DETAILED ACTION
Currently, claims 1 and 4-14 are being examined, while claims 15-20 remain withdrawn.
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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 15, 2026 has been entered.
Claim Rejections - 35 USC § 102
Claim(s) 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balbierz, U.S. 6,770,070 (hereinafter Balbierz).
Regarding claim 12, Balbierz discloses (note fig. 2; col. 8, line 66 and col. 11, line 56) a system of medical devices, comprising: a puncture device (inner component in fig. 2) extending from a puncture device proximal end to a puncture device distal end, wherein the puncture device necessarily comprises a first radiolucent section (composed of polycarbonate – note col. 11, line 36) between a ‘radiopaque marker’ (proximal ‘18’ in fig. 9A - note col. 15, line 53) and a radiofrequency puncture electrode (distal ‘18’ in fig. 9A) at the puncture device distal end, and wherein the radiofrequency puncture electrode is radiopaque (note col. 15, line 53); and an introducer (outer component in fig. 2) extending between an introducer proximal end and an introducer distal end, wherein the introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end, and wherein the introducer comprises an introducer shaft, and the introducer shaft comprises a polymeric sheathing (12’) and a radiopaque ‘tube’ (11) necessarily ‘embedded’ in the polymeric sheathing (note col. 11, line 56); wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncture device in a puncture position in which the radiofrequency puncture electrode is proud of the introducer distal end and in which at least a portion of the radiopaque marker is proud of the radiopaque tube; and wherein when the puncture device is in the puncture position, the radiofrequency puncture electrode is spaced distally from the radiopaque tube. It should be noted that a 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.
Regarding claim 13, Balbierz discloses (see above) a system wherein the radiopaque tube necessarily ‘extends to’ the introducer distal end (also note col. 8, line 66 and col. 11, line 56).
Regarding claim 14, Balbierz discloses (see above) a system wherein the polymeric sheathing extends to the introducer distal end, and the radiopaque tube extends to a position shy of the introducer distal end (see fig. 2), which necessarily provides a second radiolucent section (composed of polyethylene or PEBAX – note col. 10, line 17) at the introducer distal end.
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.
Claim(s) 1 and 4-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, U.S. 2019/0231424 (hereinafter Davies) in view of Balbierz.
Regarding claims 1, 10, and 11, Davies discloses (note figs. 2 and 5; paragraphs 75-76) a system of medical devices, comprising: a puncture device (device in fig. 2) extending from a puncture device proximal end to a puncture device distal end, wherein the puncture device necessarily comprises a first radiolucent section (composed of PEBAX, PEEK, or PTFE – note paragraph 60), a core wire (1/18) and an electrically insulative material (7) on the core wire, and a radiofrequency puncture electrode (19) comprising an electrode puck (2) received on the core wire and a domed electrode tip (16) adjacent the electrode puck at the puncture device distal end, and wherein the radiofrequency puncture electrode is radiopaque (note paragraphs 75 and 78) and distally adjacent to the first radiolucent section; and an introducer (‘50/52’ – note figs. 23A-B) extending between an introducer proximal end and an introducer distal end, wherein the introducer has a lumen extending therethrough from the introducer proximal end to the introducer distal end, and wherein the introducer comprises at least a first radiopaque marker (note paragraphs 12 and 137) associated with the introducer distal end; wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncture device in a puncture position. However, Davies fails to explicitly disclose an introducer comprising a second radiolucent section connected to a first radiopaque marker distal end (at the introducer distal end), wherein the radiopaque marker comprises a band in the introducer shaft that is positioned shy of the introducer distal end. Balbierz teaches a relevant system comprising an introducer (outer component in fig. 2) having a radiolucent section (composed of polyethylene or PEBAX – note col. 10, line 17) connected to a first radiopaque marker (11) distal end (at the introducer distal end), wherein the radiopaque marker comprises a band in the introducer shaft that is positioned shy of the introducer distal end. It is well known in the art that any of a variety of different introducer materials could be used interchangeably, as can be seen by the different introducer materials listed in Balbierz (note col. 10, line 17). Furthermore, it is well known in the art that any of a variety of different radiopaque marker configurations could be used interchangeably, as can be seen by the different marker locations/types described in Balbierz (note col. 8, line 66; col. 11, line 56). Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the apparatus of Davies (in view of Balbierz) to comprise an introducer having a second radiolucent section connected to a first radiopaque marker distal end, wherein the radiopaque marker comprises a band in the introducer shaft that is positioned shy of the introducer distal end. This is because this modification would have merely comprised a simple substitution with a known introducer material and marker configuration in order to produce a predictable (and desirable) result (see MPEP 2143). Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Finally, it should be noted that a 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.
Regarding claim 4, Davies discloses (see above) a system wherein the puncture device further comprises a second radiopaque marker (see ‘5’ in fig. 4).
Regarding claim 5, Davies discloses (see above) a system wherein the second radiopaque marker comprises radiopaque coil (note paragraph 82) ‘embedded’ in the electrically insulative material (7).
Regarding claim 6, Davies discloses (see above) a system wherein the radiopaque coil is necessarily positioned ‘adjacent’ and proximally of the electrode puck (see fig. 4).
Regarding claim 7, Davies discloses (see above) a system wherein the radiopaque coil is spaced proximally from the electrode puck (see fig. 4) to necessarily provide the first radiolucent section.
Regarding claim 8, Davies in view of Balbierz teaches (see above) a system wherein the first radiopaque marker is necessarily ‘at’ the introducer distal end.
Regarding claim 9, Davies in view of Balbierz teaches (see above) a system wherein the first radiopaque marker is necessarily ‘proximate’ the introducer distal end.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Regarding Applicant’s arguments concerning the rejection of claims 12-14 in view of Balbierz, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met by Balbierz as they are currently written, due to the breadth of limitations such as “radiopaque marker,” “sheathing,” and ‘embedded tube’. While Applicant’s arguments have been noted, Examiner asserts that these limitations do not convey significant structure, and that the current language would not preclude Examiner’s current interpretation. In response to Applicant’s argument that the radiopaque marker of Balbierz (as mapped by Examiner) does not meet the claim, a 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. Furthermore, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., ‘laminated construction’ and ‘passive fiducial positional marker’) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to Applicant’s argument that the embedded tube of Balbierz (as mapped by Examiner) does not meet the claim, Examiner respectfully disagrees. More specifically, Examiner maintains that the ‘tubular’ radiopaque marker of Balbierz could necessarily be described in this manner, since it has been disclosed as being “integrated” with the sheathing (see col. 11, line 55 as noted previously).
Regarding Applicant’s arguments concerning the rejection of amended claim 1 in view of Davies in combination with Balbierz, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met by this combination as they are currently written, due to the breadth of limitations such as “radiolucent section,” “at,” and ‘distal end’. While Applicant’s arguments have been noted, Examiner asserts that these limitations do not convey significant structure, and that the current language would not preclude Examiner’s current interpretation. Furthermore, Examiner asserts that Balbierz has merely been used for its teaching of the introducer material and the introducer/radiopaque marker configuration, and that the modification of Davies in view of Balbierz would not affect the puncture device/electrodes of Davies. In other words, Examiner maintains that this combination of references would still meet the claims, since it would teach the system of Davies (including the electrode configuration) with the introducer material and the introducer/radiopaque marker configuration taught by Balbierz. In response to Applicant’s argument that the modified system does not meet the claimed spatial alignment configuration, a 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. More specifically, Examiner asserts that this modified system would be capable of assuming the claimed spatial alignment configuration (e.g., when puncture electrode tip extends slightly beyond the introducer tip), due to the breadth of its limitations and their movable nature.
Regarding Applicant’s arguments concerning the rejection of claim 7, Examiner respectfully disagrees. More specifically, Examiner maintains that the claim is still met by the cited art (Davies – note fig. 4), as can be seen above. While Examiner acknowledges the usage of the phrase “as best understood by Examiner” in the Final Office Action, it should be noted that this language is no longer in use since it was merely a result of the 112 issue affecting the clarity of the claim language at that time.
In view of this, Examiner maintains that the claims are still met by the cited references, as can be seen above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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