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 .
Election/Restrictions
Claims 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Applicant’s election without traverse of Group I in the reply filed on 12/30/2025 is acknowledged.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13, line 4 recites “the tap” but should read “the tab” as recited in claim 13, line 2 likely due to a clerical error.
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 6, 12-13, and 19 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 6 recites the limitation "the outer surface" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the outer surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the distal end " in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the access lumen proximal access port" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-2, 4-5, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whitman et al. (US 10603071 B1).
Regarding claim 1, Whitman discloses a catheter placement system (1200/1250, Figs. 12A-12C), comprising:
a catheter (1250) comprising:
a dilation section (Image 1);
an access section (Image 1) extending distally away from the dilation section;
a catheter section (Image 1) extending proximally away the dilation section; and
a notch (1256) extending longitudinally along at least a portion of the dilation section; and
a skin nicking device (1202/1210) coupled with the catheter, comprising:
a handle (1202); and
a blade (1210) extending distally away from the handle, wherein a portion of the blade is disposed within the notch (Fig. 12B).
Regarding claim 2, Whitman discloses the system according to claim 1, wherein the catheter is a rapidly insertable central catheter (Col 15, lines 59-62, Col 1, lines 6-10, Col 4, lines 6-13, Col 6, lines 64-67).
Regarding claim 4, Whitman discloses the system according to claim 1, wherein:
the access section defines a first outer diameter (Image 1),
the catheter section defines a second outer diameter (Image 1) greater than the first outer diameter, and
the dilation section defines a tapered outer profile (Image 1) including:
the first outer diameter at a distal end of the dilation section (Image 1); and
the second diameter at a proximal end of the dilation section (Image 1).
Image 1:
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Regarding claim 5, Whitman discloses the system according to claim 1, wherein the blade is removable from the notch (Col 17, lines 1-10).
Regarding claim 12, Whitman discloses the system according to claim 1, wherein a distal end of the blade is disposed radially inward of the outer surface of the dilation section (Figs. 12A-12B).
Regarding claim 15, Whitman discloses the system according to claim 1, wherein the handle extends proximally along the catheter section (Fig. 12A).
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.
Claims 3 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Whitman et al. (US 10603071 B1) in view of Mitchell et al (US 20160220786 A1).
Regarding claim 3, Whitman discloses the system according to claim 1, wherein the access section is mono- luminal (Figs. 12A-12C).
Whitman is silent regarding the catheter section is multi-luminal.
In analogous art, Mitchell teaches a catheter section (Image 2) is multi-luminal (16, 18, Image 2, Fig. 2).
Image 2:
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It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter section of Whitman to incorporate the teachings of Mitchell to incorporate being multi-luminal in order to allow for insertion of additional medical devices (i.e. stylets), allow for medicine and/or fluids to be introduced into the catheter, pass through the lumens, and exit to the vessel in which the catheter has been placed, or extraction of fluids or blood (Paragraphs [0026]-[0027] and [0029]).
Regarding claim 16, Whitman discloses the system according to claim 1, wherein:
the catheter includes an access lumen extending along the access, dilation, and catheter sections (Fig. 12A, Col 16, lines 7-12), and
Whitman is silent regarding the access section includes a needle access port in fluid communication with the access lumen.
In analogous art, Mitchell teaches an access section (12) includes a needle access port (25) in fluid communication with an access lumen (36).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the access section of Whitman to incorporate the teachings of Mitchell to incorporate a needle access port in fluid communication with the access lumen in order to allow receival of a needle (Paragraph [0031]).
Regarding claim 19, Whitman in view of Mitchell disclose the system according to claim 16, further comprising an advancement guidewire (1253, Whitman) disposed within the access lumen proximal access port (1252, Whitman).
Regarding claim 17, Whitman in view of Mitchell disclose the system according to claim 16, but Whitman is silent regarding further comprising a needle disposed within the access lumen between the needle access port and a distal end of the catheter.
Mitchell teaches a needle (14) disposed within the access lumen between the needle access port and a distal end of a catheter (Fig. 5).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Whitman in view of Mitchell to incorporate the teachings of Mitchell to incorporate a needle disposed within the access lumen between the needle access port and a distal end of the catheter in order to facilitates dilation through the soft tissues and vessel wall for the needle and simultaneously dilates the soft tissues and vessel wall for the catheter insertion (Paragraph [0033]).
Regarding claim 18, Whitman in view of Mitchell disclose the system according to claim 17, but Whitman is silent regarding further comprising an access guidewire disposed within a lumen of the needle.
Mitchell teaches an access guidewire (15) disposed within a lumen of the needle (Fig. 5).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Whitman in view of Mitchell to incorporate the teachings of Mitchell to incorporate an access guidewire disposed within a lumen of the needle in order to determine depth of insertion and allow advancement of the catheter to achieve intravascular placement of the catheter (Paragraph [0037]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Whitman et al. (US 10603071 B1) in view of Chen et al. (US 20220087708 A1).
Regarding claim 8, Whitman discloses the system according to claim 1, wherein:
an edge of the blade is disposed within the notch (Figs. 12A-12C, bottom part of 1211 adjacent 1253 in Fig. 12C), and
a sharp edge (1211) of the blade is directed radially outward from the catheter (Fig. 12A).
Whitman is silent regarding a dull edge of the blade is disposed within the notch
In analogous art, Chen teaches non-cutting edges being relatively dull (Paragraph [0029]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the edge of the blade disposed within the notch (which is non-cutting) of Whitman to incorporate the teachings of Chen to incorporate being dull because they are not required for slicing tissue (Paragraph [0029]) and therefore may prevent a higher chance of accidental pricking after using of the cutting device.
Regarding claim 9, Whitman in view of Chen disclose the system according to claim 8, wherein the sharp edge defines an angle with respect to a longitudinal axis of the catheter such that a distal portion of the sharp edge is closer to the longitudinal axis than a proximal portion of the sharp edge (Fig. 12A, Whitman).
Regarding claim 10, Whitman in view of Chen disclose discloses the system according to claim 9, wherein the notch is configured to align the blade with the longitudinal axis (Figs. 12A-12C, Whitman).
Allowable Subject Matter
Claims 6 and 13-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 7 and 11 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.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 6, although Whitman teaches the limitations of claim 5 as described above, Whitman is silent to wherein the notch is formed of a slit such that: upon removal of the blade from the notch, the notch transitions to a closed state, and the outer surface of the dilation section forms a continuous circumferential surface in combination with the limitations of claims 1 and 5.
As to claim 7, although Whitman teaches the limitations of claim 1 as described above, Whitman is silent to wherein the notch defines a notch width that is less than a thickness of the blade such that the notch defines an interference fit with the blade in combination with the limitations of claim 1.
As to claim 11, although Whitman and Chen teach the limitations of claim 8 as described above, Whitman and Chen are silent to wherein the sharp edge is parallel with an outer surface of the dilation section in combination with the limitations of claims 1 and 8.
As to claim 13, although Whitman teaches the limitations of claim 1 as described above, Whitman is silent to the blade includes a tab extending distally from the distal end of the blade, the notch includes a cavity at a distal end of the notch, and the tab is disposed within the cavity in combination with the limitations of claim 1. Because claim 13 contains allowable subject matter, dependent claim 14 contains allowable subject matter for the same reasons above.
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783