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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/25 has been entered.
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, 4, and 7-24 are rejected under 35 U.S.C. 103 as being unpatentable over Sunagawa (US Pub 2021/0275794 -cited by applicant) in view of Radman et al (US Pub 2017/0055908-cited by applicant).
Re claims 1, 11, 12, 16, 17, 19, 20: Sunagawa discloses a percutaneous circulatory support device, comprising:
a housing comprising an inlet and an outlet [0034, fig 4A; see outer housing of pump 400/410];
an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out of the outlet [0034, fig 4A; see impeller pump 410];
a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a catheter coupled to the motor [0034, fig 4A; see motor 412]; and
a pressure sensor disposed within the catheter [0034, fig 4A; see pressure sensor 432].
Sunagawa further discloses the principles of a method of manufacturing the device which necessarily including steps of positioning an impeller within a housing such that the impeller is rotatable relative to the housing; operably coupling a motor to the impeller; coupling a catheter to the motor; and providing a pressure sensor [0028; see the “manufacture” and see the above citations].
Sunagawa discloses all features except a collar coupled to the catheter and disposed proximally relative to the housing, the collar comprising an internal chamber, a distally facing aperture and a transversely facing aperture each opening into the chamber with the distally facing aperture being distal to the transversely facing aperture, a proximally facing aperture coupled to the chamber; and an optical or electrical pressure sensor disposed within the internal chamber of the collar with a sensor cable extending through the proximally facing aperture. However, Radman teaches of a device for monitoring fluid pressure within a blood vessel including a collar coupled to the catheter and disposed proximally relative to the housing, the collar comprising an internal chamber, a distally facing aperture and a transversely facing aperture each opening into the chamber with the distally facing aperture being distal to the transversely facing aperture, a proximally facing aperture coupled to the chamber; and an optical pressure sensor disposed within the internal chamber of the collar with a sensor cable extending through the proximally facing aperture [0097, figure 5; see the cavity containing pressure sensor 226 wherein the cavity includes a distal aperture 230 and several side apertures 232]. It would have been obvious to the skilled artisan to modify Sunagawa to incorporate the collar with sensor as taught by Radman, as such is a well known manner in which to couple a sensor and catheter and would facilitate sensor measurement within a blood vessel. The combination further provides for manufacture steps of coupling the sensor to a collar, coupling the collar and the pressure sensor to the catheter proximally of the motor by distally advancing the collar and the pressure sensor along the catheter [0028; see Sunagawa’s manufacture application wherein modification with Radman’s collar and sensor within the chamber necessarily results in coupling the collar and distally advancing the collar in order to configure the device].
Re claims 4, 7, 8, 13-15: Sunagawa discloses all features except the collar further comprises an outer surface, the outer surface comprising a tapering distal portion forming the distally-facing aperture with a slope and the outer surface comprising a tapering proximal portion with a slope forming the proximally-facing aperture, and wherein the aperture is a first transversely-facing aperture and wherein one or more additional second transverse aperture is coupled to the chamber. However, Radman teaches the collar further comprises an outer surface, the outer surface comprising a tapering distal portion forming the distally-facing aperture and a tapering portion of a proximal aperture, the tapering portions having slopes with the distal slope is greater than the proximal slope, and wherein the aperture is a first transversely-facing aperture extending at an acute angle relative the longitudinal axis of the chamber and one or more additional transverse aperture is coupled to the chamber [0097, figure 5; see the distal aperture 230, transverse apertures 232, and proximal aperture at the proximal end, wherein the distal end is tapered with sloping portions (i.e. the rounded distal end) forming the distal aperture]. It would have been obvious to the skilled artisan to modify Sunagawa to incorporate the collar with sensor as taught by Radman, as such is a well known manner in which to couple a sensor and catheter and would facilitate sensor measurement within a blood vessel.
Re claims 9, 10: Sunagawa discloses all features except for a sensor mount disposed within the internal chamber of the collar and adhered to the pressure sensor. However, Radman teaches a sensor mount disposed within the internal chamber of the collar and adhered to the pressure sensor (figure 5; see the sensor 226 mounted within the collar and including a cable 228). It would have been obvious to the skilled artisan to modify Sunagawa to incorporate the collar with sensor as taught by Radman, as such is a well known manner in which to couple a sensor and catheter and would facilitate sensor measurement within a blood vessel.
Re claim 18: Sunagawa nor Radman teach that the pressure sensor is disposed apart from an outer surface of the catheter by at least 0.001 inches. However, the combination results in the sensor disposed within the chamber and it would have been obvious to dispose these components by at least 0.001 inches as a design consideration in order to permit an arrangement to be inserted in a blood vessel.
Re claims 21-24: Sunagawa discloses all features except for a central longitudinal axis extending through the internal chamber also extends through the distally-facing aperture, at least a portion of the transversely-facing aperture is radially over a portion of the pressure sensor, wherein the collar defines an outer surface parallel to a longitudinal axis of the catheter, wherein an entirety of the transversely-facing aperture extends through the outer surface of the collar, or wherein a central longitudinal axis extending through the internal chamber also extends through the distally-facing aperture. However, Radman teaches a central longitudinal axis extending through the internal chamber also extends through the distally-facing aperture, at least a portion of the transversely-facing aperture is radially over a portion of the pressure sensor, wherein the collar defines an outer surface parallel to a longitudinal axis of the catheter, wherein an entirety of the transversely-facing aperture extends through the outer surface of the collar, or wherein a central longitudinal axis extending through the internal chamber also extends through the distally-facing aperture [0097, figure 5; see the chamber 224 of the collar with its axis extending through the distal aperture, see the transverse apertures which are radially over the sensor, see the collar outer surface that is parallel to the catheter axis]. It would have been obvious to the skilled artisan to modify Sunagawa to incorporate the collar with sensor as taught by Radman, as such is a well known manner in which to couple a sensor and catheter and would facilitate sensor measurement within a blood vessel.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, and 7-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 8-11, 16-19, 21, and 25 of copending Application No. 17/988,164. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘164 includes a support device and method of manufacture of a housing, impeller, motor, catheter, and pressure sensor disposed within an internal chamber with apertures. While ‘164 refers to other features such as the “wall”, it would have been obvious to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, and 7-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/618,554. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘554 includes a support device and method of manufacture of a housing, impeller, motor, and pressure sensor disposed within an internal chamber with apertures. While the instant application refers to a catheter, it would have been obvious to conclude that the instant claims are an obvious variant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, and 7-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The double patenting rejections are maintained and held in abeyance.
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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797