DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
Currently, claims 1-5, 8-10, 12-14 and 16-21 are pending with claims 6, 7, 11 and 15 cancelled, claim 21 newly added, and claims 1, 8-10, 12, 16-18 and 20 amended. The following is a complete response to the January 28, 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 § 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 8-10 and 12 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.
Regarding claim 8, the claim recites therein that “the at least one proximal marker comprised a plurality of proximal markers”. Parent claim 1, as amended, requires that “the at least one proximal marker comprises a leading edge and a trailing edge” and then recites additional limitations regarding the location of the atraumatic distal tip relative to the distal end of the supporting member for each of the leading edge and trailing edge.
It is the Examiner’s position that the scope of claim 8 is indefinite since it is, at most, unclear if each of the plurality of the proximal markers required by the claim each include a leading edge and trailing edge as required in claim 1. To this end, the Examiner is unclear what structural requirements of each of the plurality of proximal markers would be required if each proximal marker was required to have a leading edge and a trailing edge in order to meet the requirements of claim 1 regarding the atraumatic distal tip and the distal end of the supporting member.
Thus, it is for at least the reasoning set forth above that the Examiner finds that the scope of claim 8 is indefinite. Claims 9-10 and 12 are rejected due to their dependency on claim 8. Appropriate correction is required.
Regarding each of claims 9 and 10, the additional limitations set forth therein render the scope of each claim as indefinite. The Examiner is of the position, much like the rationale set forth in the rejection of claim 8 under 35 U.S.C. 112(b) above, that the additional features set forth in each claim fail to be related to the at least one proximal marker of claim 1, the at least one marker’s leading and trailing edges, and the relative locations of the atraumatic distal tip and the distal end of the supporting member. Appropriate correction and clarification is required.
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 use with a supporting member having a proximal end, a distal end, and a lumen therebetween (for use with the sheath 300 and dilator 100), 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 the supporting member so as to enable advancement and withdrawal of the supporting member overtop of the puncture device (via the guidewire 200 being capable of advancing through the sheath 300 and dilator 100), and
While Davies provides for the use of the radiopaque coil at the distal end of the device, Davies fails to provide for the claimed at least one 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 then the puncture device is received in the lumen of the supporting member and the leading edge is aligned with a predetermined distance from a hub of the support member, the atraumatic tip does not protrude from the distal end of the supporting member, and
wherein when the puncture device is received in the lumen of the supporting member and the trailing edge is aligned with a predetermined distance from the hub of the supporting member, the atraumatic distal tip protrudes from the distal end of the supporting member.
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 a supporting 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 visually monitoring insertion depth and device status at the proximal end of the device and without necessitating 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 supporting member, the Examiner notes that the supporting member having the proximal end, the distal end, and the lumen appears in the preamble of the claim. MPEP 2111.02 discusses the effect of the preamble including the manner in which the limitations set forth therein are to be interpreted. The Examiner is of the position that the claimed supporting member is being interpreted to a have a limiting effect in as much as the recited structure implies, with such being a member having a lumen, a proximal end and a distal end wherein the claimed puncture device need be capable of being inserted through such a supporting member. Further, the Examiner notes that the claimed supporting member has no specific implied length, diameter, shape, width, etc. associated with its inclusion.
Accordingly, the Examiner is 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 supporting member and the leading edge is aligned with a predetermined distance from a hub of the support member, the atraumatic tip does not protrude from the distal end of the supporting member, and
b) wherein when the puncture device is received in the lumen of the supporting member and the trailing edge is aligned with a predetermined distance from the hub of the supporting member, the atraumatic distal tip protrudes from the distal end of the supporting member.
In particular, the Examiner is of the position that recited features of the supporting member fail to structurally distinguish the claimed invention from the prior art combination of Davies and Cosman. Specifically, the Examiner finds that the combined puncture device is structurally and functionally capable of providing the above claimed features in a) and b) above in combination with a supporting member as recited in the claim. Said differently, it is the Examiner’s position that the combined puncture device is functionally capable of being inserted through a suitable supporting member having the claimed lumen, proximal end and distal end. The claimed supporting member 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 supporting member from an arbitrary supporting member in the prior art. To this end, the Examiner further notes that Davis discloses a supporting member (at 300) and Cosman also discloses a supporting member as well (1400).
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 the at least one proximal maker comprises a plurality of proximal makers (a plurality of marks at 1413S).
Regarding claim 9, in view of the rejections in claims 1 and 8 above, each of the plurality proximal makers indicates a separate relative position of the distal tip of the puncture device and distal end of the supporting member (given that each of the various markers 1413S would readily indicate different relative positions relative to a respective supporting member).
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 first proximal marker corresponding to a first position of the puncture device relative to the supporting member (a first one of 1413S), a second proximal marker corresponding to a second position of the puncture device relative to the supporting member (a second one of 1413S), and a third proximal marker corresponding to a third position of the puncture device relative to the supporting member (a third one of 1413S).
Regarding claim 12, in view of the rejections in claims 1 and 8 above, and further in view of the direction in MPEP 2111.02 regarding the effect of the preamble in the interpretation of a claim, the Examiner is of the position that the plurality of the proximal markers provided for by the plurality of 1413s would correspond to a particular length of an arbitrary supporting member.
Regarding claims 13 and 14, the Examiner notes that each claim requires additional limitations directed towards the support member wherein the support member is recited within the preamble of the claim. 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 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 supporting member 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 at least one 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 at least one 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 at least one 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 the support 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 support member. 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 sufficient supporting member 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 at least one proximal marker to be in the form of the marks at 1411D and S, Cosman fails to specifically provide that the at least one proximal marker is a different color than the puncture device (claim 19) or the at least one 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 at least one 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 January 28, 2026 have been fully considered but they are not persuasive.
Applicant argues on pages 5-7 of the Remarks filed January 28, 2026 with respect to the rejection of claim 1 under 35 U.S.C. 103 an unpatentable over the combination of Davies in view of Cosman. Applicant alleges on page 6, with respect to the amended language set forth in claim 1, that “one of ordinary skill in the art would not look to Cosman in combination with Davies in order to practice the invention of claim 1” and that the relied upon teachings in Cosman only appear “in passing in a single paragraph”. Applicant continues on page 6 in arguing that Cosman’s intended manner of use is not the same as the puncturing the septum of the heart.
Applicant also alleges that the prior action “appears to acknowledged that Cosman does not specifically disclose the previously presented claim limitation regarding the trailing edge corresponding to a trailing edge position at which the atraumatic tip protrudes from the distal end of the supporting member” and continues that the “there is nothing in Cosman that would indicate where the hatched insulation 1411S and/or depth markers 1411D of Cosman would be disposed on the modified wire of Davies”. To this end, Applicant further points to the amended language in claim 1 and alleges that “Cosman is completely silent …” as the claimed proximal marker having each of a leading edge and a trailing edge as presently recited in the claim.
This is not persuasive.
First, while Applicant appears to allege that the Examiner’s combination of Davies and Cosman relies on impermissible hindsight to arrive at the invention set forth in claim 1, the Examiner must note that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, the Examiner recognizes that the Cosman disclosure, Cosman’s guideblock, and the plurality of markers contained on each of the probes is not limited to solely the treatment of spinal nerves. Rather, Cosman contemplates the includes of a visible marker on the probe (see at least [0016]-[0018]) as well as for treatment in other locations and for other treatments (see [0022]). Thus, while Applicant contends that there is no reason to look to the teaching of Cosman and that doing so would require impermissible hindsight, the Examiner finds that the disclosure of Cosman is particularly relevant to the disclosure of Davies in that it teaches a visibly identifiable distal marker and then further including a plurality of proximal markers for placing the device within the body.
Turning to the amended subject matter of independent claim 1, the Examiner notes that the claim 1 presently requires the following claim language with respect to the leading and trailing edges:
at least one 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 then the puncture device is received in the lumen of the supporting member and the leading edge is aligned with a predetermined distance from a hub of the support member, the atraumatic tip does not protrude from the distal end of the supporting member, and
wherein when the puncture device is received in the lumen of the supporting member and the trailing edge is aligned with a predetermined distance from the hub of the supporting member, the atraumatic distal tip protrudes from the distal end of the supporting member
The Examiner further notes that the claimed supporting member is introduced in the preamble of claim 1 in the language of “[a] puncture device for use with a supporting member having a proximal end, a distal end, and a lumen therebetween”.
The Examiner has updated the rejection of claim 1 in the Action above to reflect the present interpretation of the claim language based on the amendments filed in the instant response. The Examiner reiterates the position, in light of the direction in at least MPEP 2111.02, that the claimed supporting member is being interpreted to a have a limiting effect in as much as the recited structure implies, with such being taken as a member having a lumen, a proximal end and a distal end wherein the claimed puncture device need be capable of being inserted through such a supporting member. The Examiner further maintains that the proposed combination of Davies in view of Cosman in the rejection of claim 1 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 supporting member and the leading edge is aligned with a predetermined distance from a hub of the support member, the atraumatic tip does not protrude from the distal end of the supporting member, and
b) wherein when the puncture device is received in the lumen of the supporting member and the trailing edge is aligned with a predetermined distance from the hub of the supporting member, the atraumatic distal tip protrudes from the distal end of the supporting member.
In particular, the Examiner is of the position that recited features of the supporting member fail to structurally distinguish the claimed invention from the prior art combination of Davies and Cosman. Specifically, the Examiner finds that the combined puncture device is structurally and functionally capable of providing the above claimed features in a) and b) above in combination with a supporting member as recited in the claim. Said differently, it is the Examiner’s position that the combined puncture device is functionally capable of being inserted through a suitable supporting member having the claimed lumen, proximal end and distal end. The claimed supporting member 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 supporting member from an arbitrary supporting member in the prior art.
It is, therefore, in view of at least the reasoning set forth in the rejections and Remarks above that the Examiner finds that the proffered rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Davies in view of Cosman remains tenable. The Examiner further maintains that the respective rejections for each of the dependent claims under 35 U.S.C. 103 utilizing the combination of Davies in view of Cosman as their basis are tenable as well.
Conclusion
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794