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.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (U.S. 20200016374) (cited by Applicant) in view of Belson (EP 2272432).
Regarding claim 1, Burkholz teaches an instrument delivery device (Fig. 1A, delivery device 10), comprising: a housing (14), comprising a proximal end (18), a distal end (16), and a slot (20) (Paragraph [0033]); an advancement element (guide feature 22) extending through the slot and configured to move linearly along the slot (Paragraph [0034]);
a guidewire (34) comprising a first end (Fig. 2A, first end 38) and a second end (Fig. 2A, distal end 36), wherein in response to movement of the advancement element (22) distally a first distance along the slot (20), the second end of the guidewire (34) is configured to advance a second distance (See Paragraph [0041], which states that 34 and 12 may be advanced and/or retracted together, and para [0052], which states 34 provides support along the “full” length of 12) (Examiner’s Note: a skilled artisan, considering the reference as a whole, would glean that the distal ends of 34 and 12 advance/retract together since 34 and 12 advance/retract together and 34 can provide support along the full length of 12) wherein the second distance at least twice the first distance. (Paragraphs [0049]-[0050] and [0054], “a 1:2 advancement ratio”); and a tubing (52) comprising a distal end (28) and a proximal end (54), wherein in response to movement of the advancement element distally the first distance along the slot (20), the proximal end (54) of the tubing (52) is configured to advance the first distance. (Paragraph [0054] In some embodiments, in response to movement of the guide feature 22 along the slot 20 in the distal direction 23 the first distance, a distal end 56 (and, in turn, proximal end 54) of the support tubing 52 may be advanced in the distal direction 23 a distance equal to the first distance (a “1:1 advancement ratio”).
However, Burkholz does not teach “a groove, wherein an inner surface of the housing comprises the groove and the groove is disposed between the proximal end of the housing and the distal end of the housing.”
Belson, in a related field of endeavor, teaches a device for guidewire assisted placement of catheters into blood vessels (Fig. 44A) comprising a groove (guidewire carrier 15) wherein an inner surface of the housing (5) comprises the groove (15) and the groove is disposed between the proximal end of the housing and the distal end of the housing. (See Fig. 44A).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the advancement element Burkholz to provide “a groove, wherein an inner surface of the housing comprises the groove and the groove is disposed between the proximal end of the housing and the distal end of the housing” as taught by Belson. Doing so enables guidance and advancement of the guidewire.
Regarding claim 2, Burkholz teaches wherein the proximal end (54) of the tubing (52) is coupled to the advancement element (22). (Paragraphs [0053]-[0054]).
Regarding claim 3, Burkholz teaches an extension tube (32) coupled to the advancement element (22), wherein a blood collection pathway extends through the tube (52), the advancement element (22), and the extension tube (32). (Paragraph [0039]).
Regarding claim 5, Burkholz teaches wherein the advancement element (22) comprises an arc-shaped channel (U-shaped channel), wherein the guidewire moves within the arc-shaped channel, wherein the first end (34) of the guidewire (36) is secured within the housing (14). (See Figs. 1A, 1C).
Regarding claim 6, Burkholz teaches wherein in response to movement of the advancement element (22) distally the first distance along the slot (20), the second end (56) of the guidewire (34) and the distal end (28) of the tubing (52) move from inside the housing (14) to outside of the housing. (See Figs. 3A-3B).
Regarding claim 7, Burkholz teaches wherein a distal end (16) of the housing (14) comprises a distal connector (40), wherein in response to the advancement element (22) being disposed at a proximal end of the slot (20), the second end (56) of the guidewire (34) and the distal end (28) of the tubing (52) are aligned with a distal end (16) of the distal connector (40). (See Figs. 3A-3B).
Regarding claim 8, Burkholz teaches wherein a distal end (16) of the housing (14) comprises a distal connector (40), wherein in response to the advancement element (22) being disposed at a proximal end of the slot (20), the second end (56) of the guidewire (34) and the distal end (28) of the tubing (52) are proximal to a distal end (16) of the distal connector (40). (See Figs. 3A-3B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Belson, further in view of Huang (U.S. 20200001051) (cited by Applicant).
Regarding claim 4, Burkholz as modified does not teach “a seal disposed within the advancement element and preventing fluid communication between the blood collection pathway and a portion of a guidewire pathway.”
Huang, in a related field of endeavor, teaches a seal (septum 100) disposed within the advancement element (advancement element 20 includes safety cap 26) (See Fig. 9; Abstract; Paragraphs [0087]-[0088]) and preventing fluid communication between the blood collection pathway and a portion of a guidewire pathway. (Paragraph [0087] seal (100) prevents fluid communication between a portion distal of the seal and a portion proximal of the seal.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the advancement element Burkholz to provide “a seal disposed within the advancement element and preventing fluid communication between the blood collection pathway and a portion of a guidewire pathway” as taught by Huang. Doing so prevents blood exposure while the needle is inserted. (Paragraph [0087]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Belson, further in view of Yokomizo (JP 2020011075).
Regarding claim 9, Burkholz as modified does not teach “wherein the guidewire and the tubing are disposed within the groove.”
Yokomizo, in a related field of endeavor, illustrates guidewire insertion assist tool (Fig. 8) wherein the guidewire (51) and the tubing (sheath 60) are disposed within the groove (slit 21).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the advancement element Burkholz as modified to provide “wherein the guidewire and the tubing are disposed within the groove” as taught by Yokomizo. Doing so secures the tube in the groove such that operation of inserting the guidewire becomes easier. (Page 6, last two lines, Page 7, lines 1-2 of Machine Translation).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 1/16/2026, with respect to the rejections of claims 1-9 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Belson.
Conclusion
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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