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 § 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.
Claims 1 and 3-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the bag is configured to bunch or collapse in response to advancement of the instrument by pinching the instrument with the pincher.” Such a limitation appears to pertain to a physical property of the bag material. However, the metes and bounds of the scope of this property cannot be clearly ascertained. For example, is unclear how much bending is required for the bag to be sufficiently “bunched” or “collapsed.” Would a single fold suffice or would there need to be N number of folds. Given the present claim language, bunching and collapsing are not quantifiable terms and are thereby considered indefinite absent specific values as to the material properties. For the purpose of examination, the bag of the prior are will be considered capable of bunching or collapsing at least to some extent, given sufficient force.
Claims 3-11 are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2020/0316346 to Burkholz et al. (“Burkholz”), in view of U.S. Patent No. 4,752,292 to Lopez et al. (“Lopez”), U.S. Patent No. 6,626,869 to Bint, and U.S. Patent No. 11,020,564 to Madlung et al. (“Madlung”), and alternatively further in view of U.S. Patent Publication No. 2019/0070391 to Dyall.
Regarding claim 1, Burkholz teaches a vascular access device (Fig. 1A) comprising a housing (34/39, Fig. 1D) comprising a distal end, a proximal end, a port (38) between the distal end of the housing and the proximal end of the housing, and a lumen extending through the distal end of the housing and the proximal end of the housing (39, Fig. 1D), wherein the distal end of the housing comprises a connector (28) capable of coupling to a catheter assembly (14), a bag (collapsible or flexible tube, [0075]), an instrument (48, Fig. 1D) disposed within the bag comprising a distal end and a proximal end (distal and proximal ends of 48), and an instrument mover (hub 62) disposed within the bag ([0075], the flexible tube surrounds the instrument which would include 62) and configured to directly contact the instrument (Fig. 1D) and move the instrument distally through the lumen of the housing (Fig. 1E), but does not teach the connector being coupled to the catheter using lever arms, where the bag is coupled, and that the instrument mover is a pincher, although element 62 could be broadly interpreted as “pinching” the guidewire, and does not explicitly teach that the pincher is disposed entirely within the bag.
Lopez teaches a connector including a pair of opposing lever arms, with the opposing lever arms being actuatable to selective engage and release a catheter assembly (Figs. 5-6). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the connector of Burkholz with the connector of Lopez to yield the predictable result of providing a connection to a catheter. The provision of releasability allows for ease of removal from the catheter or use of a subsequent different/new catheter during treatment.
Bint teaches a bag (68, Fig. 1) coupled to the proximal end of a housing (42) of a vascular access device (30). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coupled the bag of Burkholz at the proximal end of the housing of the vascular access device as taught by Bint in order to protect the guidewire which extends from the proximal end of the housing from contamination (column 4, lines 33-36). It is noted that once Burkholz is modified by Bint, that the instrument mover of Burkholz would be disposed within the bag.
Madlung teaches a pincher (1, Figs. 1-9) capable of pinching an instrument directly (Fig. 9) to move an instrument distally. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the instrument mover of Burkholz with the pincher-type instrument inserter of Madlung, since such a modification would be considered a simple substitution to provide the predictable result of providing a simple yet effective means of instrument insertion. It is noted that since the instrument mover of Burkholz is already disposed within the bag once modified by Bint, that the alternative instrument mover of Madlung would also be disposed within the bag, such that the pincher can be actuated by a user through the bag to cause the pincher to pinch the instrument.
Alternatively, Dyall teaches a pincher disposed entirely within the bag (Fig. 15) and is actuated by a user through the bag to cause the pincher to pinch the instrument. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the pincher of Madlung within the bag as taught by Dyall in order to advance a medical device inside a sterile bag without touching the device for advancing ([0103]) and maintain a sterile environment.
Once combined, the bag of Burkholz, Lopez, Bint, and Madlung or Dyall would be capable of bunching or collapsing in response to advancement of the instrument by pinching the instrument with the pincher (see 112 rejection above for interpretation).
Regarding claim 5, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, Burkholz further teaching an extension tube (40) and a blood collection device (46, Fig. 1A), wherein the extension tube comprises a distal end integrated with the port (Fig. 1D) and a proximal end coupled to the blood collection device (Fig. 1A).
Regarding claim 6, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 5 as shown above, Burkholz further teaching the blood collection device comprising a sharp cannula ([0081]).
Regarding claim 7, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, Burkholz further teaching the instrument comprising a guidewire (48).
Regarding claim 8, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, the pincher of Madlung comprising a U-shaped body (Figs. 1-9) having two arms (13/14) capable of moving towards each other to pinch the instrument (Fig. 9).
Regarding claim 9, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 8, Madlung further teaching an inner surface of two arms (1, Figs. 1-9) comprising a textured surface (column 5, lines 36-46).
Regarding claim 10, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, Burkholz further teaching a position indicator (76 of 60, Fig. 1D & Fig. 2D) disposed on the instrument (48), wherein the instrument is in a retracted position (Fig. 1D), wherein in response to the instrument being in the retracted position the distal end of the instrument is disposed within the housing (at least a portion of 60 is in the proximal portion of housing 39 in the retracted position) and the position indicator is disposed within the bag (the bag is coupled to the proximal end of the housing as taught by Bint, and would thereby enclose the portion of the instrument extending from the housing of Burkholz including 76 of 60, Fig. 1D & Fig. 2D).
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, Lopez, Bint, Madlung, and Dyall as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2002/0168317 to Daighighian et al. (“Daighighian”).
Regarding claim 3, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, but do not teach the pull cord.
Daighighian teaches a pull cord (translational drive means 406, [0105]) coupled to the proximal end of an instrument (404, Fig. 11) of vascular access device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a pull cord onto the guidewire/gripper configuration of Burkholz and Madlung, as the guidewire of Burkholz and Madlung would require some means of retraction after completion of the procedure and Daighighian teaches several embodiments of guidewire retractors that are known in the art. The pull cord provides simple and convenient manual means of providing retraction that allows the user greater control and flexibility in terms of speed and force, as well as greater efficiency as compared to using the gripper alone for retraction. Once combined, the pull cord would extend through an opening in the bag of the device of Burkholz, Lopez, Bint, Madlung, and Dyall in order to be grasped by a user.
Regarding claim 11, Burkholz, Lopez, Bint, Madlung, and Dyall, teach the vascular access device of claim 10 as shown above, but do not teach the pull cord.
Daighighian teaches a pull cord (translational drive means 406, [0105]) coupled to the proximal end of an instrument (404, Fig. 11) of vascular access device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a pull cord onto the guidewire/gripper configuration of Burkholz and Madlung, as the guidewire of Burkholz and Madlung would require some means of retraction after completion of the procedure and Daighighian teaches several embodiments of guidewire retractors that are known in the art. The pull cord provides simple and convenient manual means of providing retraction that allows the user greater control and flexibility in terms of speed and force. Once combined, the pull cord would extend through an opening in the bag of the device of Burkholz, Lopez, Bint, Madlung, and Dyall, in order to be grasped by a user and is capable of being compacted in response to the instrument being retracted position (inasmuch as Applicant’s instrument is compacted as a result of retracting the instrument using the pincher and not the pull cord).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, Lopez, Bint, Madlung, Dyall, and Daighighian as applied to claim 3 above, and further in view of U.S. Patent Publication No. 2006/0089627 to Burnett et al., herein referred to as Burnett.
Regarding claim 4, Burkholz, Lopez, Bint, Madlung, Dyall, and Daighighian teach the vascular access device of claim 3 as shown above, but do not teach the grip element.
Burnett teaches a proximal end of the pull cord (24, Fig. 1) being coupled to a grip element (25, [0033]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a grip element onto the pull cord of Daighighian as taught by Burnett, because grip elements such as rings are old and well-known in the art. The retraction means of the device of Burkholz, Lopez, Bint, Madlung, Dyall, and Daighighian is a manually operated pull cord, and a grip element at the proximal end of a pull cord provides a simple and effect means to allow the user to better grip and hold the end of the pull cord in order to facilitate retraction of the guidewire without unnecessary slippage while improving control.
Response to Arguments
Applicant’s arguments amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burkholz, Lopez, Bint, Madlung, and Dyall. Burkholz teaching the port, Lopez teaching the lever arms, and the bag being capable of performing the claimed function and interpreted in light of the 112 rejection as shown above.
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.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783