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
This office action is in response to the claims filed on 11/24/2025. Claims 38-44 are previously withdrawn. Claims 27-37 and 45-46 are pending and addressed below.
Response to Arguments
Applicant’s arguments, filed on 11/24/2025, with respect to claims 27 and 45 have been fully considered but they are not persuasive.
Regarding arguments on page 10, the applicant states that “The dilator 11 of Egnelov is a one-piece device. There is no disclosure or even the hint of a teaching in the reference that the dilator includes a "distal component" and a separate "proximal component .. configured to be coupled together to form an elongate introducer body". Egnelov's device is a one-piece design, not the claimed introducer formed from (at least) two separate components. The Office points to no citation in Egnelov disclosing a two- component device, because it cannot, as there is none. Rather the Office imagines a two- component dilator where none exists”. The examiner disagrees with the applicant because Figure 4 clearly shows the proximal component and the distal component being coupled together to form the introducer. Nowhere in the claims does it recite the proximal component and the distal component being detachably coupled which is more specific and clearer than the current claim limitation. Also, the introducer of Egnelov is not a one-piece device since there are different components that make the introducer which are segmented as shown in Figure 4. A one-piece device would be seamless design and would not be segmented which is not the case for Egnelov since Egnelov’s introducer appears to be made of three components that are fixed together as shown in Figure 4. Therefore, the 103 rejection of Egnelov in view of Donadio will be maintained.
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 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 of this title, 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 27, 33, 35-36 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Egnelov (US Pub No. 2004/0138674) in view of Donadio (US Patent No. 6,107,004).
Regarding claim 27, Egnelov discloses (Figures 1-12) a vascular closure system comprising: an introducer (11) having a distal component (see annotated figure below) and proximal component (see annotated figure below), wherein: the distal component defines a distal tapered tip (see annotated figure below), the proximal component defines a proximal tapered tip (see annotated figure below), the distal component and the proximal component are configured to be coupled together to form an elongate introducer body (clearly show in Figure 4 which shows the distal component and the proximal component already coupled together), and a closure device (1) configured to seal a puncture in a vessel wall [Fully configured in doing this] (Paragraph 0024), the closure device including an access sheath (Figure 1), the access sheath having a front end (2), a rear end (5), and a second lumen extending therebetween, wherein the introducer is configured to be received in the second lumen to facilitate placement of the closure device (clearly shown in Figure 5) (Paragraph 0024).
Egnelov fails to disclose the introducer body includes a lumen extending from the distal tapered tip to the proximal tapered tip along a central axis when the distal component and the proximal component are coupled together, and the lumen is configured to receive a guidewire.
Donadio, in the analogous art of dilators that are inserted into the body, teaches (Figures 12-13) an introducer or dilator (93) that includes a lumen that is configured to receive a guidewire (95) (Col. 19, lines 6-10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the introducer body of Egnelov to have included a lumen that is configured to receive a guidewire as taught by Donadio, in order to facilitate the step of positioning the introducer into the vessel and also, to support the access sheath during its insertion into the blood vessel (Donadio, Col. 19, lines 6-20).
[Egnelov modified by Donadio as a whole would result in the introducer body to include a lumen extending from the distal tapered tip to the proximal tapered tip along a central axis when the distal component and the proximal component are coupled together, and the lumen is configured to receive a guidewire]
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Regarding claim 33, Egnelov modified by Donadio further discloses wherein the introducer body defines an outer surface and an outer cross-sectional dimension that is consistent along a length of the introducer body between the distal tapered tip and the proximal tapered tip (clearly shown in Figure 4).
Regarding claims 35 and 36, Egnelov modified by Donadio further discloses a deployment assembly (41) insertable into the access sheath to position a sealing device (43, 44, 45) within the vessel and wherein the sealing device comprises a toggle (43), a plug (44) and a suture (45), and the toggle is configured to be adjacent an inner surface of the vessel wall and the plug is configured to be adjacent an outer surface of the vessel wall to seal the puncture (clearly shown in Figure 12) (Paragraph 0028).
Regarding claim 45, Egnelov discloses (Figures 1-12) a vascular closure system comprising: an introducer (11) having a distal component (see annotated figure above for claim 27) and proximal component (see annotated figure above for claim 27), wherein: the distal component defines a distal tapered tip (see annotated figure above for claim 27), the proximal component defines a proximal tapered tip (see annotated figure above for claim 27), the distal component and the proximal component are configured to be coupled together to form an elongate introducer body (clearly show in Figure 4 which shows the distal component and the proximal component already coupled together), and a closure device (1) configured to seal a puncture in a vessel wall [Fully configured in doing this] (Paragraph 0024), the closure device including an access sheath (Figure 1), the access sheath having a front end (2), a rear end (5), and a second lumen extending therebetween, wherein the introducer is configured to be received in the second lumen to facilitate placement of the closure device (clearly shown in Figure 5) (Paragraph 0024).
Egnelov fails to disclose the proximal component defines a proximal portion of a lumen in the introducer body, the distal component defines a distal portion of the lumen, the proximal and distal portions are aligned when the proximal and distal components are coupled together, and the lumen is configured to receive a guidewire.
Donadio, in the analogous art of dilators that are inserted into the body, teaches (Figures 12-13) an introducer or dilator (93) that includes a lumen that is configured to receive a guidewire (95) (Col. 19, lines 6-10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the introducer body of Egnelov to have included a lumen that is configured to receive a guidewire as taught by Donadio, in order to facilitate the step of positioning the introducer into the vessel and also, to support the access sheath during its insertion into the blood vessel (Donadio, Col. 19, lines 6-20).
[Egnelov modified by Donadio as a whole would result in the proximal component to define a proximal portion of a lumen in the introducer body, the distal component to define a distal portion of the lumen, the proximal and distal portions to be aligned when the proximal and distal components are coupled together, and the lumen is configured to receive a guidewire]
Claims 28, 29, 31 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Egnelov (US Pub No. 2004/0138674) in view of Donadio (US Patent No. 6,107,004) as applied to claims 27 and 45 above, and further in view of Veronikis (US Patent No. 5,681,340).
Regarding claims 28 and 29, Egnelov modified by Donadio discloses the invention of claim 27 above except for wherein the proximal component and the distal component are coupled together via at least one of an interference fit, a snap-fit connection, or a threaded connection, wherein when the distal component and the proximal component are coupled together via the interference fit, the distal component includes a projection and the proximal component includes a corresponding cavity for receiving the projection.
Veronikis, in the analogous art of dilators that are inserted into the body, teaches (Figures 1-2) an introducer or dilator (Figure 1) that has a proximal component (12) and a distal component (14) being coupled together via an interference fit [Threaded connection as shown in Figure 2 is considered an interference fit], the distal component includes a projection (40) and the proximal component includes a corresponding cavity (28) for receiving the projection (Figure 2) (Col.2, lines 62-67 and Col. 3, lines 1-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Egnelov modified by Donadio to have the proximal component and the distal component to be coupled together via an interference fit, such that the distal component includes a projection and the proximal component includes a corresponding cavity for receiving the projection as taught by Veronikis, in order to have the introducer to be adjustable in length to achieve a selected desired length to assist in the medical procedure (Veronikis, Abstract and Col. 1, lines 34-65).
Regarding claims 28, 31 and 46, Egnelov modified by Donadio discloses the invention of claims 27 and 45 above except for wherein the proximal component and the distal component are coupled together via at least one of an interference fit, a snap-fit connection, or a threaded connection, wherein when the distal component and the proximal component are coupled together via the threaded connection, the distal component includes external threads and the proximal component includes internal threads configured to threadably mate with the external threads.
Veronikis, in the analogous art of dilators that are inserted into the body, teaches (Figures 1-2) an introducer or dilator (Figure 1) that has a proximal component (12) and a distal component (14) being coupled together via a threaded connection (clearly shown in Figure 2), the distal component includes external threads (40) and the proximal component includes internal threads (28) configured to threadably mate with the external threads (Figure 2) (Col.2, lines 62-67 and Col. 3, lines 1-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Egnelov modified by Donadio to have the proximal component and the distal component to be coupled together via a threaded connection, such that the distal component includes external threads and the proximal component includes internal threads configured to threadably mate with the external threads as taught by Veronikis, in order to have the introducer to be adjustable in length to achieve a selected desired length to assist in the medical procedure (Veronikis, Abstract and Col. 1, lines 34-65).
Claims 28, 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Egnelov (US Pub No. 2004/0138674) in view of Donadio (US Patent No. 6,107,004) as applied to claim 27 above, and further in view of Mendius (US Pub No. 2004/0068286).
Regarding claims 28 and 30, Egnelov modified by Donadio discloses the invention of claim 27 above except for wherein the proximal component and the distal component are coupled together via at least one of an interference fit, a snap-fit connection, or a threaded connection, wherein when the distal component and the proximal component are coupled together via the snap-fit connection, the distal component includes a ridge and the proximal component includes a corresponding groove for receiving the ridge.
Mendius, in the analogous art of dilators that are inserted into the body, teaches (Figure 8) an introducer or dilator (312) that has a proximal component (312a) and a distal component (312b) being coupled together via a snap-fit connection (via coupling element 356) (Paragraph 0049), the distal component includes a ridge (356) and the proximal component includes a corresponding groove (354a) for receiving the ridge (Figure 8) (Paragraph 0049). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Egnelov modified by Donadio to have the proximal component and the distal component to be coupled together via a snap-fit connection, such that the distal component includes a ridge and the proximal component includes a corresponding groove for receiving the ridge as taught by Mendius, since it has been held that forming into two pieces and putting together the pieces to form an article which has formerly been formed as a single piece involves only routine skill in the art. In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 32, Egnelov modified by Donadio discloses the invention of claim 27 above except for wherein the introducer further comprises a coupler, the coupler having first and second ends configured to engage respective engagement members of the proximal and distal components, wherein when the coupler is engaged with the respective proximal and distal components, the coupler forms a portion of the introducer body.
Mendius, in the analogous art of dilators that are inserted into the body, teaches (Figure 8) an introducer or dilator (312) that has a coupler (356), the coupler having first and second ends configured to engage respective engagement members (354a, 354b) of the proximal (312a) and distal (312b) components (Figure 8) (Paragraph 0049), wherein when the coupler is engaged with the respective proximal and distal components (Figure 8), the coupler forms a portion of the introducer body (clearly shown in Figure 8) (Paragraph 0049). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Egnelov modified by Donadio to have the introducer to include a coupler, the coupler having first and second ends configured to engage respective engagement members of the proximal and distal components, wherein when the coupler is engaged with the respective proximal and distal components, the coupler forms a portion of the introducer body as taught by Mendius, since it has been held that forming into two pieces and putting together the pieces to form an article which has formerly been formed as a single piece involves only routine skill in the art. In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Egnelov (US Pub No. 2004/0138674) in view of Donadio (US Patent No. 6,107,004) as applied to claim 27 above, and further in view of Martin (US Pub No. 2012/0296275).
Regarding claim 34, Egnelov modified by Donadio discloses the invention of claims 27 above but fails to disclose wherein the introducer body further comprises at least one radio-opaque marker disposed between the distal tapered tip and the proximal tapered tip.
Martin, in the analogous art of dilators that are inserted into the body, teaches (Figure 16) an introducer (1602) that includes radiopaque markers (1600, 1601) disposed on the body (Paragraph 0085). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the introducer of Egnelov modified by Donadio to have included radiopaque markers disposed on the body as taught by Martin, in order to provide visual indicators to an operator of the location of the introducer (Martin, Paragraph 0085).
[Egnelov modified by Donadio and Martin as a whole would result in the introducer body to include at least one radio-opaque marker disposed between the distal tapered tip and the proximal tapered tip]
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Egnelov (US Pub No. 2004/0138674) in view of Donadio (US Patent No. 6,107,004) as applied to claim 27 above, and further in view of Fuimaono (US Patent No. 6,245,054).
Regarding claim 37, Egnelov modified by Donadio discloses the invention of claim 27 above including wherein the introducer defines an introducer length that extends from a proximal end to the distal end along a central axis but fails to disclose wherein a length of the introducer body is between about 20 cm and about 130 cm.
Fuimaono, in the analogous art of dilators that are inserted into the body, teaches (Figure 4) an introducer or dilator (30) that has a length from about 115 cm to about 155 cm (Col. 5, lines 17-44) [Meets the range above between about 20 cm and about 130 cm]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Egnelov modified by Donadio to have the introducer length to be from about 115 cm to about 155 cm as taught by Fuimaono, in order to be used in a transseptal left heart catheterization method to treat the heart (Fuimaono, Col. 1, lines 37-67). [Egnelov modified by Donadio and Fuimaono would result in a length of the introducer body is between about 20 cm and about 130 cm]
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 MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771