DETAILED ACTION
Applicant’s amendments and remarks, filed May 26, 2026, are fully acknowledged by the Examiner. Currently, claims 1-5, 8-10, 12-14, and 16-21 are pending with claims 6, 7, 11 and 15 cancelled, and claims 1, 8-10, 12-13, and 16-20 amended. Applicant’s amendments to the claims have obviated the previously-filed rejections under 35 U.S.C. 112(b). The following is a complete response to the May 26, 2026 communication.
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
Claims 1-5, 8-10, 12-14, 17, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US Pat. Pub. 2016/0175009 A1) further in view of Cosman et al. (US Pat. Pub. 2017/0049503 A1).
Regarding claim 1, Davies provides for a puncture device (guidewire 200) for puncturing a septum of a heart (the guidewire is capable of such functionality), the puncture device comprising:
a flexible wire having an atraumatic distal tip configured to puncture the septum, the flexible wire having a distal curve portion (wire 212 with the atraumatic tip at 208; see [0103]),
an insulation layer covering a proximal portion of the flexible wire (214),
a radiopaque coil which extends around the distal curve portion (marker 210), and
wherein the puncture device is configured to be received in the lumen of a dilator so as to enable advancement and withdrawal of the dilator overtop of the puncture device, the dilator comprising an elongate shaft defining a proximal end and a tapered distal end (via the guidewire 200 being capable of advancing through the sheath 300 and dilator 100).
While Davies provides for the use of the radiopaque coil at the distal end of the device, Davies fails to provide for the claimed first proximal marker formed on a proximal portion of the puncture device wherein the at least one proximal marker comprises a leading edge and a trailing edge,
wherein when the puncture device is received in the lumen of the dilator and the leading edge is aligned with a predetermined distance from a hub of the dilator, the atraumatic tip does not protrude from the distal end of the dilator, and
wherein when the puncture device is received in the lumen of the dilator and the trailing edge is aligned with a predetermined distance from the hub of the dilator, the atraumatic distal tip protrudes from the distal end of the dilator.
Cosman disclose a similar manner device for advancing a puncture device through the body to a desired location. Cosman specifically provides with respect to figure 14A for a puncture device (1411) to have a plurality of markers formed thereon with a marker at a distal end of the device (a distal most one of 1413 such as 1413D in figure 14A), and then a plurality of proximal marks formed on a proximal portion of the puncture device (respective ones of hatched section 1413S and depth markers 1413D other than the distal most marker).
Cosman further provides for the puncture device to be inserted through the lumen of an elongated member (passage through the various ones of 1401H/1403H/1404H/1405H/1406H of the support member 1400). Cosman also teaches that a proximal marker comprises both a leading edge (a distal edge of one of 1413S) and a trailing edge (a proximal edge of the same one of 1413S).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the proximal markers in the form of the hatched sections and depth markers 1411S/1411D as in Cosman to the guidewire 200 of Davies to provide the user with a manner of ready visual monitoring insertion depth of the device within the body at the proximal end of the device in addition to confirming the placement of the distal end of the device relative to tissue with fluoroscopic imaging.
With respect to the functional requirements set forth in the claim with respect to each of the leading and trailing edges and the lumen of the dilator, the Examiner notes that the dilator is recited within a functional recitation prescribed to the puncture device (“the puncture device is configured to be received in a lumen of a dilator … the dilator comprising an elongate shaft defining a proximal end and a tapered distal end”). It is well established that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the Examiner is of the position that the functionally recited dilator in claim 1 fails to structurally distinguish the claimed puncture device including the flexible wire from the prior art combination of Davies and Cosman. The combined puncture of Davies and Cosman is readily configured to be inserted through the lumen of a suitable dilator, with such displayed by the disclosure of the guidewire 200 being capable of advancing through the sheath 300 and dilator 100 in Davies.
Accordingly, the Examiner is of then of the position that the proposed combination of Davies in view of Cosman above would then result in a puncture device that is functionally capable of having the claimed features of:
a) wherein then the puncture device is received in the lumen of the dilator and the leading edge is aligned with a predetermined distance from a hub of the dilator, the atraumatic tip does not protrude from the distal end of the dilator, and
b) wherein when the puncture device is received in the lumen of the dilator and the trailing edge is aligned with a predetermined distance from the hub of the dilator, the atraumatic distal tip protrudes from the distal end of the dilator.
To reiterate, the Examiner finds that the combined puncture device of Davies and Cosman is structurally and functionally capable of providing the above claimed features in a) and b) above in combination with a dilator as recited in the claim. The functionally claimed dilator fails to define any other structural features including the overall length of the lumen from the proximal-to-distal end that would otherwise structurally define the recited dilator from a suitable dilator in the prior art.
Regarding claim 2, Davies further provides that the puncture device comprises a straight portion distal to the curved distal portion (see figure 5D with the straight portion distal to the curve portion that is proximal to 210).
Regarding claim 3, Davies provides that the curved distal portion is in a J-shape (see at least [0128], [0129] and [0153]).
Regarding claim 4, Davies provides that he curved distal portion is in a pig-tail shape (see at least [0099] and [0145]).
Regarding claim 5, Davies provides that the distal tip of the puncture device is configured to deliver radiofrequency energy to the target tissue (see [0084]).
Regarding claim 8, in view of the combination with Cosman above, the combination provides that for a second proximal marker spaced from the first proximal marker (a second marker of the plurality of marks at 1413S).
Regarding claim 9, in view of the rejections in claims 1 and 8 above, the second proximal marker would correspond to a second relative position of the distal tip of the puncture device and distal end of the dilator (given that each of the various markers 1413S would readily indicate different relative positions relative to a respective dilator).
Regarding claim 10, in view of the rejections of claims 1, 8 and 9 above, the combined puncture device provides for the plurality of proximal makers to comprise a third proximal marker corresponding to a third position of the puncture device relative to the dilator (a third one of 1413S with each of the various markers 1413S readily indicating different relative positions relative to a respective dilator).
Regarding claim 12, in view of the rejections in claims 1 and 8 above, and further in view of the Examiner’s functional interpretation of the “dilator” set forth in claim 1, the Examiner is of the position that each of the first and second proximal markers (provided for by the plurality of 1413s) would correspond to a particular length of an suitable dilator.
Regarding claims 13 and 14, the Examiner notes that each claim requires additional limitations directed towards the functionally recited dilator in claim 1. As such, the Examiner is of the position, much like the interpretation taken in the rejection of claim 1 above, that the additional requirement of a radiopaque coil fails to structurally define the claimed puncture device over the combined puncture device of Davies and Cosman. For the sake of completeness, the Examiner is of the position that puncture device as in the rejection of claim 1 above would readily be capable of being utilized with a suitable dilator having a radiopaque marker in the form of a radiopaque coil.
Regarding claim 17, Davies provides that the diameter of the puncture device is constant at, and adjacent to, the first proximal maker (see figure 5F with the constant diameter section at 224; see also [0114]).
Regarding claim 18, in view of the combination in the rejection of claim 1 above, the Examiner is of the position that the manner in forming the first proximal marker set forth in the claim is a product-by-process limitation. As set forth in MPEP 2113, a product-by-process limitation in a claim are not limited to the manipulations as set forth in the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to application to show an unobvious different.
It is the Examiner’s position in view of the reasoning set forth above that the first proximal marker as in the combination of Davies and Cosman in the rejection of claim 1 would result in a substantially similar structure as implied by the process steps set forth in claim 18.
Regarding claim 21, in view of the rejection in claim 1 above, the Examiner is of the position that the disclose of Cosman readily contemplates utilizing 1 cm intervals between the various depth markers to provide an indication of the user of the relative position of the puncture device to an elongate member. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a 1 cm spacing as in Cosman between the plurality of proximal markers of the combined device with Davies to provide for an exemplary manner to, again, provide an indication of the user of the relative position of the puncture device to the dilator. The resultant spacing would provide for the device to have a predetermined distance of between about 0 cm and about 5 cm as required in the claim to a suitable dilator having a hub thereon.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US Pat. Pub. 2016/0175009 A1) further in view of Cosman et al. (US Pat. Pub. 2017/0049503 A1) as applied to claim 1 above, and further in view of Uchida et al. (US Pat. No. 7,449,019 B2).
Regarding claim 16, Davies further provides that the distal tip of the puncture device comprises an exposed active tip for delivering radiofrequency energy to the target tissue (see [0104] providing that the tip 208 is an active tip for delivering energy to tissue; see also claim 75 providing that the energy is in the radiofrequency range). Neither Davies nor Cosman specifically contemplate that the puncture device comprises a layer of insulation overtop of an outer surface of the proximal marker. Uchida provides for an similar puncture device as that of Davies and specifically provides for the use of a transparent coating over a mark on a shaft to provide for visualization of the shaft (See col. 15; 28-53). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a transparent insulation over the top of the at least one proximal marker provided by the combination in the rejection of claim 1 above in view of the teaching of Uchida. Such provides for a known alternative in the art that would function equally as well as other manner of marking to provide for depth/motion indication to the user at the proximal end of the device.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US Pat. Pub. 2016/0175009 A1) further in view of Cosman et al. (US Pat. Pub. 2017/0049503 A1) as applied to claim 1 above, and further in view of Conquergood et al. (US Pat. Pub. 2006/0206131 A1).
Regarding claims 19 and 20, while the disclosure of Cosman provides for the first proximal marker to be in the form of the marks at 1411D and S, Cosman fails to specifically provide that the first proximal marker is a different color than the puncture device (claim 19) or the first proximal maker is configured to provide visual and tactile feedback (claim 20).
Conquergood provides for a similar device as that of Davies and Cosman and further teaches for the use of a proximal marker that is colors differently from the device it is located on, and to form both a visual and tactile indicator (see [0057] – [0058]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have used a differently-colored and/or visual distinct tactile markers as in Conquergood as one or more of the markings 1411S/D in the combination with Cosman. Conquergood readily contemplates that various manners of forming depth-indicating markers are known and interchangeable in the art with such allowing for readily visualization by the user on the proximal end of the device.
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Davies and Cosman on pages 6-7 of the Remarks. Therein, Applicant contends that amended language set forth in claim 1 including the now-recited dilator are “positively-recited limitations [that] are not present in the proposed combination of Davies and Cosman.” Applicant then further submits that the combination of Davies and Cosman is deficient in providing for the various functional/structural requirements of the first proximal marker relative to the claimed dilator.
This is not persuasive. The Examiner must respectfully disagree that Applicant’s amendments to claim 1 has positively set forth the claimed dilator as a required structural feature of the puncture device. Rather, the Examiner has held in the rejection of claim 1 above that the dilator is recited within a functional recitation prescribed to the puncture device. Such is in the claim language of “the puncture device is configured to be received in a lumen of a dilator … the dilator comprising an elongate shaft defining a proximal end and a tapered distal end”. Said differently, the dilator and its associated limitation in claim 1 only appear in terms of structure that the puncture device is capable/configured to be used with and is not a positively required feature of the puncture device.
As such, the Examiner maintains the position proffered in the rejection of claim 1 above that the functionally recited dilator in claim 1 fails to structurally distinguish the claimed puncture device including the flexible wire from the prior art combination of Davies and Cosman given that the puncture device of Davies and Cosman is readily configured to be inserted through the lumen of a suitable dilator. Further, the combined puncture device of Davies and Cosman is structurally and functionally capable of providing for each of the claimed features relative to the first proximal marker, the markers leading and trailing edges, and relative position of the marker, the edges and the puncture device relative to a suitable dilator. Again, the functionally claimed dilator fails to define any other structural features such as the overall length of the lumen from the proximal-to-distal end that would otherwise define the claimed dilator from some suitable dilator in the prior art.
Applicant further argues on page 7 that “one of ordinary skill would not look to Cosman in combination with Davies in order to practice the invention of claim 1” and specifically contends that Cosman “does not relate to puncturing a septum of a heart using a flexible wire” and “does not appear to mention a dilator at all, much less as claimed”. This is not persuasive.
The Examiner must reiterate, as a preliminary matter, that the dilator presently set forth in claim 1 is not being interpreted as a positively required structural feature of the claimed puncture device, but rather as a functionally claimed feature that the claimed puncture device only need be capable of use with. Thus, while applicant may argue that there is no teaching, suggestion, or motivation to combine the Davies and Cosman references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner finds that the combination of the proximal marker(s) of Cosman with the device of Davies would provide for ready visual monitoring insertion depth of the device within the body at the proximal end of the device in addition to confirming the placement of the distal end of the device relative to tissue with fluoroscopic imaging.
Therefore, it is in view of at least the reasoning set forth in the rejections and remarks above that the Examiner finds that each of the pending rejections under 35 U.S.C. 103 remain tenable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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