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 5/6/2026. Currently claims 1, 3-16, 18-20, 22 are pending.
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 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 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.
Response to Arguments
Applicant's arguments filed 5/6/2026 have been fully considered but they are not persuasive. Applicant argues that Royo does not disclose the claimed structural arrangement of "the housing includ[ing] a releasable lid and an internal compartment adapted to receive and hold the disposable syringe unit," as recited in claim 1. Examiner disagrees. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also, During examination, claim limitations are to be given their broadest reasonable reading. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989); In re Prater, 415 F.2d 1393, 1404-1405, 162 USPQ 541, 550-51 (CCPA 1969).
Examiner is of the position that Royo does disclose a lid and an internal compartment adapted to receive and hold the disposable syringe unit (as claimed).
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Figure 2 shows the internal compartment (the area that the portion between 22 and 23 which syringe is placed into) and the lid (22) and housing (23). Examiner is of the position that under the broadest reasonable reading of the claims terms Royo teaches this claim language.
In response to applicant's argument that Smith and Royo is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, examiner is of the position that both are true, both devices are drawn to the medical field of pumps for delivery of fluids to a body. Also both are pertinent to the problem of transfer of fluids from a container along tubing to a body and the automated functions and processes of this operation. Examiner if of the position that a PHOSITA would look to both Smith and Royo as analogous art since they are in the medical field of endeavor for fluid transfer to a patient and both are pertinent to fluid transfer to a patient via a pump and tubing.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner is of the position that 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]. Examiner is of the position that Royo teaches 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). Examiner understands that applicant’s specification has differences that Smith alone. Examiner as discussed in the 103 rejection above that the combination of Royo in view of Smith teaches the claim limitations.
It is recommended that applicant amend the claims to greater distinguish over the prior art and any obvious modifications thereof.
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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