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 .
This office action is in response to applicant’s communication of 7/19/2022. Currently claims are pending and rejected below.
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.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim limits the claim with “configured-to-be-powered syringe assembly includes a reusable drive unit and a disposable syringe unit”, however these elements are already claimed in the parent claim (1).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Royo et al. (US 2002/0045854 A1).
Concerning claim 1, Royo discloses an apparatus, comprising: an endovascular device (14/17); and a configured-to-be-powered syringe assembly (device upstream of 14/17) connected to the endovascular device, wherein the syringe assembly comprises a reusable drive unit (18) including a housing (23); and a disposable syringe unit (19); wherein the housing includes a releasable lid (22) and an internal compartment adapted to receive and hold the disposable syringe unit (interior portion of 22 that holds the syringe 19).
Concerning claim 2 and said configured-to-be-powered syringe assembly includes a reusable drive unit and a disposable syringe unit (see figure 3).
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) 3-16, 18-20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Royo et al. (US 2002/0045854 A1) in view of Smith (US 2019/0015585 A1).
Concerning claim 3 and Royo discloses the claimed invention except for the reusable drive unit further includes a housing and a drive motor having a pinion, and wherein the drive motor and pinion are held in the housing; and the disposable syringe unit includes a syringe body, a plunger received in the syringe body, a spindle nut carried on the syringe body and a threaded spindle carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion meshes with and drives the spindle nut in a first direction to retract the plunger into the syringe body and in a second direction to withdraw the plunger from the syringe body. Smith teaches that it is known to use the reusable drive unit (200) further includes a housing and a drive motor (224) having a pinion (332),and wherein the drive motor and pinion are held in the housing (350); and the disposable syringe unit (336) includes a syringe body (338), a plunger (335) received in the syringe body, a spindle nut (333) carried on the syringe body and a threaded spindle (334) carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion (332) meshes with and drives the spindle nut (333) in a first direction to retract the plunger into the syringe body and in a second direction to withdraw the plunger from the syringe body.as set forth in Smith at paragraphs [0050]-[0051], [0070], [0075] to provide as a known means to provide efficient and compact driving of a syringe device by a motor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Royo with the reusable drive unit further includes a housing and a drive motor having a pinion,and wherein the drive motor and pinion are held in the housing; and (b) the disposable syringe unit includes a syringe body, a plunger received in the syringe body, a spindle nut carried on the syringe body and a threaded spindle carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion meshes with and drives the spindle nut in a first direction to retract the plunger into the syringe body and in a second direction to withdraw the plunger from the syringe body as taught by Smith, since such a modification would provide the system with the reusable drive unit further includes a housing and a drive motor having a pinion,and wherein the drive motor and pinion are held in the housing; and the disposable syringe unit includes a syringe body, a plunger received in the syringe body, a spindle nut carried on the syringe body and a threaded spindle carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion meshes with and drives the spindle nut in a first direction to retract the plunger into the syringe body and in a second direction to withdraw the plunger from the syringe body for providing as a known means to provide efficient and compact driving of a syringe device by a motor.
Examiner is of the position that although the pinon of the drive unit is included in the disposable section of the device a PHOSITA would known that as an alternative the pinion may be part of the reuable portion of the device and not the disposable portion in order to save cost on the pinion and replacement thereof.
Concerning claim 4 and endovascular device is selected from a group of devices consisting of a catheter, an angiographic catheter, a diagnostic catheter, a guiding catheter, a microcatheter, a specialty catheter, a sheath, an angioplasty balloon, a drug coated balloon, a specialty balloon, an embolectomy balloon, a valvuloplasty balloon, a balloon expandable stent, a self-expanding stent, a balloon expandable covered stent, a self expanding covered stent, a drug delivery device, an embolization device, an atherectomy device, a CTO crossing device, a thrombectomy device, a contrast management device, a contrast injection line, a thrombus aspiration device, a dialysis catheter, a central line catheter, a peripheral IV catheter, a PICC line and an endoscope (see Balloon catheter of Royo).
Concerning claim 5 and the spindle nut (333) includes an integral gear (as in figure 5a for example) that meshes with the pinion ((332) see Smith).
Concerning claim 6 and the disposable syringe unit further includes a tube ( Royo 4) extending from the syringe body to a first connector (10) and the endovascular device includes a second connector (distal portion of 14) at the distal end thereof whereby the first connector and the second connector may be connected to establish a fluid pathway between the syringe body and the endovascular device.
Concerning claim 7 and the housing is a handheld housing that is ergonomically adapted to be held in a hand of a user (see Royo handle 24).
Concerning claim 8 and the housing includes at least one actuator for the drive motor (note royo control buttons).
Concerning claim 9 and the housing includes a speed switch for adjusting an operating speed of the drive motor (see Royo [0027]).
Concerning claim 10 and the housing includes a digital display for displaying operating information respecting the apparatus (see Royo [0042]).
Concerning claim 11 and including a controller configured to control operation of the drive motor and the digital display (see 21 touch screen).
Concerning claim 12 and the digital display displays at least one of a balloon inflation pressure and a volume of liquid injected from the syringe body (see Royo [0027]).
Concerning claim 13 and at least one actuator includes a first push button to retract the plunger and a second push button to withdraw the plunger (see 21 touch screen).
Concerning claim 14 and the drive motor is an electric motor (see Royo 6).
Concerning claim 15 and a battery carried on the housing and adapted for powering the electric motor (See Smith para [0051] and note teaching that the power supply can be supplied electric or battery 221).
Concerning claim 16 and the drive motor is a pneumatic motor. Royo in view of Smith discloses the claimed invention except for the motor being a “pneumatic” motor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electric motor be a pneumatic motor since the examiner that an electirc motor and pneumatic motor for their use in driving rotation of a shaft in the medical art and the selection of any of these known equivalents to an Air (Pneumatic) motor or Electric motor would be within the level of ordinary skill in the art.
Concerning claim 18 and the housing includes a seat for holding the syringe body in place within the housing while the plunger is displaced in the syringe body (see figure 2 of Royo and note where 19 sits).
Concerning claim 19 and a controller configured to control operation of the drive motor and as a consequence, retraction or withdrawal of the syringe with respect to the syringe body (see 21 touch screen).
Concerning claim 20 and an apparatus, comprising: a catheter (Royo 14) ;a balloon (17) carried on the catheter; and a configured-to-be-powered syringe assembly; wherein the syringe assembly comprises a reusable drive (18) unit including a housing (23), and a disposable syringe unit (19);wherein the housing includes a releasable lid (22) and an internal compartment adapted to receive and hold the disposable syringe unit (interior of 22 and 23)
Concerning claim 22 and wherein (a) the reusable drive unit further includes a housing and a drive motor having a pinion,and wherein the drive motor and pinion are held in the housing; and (b) the disposable syringe unit includes a syringe body, a plunger received in the syringe body, a spindle nut carried on the syringe body and a threaded spindle carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion meshes with and drives the spindle nut in a first direction to retract the plunger into the syringe body and inflate the balloon and in a second direction to withdraw the plunger from the syringe body and deflate the balloon (see Smith prior art disclosure above as it pertains to claim 3). Smith teaches that it is known to use the reusable drive unit (200) further includes a housing and a drive motor (224) having a pinion (332),and wherein the drive motor and pinion are held in the housing (350); and the disposable syringe unit (336) includes a syringe body (338), a plunger (335) received in the syringe body, a spindle nut (333) carried on the syringe body and a threaded spindle (334) carried on the plunger wherein the disposable syringe unit is held in the housing and the pinion (332) meshes with and drives the spindle nut (333) in a first direction to retract the plunger into the syringe body and in a second direction to withdraw the plunger from the syringe body.as set forth in Smith at paragraphs [0050]-[0051], [0070], [0075] to provide as a known means to provide efficient and compact driving of a syringe device by a motor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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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.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783