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 .
Claim Objections
Claims 8, 11, and 15- 18 are objected to because of the following informalities:
Claim 8, Line 2 states “upon the disengagement surface”, it is suggested to change this to “upon the angled disengagement surface”.
Claim 11, Line 1 states “the angled disengagement and”, it is suggested to change this to “the angled disengagement surface and”.
Claim 15, Line 5 states “ a dilator”, it is suggested to change this to “the dilator”.
Claims 16- 18 are objected to for being dependent on or from objected claim 15.
Appropriate correction is required.
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 5 and 6 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 5 recites the limitation "the axial lock feature" in Line 1. There is insufficient antecedent basis for this limitation in the claim. The limitation “an axial lock feature” is established within claim 4, not claim 1 from which claim 5 depends. Therefore for purposes of examination, this limitation is herein considered “an axial lock feature”.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnett et al. (WO 2019/215623).
Regarding claim 19, Arnett (Arnett et al.) teaches a dilator hub (222)(Figs. 1A- 1C, 9A(iii)) for use with a dilator (220)(abstract and Paragraph 00159), the dilator hub comprising:
A rotational coupling structure (400) for coupling to a sheath hub (122) so as to inhibit relative rotation between the dilator and a sheath (120)(Paragraphs 00156- 00159); and
An axial lock feature (coupling mechanism 300) configured to create a resistance to an axial disengagement force (Paragraph 00100), such that the dilator hub is secured axially within the sheath hub (Paragraphs 0089, 00156, 00159).
Regarding claim 20, Arnett teaches the dilator hub as discussed above.
Arnett further teaches wherein the rotational coupling structure includes a plurality of tapered surfaces (guide portions 202)(Paragraph 00159), and the axial lock feature includes annular protrusion (288) configured to mate with a shoulder in the sheath hub (Paragraphs 0094 and 00140)(see annotated Fig. 1A below).
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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 (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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al. (WO 2019/215623) in view of Urbanski et al. (US 2020/0060710).
Regarding claim 1, Arnett (Arnett et al.) teaches a dilator (220)(Figs. 1A- 1B and 9A(iii)) for facilitating access to a patient’s heart (abstract and Paragraph 0057) and for coupling with a sheath (120) including a sheath hub (122)(abstract and Paragraph 0095), the dilator comprising:
A dilator shaft defining a lumen adapted to receive and support a puncturing device (Paragraphs 0057 and 0091), the dilator shaft includes a proximal portion for manipulation by a user (see annotated Fig. 1A below)(Paragraph 00156); and
A dilator hub (222) coupled to the proximal portion of the dilator shaft (see annotated Fig. 1A below), the dilator hub including a rotational coupling structure (400) for coupling to the sheath hub so as to inhibit relative rotation between the dilator and the sheath, wherein the dilator hub is configured to self-align into proper engagement with the sheath hub (Paragraphs 00156- 00159).
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Arnett does not teach a tapered distal portion for placement in or near the heart.
Urbanski (Urbanski et al.) teaches a dilator (30A)(Figs. 1A- 2G) for facilitating access to a patient’s heart (abstract and Paragraphs 0023 and 0066) and for coupling with a sheath (20) including a sheath hub (21), the dilator comprising a dilator hub (51) and a dilator shaft (32) defining a lumen adapted to receive and support a puncturing device (114)(Paragraph 0083, see Figs. 2D- 2G), the dilator shaft includes a proximal portion for manipulation by a user (Paragraph 0094) and a tapered distal portion for placement in or near the heart (see Fig. 1B and 2E)(Paragraph 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dilator as taught by Arnett to have a tapered distal portion for placement in or near the heart as taught by Urbanski, since Urbanski teaches that the tip provides “a substantially atraumatic distal tip” and “ease of trackability and crossing” (Paragraph 0115).
Regarding claim 2, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the dilator hub is directly coupled to the dilator shaft (see annotated Fig. 1A below).
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Regarding claim 3, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett does not teach wherein the sheath is a therapy sheath and wherein the puncturing device is an RF puncturing device.
Urbanski (Urbanski et al.) teaches a dilator (30A)(Figs. 1A- 2G) for facilitating access to a patient’s heart (abstract and Paragraphs 0023 and 0066) and for coupling with a sheath (20) including a sheath hub (21), the dilator comprising a dilator hub (51) and a dilator shaft (32) defining a lumen adapted to receive and support a puncturing device (10, 114)(Paragraph 0083, see Figs. 2D- 2G), the dilator shaft includes a proximal portion for manipulation by a user (Paragraph 0094) and a tapered distal portion for placement in or near the heart (see Fig. 1B and 2E)(Paragraph 0115). Urbanski further teaches wherein the puncturing device is an RF puncturing device (Paragraphs 0073, 0075 and 0080) and wherein the sheath is a therapy sheath (As Urbanski teaches in Paragraphs 0050, 0084, and 0125, that the sheath is used during a treatment of tissue and can remain after the puncturing needle is inserted, then the sheath is a therapy sheath.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sheath and the puncturing device as taught by Arnett to be the therapy sheath and RF puncturing device as taught by Urbanski, since Arnett teaches that the sheath and puncturing device can be any sheath or puncturing device used within a medical procedure (abstract and Paragraph 0057), and Urbanski teaches that the sheath and puncturing device are used during a medical procedure (Paragraphs 0023 and 0066).
Regarding claim 4, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches the dilator further comprising an axial lock feature (coupling mechanism 300) configured to create a resistance to an axial disengagement force (Paragraph 00100), such that the dilator hub is secured axially within the sheath hub (Paragraphs 0089, 00156, 00159).
Regarding claims 5 and 6, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches the dilator further comprising an axial lock feature (coupling mechanism 300), wherein the axial lock feature includes a protrusion (228) adapted to mate with a shoulder and wherein the protrusion is annular (Paragraphs 0094 and 00140).
Regarding claim 7, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the dilator hub includes an angled disengagement surface (guide portions 202) adapted to contact a mating surface (406) on the sheath hub (Paragraph 00159).
Regarding claim 8, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein upon rotation of the dilator hub, the mating surface generates an axial disengagement force upon the angled displacement surface (Paragraphs 00159 and 00160).
Regarding claim 9, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein when the disengagement force becomes high enough to overcome an axial lock, relative motion in both axial and rotation directions occurs (Paragraphs 00159 and 00160).
Regarding claim 10, Arnett and Urbanski make obvious the dilator as discussed above.
In an alternate interpretation of the angled disengagement surface and the mating surface where it is only one surface of the guide portions 202 and one surface of the mating surface 406, Arnett further teaches wherein the angled disengagement surface and the mating surface have a different angle (see annotated Fig. 1A below).
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Regarding claim 11, Arnett and Urbanski make obvious the dilator as discussed above.
In an alternate interpretation of the angled disengagement surface and the mating surface where it is only one surface of the guide portions 202 and one surface of the mating surface 406, Arnett further teaches wherein the angled disengagement and the mating surface have a same angle (see annotated Fig. 1A below)(Paragraph 00159).
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Regarding claims 12 and 13, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the rotation coupling structure includes a plurality of tapered surfaces (guide portions 202) and wherein the sheath hub includes surfaces (406) corresponding to the plurality of tapered surfaces (Paragraph 00159).
Regarding claim 14, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the sheath hub has a tapered or funnel shape opening (Paragraph 00159).
Regarding claim 15, Arnett (Arnett et al.) teaches a system (Figs. 1A- 1B and 9A(iii)) for facilitating access to a patient’s heart (abstract and Paragraph 0057), the system comprising:
A sheath (120) having a sheath body defining a lumen adapted to receive a dilator, the sheath body including a proximal portion and a distal portion (see annotated Fig. 1A below);
A sheath hub (122) coupled to the proximal portion of the sheath (Paragraphs 0088 and 0089);
The dilator having a dilator shaft defining a lumen adapted to receive and support a puncturing device (Paragraphs 0057 and 0091), the dilator shaft including a proximal portion for manipulation by a user (see annotated Fig. 1A below)( Paragraph 00156);
A dilator hub (222) coupled to the proximal portion of the dilator shaft (see annotated Fig. 1A below), the dilator hub comprising a rotational coupling structure (400) for coupling to the sheath hub so as to inhibit relative rotation between the dilator and the sheath (Paragraphs 00156- 00159) and an axial lock feature (coupling mechanism 300) configured to create a resistance to an axial disengagement force (Paragraph 00100), such that the dilator hub is secured axially within the sheath hub (Paragraphs 0089, 00156, 00159).
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Arnett does not teach a tapered distal portion for placement in or near the heart.
Urbanski (Urbanski et al.) teaches a dilator (30A)(Figs. 1A- 2G) for facilitating access to a patient’s heart (abstract and Paragraphs 0023 and 0066) and for coupling with a sheath (20) including a sheath hub (21), the dilator comprising a dilator hub (51) and a dilator shaft (32) defining a lumen adapted to receive and support a puncturing device (114)(Paragraph 0083, see Figs. 2D- 2G), the dilator shaft includes a proximal portion for manipulation by a user (Paragraph 0094) and a tapered distal portion for placement in or near the heart (see Fig. 1B and 2E)(Paragraph 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dilator as taught by Arnett to have a tapered distal portion for placement in or near the heart as taught by Urbanski, since Urbanski teaches that the tip provides “a substantially atraumatic distal tip” and “ease of trackability and crossing” (Paragraph 0115).
Regarding claim 16, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the sheath hub includes an opening having a tapered mating surface (406), and the dilator hub includes an angled disengagement surface (guide portions 202) adapted to contact the tapered mating surface (Paragraph 00159).
Regarding claim 17, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the rotational coupling structure includes a plurality of tapered surfaces (guide portions 202)(Paragraph 00159).
Regarding claim 18, Arnett and Urbanski make obvious the dilator as discussed above.
Arnett further teaches wherein the axial lock feature includes an annular protrusion (228) adapted to mate with a shoulder in the sheath hub (Paragraphs 0094 and 00140).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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