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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 29, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on October 29, 2025. As directed by the amendment: claim 1 has been amended, claims 2-3, 5-9 and 14-20 have been cancelled previously, and no claims have been added. Thus, claims 1, 4, 10-13 and 21-34 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed October 29, 2025, with respect to the rejection of claim 1 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Korkuch et al. (Korkuch) US 2019/0247627 A1.
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 10-12, 21-22 and 25-33 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 10 line 3 recites “…an outer catheter reinforcement structure…”. It is not clear if this the outer catheter reinforcement structure of claim 1 line 14, or a newly introduced outer catheter reinforcement structure. Claims 11, 21, 22, 25, 26, 29, 30, 32 are also made unclear by this. For purposes of examination, this is interpreted as “…the outer catheter reinforcement structure…”. Claims 11-12, 21-22, and 25-33 are rejected at least because they depend from claim 10.
Claim 31 recites “…wherein the at least one polymer of the outer catheter comprises a first layer and a second layer…”. It is not clear how a polymer can comprise layers because a polymer is a material, and not a structure. For purposes of examination, this is interpreted “…wherein the outer catheter device wall is comprised of a first and second polymer layers, wherein the first layer is comprised of the at least one polymer coupled to the outer catheter reinforcement structure…”. Claims 32-33 are rejected at least because they depend from claim 31.
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.
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.
Claims 1, 4, 10, 13, 23-28, 31-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (Chou) US 2020/0038628 A1 in view of Korkuch et al. (Korkuch) US 2019/0247627 A1.
Regarding claim 1, Chou discloses a catheter system (distal access system 100, P0082 and shown in Fig. 2A), comprising: an outer catheter (guide sheath 400, P0082 and shown in Fig. 2A) having a proximal end (proximal end, see annotated Fig. 2A below), a distal end located opposite the proximal end (distal end, see annotated Fig. 2A below), a working lumen (working lumen 410, P0087) extending between the proximal end and the distal end, an outer surface defining an outer diameter, and an inner surface defining an inner diameter (Examiner notes that the guide sheath 400 is interpreted to include the recited outer surface defining an outer diameter and the inner surface defining an inner diameter); and an inner catheter (catheter 200, P0082 and shown in Fig. 2A) having a proximal hub (proximal tab 234, P0108), a distal portion (distal portion 222, P0108) having a distal end located opposite the proximal hub (distal end, see annotated Fig. 2A below), an outer surface defining an outer diameter, an inner surface defining an inner diameter (Examiner notes that distal portion is interpreted to include the recited outer surface defining an outer diameter and the inner surface defining an inner diameter), and a pusher wire (control element 230, P0099) extending between the proximal hub and the distal portion; a hydrophilic coating (hydrophilic coating, P0093) adhering to the outer surface of the outer catheter (surface of body 402, P0093), the first hydrophilic coating configured to reduce surface friction and increase lubricity between the outer surface of the outer catheter and a vessel wall (hydrophilic coatings are lubricious, P0118), wherein the working lumen of the outer catheter is configured to at least partially receive the inner catheter (Fig. 9I).
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Chou does not teach the outer surface of the outer catheter wherein the outer surface of the outer catheter comprises a smoother surface than the inner surface of the outer catheter; a textured surface located on the inner surface of the outer catheter, the textured surface formed from a portion of an outer catheter reinforcement structure of the outer catheter; and a second hydrophilic coating located on the inner surface of the outer catheter and configured to reduce surface friction and increase lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter, the second hydrophilic coating adhering to the textured surface.
However, Korkuch teaches an expandable introducer sheath (sheath 200 comprised of a braid, a polymer coating encapsulating the braid, and a hydrophilic coating on an inner surface and on an outer surface of the polymer coated braid, P0141 and shown in Fig. 2, with details shown in Fig. 51) for a medical device wherein the outer surface of the outer catheter comprises a smoother surface (smooth outer surface 5106, P0162) than the inner surface of the outer catheter (because the inner surface is textured); a textured surface located on the inner surface of the outer catheter (textured inner surface, P0104 and shown in Fig. 51), the textured surface formed from a portion of an outer catheter reinforcement structure of the outer catheter (wire strands 5105 and 5107, P0162); and a second hydrophilic coating located on the inner surface of the outer catheter (the first and second hydrophilic coatings are the hydrophilic coating of Korkuch noted above coating both the inner and outer surfaces) and configured to reduce surface friction and increase lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter (hydrophilic lubricious coating, P0029-0030), the second hydrophilic coating adhering to the textured surface.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the sheath of Chou for the sheath of Korkuch for the purpose of reducing stress on the blood vessel at the insertion site by allowing for a reduced outer diameter sheath that can be expanded, Korkuch P0008.
Regarding claim 4, Chou in view of Korkuch teaches the catheter system of Claim 1, wherein the pusher wire is configured to facilitate navigation of the inner catheter through the working lumen of the outer catheter (Chou, P0114).
Regarding claim 10, Chou in view of Korkuch teaches the catheter system of Claim 1, wherein the outer catheter comprises a device wall and the inner catheter comprises a device wall, wherein the device wall of the outer catheter includes at least one polymer (Korkuch, polymer coating encapsulating the braid, P0141) coupled to an outer catheter reinforcement structure, and wherein the device wall of the inner catheter includes at least one polymer (Chou, polymer, P0118) coupled to an inner catheter reinforcement structure (Chou, reinforcement layer including a coil or braid, P0118).
Regarding claim 13, Chou in view of Korkuch teaches the catheter system of Claim 1, wherein the pusher wire comprises one of a round wire and a flat wire (Chou, the proximal control element 230 can be a solid metal wire that is round, P0125).
Regarding claim 23, Chou in view of Korkuch teaches the catheter system of Claim 4, wherein the pusher wire is fixedly coupled to the distal portion of the inner catheter (Chou, P0128).
Regarding claim 24, Chou in view of Korkuch teaches the catheter system of Claim 23, wherein the pusher wire is sufficiently rigid to advance the distal portion of the inner catheter through the working lumen of the outer catheter (Chou, P0120 and P0124).
Regarding claim 25, Chou in view of Korkuch teaches the catheter system of Claim 10, wherein the at least one polymer coupled to the outer catheter reinforcement structure is configured to provide flexibility to the outer catheter (Korkuch, the sheath can turn corners as required by patient anatomy, P0141).
Regarding claim 26, Chou in view of Korkuch teaches the catheter system of Claim 10, wherein the at least one polymer coupled to the outer catheter reinforcement structure is configured to provide structural support to the outer catheter (Korkuch, polymer coating encapsulates the braid, P0141).
Regarding claim 27, Chou in view of Korkuch teaches the catheter system of Claim 10, wherein the at least one polymer coupled to the inner catheter reinforcement structure is configured to provide flexibility to the inner catheter (Chou, flexibility, P0099).
Regarding claim 28, Chou in view of Korkuch teaches the catheter system of Claim 10, wherein the at least one polymer coupled to the inner catheter reinforcement structure is configured to provide structural support to the inner catheter (Chou, suitable to be advanced without kinking or ovalizing even when navigating hairpin turns, P0099).
Regarding claim 31, Chou in view of Korkuch teaches the catheter system of Claim 10, wherein the at least one polymer of the outer catheter comprises a first layer and a second layer (Korkuch, a polymer coating encapsulating the braid is the first layer, and a hydrophilic coating on an inner surface and on an outer surface of the polymer coated braid is the second layer, P0141, wherein the hydrophilic coatings may be elastomers that are urethane based, P0170).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the hydrophilic second coating to be urethane based (a polymer) to allow for additional coatings to reduce frictional forces, Korkuch P0170.
Regarding claim 32, Chou in view of Korkuch teaches the catheter system of Claim 31, wherein the outer catheter reinforcement structure is located between the first layer and the second layer (Korkuch, Fig. 51 shows wire strands 5105 and 5107 encapsulated by the coating layer 5102, and wherein the coating layer 5102 is encapsulated by the hydrophilic second layer, and therefore wire strands 5105 and 5107 are located between the first layer and the second layer because wire strands 5105 and 5107 are between the inner and outer surfaces of the outer catheter both comprised of the first and second layer).
Regarding claim 34, Chou in view of Korkuch teaches the catheter system of Claim 1, wherein the distal portion of the inner catheter defines a length of about 20 centimeters (Chou, portion 222 may range from about 10cm to 40 cm, P0108).
Potentially Allowable Subject Matter
Claims 11-12, 21-22, 29-30 and 33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, in addition to successfully overcoming the 112(b) rejections above.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed catheter system.
The closest prior art is Korkuch et al. (Korkuch) US 2019/0247627 A1.
Regarding claims 11 and 21-22, Korkuch fails to teach among all the limitations or render obvious a catheter system as claimed, which includes the outer catheter reinforcement structure comprises a braid and coil reinforcement structure, in combination with the total structure and function of the catheter system as claimed. The sheath of Korkuch is a radially expandable sheath, and a modification to include a coil would prevent radial expansion.
Regarding claim 33, Korkuch fails to teach among all the limitations or render obvious a catheter system as claimed, which includes a coil structure located in the outer catheter, in combination with the total structure and function of the catheter system as claimed. The sheath of Korkuch is a radially expandable sheath, and a modification to include a coil would prevent radial expansion.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783