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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 10/24/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 10/13/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Monroe (US 2002/0052641 A1).
Regarding claim 1, Monroe discloses a delivery system for an implant (88, catheter assembly, fig. 5), the delivery system comprising:
an elongate shaft (82, inner tube, fig. 5) having a distal end (see annotated fig. 5, below) and a proximal end (see annotated fig. 5, below)and including an implant retention area for retaining the implant (66, annular space, figs, 1-2);
a nose cone (86, distal tip, fig. 5); and
one or more angled projections configured to couple the nose cone to the distal end of the elongate shaft (84, barbs, fig. 6).
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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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Capes (US 2002/0007147 A1).
Regarding claim 2, Monroe fails to teach a retention ring. However, Capes discloses two tubular components connected together that includes a retention ring coupled to the elongate shaft (53, projection, fig. 5, ¶ [0038] states the projection can extend 360 degrees around the hub), and wherein the one or more angled projections (34, locking tabs, fig. 5) are configured to engage the retention ring to couple the nose cone to the distal end of the elongate shaft (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe to include a retention ring as taught by Capes since is it a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 3, Monroe fails to teach one or more angled projections extend inward from the inner surface of the nose cone. However, Capes further discloses the one or more angled projections extend inward from an inner surface of the nose cone (fig. 5) and are angled toward a distal end of the nose cone (see annotated fig. 5), the one or more angled projections each having a tip (see annotated fig. 5) configured to engage a proximal end of the retention ring to couple the nose cone to the distal end of the elongate shaft (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe to include the one or more angled projection extend inward from the inner surface of the nose cone as taught by Capes since is it a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Trocki (US 2001/0047153 A1).
Regarding claim 4, Monroe fails to teach a retention ring and a gap. However, Trocki discloses a connection between two tubular members that includes
a retention ring coupled to the elongate shaft (see annotated fig. 18, below) and having a distal end (see annotated fig. 18, below), a proximal end (see annotated fig. 18, below), and an outer surface (see annotated fig. 18, below),
wherein the one or more angled projections extend outward from the outer surface of the retention ring (30, tabs, fig. 18) and are angled toward the proximal end of the retention ring (fig. 18), and
wherein the nose cone further comprises a gap located along an inner surface of the nose cone (see annotated fig. 18, below) and configured to be engaged by the one or more angled projections to couple the nose cone to the distal end of the elongate shaft (fig. 19). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe to include a retention ring and a gap as taught by Trocki since is it a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Trocki as applied to claim 4 above, and further in view of Chiang (US 5,899,890 A).
Regarding claim 5, Monroe in view of Trocki fails to teach a support ring with an outer surface configured to contact the inner surface of the nose cone. However, Chiang discloses a tubular delivery device that includes a support ring located within a lumen of the nose cone (32, ring fig. 2) and having a proximal end (see annotated fig. 2, below), a distal end (see annotated fig. 2, below), and an outer surface configured to contact the inner surface of the nose cone (see annotated fig. 2, below), the distal end of the support ring forming a surface of the gap of the nose cone (see annotated fig. 18, below, Trocki). It would be obvious to place the marker ring at any location that would be expedient for the purpose of indicated a position of the device to the operator, including a position where the nose cone contacts the elongate shaft. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe and Trocki to include a support ring as taught by Chiang since it reduces the chance that the marker will be lost from the catheter (col 7 lines 16-36, Chiang) and it is combining prior art elements according to known methods to yield predictable result, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Hannon (US 2015/0352321 A1).
Regarding claim 6, Monroe fails to teach a retention sleeve. However, Hannon discloses a connection between two tubular members that includes the one or more angled projections are coupled to a retention sleeve (620, insert, fig. 28) configured to be positioned between the nose cone and the elongate shaft (fig. 27). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe to include a retention sleeve as taught by Hannon in order to prevent the catheter from being retracted or withdrawn from the tip (¶ [0110], Hannon).
Regarding claim 7, Monroe fails to teach angled projection extending from the inner and outer surfaces of the retention sleeve. However, Hannon further discloses the retention sleeve includes an outer surface (see annotated fig. 29, below) and an inner surface (see annotated fig. 29, below), and the one or more angled projections include one or more angled projections extending from the outer surface of the retention sleeve (see annotated fig. 29, below) and one or more angled projections extending from the inner surface of the retention sleeve (630, projection, fig. 29). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe to include angled projection extending from the inner and outer surfaces of the retention sleeve as taught by Hannon in order to prevent the catheter from being retracted or withdrawn from the tip (¶ [0110], Hannon).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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