DETAILED ACTION
Currently, claims 1 and 3-14 are being examined, while claims 15-20 remain withdrawn.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.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 11, “maker” should be replaced with -marker-; In line 17, “inducer” should be replaced with -introducer-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-7 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites that the “puncture device further comprises a second radiopaque marker”. Due to the prior claim language reciting ‘an introducer comprising a second radiolucent section connected to a first radiopaque marker distal end at the introducer distal end,’ it appears as though multiple embodiments from Applicant’s disclosure are being combined (note Applicant’s figs. 12 and 16). However, there is insufficient support for this combination of embodiments in Applicant’s disclosure.
Claim 14 recites that the system comprises a “second radiolucent section at the introducer distal end”. Due to the prior claim language reciting ‘a puncture device comprising a first radiolucent section between a radiopaque marker and a radiopaque puncture electrode,’ it appears as though multiple embodiments from Applicant’s disclosure are being combined (note Applicant’s figs. 16 and 12). However, there is insufficient support for this combination of embodiments in Applicant’s disclosure.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 7 and 11 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.
Claim 7 recites the limitation "the radiolucent section" in line 2. The antecedent basis for this limitation is confusing, since it is unclear which “radiolucent section” is being referred to.
Claim 11 recites the limitation "a radiolucent section" in line 2. The antecedent basis for this limitation is confusing, since it is unclear how/whether it is related to the previously-recited “radiolucent sections”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, and 8-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by the following references:
U.S. 2021/0137584 (hereinafter Urbanski).
U.S. 2024/0032991 (hereinafter Urbanski-2).
U.S. 2021/0068892 (hereinafter Urbanski-3).
The applied references have some common inventors with the instant application (but a different inventive entity). Based upon the earlier effectively filed date of the references, they constitute prior art under 35 U.S.C. 102(a)(2). These rejections under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the references was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the references and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1, 3-6, and 8-11, Urbanski discloses (note figs. 3 and 36) a system comprising the claimed limitations, including a first/inner radiolucent section (composed of PTFE – note paragraph 66) and a second/outer radiolucent section (composed of polyethylene – note paragraphs 79 and 91).
Regarding claims 1, 3-6, and 8-11, Urbanski-2 discloses (note figs. 3 and 36) a system comprising the claimed limitations, including a first/inner radiolucent section (composed of PTFE – note paragraph 66) and a second/outer radiolucent section (composed of polyethylene – note paragraphs 79 and 91).
Regarding claims 1, 3-6, and 8-11, Urbanski-3 discloses (note figs. 3, 12, and 30A-C) a system comprising the claimed limitations, including a first/inner radiolucent section (composed of PTFE – note paragraph 77) and a second/outer radiolucent section (composed of HDPE – note paragraphs 92 and 102).
Claim(s) 1 and 8-14 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 1, 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) and a radiofrequency puncture electrode (‘18’ – note figs. 9A-C) distally adjacent to the first radiolucent section 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 necessarily comprises at least a first radiopaque marker (11) and a second radiolucent section (composed of polyethylene or PEBAX – note col. 10, line 17) connected to a first radiopaque marker distal end at 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 in which the radiofrequency puncture electrode is proud of the second radiolucent section at the introducer distal end and in which at least a portion of the first radiolucent section is proud of the first radiopaque marker, is proximal to the introducer distal end, and is at least partially aligned with the second radiolucent section; and wherein when the puncture device is in the puncture position, the radiofrequency puncture electrode is spaced distally from the first radiopaque marker. 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 8, Balbierz discloses (see above) a system wherein the first radiopaque marker is necessarily ‘at’ the introducer ‘distal end’ (see fig. 2).
Regarding claim 9, Balbierz discloses (see above) a system wherein the first radiopaque marker is necessarily ‘proximate’ the introducer ‘distal end’ (see fig. 2).
Regarding claim 10, Balbierz discloses (see above) a system wherein the introducer comprises an introducer shaft, and the first radiopaque marker comprises a ‘band’ in the introducer shaft (see fig. 2).
Regarding claim 11, Balbierz discloses (see above, as best understood by Examiner) a system wherein the band is positioned shy of the introducer distal end (see fig. 2), which necessarily yields a radiolucent section (composed of polyethylene or PEBAX – note col. 10, line 17) at the introducer distal end.
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 3-10 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 and 10, 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) and a radiofrequency puncture electrode (19) distally adjacent to the first radiolucent section at the puncture device distal end, and wherein the radiofrequency puncture electrode is radiopaque (note paragraphs 75 and 78); 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. 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. 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. 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 3, Davies discloses (see above) a system wherein the puncture device comprises a core wire (1/18) and an electrically insulative material (7) on the core wire, and the radiofrequency puncture electrode comprises an electrode puck (2) received on the core wire and a domed electrode tip (16) adjacent the electrode puck.
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, as best understood by Examiner) a system wherein the radiopaque coil is spaced proximally from the electrode puck (see fig. 4) which necessarily provides the (corresponding) 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 Urbanski-1, Urbanski-2, and Urbanski-3, Examiner respectfully disagrees. More specifically (and upon further consideration), Examiner maintains that these references necessarily teach the claimed ‘radiolucent sections,’ due to the inherently radiolucent materials that they disclose (see above rejections).
In response to applicant's argument that Balbierz is used for a different purpose than the one that is claimed, 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. Despite Applicant’s arguments, Examiner asserts that this reference is analogous, and that it meets the required structural/material claim limitations (as they are currently written; see above) and would be capable of performing the claimed functional limitations. Therefore, Examiner maintains that the claims are still met by the cited references, as can be seen above.
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 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