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 1-18, drawn to a catheter and Species A1 (Figs 7A-8) and B1 (Figs 2A-5C), encompassing claims 1-8 and 11-15, in the reply filed on June 15, 2026 is acknowledged.
Claims 9-10 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alaswad et al. (US 11,779,362, hereinafter “Alaswad”).
Regarding claim 1, Alaswad discloses a catheter (Figs 12-18) comprising:
an elongated body (1202) comprising a proximal end (1206), a distal end (see annotated Figs 14 and 16 below), a longitudinal axis, and an elongated body outer diameter;
a tip (see annotated Figs 14 and 16 below) disposed at the distal end of the elongated body along the longitudinal axis, comprising: an opening (1230) comprising a tip outer diameter (at cross section A-A) smaller than the elongated body outer diameter (at cross section E-E); a neck (distal portion of tip; see annotated Figs 14 and 16 below for example) proximal of the opening comprising the tip outer diameter; and a shoulder (proximal portion of tip; see annotated Figs 14 and 16 below for example) disposed between the neck and the elongated body;
a central lumen (1232) extending from the proximal end to the distal end along the longitudinal axis through the tip; and
a bump (1210) extending longitudinally from the elongated body to proximate the opening and being partially circumferentially attached to at least a portion of the neck and the elongated body, forming an asymmetric cross section of the distal end (see annotated Figs 14 and 16 below).
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Regarding claim 2, wherein the asymmetric cross section (cross-section of B-B or C-C) comprises an outer diameter greater than an average inner diameter of an ophthalmic artery to prevent the catheter from entering the ophthalmic artery (fully capable of being larger an average ophthalmic artery and preventing the catheter from entering the ophthalmic artery depending on the type of ophthalmic artery - for example infant, pediatric or smaller animal. It is noted the required dimensions are not recited).
Regarding claim 3, wherein the outer diameter of the asymmetric cross section (cross-section of B-B or C-C) is smaller than an average inner diameter of a cerebral vessel to allow the catheter to go through the cerebral vessel (fully capable of being smaller than an average inner diameter of a cerebral vessel to allow the catheter to go through the cerebral vessel depending on the type of cerebral vessel – for example adult sized, diseased vessel, or larger animal. It is noted the required dimensions are not recited).
Regarding claim 4, further comprising: a side lumen (1236) disposed within a sidewall of the catheter extending from the proximal end to the distal end along the longitudinal axis and exiting through the tip, configured to receive a guidewire (1240 or 1806).
Regarding claim 5, wherein the central lumen (1232) comprises a uniform inner diameter (see Figs 14 and 16 above).
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.
Claim(s) 6 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alaswad (US 11,779,362) in view of Sarabia (US 2021/0016062)
Regarding claims 6, 11, and 12, Alaswad discloses a catheter (Figs 12-18), comprising:
an elongated body comprising a proximal end (1206), a distal end (see annotated Figs 14 and 16 below), a longitudinal axis, and an elongated body outer diameter;
a tip (see annotated Figs 14 and 16 above) disposed at the distal end of the elongated body along the longitudinal axis, comprising: an opening (1230) comprising a tip outer diameter (cross-section A-A) smaller than the elongated body outer diameter (cross section E-E); a neck (distal portion of tip; see annotated Figs 14 and 16 below for example) proximal of the opening comprising the tip outer diameter; and a shoulder (distal portion of tip; see annotated 14 and 16 below for example) disposed between the neck and the elongated body;
a central lumen (1232) extending from the proximal end to the distal end along the longitudinal axis through the tip; and
However, Alaswad fails to disclose the claimed sterling lumens. Sarabia discloses a similar catheter or sheath and teaches the benefit of providing a steering mechanism to facilitate accurate positioning of the catheter or sheath within the body (para [0005-0007]). In particular Sarabia teaches at least one, two, or four steering lumens (1460, 1480, 1500, or 1420) extending within a sidewall of the catheter from the proximal end to the distal end along the longitudinal axis through the tip, the at least one steering lumen being closed proximate the distal opening of the catheter (Fig 3B; para [0057]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Alaswad to include at least four steering lumens within the sidewall of the catheter, as taught by Sarabia, for the purpose of facilitating more accurate positioning of the catheter within the body.
Regarding claim 13, Alaswad discloses the catheter further comprises: a side lumen (1236) disposed within a sidewall of the catheter extending from the proximal end to the distal end along the longitudinal axis and exiting through the tip, configured to receive a guidewire (1240 or 1806) (Fig 14).
Regarding claim 14, Alaswad teaches the catheter further comprises a guidewire (1240 or 1806) incorporated within the side lumen (1236) (Fig 14).
Regarding claim 15, Alaswad teaches the catheter further comprises: a side lumen (1236) disposed within a sidewall of the catheter extending from the proximal end to the distal end along the longitudinal axis and exiting through the shoulder (at port 1208), configured to receive a guidewire (1240 or 1806) (Fig 14).
Claim(s) 6-8 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alaswad (US 11,779,362) in view of Jones et al. (US 2021/0252254, hereinafter “Jones”).
Regarding claims 6-8, Alaswad discloses a catheter (Figs 12-18), comprising:
an elongated body comprising a proximal end (1206), a distal end (see annotated Figs 14 and 16 below), a longitudinal axis, and an elongated body outer diameter;
a tip (see annotated Figs 14 and 16 above) disposed at the distal end of the elongated body along the longitudinal axis, comprising: an opening (1230) comprising a tip outer diameter (cross-section A-A) smaller than the elongated body outer diameter (cross section E-E); a neck (distal portion of tip; see annotated Figs 14 and 16 below for example) proximal of the opening comprising the tip outer diameter; and a shoulder (distal portion of tip; see annotated 14 and 16 below for example) disposed between the neck and the elongated body;
a central lumen (1232) extending from the proximal end to the distal end along the longitudinal axis through the tip; and
However, Alaswad fails to disclose the claimed sterling lumens. Jones discloses a similar catheter and teaches the benefit of providing a steering mechanism to improve the maneuverability of the catheter and thereby improve a physician’s ability to effectively orient the catheter (para [0005-0007]). In particular Jones teaches a catheter (Figs 5A-C) comprising at least one steering lumen (lumen 7100 for steering line 5700 isolated from primary interior lumen 5010 – Fig 7b; [0071]) extending within a sidewall of the catheter from the proximal end to the distal end along the longitudinal axis through the tip, the at least one steering lumen being closed proximate the distal opening of the catheter, wherein the at least one steering lumen comprises a steering lumen opening (5600) on a circumferential tip outer surface proximate the opening such that the opening extends substantially radially through the sidewall (Fig 5A; para [0065]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Alaswad to include a steering lumen with a steering lumen opening through the sidewall of the catheter, as taught by Jones, for the purpose of facilitating more accurate positioning of the catheter within the body.
Regarding claim 13, Alaswad discloses the catheter further comprises: a side lumen (1236) disposed within a sidewall of the catheter extending from the proximal end to the distal end along the longitudinal axis and exiting through the tip, configured to receive a guidewire (1240 or 1806) (Fig 14).
Regarding claim 14, Alaswad teaches the catheter further comprises a guidewire (1240 or 1806) incorporated within the side lumen (1236) (Fig 14).
Regarding claim 15, Alaswad teaches the catheter further comprises: a side lumen (1236) disposed within a sidewall of the catheter extending from the proximal end to the distal end along the longitudinal axis and exiting through the shoulder (at port 1208), configured to receive a guidewire (1240 or 1806) (Fig 14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2017/0296221 additionally discloses a catheter comprising an elongated body, tip having a neck and shoulder and opening having a smaller outer diameter than the elongated body outer diameter, and a bump, as claimed (Figs 2T-U).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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