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
Applicant’s election without traverse of Invention I (claims 1-9 and17-20), in the reply filed on 05/18/2026, is acknowledged.
Claims 10-16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 03/13/2024, 05/15/2024, and 06/16/2026, have been considered by the examiner.
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 1-9 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 1] The claim recites the limitation of “the middle layer includes an exposed region that is exposed from the outer layer between the distal end of the outer layer and a proximal end of the marker band.” However, the claim further recites “wherein the distal tip is formed over the exposed region of the middle layer and the marker band.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the “exposed region” can be termed exposed if it is covered by the distal tip. For purposes of examination, it is interpreted that the region simply refers to an area of the middle layer that is not covered by the outer layer.
[Claims 2-9] The claims are rejected based upon their dependency from independent claim 1.
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, 5, 6, and 17-20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garabedian et al. (USPN 6,171,295).
[Claim 1] Garabedian teaches a catheter (figure 1, item 10) comprising:
an elongated tubular shaft (figure 2, item 12) having a distal end (figure 2, item 54), a proximal end (figure 2, item 22), and a lumen (figure 3, item 18) extending therethrough (figures 1-3), the elongated tubular shaft (figure 2, item 12) including:
a polymeric outer layer (figure 2, items 44/47; column 5, lines 41-44);
a polymeric inner layer (figure 2, items 36/38; column 3, lines 66-67; column 4, lines 1-23); and
a braided middle layer (figure 2, item 32; column 4, lines 24-32) positioned between the inner layer (figure 2, items 36/38) and the outer layer (figure 2, items 44/47) (figure 2);
a marker band (figure 2, item 60) positioned adjacent the distal end of the elongated tubular shaft (figure 2, item 12) and surrounding the middle layer (figure 2, item 32) (figure 2; column 6, lines 6-12); and
a polymeric distal tip (figure 2, items 49/50/52; column 5, lines 43-44 and lines 62-67; column 6, lines 1-4) attached to the distal end of the elongated tubular shaft (figure 2, item 12) (figure 2);
wherein a distal end (figure 2, item 47) of the outer layer (figure 2, items 44/47) terminates proximal to the marker band (figure 2, item 60) such that the middle layer (figure 2, item 32) includes an exposed region (figure 2; see 112b interpretation above) that is exposed from the outer layer (figure 2, items 44/47) between the distal end (figure 2, item 47) of the outer layer (figure 2, items 44/47) and a proximal end of the marker band (figure 2, item 60) (figure 2);
wherein the distal tip (figure 2, items 49/50/52) is formed over the exposed region (figure 2) of the middle layer (figure 2, item 32) and the marker band (figure 2, item 60) (figure 2), and extends distally beyond the distal end (figure 2, item 54) of the elongated tubular shaft (figure 2, item 12) (figure 2).
[Claim 5] Garabedian teaches the limitations of claim 1, upon which claim 5 depends. Garabedian further discloses the distal tip (figure 2, items 49/50/52) is formed from a polyether- block-amide copolymer (column 6, lines 1-4).
[Claim 6] Garabedian teaches the limitations of claim 1, upon which claim 6 depends. Garabedian also teaches a proximal portion (figure 2, item 49) of the distal tip (figure 2, items 49/50/52) surrounds and overlaps with a distal portion (figure 2, item 47) of the outer layer (figure 2, items 44/47) (figure 2).
[Claim 17] Garabedian teaches a catheter (figure 1, item 10) comprising:
an elongated tubular shaft (figure 2, item 12) having a distal end (figure 2, item 54), a proximal end (figure 2, item 22), and a lumen (figure 3, item 18) extending therethrough (figures 1-3), the elongated tubular shaft (figure 2, item 12) including:
a polymeric inner layer (figure 2, items 36/38; column 3, lines 66-67; column 4, lines 1-23) having an inner surface (figure 2, item 36) defining the lumen (figure 3, item 18) of the elongated tubular shaft (figure 2, item 12), the inner layer (figure 2, items 36/38) extending continuously from the proximal end (figure 2, item 22) of the elongated tubular shaft (figure 2, item 12) to the distal end (figure 2, item 54) of the tubular shaft (figure 2, item 12) (figure 2);
a braided middle layer (figure 2, item 32; column 4, lines 24-32) surrounding the inner layer (figure 2, items 36/38) (figure 2), the middle layer (figure 2, item 32) extending continuously from the proximal end (figure 2, item 22) of the elongated tubular shaft (figure 2, item 12) to the distal end (figure 2, item 54) of the elongated tubular shaft (figure 2, item 12) (figure 2);
a polymeric outer layer (figure 2, items 44/47; column 5, lines 41-44) surrounding the middle layer (figure 2, item 32) (figure 2), the outer layer (figure 2, items 44/47) extending continuously from the proximal end (figure 2, item 22) of the elongated tubular shaft (figure 2, item 12) to a distal end (figure 2, item 47) of the outer layer (figure 2, items 44/47) that is located proximal of the distal end (figure 2, item 54) of the elongated tubular shaft (figure 2, item 12) such that the middle layer (figure 2, item 32) includes a distal end region (figure 2) extending distal of the distal end (figure 2, item 47) of the outer layer (figure 2, items 44/47); and
a polymeric distal tip (figure 2, items 49/50/52; column 5, lines 43-44 and lines 62-67; column 6, lines 1-4) extruded over the distal end region (figure 2) of the middle layer (figure 2, item 32) and extending distally beyond the distal end (figure 2, item 54) of the elongated tubular shaft (figure 2, item 12) (figure 2).
[Claim 18] Garabedian teaches the limitations of claim 17, upon which claim 18 depends. Garabdian further discloses proximal portion (figure 2, item 49) of the distal tip (figure 2, items 49/50/52) surrounds and overlaps with a distal portion (figure 2, item 47) of the outer layer (figure 2, items 44/47) (figure 2).
[Claim 19] Garabedian teaches the limitations of claim 18, upon which claim 19 depends. Garabedian also teaches an outer diameter of the distal portion (figure 2, item 47) of the outer layer (figure 2, items 44/47) tapers distally (figure 2).
[Claim 20] Garabedian teaches the limitations of claim 18, upon which claim 20 depends. In addition, Garabedian teaches a marker band (figure 2, item 60) positioned adjacent the distal end (figure 2, item 54) of the elongated tubular shaft (figure 2, item 12) and surrounding the middle layer (figure 2, item 32) (figure 2; column 6, lines 6-12), wherein the distal tip (figure 2, items 49/50/52) extends over and surrounds the marker band (figure 2, item 60) (figure 2).
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Garabedian et al. (USPN 6,171,295).
[Claim 2] Garabedian teaches the limitations of claim 1, upon which claim 2 depends. Garabedian does not specifically disclose the outer layer terminates at a distance in the range of about 0.5 mm to about 1.5 mm proximal of the marker band.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the structure taught by Garabedian to utilize the claimed relative locations of the outer layer and the marker band, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Garabedian would not operate differently with the claimed relative dimensions. Further, applicant has placed no criticality on the claimed relative dimensions, indicating that the outer layer “may” be within the claimed distances relative to the marker band (Specification; paragraph [0050]).
[Claims 3 and 4] Garabedian teaches the limitations of claim 1, upon which claims 3 and 4 depend. Garabedian does not specifically disclose the distal tip provides a tensile strength in the range of 1.42 N to 1.55 N, or more specifically 1.5 N.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the structure taught by Garabedian to utilize the claimed tensile strengths for the distal tip, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Garabedian would not operate differently with the claimed relative tensile strengths. Specifically, Garabedian teaches the same connection (lap joint; Specification, paragraph [0066]) between the distal tip and the distal end of the tubular shaft, as well as similar polymeric materials. Further, applicant has placed no criticality on the claimed relative tensile strengths, indicating that the lap joint of the distal tip “may” be within the claimed relative tensile strengths (Specification, paragraphs [0007], [0017], [0066]).
Allowable Subject Matter
Claims 7-9 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 07/21/2026
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