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 .
Acknowledgment
Claims 1-2, 6-7, 9, 11-12 are amended and filed on 12/1/2025.
Claims 3-4, 16-19 are canceled and claims 20-23 are newly added.
The amendment to claims overcome the 112 rejection in the action mailed on 9/4/2025.
Election/Restrictions
Newly submitted claims 20-23 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions Group of claim 1 and Group of claim 20 are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed group of claims 1 require to have a catheter with one or more layers and group of claim 20 require to have a delivery system comprises a steerable catheter and implant catheter. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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, 5, 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser et al. (US. 20040122360A1 (“Waldhauser”) in view of Landon et al. (US. 20190008639A1) (“Landon”).
Re Claim 1, Waldhauser discloses a catheter (12, ¶0049, Figs. 1-13) comprising: an outer jacket (40, ¶0047); a main lumen (24) defined by an inner liner (44, ¶0049) that is disposed inside the outer jacket (Fig. 2); one or more layers positioned between the outer jacket and the inner liner (40.42, 45, ¶0047, ¶0069) ; a coil layer positioned inside the outer jacket (one wire of the braided 28 is coiled, braided has a wire in a coil pattern/ spiral, Fig. 7, ¶0052); wherein at least one of the outer jacket and the one or more layers are reflowed to bond the outer jacket, the coil layer, the inner liner; and the one or more layers together (¶0056), but it fails to disclose wherein a leakage shield is disposed around only a portion of the coil layer to prevent material of the outer jacket and the one or more layers that are reflowed from contacting the portion of the coil layer such that the portion of the coil layer is free from all material of the outer jacket and the one or more layers that are reflowed.
However, Landon discloses a catheter shaft (Fig. 45a-b) and the catheter comprises an outer shield (4502), inner lumen (104) and reinforced layer (4506, ¶0243) and wherein a leakage shield (4506, Fig. 45b) is disposed around only a portion of the coil layer (¶0243) to prevent material of the outer jacket and the one or more layers that are reflowed from contacting the portion of the coil layer such that the portion of the coil layer is free from all material of the outer jacket and the one or more layers that are reflowed (¶0243).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter of Waldhauser to include a leakage shield so that a leakage shield is disposed around only a portion of the coil layer to prevent material of the outer jacket and the one or more layers that are reflowed from contacting the portion of the coil layer such that the portion of the coil layer is free from all material of the outer jacket and the one or more layers that are reflowed as taught by Landon for the purpose of increasing the catheter shaft flexibility while maintaining standard reinforced shaft performance features (Landon, ¶0241).
Re Claim 5, Waldhauser discloses wherein a first portion of the outer jacket is formed from a material with an enhanced level of flexibility as compared to remaining portions of the outer jacket (portion 52, 54, ¶0047, Fig. 3).
Re Claim 7, Waldhauser discloses a second leakage shield located adjacent to the coil layer and situated between the coil layer and the inner liner that forms the main lumen (48, Fig. 7, ¶0056).
Re Claim 8, Waldhauser discloses a plurality of sub-lumens (¶204) .
Re Claim 9, Waldhauser discloses wherein the second leakage shield is formed from polytetrafluoroethylene (¶0056, PTFE).
Re Claim 10, Waldhauser discloses wherein a first portion of the outer jacket is formed from a material with an enhanced level of flexibility with regard to remaining portions of the outer jacket (52, ¶0047, Fig. 3).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser in view of Landon and further in view of Kampa et al. (US. 20080251966A1) (“Kampa”).
Re Claim 2, Waldhauser fails to disclose further comprising a plurality of sub-lumens disposed between the main lumen and the coil layer.
However, Kampa discloses a catheter shaft (Fig. 7) and the catheter comprises a plurality of sub-lumens (30, ¶0061) disposed between the main lumen (core of 70, ¶0072) and the coil layer (55, ¶0061, Fig. 7).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the catheter of Waldhauser to include a plurality of sub-lumens disposed between the main lumen and the coil layer as taught by Kampa for the purpose of inserting the functional components such as steering wire or conductor wire into their respective lumen (Kampa, ¶0061).
Claim(s) 6, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser in view of Landon and further in view of Mizuno (US. 20160057271A1).
Re Claim 6, Waldhauser fails to disclose wherein the coil layer comprises a plurality of coils formed from wire having a convex face and a concave face where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place.
However, Kampa discloses a catheter shaft (Fig. 8-9) and the catheter comprises a coil layer comprises a plurality of coils formed from wire having a convex face (41) and a concave face (42) where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place (¶0026, Fig. 9).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the coil layer of Waldhauser so that coil layer comprises a plurality of coils formed from wire having a convex face and a concave face where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place as taught by Mizuno for the purpose of enabling bending and reducing misalignment (Mizuno , ¶0059).
Re Claim 11, Waldhauser fails to disclose wherein the coil layer comprises a plurality of coils formed from wire having a convex face and a concave face where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place.
However, Kampa discloses a catheter shaft (Fig. 8-9) and the catheter comprises a coil layer comprises a plurality of coils formed from wire having a convex face (41) and a concave face (42) where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place (¶0026, Fig. 9).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the coil layer of Waldhauser so that coil layer comprises a plurality of coils formed from wire having a convex face and a concave face where the convex face of a first portion of the wire intrudes into a space formed by the concave face of a second portion of the wire to prevent the plurality of coils from slipping out of place as taught by Mizuno for the purpose of enabling bending and reducing misalignment (Mizuno , ¶0059).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser in view of Mizuno (US. 20160058271A1).
Re Claim 12, Waldhauser discloses a catheter (12, ¶0049, Figs. 1-13) comprising: an outer jacket (40, Fig. 7); one or more layers positioned inside the outer jacket (44, Fig. 2); a coil layer (28 in ¶0052 or 49 in ¶0049, at least one spiral wire) formed from a plurality of coils of a wire ( at least one wire of 28), wherein the coil layer is positioned inside the outer jacket the outer jacket (Fig. 7); but it fails to disclose the wire have a convex face and a concave face; and wherein the coil layer is configured such that the convex face of a first portion of the wire that forms a first adjacent coil of the plurality of coils intrudes into a space formed by the concave face a second portion of the wire that forms a second adjacent coil of the plurality of coils to prevent the plurality of coils from slipping out of place.
However, Kampa discloses a catheter shaft (Fig. 8-9) and the catheter comprises a coil layer comprises a plurality of coils formed from wire having a convex face (41) and a concave face (42); and wherein the coil layer is configured such that the convex face of a first portion of the wire that forms a first adjacent coil of the plurality of coils intrudes into a space formed by the concave face a second portion of the wire that forms a second adjacent coil of the plurality of coils to prevent the plurality of coils from slipping out of place (¶0026, Fig. 9).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the coil layer of Waldhauser so that the wire have a convex face and a concave face; and wherein the coil layer is configured such that the convex face of a first portion of the wire that forms a first adjacent coil of the plurality of coils intrudes into a space formed by the concave face a second portion of the wire that forms a second adjacent coil of the plurality of coils to prevent the plurality of coils from slipping out of place as taught by Mizuno for the purpose of enabling bending and reducing misalignment (Mizuno , ¶0059).
Re Claim 13, Waldhauser discloses wherein a portion of the coil layer is free from all material of the outer jacket and the one or more layers positioned inside the outer jacket (a portion of 28 around 46 to form a port 90 see Fig, 7, or 49, Fig. 5, ¶0050).
Re Claim 14, Waldhauser discloses wherein a leakage shield (46, 48) prevents material of the outer jacket that is reflowed from contacting the coil layer (¶0051, ¶0056).
Re Claim 15, Waldhauser discloses wherein the coil layer is disposed inside the leakage shield (49 is inside 46, Fig. 7).
Response to Arguments
Applicant’s arguments, see remark, filed 12/1/2025, with respect to the rejection(s) of claim(s) 1 and 12 under 102 rejection using Waldhauser have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Waldhauser in view of Landon( for claim 1) and in view of Mizuno ( for claim 12) .
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783