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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “un-bunching and retraction of the bag proximally along the instrument increase a length of the bag, back to its original length.” However, the limitations pertaining to un-bunching, increasing a length, and the original length is not supported in the original specification and therefore considered new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, 7-10, and 21 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 (flexible envelope 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 modified Burkholz to couple a flexible envelope 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 or flexible envelope.
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 or flexible envelope once modified by Bint, that the alternative instrument mover of Madlung would also be disposed within the bag or flexible envelope, 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 or flexible envelope 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 up in a distal direction in response to distal advancement of the instrument provided by pinching the instrument with the pincher and moving the pincher distally, and un-bunching and retracting proximally along the instrument upon releasing of the pincher.
Additionally regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. See MPEP § 2112(V). In the instant case, the flexible envelope or bag in the prior art is substantially identical to the bag, as claimed, thereby having the same inherent properties such as the ability to be bunched or un-bunched as would be known by one of ordinary skill.
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 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).
Regarding claim 21, Burkholz, Lopez, Bint, Madlung, and Dyall teach the vascular access device of claim 1 as shown above, the combination of Burkholz, Lopez, Bint, Madlung, and Dyall further teaching the bunching up of the bag in the distal direction shortens a length of the bag and the un-bunching and retraction of the bag proximally along the instrument increase a length of the bag, back to its original length (given the bag or flexible envelope and the pincher being positioned therein as shown above, one of ordinary skill would understand that pinching the instrument to grab the instrument to move it distally would bunch and shorten the bag while releasing the pincher would release the bag to it’s original length, such a feature would be a normal property of such flexible bags or envelopes used for sterilization purposes.
Additionally regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties are presumed to be inherent. See MPEP § 2112(V). In the instant case, the flexible envelope or bag in the prior art is substantially identical to the bag, as claimed, thereby having the same inherent properties such as the ability to be bunched or un-bunched as would be known by one of ordinary skill.
Claim 11 is 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 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).
Allowable Subject Matter
Claims 3 and 4 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 following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the closest prior art to Burkholz, Lopez, Bint, Madlung, Dyall, and Daighighian
teach the vascular access device, Dyall and Bint teaching details of the bag and Daighighian teaching the pull cord as shown above, however the prior art, either alone or in combination does not show or suggest an opening of the bag and the pull cord are sized such that the opening forms a seal about the pull cord, in combination with all the other limitations of the invention as substantially claimed.
Claim 4 is objected to by virtue of being dependent on claim 3, which includes allowable subject matter.
Response to Arguments
Applicant’s arguments amendments with respect to 112 rejections have been fully considered and are persuasive. Therefore, the 112 rejections have been withdrawn.
Applicant’s arguments amendments with respect to the art rejections have been fully considered and are not persuasive. As shown above, the newly introduced limitation is further taught by the prior art of record. Applicant argues that the prior art fails to teach the bag bunching and un-bunching. However, as shown above, Examiner submits that the combination of prior art is capable of bunching or un-bunching. Additionally, such limitations are considered inherent features of the bag, given that that bag or flexible envelope in the prior art is substantially identical to the claimed bag. The rejection stands.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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