DETAILED ACTION
This is in response to the Patent Application filed 10/14/2023 wherein claims 1-20 are presented for examination.
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Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 7/6/2026.
Claims 15-20 are examined.
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 19-20 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 19 recites the limitation "an introducer hub" in line 3. It is unclear if the “introducer hub” recited in claim 19 is referring to the introducer hub recited in claim 15 or if it is referring to a different introducer hub.
Claim 19 recites the limitation "an introducer sheath" in line 4. It is unclear if the “introducer sheath” recited in claim 19 is referring to the introducer sheath recited in claim 15 or if it is referring to a different introducer sheath.
Claim 19 recites the limitation "a medical device" in line 4. It is unclear if the “medical device” recited in claim 19 is referring to the device recited in claim 15 or if it is referring to a different device.
Claim 20 is rejected for the same reasons discussed above based on its dependency to claim 19.
Claim 20 recites the limitation "the vasodilating drug" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. (US 5,800,384) in view of Leckrone (US 2009/0170933) and Spurchise et al. (US 2008/0269800).
Regarding Independent Claim 15, Russell teaches (Figures 1-4) a method comprising:
inserting an introducer (10) into a vessel (62) of a patient (see Figure 2) such that an introducer sheath (12) of the introducer (15) is disposed within (see Figure 2) the vessel (62) and an introducer hub (30) of the introducer (10) is disposed outside of the patient (see Figure 2);
advancing a device (15, 14) distally through (see Figure 2) the introducer sheath (12);
Russell does not teach, as discussed so far, introducing a vasodilating therapeutic agent within the vessel through the introducer such that the vasodilating therapeutic agent dilates the vessel; and removing the introducer sheath from the vessel after the vessel is dilated.
Leckrone teaches (Figure 1-2) introducing a vasodilating therapeutic agent (Paragraphs 0024-0025) within the vessel through an introducer (10) such that the vasodilating therapeutic agent dilates the vessel (see Paragraphs 0024-0025).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell to introduce a vasodilating therapeutic agent within the vessel through the introducer such that the vasodilating therapeutic agent dilates the vessel, as taught by Leckrone, in order to relax the tissue of the vessel wall to minimize or prevent the constriction of the vessel wall about the medical device (Paragraphs 0024-0025 of Leckrone). Although Leckrone teaches that the vasodilator is added to the vessel prior to, or contemporaneous with, the introduction of the medial device (Paragraph 0025). Russell in view of Leckrone does not teach, as discussed so far, removing the introducer sheath from the vessel after the vessel is dilated.
Spurchise teaches (Figures 1-10) removing an introducer sheath (10) from the vessel after the removal of a dilator and guidewire from the vessel (Paragraphs 0003-0004).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell and Leckrone to remove the introducer sheath from the vessel after the vessel is dilated, as taught by Spurchise, in order to remove the devices after the procedure has been completed (Paragraphs 0003-0004 of Spurchise).
Regarding Claim 16, Russell in view of Leckrone and Spurchise teaches the invention as claimed and as discussed above. Russell further teaches (Figures 1-4) prior to removing the introducer (10) from the vessel (62), removing the device (15, 14) from the vessel (62) through the introducer sheath (12; see Column 2, lines 52-67).
Regarding Claim 17, Russell in view of Leckrone and Spurchise teaches the invention as claimed and as discussed above. Russell in view of Leckrone and Spurchise does not teach, as discussed so far, wherein the vasodilating therapeutic agent is introduced prior to removing the device from the vessel.
Leckrone teaches (Figures 1-2) wherein the vasodilating therapeutic agent (Paragraphs 0024-0025) is introduced prior to removing the device from the vessel (the vasodilator may be added to the vessel prior to, or contemporaneous with, the introduction of the medical device; see Paragraph 0025).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell in view of Leckrone and Spurchise to have the vasodilating therapeutic agent is introduced prior to removing the device from the vessel, as taught by Leckrone, in order to relax the tissue of the vessel wall to minimize or prevent the constriction of the vessel wall about the medical device (Paragraphs 0024-0025 of Leckrone).
Regarding Claim 18, Russell in view of Leckrone and Spurchise teaches the invention as claimed and as discussed above. Russell further teaches (Figures 1-4) wherein fluids are introduced after removing (see Column 2, lines 52-67) the device (15, 14) from the vessel (62).
Although Leckrone does not teach that the fluids introduced include a vasodilating therapeutic agent, Leckrone teaches (Figure 1-2) introducing a vasodilating therapeutic agent (Paragraphs 0024-0025) within the vessel through an introducer (10) such that the vasodilating therapeutic agent dilates the vessel (see Paragraphs 0024-0025).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell in view of Leckrone and Spurchise to introduce a vasodilating therapeutic agent within the vessel through the introducer such that the vasodilating therapeutic agent dilates the vessel, as taught by Leckrone, in order to relax the tissue of the vessel wall to minimize or prevent the constriction of the vessel wall about the medical device (Paragraphs 0024-0025 of Leckrone).
Regarding Claim 19, Russell in view of Leckrone and Spurchise teaches the invention as claimed and as discussed above. Russell further teaches (Figures 1-4) wherein the introducer (10) comprises: an introducer hub (30); and an introducer sheath (12) defining a primary lumen (12b) configured to receive a medical device (15, 14) therethrough, wherein introducing fluid within the vessel (62) through the introducer (10) comprises introducing through the introducer sheath (12; see Column 2, lines 52-67).
Although Leckrone does not teach that the fluids introduced include a vasodilating therapeutic agent, Leckrone teaches (Figure 1-2) introducing a vasodilating therapeutic agent (Paragraphs 0024-0025) within the vessel through an introducer (10) such that the vasodilating therapeutic agent dilates the vessel (see Paragraphs 0024-0025).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell in view of Leckrone and Spurchise to introduce a vasodilating therapeutic agent within the vessel through the introducer such that the vasodilating therapeutic agent dilates the vessel, as taught by Leckrone, in order to relax the tissue of the vessel wall to minimize or prevent the constriction of the vessel wall about the medical device (Paragraphs 0024-0025 of Leckrone).
Regarding Claim 20, Russell in view of Leckrone and Spurchise teaches the invention as claimed and as discussed above. Russell in view of Leckrone and Spurchise does not teach, as discussed so far, wherein the introducer sheath further includes an infusion lumen adjacent to the primary lumen and a plurality of ports extending from an exterior surface of the introducer sheath to the infusion lumen, wherein the introducer sheath is configured to receive the vasodilating therapeutic agent in the infusion lumen and to release the vasodilating drug through the plurality of ports.
Leckrone teaches (Figures 1-2) an introducer sheath (12) including an infusion lumen (15) adjacent to a primary lumen (22) and a plurality of ports (18) extending from an exterior surface (see Figure 1 and Paragraphs 0017 and 0023) of the introducer sheath (12) to the infusion lumen (15), wherein the introducer sheath (12) is configured to receive the vasodilating therapeutic agent (see Paragraphs 0023-0025) in the infusion lumen (15) and to release the vasodilating drug (Paragraphs 0023-0025) through the plurality of ports (18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Russell in view of Leckrone and Spurchise to have the introducer sheath include an infusion lumen adjacent to the primary lumen and a plurality of ports extending from an exterior surface of the introducer sheath to the infusion lumen, wherein the introducer sheath is configured to receive the vasodilating therapeutic agent in the infusion lumen and to release the vasodilating drug through the plurality of ports, as taught by Leckrone, in order to relax the tissue of the vessel wall to minimize or prevent the constriction of the vessel wall about the medical device (Paragraphs 0024-0025 of Leckrone).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format.
For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS P BURKE/Primary Examiner, Art Unit 3741
Prosecution Insights