cam shaft) to be formed as a single body would have obvious to one having ordinary skill in the art before the effective filing date of the claimed invention. It has been held that the use of a one piece construction instead of multiple parts rigidly secured together as a single unit would be merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). See MPEP § 2144.04.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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, Darwin Erezo can be reached at 571-272-4695. 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.
/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771