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 .
Response to Amendment
The Amendments filed 12/24/2025 have been entered.
Claim 1 has thereby been amended.
Claims 8-20 are withdrawn from consideration per the Election filed 09/09/2025.
Claims 1-7 are being examined in this office action.
Claim Rejections - 35 USC § 102
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 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz (US 20190321590).
Regarding claim 1, Burkholz discloses an instrument advancement device (10), comprising: a housing (14), comprising a proximal end (18), a distal end (end at 51), a lumen disposed between the proximal end and a distal end (Fig. 1B: lumen from end at 51 to end 18), a slot disposed between the proximal end and the distal end (20), and a septum pocket disposed within the housing (Fig. 1B: distal pocket of the lumen, just proximal of 51; see annotated Fig. 1B below); an advancement element (42+46) extending through the slot and configured to move linearly along the slot (Figs. 1B and 2B: 42+46 extends through slot 20) between a retracted position (Fig. 1B: advancement element in retracted position at proximal end) and an advanced position (Fig. 2B: advancement element in advanced position at distal end); an instrument (guidewire 36) comprising a first end (proximal end 38) and a second end (distal end 40), wherein when the advancement element is moved linearly along the slot from the retracted position to the advanced position (Fig. 1B: guidewire in the retracted, proximal position; Fig. 2B: guidewire moved along slot to the advanced, distal position), the second end of the instrument is advanced beyond the distal end of the housing (Fig. 2B: second end 40 is distal to 16); and a septum (septum 48) positionable within the septum pocket (Fig. 2B: 48 within septum pocket); wherein the septum is coupled to the instrument at a location distal to the advancement element (Figs. 1B and 2B: guidewire 36 is coupled to 48 distal to 42+46), wherein when the advancement element is moved linearly along the slot from the retracted position to the advanced position, the septum advances distally along with the instrument and is inserted into the septum pocket to seal a portion of the lumen proximal to the septum (Fig. 2B: septum 48 coupled to 26 is inserted into the pocket as 42+46 is advanced).
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Annotated Fig. 1B, Burkholz
Regarding claim 2, Burkholz discloses the instrument advancement device of claim 1, as described above, wherein the distal end comprises a connector (Fig. 1A: connector 49 at distal end) configured to couple to a catheter assembly (Fig. 5A: 49 is connected to catheter assembly 52 via connector 72).
Regarding claim 3, Burkholz discloses the instrument advancement device of claim 1, as described above, wherein the instrument comprises a guidewire (para. [0046], sentence 1).
Regarding claim 4, Burkholz discloses the instrument advancement device of claim 1, as described above, further comprising an extension tube extending from the distal end of the housing distal to the septum pocket (Figs. 1A-B: distal end 16 of extension tube which extends from housing 14 at 51; see annotated Fig. 1B above).
Regarding claim 6, Burkholz discloses the instrument advancement device of claim 1, as described above, wherein a cross-section of the septum is an oval or circular shape (Figs. 1A-2B: 48 is cylindrical, fitting into cylindrical 26 in cylindrical 14, thereby having a circular cross-section in the radial direction).
Regarding claim 7, Burkholz discloses the instrument advancement device of claim 1, as described above, wherein a cross-section of the septum is a rectangular or square shape (Figs. 1B and 2B: cross-section of cylindrical 48 is square/rectangular in this axial direction shown).
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321590) in view of Hyer (US 20130218082).
Regarding claim 5, Burkholz discloses the instrument advancement device of claim 1, as described above, but fails to explicitly disclose the septum and septum pocket comprising annular tapers.
Hyer teaches an analogous instrument (needle) advancement assembly with a sealing septum (10), wherein the septum comprises an annular taper (Figs. 3-4: septum is annularly tapered at distal edges, see annotated Fig. 6 below), wherein the septum pocket comprises another annular taper (Fig. 6, see annotated Fig. 6 below). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the geometries of the distal end of the septum pocket and distal edges of the septum, by incorporating the annularly tapered edges taught by Hyer in order to eliminate the sharp cylindrical edges in order to create a more secure and more fluid-tight seal between the elements.
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Annotated Fig. 6, Hyer
Response to Arguments
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that Burkholz fails to disclose that “the septum is coupled to the instrument at a location distal to the advancement element, wherein when the advancement element is moved linearly along the slot from the retracted position to the advanced position, the septum advanced distally along with the instrument and is inserted into the septum pocket.” However, as cited in detail in the rejection of claim 1 above, each of these limitations is disclosed by Burkholz. Specifically, Figures 1B and 2B of Burkholz show the distal advancement of the advancement element, the instrument, and the septum. As cited in the rejection above, the advancement element is specifically cited to elements 42 and 46 of Burkholz, and the septum can be seen existing distally to these elements, before and after the advancement element is slidably advanced. In the Remarks, Applicant attributes element 44 of Burkholz to the advancement element. However, Examiner specifically cited elements 42 and 46 to the advancement element, even originally.
For these reasons, Examiner maintains the rejection of independent claim 1 as anticipated by Burkholz, along with its depending claims, as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783