` 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 3 and 15-20 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 3 recites “the tube” in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner believes this is a typographical mistake and that the Applicant meant to recite “the tubing”.
Claim 15 recites the limitation “a slot” in line 8. It is unclear if this is meant to be the same slot in line two or a different slot. For the sake of examination, the Examiner interprets “a slot” in line 8 as a different slide than the once in line 2.
Claims 16-20 are similarly rejected by virtue of their dependency upon claim 15.
Claim 18 recites “the septum” in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner believes this is a typographical mistake and that the Applicant meant to recite “a septum”.
Claims 19 is similarly rejected by virtue of their dependency upon claim 18.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Belson et al. (U.S. Patent Pub. 20140188003), hereinafter Belson.
Regarding claim 1, Belson discloses an instrument advancement device (blood draw device 1d; see FIG. 37A; the Examiner notes that all reference characters cited below refer to FIGS. 37A-42 unless otherwise stated), comprising:
a housing (housing 5, see [0156]), comprising a distal end (distal end of housing 5) and a proximal end (proximal end 6 of housing 5);
an instrument (guide wire 10) disposed within the housing;
an advancement element (guide wire advancement lever 14), wherein in response to movement of the advancement element with respect to the housing, the instrument is configured to advance distal to the distal end of the housing (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]),
wherein the distal end of the housing comprises a compressible portion (flexible tube 195) proximate a chamber (interior of tube 195) configured to hold blood, wherein in response to compression of the compressible portion, the housing is configured to dispense blood distally from the chamber through the distal end of the housing (the Examiner notes “configured to” is intended use language. The housing is fully capable of dispensing blood 4 through tube 195 out the distal end of housing 6 into the vessel 3).
Regarding claim 2, Belson discloses the claimed invention as discussed above concerning the rejection of claim 1, and Belson further discloses wherein the instrument comprises a guidewire (guide wire 10; see FIG. 37A).
Regarding claim 3, Belson discloses the claimed invention as discussed above concerning the rejection of claim 2, and Belson further discloses comprising another instrument (needle 20) coupled to the advancement element, wherein the other instrument comprises a tubing (needle lumen 23), wherein blood is configured to flow proximally through the tube, wherein the guidewire is disposed within the tubing (see [0157]).
Regarding claim 4, Belson discloses the claimed invention as discussed above concerning the rejection of claim 1, and Belson further discloses wherein the distal end of the housing comprises a distal connector (a luer fitting, valve or a seal 386), wherein the distal connector comprises the compressible portion and the chamber (“flexible tube 195 is within an outer flexible tube 195 rather than the distal end of the housing.”, [0156]; see FIG. 37A).
Regarding claim 5, Belson discloses the claimed invention as discussed above concerning the rejection of claim 4, and Belson further discloses the compressible portion (flexible tube 195) further comprising a tab (flaps 384) forming an upper surface of the compressible portion (see FIG. 37A).
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 7, 10-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. (U.S. Patent Pub. 20140188003), hereinafter Belson.
Regarding claim 7, Belson discloses the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiment of Belson FIGS. 37A-42 does not expressly state wherein the housing comprises a slot, wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position, wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing.
Belson teaches an embodiment in FIGS. 43A-43C wherein the housing comprises a slot (slot 390), wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position (see FIGS. 43A-43C), wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing (“Here the guide wire advancement lever 14 is moved distally and the guide wire 10 is moved relative to the access needle lumen 23”, [0079]; “ a slot in the housing; a handle within the slot coupled to the guidewire wherein movement of the handle along the slot moves the guidewire relative to the access needle lumen.”, [Claim 47]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing in Belson’s embodiment of FIGS. 37A-42 to include a slot, wherein the advancement element extends through the slot and is configured to move linearly along the slot between a retracted position and an advanced position, wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is configured to advance distal to the distal end of the housing. Doing so provides a mechanical stop to allow for inspection of the guidewire tip, as taught by the embodiment of Belson in FIGS. 43A-43C (see [0162]).
Regarding claim 10, Belson discloses an instrument advancement device (blood draw device 1d; see FIG. 37A; the Examiner notes that all reference characters cited below refer to FIGS. 37A-42 unless otherwise stated), comprising:
a housing (housing 5, see [0156]), comprising a proximal end (proximal end 6 of housing 5), a distal end (distal end of housing 5),
wherein the housing comprises a compressible portion (flexible tube 195), wherein in response to compression of the compressible portion, the housing is configured to dispense blood distally through the distal end of the housing (the Examiner notes “configured to” is intended use language. The housing is fully capable of dispensing blood 4 through tube 195 out the distal end of housing 6 into the vessel 3). However, the embodiment of Belson FIGS. 37A-42 does not expressly state wherein the housing comprises a slot, an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and an instrument comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing,
Belson teaches an embodiment in FIGS. 43A-43C wherein the housing comprises a slot (slot 390, see 43A-43C),
an advancement element (guide wire advancement lever 14) extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and
an instrument (guide wire 10) comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing in Belson’s embodiment of FIGS. 37A-42 to include a slot, an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and an instrument comprising a first end and a second end, wherein in response to movement of the advancement element linearly along the slot from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing. Doing so provides a mechanical stop to allow for inspection of the guidewire tip, as taught by the embodiment of Belson in FIGS. 43A-43C (see [0162]).
Regarding claim 11, the combination of Belson’s embodiments seen in FIGS. 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the instrument comprises a guidewire (guide wire 10).
Regarding claim 12, the combination of Belson’s embodiments seen in FIGS. 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the housing comprises a lumen (flexible tube or cannula 43)) configured for blood to flow therethrough, wherein the compressible portion is proximate the lumen (see FIG. 37A and 37B).
Regarding claim 13, the combination of Belson’s embodiments seen in FIGS. 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 12, and Belson further teaches wherein the proximal end of the housing comprises a proximal connector (carrier 15), further comprising an extension tube (lumen 44) extending through the lumen (flexible tube or cannula 43) and coupled to the proximal connector, wherein the blood is configured to flow through the extension tube, wherein in response to compression of the compressible portion, the extension tube is pinched and the housing is configured to dispense the blood from the extension tube distally through the distal end of the housing (see [0156-0157]; the Examiner notes “configured to” is intended use language. Blood is fully capable of dispensing through lumen 44).
Regarding claim 14, the combination of Belson’s embodiments seen in FIGS. 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 10, and Belson further teaches wherein the compressible portion (flexible tube 195) is aligned with the slot (see FIG. 37A and 43A-43C; the Examiner notes placement of slot 390 and tube 195 are in axial alignment as they are positioned linearly on the same main axis of the housing 5. The Examiner is of the position this is sufficient disclosure to teach or suggest the compressible tube is aligned with the slot.).
Regarding claim 15, Belson discloses an instrument advancement device (blood draw device 1d; see FIG. 37A; the Examiner notes that all reference characters cited below refer to FIGS. 37A-42 unless otherwise stated), comprising:
a housing (housing 5, see [0156]), comprising a proximal end (proximal end 6 of housing 5), a distal end (distal end of housing 5),
an advancement element (guide wire advancement lever 14); and
an instrument (guide wire 10) comprising a first end and a second end (proximal end of wire 10 and distal tip 13), wherein in response to movement of the advancement element from the retracted position to the advanced position, the instrument is advanced beyond the distal end of the housing (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]). However, the embodiment of Belson FIGS. 37A-42 does not expressly state wherein the housing comprises a slot, an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and wherein the distal end of the housing comprises a slot and a slider configured to move along the slot, wherein in response to movement of the slider from a proximal end of the slot to a distal end of the slot, blood is dispensed distally through the distal end of the housing.
Belson teaches an embodiment in FIGS. 43A-43C wherein the housing comprises a slot (slot 390, see 43A-43C),
an advancement element (guide wire advancement lever 14) extending through the slot and configured to move linearly along the slot between a retracted position (see FIG. 43C) and an advanced position (see FIG. 43A); and
Belson teaches an embodiment in FIG. 1 wherein the distal end of the housing comprises a slot (slot 8) and a slider (catheter hub 45) configured to move along the slot, wherein in response to movement of the slider from a proximal end of the slot to a distal end of the slot, blood is dispensed distally through the distal end of the housing (see [0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing in Belson’s embodiment of FIGS. 37A-42 to include a slot with the advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position; and wherein the distal end of the housing comprises a slot and a slider configured to move along the slot, wherein in response to movement of the slider from a proximal end of the slot to a distal end of the slot, blood is dispensed distally through the distal end of the housing. Doing so allows movement of the catheter hub along the interior space and provides a mechanical stop to allow for inspection of the guidewire tip, as taught by the embodiment of Belson in FIGS. 1 and 43A-43C (see [0075; 0162]).
Regarding claim 18, the combination of Belson’s embodiments seen in FIGS. 1 and 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 15, and Belson further teaches wherein the distal end of the housing comprises a distal connector (distal end 7), wherein the distal connector comprises the slider, the slot, and the septum (see FIGS.1 and 37A).
Regarding claim 20, the combination of Belson’s embodiments seen in FIGS. 1 and 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 15, and Belson further teaches wherein the instrument comprises a guidewire (guidewire 10).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Belson et al. (U.S. Patent Pub. 20140188003), hereinafter Belson, and further in view of Burkholz et al. (U.S. Patent Pub. 20200170559), hereinafter Burkholz.
Regarding claim 8, Belson discloses the claimed invention as discussed above concerning the rejection of claim 1, and Belson further discloses wherein the housing comprises a slot (slot 390), wherein the advancement element extends through the slot and is configured to move linearly along the slot (see FIGS. 43A-43C), wherein the instrument comprises a guidewire (guide wire 10) having a first end and a second end (distal end 11 and proximal end 12), wherein in response to movement of the advancement element distally a first distance along the slot, the second end of the guidewire is configured to advance a second distance (“the guide wire advancement lever 14 has been moved distally. This movement advances the guide wire 10 through the access needle lumen 23 and into the vessel 3.”, [0102]), further comprising another instrument (needle 20), wherein the other instrument comprises a tubing (needle lumen 23) comprising a distal end and a proximal end, wherein in response to movement of the advancement element distally the first distance along the slot, the proximal end of the tubing is configured to advance the first distance. However, Belson does not expressly state wherein the second distance is at least twice the first distance.
Burkholz teaches a delivery device for delivering an instrument into a catheter assembly (Abstract) having a guidewire (guidewire 40) and advancement element (plunger 16), wherein in response to movement of the advancement element distally a first distance along the slot, the second end of the guidewire is configured to advance a second distance (“guidewire 40 may be advanced in the distal direction beyond the distal end of the syringe 12 in response to the plunger 16 being partially and/or fully depressed.”, [0072]); and wherein the second distance is at least twice the first distance (“In some embodiments, in response to depression of the plunger 16 and movement of the guide feature 18 the first distance, the first end 56 of the support tubing 54 may be advanced in the distal direction a distance equal to the first distance (a “1:1 advancement ratio”), while the first end 25 of the instrument 22 may be advanced a distance greater than that of the first distance, such as for example, twice the first distance”, [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the distance traveled by the guidewire of Belson to be twice as long as the distance traveled by the advancing element. Doing so would provide reliability and structural support as the instrument is distally advanced while also providing the instrument with longer reach, as taught by Burkholz (see [0077]).
Regarding claim 16, the combination of Belson’s embodiments seen in FIGS. 1 and 37A-43C teach the claimed invention as discussed above concerning the rejection of claim 15, however, neither embodiment of Belson expressly state wherein the slider is coupled to a septum disposed within a chamber of the distal end of the housing, wherein the septum is configured to move with the slider.
Burkholz teaches a delivery device for delivering an instrument into a catheter assembly (Abstract) wherein the slider (inner barrel 92) is coupled to a septum (septum 93) disposed within a chamber (inside of distal end of inner barrel 92) of the distal end of the housing, wherein the septum is configured to move with the slider (see FIGS. 8A-8B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the slider of Belson to be coupled to a septum disposed within a chamber of the distal end of the housing, wherein the septum is configured to move with the slider. Doing so would create a seal between the distal opening of the syringe and the instrument, as taught by Burkholz (see [0012]).
Regarding claim 17, Belson in view of Burholz teaches the claimed invention as discussed above concerning the rejection of claim 16, and Burholz further discloses wherein the chamber (inside of distal end of inner barrel 92) is configured to hold blood (liquid 38), wherein the septum (septum 93) extends across the chamber (see FIGS. 8A-8B).
Allowable Subject Matter
Claims 6, 9, and 19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
06/07/2025
/DUNG T ULSH/Examiner, Art Unit 3783