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 .
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) 1, 2, 4, 8, 11, 13, 17-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Haslam (US 2021/0085933) in view of Barrington (US 5,306,248).
Regarding claim 1, Haslam discloses an inflation device, comprising: a pressure member comprising: a fluid reservoir 112, wherein the fluid reservoir comprises a load transfer orifice (fig 2, in end 113 of reservoir); a threaded insert comprising: a load transfer member 118 configured to be disposed within the load transfer orifice; and internal threads 119; a plunger 130 comprising: a trigger grip 133; a thread rail 124 extending distally from the trigger grip and comprising: external threads 125 configured to engage with the internal threads of the threaded insert (fig 5); and protrusions 126 extending downward (interpreted in light of the specification as its use is somewhat atypical - ¶38 describes protrusions 156 and 164 extending downward from the rail which as seen in fig 9A is transverse to the longitudinal axis; ¶48 also describes “displaced downward perpendicular to the longitudinal axis” further solidifying an interpretation that downward is transverse/perpendicular to the longitudinal axis) from the thread rail (fig 4); and a plunger tip coupled to a distal end of the thread rail (fig 6, pointy end); and an actuator 120 comprising; a handle 131 operably coupled to the trigger grip (fig 5); and a guide member 121 extending distally from the handle and comprising: support ramps 127 configured to engage with the protrusions of the thread rail (fig 5); and slots disposed between the ramps configured to receive the protrusions (fig 5).
While Haslam substantially discloses the invention as claimed, it does not disclose the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice.
Barrington discloses a controllable inflation-deflation device where the reservoir is bifurcated (the bifurcated arms being flex members) with external threads 111 (figs 18 and 19), which allows for many advantages (Col.9 ll 40 to Col.10 ll 18). Especially as Barrington pertains to Halsam, the arrangement allows for both greater control over pressurization and rapid deflation.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haslam such that the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice as taught by Barrington to enable greater control over pressurization and rapid deflation.
Regarding claim 2, wherein the load transfer member and the load transfer orifice are configured to transfer an axial load from the internal threads of the threaded insert to the fluid reservoir (fig 2, via threaded engagement of load transfer member and fluid reservoir).
Regarding claim 4, wherein the fluid reservoir further comprises a nozzle 115 to permit transmission of a fluid pressure from the fluid reservoir to an inflatable medical device (such as balloon 105).
Regarding claim 8, wherein the internal threads of the threaded insert and the external threads of the thread rail comprise an engagement angle ranging from 45 degrees to 90 degrees (fig 2).
Regarding claim 11, wherein the actuator 120 further comprises: a channel 123 of the guide member to slidingly receive the thread rail (fig 4); a distal actuator ramp disposed adjacent a distal end of the guide member to engage with the distal plunger ramp (distalmost of ramps 127; ramps 127 can be most easily seen in fig 8A); a proximal actuator ramp disposed adjacent the handle to engage with the proximal plunger ramp; and wherein the support ramps are disposed within the guide member (proximalmost of ramps 127; ramps 127 can be most easily seen in fig 8A).
Regarding claim 13, Haslam discloses an inflation device, comprising: a threaded insert 118 comprising a load transfer member (internal threads 119); a fluid reservoir 112 comprising a load transfer orifice (opening), wherein the load transfer member is configured to engage with the a load transfer orifice of the flex member of the fluid reservoir; a plunger 130 comprising an elongate thread rail 124 to selectively engage with the threaded insert (fig 5), and an actuator 120 comprising a guide member 121 operatively coupled to the thread rail (fig 5).
While Haslam substantially discloses the invention as claimed, it does not disclose the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice.
Barrington discloses a controllable inflation-deflation device where the reservoir is bifurcated (the bifurcated arms being flex members) with external threads 111 (figs 18 and 19), which allows for many advantages (Col.9 ll 40 to Col.10 ll 18). Especially as Barrington pertains to Haslam, the arrangement allows for both greater control over pressurization and rapid deflation.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haslam such that the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice as taught by Barrington to enable greater control over pressurization and rapid deflation.
Regarding claim 17, wherein the load transfer member transfers an axial load from the threaded insert to a fluid reservoir when the inflation device is in the pressurization state (due to threaded engagement of threaded insert and fluid reservoir).
Regarding claim 18, wherein the plurality of protrusions are disposed within the slots to disengage the thread rail from the threaded insert when the inflation device is in a depressurization state (fig 6).
Regarding claim 19, Haslam discloses a method of pressurizing and depressurizing an inflation device, comprising: radial outwardly displacing a thread rail 124 to engage a threaded insert 118, wherein protrusions 126 of a thread rail engage with support ramps 127 of a guide member (¶29, fig 8A); distally displacing a plunger toward a distal end of a fluid reservoir to pressurize a fluid within the fluid reservoir (¶29, rotation also result in distal displacement); actuating an actuator 120 to distally axially displace a guide member 130 relative to the thread rail (130 moves proximally, such that actuator 120 moves distally from the reference point of the guide member 130); radial inwardly displacing the thread rail to disengage the thread rail from the threaded insert (fig 8B), wherein the protrusions disengage from the support ramps (fig 8A where protrusions press against support ramps to fig 8B where the protrusions move into the grooves but no longer presses against support ramps) and the guide member engages with a plunger ramp (figs 7A and 7B); and proximally displacing the plunger to depressurize the fluid within the fluid reservoir (¶33, ¶57).
While Haslam substantially discloses the invention as claimed, it does not disclose the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice.
Barrington discloses a controllable inflation-deflation device where the reservoir is bifurcated (the bifurcated arms being flex members) with external threads 111 (figs 18 and 19), which allows for many advantages (Col.9 ll 40 to Col.10 ll 18). Especially as Barrington pertains to Haslam, the arrangement allows for both greater control over pressurization and rapid deflation.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haslam such that the fluid reservoir comprising a flex member, the flex member comprises the load transfer orifice as taught by Barrington to enable greater control over pressurization and rapid deflation.
Regarding claim 20, further comprising transferring a proximally directed load applied to the threaded insert to the fluid reservoir, wherein the proximally directed load is transferred through a load transfer member of a threaded insert and a load transfer orifice of the fluid reservoir (due to engagement of threaded inset with fluid reservoir).
Regarding claim 22, further comprising coupling the thread rail to a plunger tip (fig 6, via intermediate structures), wherein the thread rail is displaceable perpendicularly relative to a longitudinal axis of the plunger tip (fig 8A vs fig 8B).
Claim(s) 3 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haslam (US 2021/0085933) in view of Kanner et al (US 2017/0246433) and Barrington (US 5,306,248).
Regarding claim 3, while Haslam substantially discloses the invention as claimed, it does not disclose the pressure member further comprises a pressure gage in fluid communication with the fluid reservoir to measure a fluid pressure within the fluid reservoir.
Kanner discloses a pressure gauge 32 for indicating the pressure of the device (¶74).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haslam such that he pressure member further comprises a pressure gage in fluid communication with the fluid reservoir to measure a fluid pressure within the fluid reservoir as taught by Kanner to indicate a pressure of the device.
Regarding claim 21, further comprising coupling a threaded insert 118 to the fluid reservoir (fig 8A), wherein a load transfer member of the threaded insert fits with a load transfer orifice of the fluid reservoir (fig 8A).
While Haslam substantially discloses the invention as claimed, it does not disclose the fit is a snap fit specifically.
Kanner discloses a device which has a structure attached to the rear of the fluid reservoir (fig 2), the attachment can include a snap fit (¶74) or the plunger and piston can be snap fit together (¶72). Snap fitting is a known means by which to attach two structures together.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haslam such that the fit is a snap fit specifically as suggested by Kanner as it is a known, alternative means of affixing two structures together, with every expectation of success.
Allowable Subject Matter
Claims 5-7 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 examiner did not find a teaching or suggestion for modifying closest art Haslam with a plunger tip comprising a body comprising: a circumferential groove; a pin hole; an interface member to couple with a distal end of the thread rail; and a distal end face; an O-ring disposed within the circumferential groove; and a pin disposed through the pin hole to couple the thread rail to the plunger tip, in addition to the limitations of claim 1, most notably a thread rail with external threads.
Claim 9 is 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 examiner did not find a teaching or suggestion for modifying closest art Haslam such that the plunger includes a U-shape channel of the thread rail to receive the guide member, absent impermissible hindsight.
Claim 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10 and 14-16 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 examiner did not find a teaching or suggestion for modifying closest art Haslam such that each of the support ramps in the first column are longitudinally offset from an adjacent support ramp in the second column, in addition to the other limitations.
Response to Arguments
Applicant’s amendments overcome the previous rejection, but new art Barrington is introduced which teaches said limitations.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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