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 .
Claim Objections
Claims 4, 5, 9 and 21 are objected to because of the following informalities:
Regarding claim 4, line 5, the recitation “one or more holes” appears to be amended to recite “the one or more holes” in order to refer to “one or more holes” recited in claim 1, line 3.
Regarding claim 5, line 5, the recitation “one or more holes” appears to be amended to recite “the one or more holes” in order to refer to “one or more holes” recited in claim 1, line 3.
Claim 9 recites the limitation “the same diameter” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the length” in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 9 and 14 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.
Regarding claim 9, line 2, the recitation “cross-sectional dimension” renders the claim indefinite because the claim is unclear regarding which measuring parameter is being referred by reciting “cross-sectional dimension”. “Dimension” could refer to a radius, diameter or some other measurement parameter.
Regarding claim 14, the recitation “continuous holes” renders the claim indefinite because the claim is unclear if “continuous holes” refers to one or more holes recited in claim 1 or additional. For examination purposes, examiner construes “continuous holes” as being referred to “one or more holes”.
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 1-13, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballow et al. (US 6,179,813 B1).
Regarding claim 1, Ballow teaches an intravascular delivery system 10a (figure 5) comprising:
an outer member 12 formed by a sheath 12 defining a sheath lumen 11 having a proximal end (see “P” in figure 5 below) and a distal end 12a, wherein the sheath comprises one or more holes 14 (figure 1);
an inner member 42 having an elongated body (body of element 42), wherein the inner member 42 is configured to extend internally along the sheath lumen 11 of the outer member 12.
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Regarding claim 2, Ballow teaches wherein the one or more holes 14 extend (column 6, lines 11-17) from an outer surface (outer surface of element 12) to the sheath lumen 11 of the sheath 12.
Regarding claim 3, Ballow teaches wherein the sheath 12 comprises:
a proximal section (see “PS” in figure 5 above, examiner is referring to “PS” in figure 5 above as being including entire section of element 13 and first two holes of plurality of holes 14 appearing closest to element 13), a distal section (see “DS” in figure 5 above), and a middle section (see “MS” in figure 5 above) extending between and interconnecting the proximal section (see “PS” in figure 5 above) of the sheath and the distal section (see “DS” in figure 5 above) of the sheath,
wherein the one or more holes 14 are positioned in the proximal section (see “PS” in figure 5 above) of the sheath 12.
Regarding claim 4, Ballow teaches wherein the sheath 12 comprises:
a proximal section (see “PS” in figure 5 above, examiner is referring to “PS” in figure 5 above as being including entire section of element 13 and first two holes of plurality of holes 14 appearing closest to element 13), a distal section (see “DS” in figure 5 above), and a middle section (see “MS” in figure 5 above) extending between and interconnecting the proximal section (see “PS” in figure 5 above) of the sheath and the distal section (see “DS” in figure 5 above) of the sheath,
wherein the one or more holes 14 are positioned in the proximal section (see “PS” in figure 5 above) of the sheath 12 and one or more holes 14 are positioned in the distal section (see “DS” in figure 5 above) of the sheath 12.
Regarding claim 5, Ballow teaches wherein the sheath 12 comprises:
a proximal section (see “PS” in figure 5 above, examiner is referring to “PS” in figure 5 above as being including entire section of element 13 and first two holes of plurality of holes 14 appearing closest to element 13), a distal section (see “DS” in figure 5 above), and a middle section (see “MS” in figure 5 above) extending between and interconnecting the proximal section (see “PS” in figure 5 above) of the sheath and the distal section (see “DS” in figure 5 above) of the sheath,
wherein the one or more holes 14 are positioned in the middle section (see “MS” in figure 5 above) of the sheath 12 and one or more holes 14 are positioned in the distal section (see “DS” in figure 5 above) of the sheath 12.
Regarding claim 6, Ballow teaches wherein the one or more holes 14 are positioned to permit a fluid (if the sheath is placed in the blood vessel where fluid is flowing from proximal section to the distal section of the sheath then the fluid coming out of element 14 will also flow in a direction substantially from a proximal section of the sheath substantially toward a distal section of the sheath) to flow in a direction substantially from a proximal section of the sheath substantially toward a distal section of the sheath.
Regarding claim 7, Ballow teaches wherein the one or more holes 14 are circular shaped (column 4, lines 31-33, “diameter” would mean the holes are circular shaped).
Regarding claim 8, Ballow teaches wherein the one or more holes 14 comprises a plurality of holes 14, wherein a single axial position (column 4, lines 33-35, “circumferentially” refers to being located at a single axial location) on the sheath comprises the plurality of holes 14.
Regarding claim 9, Ballow teaches wherein the one or more holes 14 comprises a plurality of holes 14 which have the same diameter or cross-sectional dimension (column 4, lines 32-34).
Regarding claim 10, Ballow teaches wherein the one or more holes comprises a plurality of holes which are circumferentially arranged (column 4, lines 33-35, “circumferentially”).
Regarding claim 11, Ballow teaches wherein the one or more holes 14 comprises a plurality of holes 14 which are longitudinally (figure 1, column 4, lines 33-35, “longitudinally”) arranged.
Regarding claim 12, Ballow wherein the one or more holes 14 comprises a plurality of holes 14 in a proximal section (see “PS” in figure 5 above, examiner is referring to “PS” in figure 5 above as being including entire section of element 13 and first two holes of plurality of holes 14 appearing closest to element 13) of the sheath 12.
Regarding claim 13, Ballow teaches wherein the one or more holes 14 comprises a plurality of holes 14 in a distal section (see “DS” in figure 5 above) of the sheath 12.
Regarding claim 17, Ballow teaches wherein the sheath comprises continuous holes 14.
Regarding claim 19, Ballow teaches wherein the one or more holes 14 promote perfusion (column 6, lines 6-9).
Claims 1, 14, 16 and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell et al. (US 2020/0179661 A1).
Regarding claim 1, Fischell teaches an intravascular delivery system (figure 2A) comprising:
an outer member 36 formed by a sheath 36 defining a sheath lumen 120 having a proximal end 132 and a distal end 160, wherein the sheath comprises one or more holes 272 (figure 15B);
an inner member 34 having an elongated body (body of element 34), wherein the inner member 34 is configured to extend internally along the sheath lumen of the outer member (paragraph 0045, lines 10-11).
Regarding claim 14, Fischell teaches wherein the sheath comprises a middle section (section between elements 132 and 160) without any holes (figure 15B, paragraph 0110, lines 7-9, element 272 is present only in proximal section).
Regarding claim 16, Fischell teaches wherein the sheath comprises a distal section (section comprising element 160) without any holes (figure 15B, paragraph 0110, lines 7-9, element 272 is present only in proximal section).
Regarding claim 20 Fischell teaches wherein a tapered outer tip 164 of the outer member 120 is an elastomeric tapered outer tip (paragraph 0048, lines 1-2).
Regarding claim 21, Fischell teaches wherein the sheath is reinforced along the length thereof (paragraph 0130, lines 1-4).
Regarding claim 22, Fischell teaches wherein the inner member 34 further comprises a balloon member 44 (figure 2A) attached to a tapered distal portion 162 (paragraph 0105, lines 1-5) of the inner member 34 in proximity to a tapered delivery micro-catheter 46 (paragraph 0106, fig. 2A).
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.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2020/0179661 A1) in view of Meguro et al. (US 2002/0087076 A1).
Regarding claim 15, Fischell discloses the claimed invention substantially as claimed, as set forth above in claim 1. Fischell is silent regarding wherein the sheath comprises a proximal section without any holes.
However, Meguro teaches a design of a catheter insertion system (figure 19) wherein the sheath 13 comprises a proximal section without any holes 9 (paragraph 0104, element 9 is present at 20 cm from element P and therefore, P is without any holes 9) for the purpose of effectively releasing the drug at the desired target site in the patient’s body (paragraph 0120).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the proximal section of Fischell to incorporate a proximal section without any holes as taught by Meguro for the purpose of effectively releasing the drug at the desired target site in the patient’s body (paragraph 0120).
Regarding claim 18, Fischell discloses the claimed invention substantially as claimed, as set forth above in claim 1. Fischell is silent regarding wherein the one or more holes are configured to reduce or eliminate myocardial ischemia risk. However, one can construe by releasing appropriate drug through element 272, the one or more holes are configured to reduce or eliminate myocardial ischemia risk.
Additionally, Meguro teaches wherein the one or more holes are configured to reduce or eliminate myocardial ischemia risk (paragraphs 0120, 0128) for the purpose of treating the appropriate medical condition in the patient’s body (paragraphs 0120, 0128).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the one or more holes of Fischell to incorporate wherein the one or more holes are configured to reduce or eliminate myocardial ischemia risk as taught by Meguro for the purpose of treating the appropriate medical condition in the patient’s body (paragraphs 0120, 0128).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Don Michael (US 5,090,960): discloses a design of a catheter with regional perfusion dissolution catheter comprising plurality of side holes.
Ginsburg (US 5,180,364): discloses a design of a guiding catheter with plurality of side holes allowing perfusion of the blood.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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