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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0002 includes an incomplete sentence.
Paragraph 0035, line 1, 10L is not shown in drawings. It appears that 10L might be referring to 10T.
The reference characters 246A and 242H in in paragraph 0051, last line appears to read 446A and 446G respectively.
Regarding paragraph 0052, line 4, the reference “Fig. 8B” appears to read “Fig. 9B”.
Regarding paragraph 0052, line 6, the reference character “14C” (second occurrence) appears to read “14D”.
Regarding paragraph 0052, line 9, “14C” (second occurrence) appears to read “14D”.
Regarding paragraphs 0041 and 0045, numerous TMs are used and it appears that these trade names or marks used in commerce should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or where appropriate, include a proper symbol indicating use in commerce such as “TM”, “SM” or ® following the term.
Appropriate correction is required.
Claim Objections
Claims 12, 15 and 18 are objected to because of the following informalities:
Regarding claim 12, line 2, the recitation “a flaring tip microcatheter” appears to be amended to recite “the flaring tip microcatheter” in order to refer to “a flaring tip microcatheter” recited in line 1.
Regarding claim 15, line 2, the recitation “a vessel” appears to be amended to recite “the vessel” because “a vessel” is recited in claim 1, line 3.
Claim 18 recites the limitation “the body” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, line 14, the limitation “a therapeutic agent”, appears to be amended to recite “the therapeutic agent” in order to refer to “a therapeutic agent” recited in line 13.
Appropriate correction is required.
Claim 21 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim 21 has not been further treated on the merits.
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 17 and 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.
Regarding claim 17, lines 1-2, the recitation “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” renders the claim indefinite because the claim is unclear if “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” are further part of “radiotherapeutic agent, chemotherapeutic agent or combinations thereof” recited in claim 16 or additional. For examination purposes, examiner construes that “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” are further part of “radiotherapeutic agent, chemotherapeutic agent or combinations thereof”.
Regarding claim 20, lines 1-2, the recitation “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” renders the claim indefinite because the claim is unclear if “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” are further part of “radiotherapeutic agent, chemotherapeutic agent or combinations thereof” recited in claim 19 or additional. For examination purposes, examiner construes that “radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof” are further part of “radiotherapeutic agent, chemotherapeutic agent or combinations thereof” when interpreting claim 20 being dependent on claim 19.
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.
Claims 12-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chomas et al. (US 2014/0207178 A1).
Regarding claim 12, Chomas discloses a method of deploying a flaring tip microcatheter 2500 (figure 37), the method comprising:
Advancing (figures 37, 38, paragraph 0112) a flaring tip microcatheter 2500 having a proximal end (end that is in user’s hand” when operating the device) and a distal end (end that gets inserted into the patient’s body) through a vessel, the flaring tip microcatheter 2500 comprising
a core (2501), wherein the core is hollow (distal end of the catheter 2501 shows its inner lumen) and defines a core lumen (hollow portion inside element 2501);
a tip (2512, 2534) comprising a petal (2512) affixed to a distal end of the core (via wires 2516), the petal comprising at least two wires (2526);
pulling the at least two wires 2526 flare at least one petal and form a flared configuration of the tip (paragraph 0112); and
wherein the flared configuration of the tip allows for laminar flow of a therapeutic agent distally from the tip (the tip is fully capable of allowing proximal laminar flow). Chomas is silent regarding a hollow shaft having a shaft lumen defined therein; and the core is disposed within the shaft lumen.
However, Chomas discloses in a second embodiment (figure 33) comprising a hollow shaft 2301 having a shaft lumen (hollow portion inside element 2301) defined therein; and the core 2304 is disposed within the shaft lumen for the purpose of steering the distal tip at the desired location only after placing the shaft at the desired target site (paragraph 0110).
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 microcatheter of one embodiment of Chomas to another embodiment of Chomas to incorporate a hollow shaft having a shaft lumen defined therein; and the core is disposed within the shaft lumen as taught by second embodiment of Chomas for the purpose of steering the distal tip at the desired location only after placing the shaft at the desired target site (paragraph 0110).
Chomas is further silent regarding the tip comprising at least two petals, the at least two petals comprising at least two wires.
However, Chomas discloses in a third embodiment (figure 19) the tip 1906, 1910, 1912 comprising at least two petals 1912, the at least two petals 1912 comprising at least two wires 1908 for the purpose of regulating the flow of the fluids out of the microcatheter (paragraph 0106).
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 number of petals of first embodiment of Chomas to incorporate the tip comprising at least two petals, the at least two petals comprising at least two wires as taught by third embodiment of Chomas for the purpose of regulating the flow of the fluids out of the microcatheter (paragraph 0106).
Regarding claim 13, Chomas discloses wherein the flaring tip microcatheter further comprises a slide 2534, wherein the at least two wires are affixed to the slide 2534, and wherein the slide is configured to pull the at least two wires (pull distally).
Regarding claim 14, Chomas discloses wherein pulling (figure 38, paragraph 0112, lines 10-16) the at least two wires further include pulling the slide 2534 affixed to the at least two wires.
Regarding claim 15, Chomas is silent regarding further comprising advancing a guidewire through the core lumen, and guiding the guidewire through a vessel within a body in one embodiment.
However, Chomas discloses in a different embodiment further comprising advancing a guidewire 2860 (figure 45) through the core lumen (hollow portion inside element 2801), and guiding the guidewire 2860 through a vessel within a body (paragraph 0116) for the purpose of advancing the guidewire to the desired location and tracking the device over the guidewire to the site (paragraph 0116).
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 method of one embodiment of Chomas to incorporate further comprising advancing a guidewire through the core lumen, and guiding the guidewire through a vessel within a body as taught by different embodiment of Chomas for the purpose of advancing the guidewire to the desired location and tracking the device over the guidewire to the site (paragraph 0116).
Regarding claim 18, Chomas discloses an embolization treatment method, the method comprising:
Advancing (figures 37, 38, paragraph 0112) a flaring tip microcatheter 2500 having a proximal end (end that is in user’s hand” when operating the device) and a distal end (end that gets inserted into the patient’s body) through a vessel within the body of a patient, the flaring tip microcatheter 2500 comprising
a core (2501), wherein the core is hollow (distal end of the catheter 2501 shows its inner lumen) and defines a core lumen (hollow portion inside element 2501);
a tip (2512, 2534) comprising a petal (2512) affixed to a distal end of the core (via wires 2516), the petal comprising at least two wires (2526);
pulling the at least two wires 2526 flare at least one petal and form a flared configuration of the tip (paragraph 0112); whereby the flared configuration of the tip allows for laminar flow of a therapeutic agent distally from the tip (the tip is fully capable of allowing proximal laminar flow); and delivering a therapeutic agent to the vessel within the body of the patient comprises expelling the therapeutic agent from the distal end of the flaring tip microcatheter through the core lumen (paragraph 0112). Chomas is silent regarding a hollow shaft having a shaft lumen defined therein; and the core is disposed within the shaft lumen.
However, Chomas discloses in a second embodiment (figure 33) comprising a hollow shaft 2301 having a shaft lumen (hollow portion inside element 2301) defined therein; and the core 2304 is disposed within the shaft lumen for the purpose of steering the distal tip at the desired location only after placing the shaft at the desired target site (paragraph 0110).
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 microcatheter of one embodiment of Chomas to another embodiment of Chomas to incorporate a hollow shaft having a shaft lumen defined therein; and the core is disposed within the shaft lumen as taught by second embodiment of Chomas for the purpose of steering the distal tip at the desired location only after placing the shaft at the desired target site (paragraph 0110).
Chomas is further silent regarding the tip comprising at least two petals, the at least two petals comprising at least two wires.
However, Chomas discloses in a third embodiment (figure 19) the tip 1906, 1910, 1912 comprising at least two petals 1912, the at least two petals 1912 comprising at least two wires 1908 for the purpose of regulating the flow of the fluids out of the microcatheter (paragraph 0106).
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 number of petals of first embodiment of Chomas to incorporate the tip comprising at least two petals, the at least two petals comprising at least two wires as taught by third embodiment of Chomas for the purpose of regulating the flow of the fluids out of the microcatheter (paragraph 0106).
Claims 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chomas et al. (US 2014/0207178 A1) in view of Reb et al. (US 2011/0182998 A1).
Regarding claim 16, Chomas discloses the claimed invention substantially as claimed, as set forth above in claims 12-15. Chomas is silent regarding wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof.
However, Reb teaches wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof (paragraph 0345) for the purpose of treating the blood vessels affected by tumors (paragraph 045).
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 therapeutic agent of Chomas to incorporate wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof as taught by Reb for the purpose of treating the blood vessels affected by tumors (paragraph 045).
Regarding claim 17, Chomas discloses the claimed invention substantially as claimed, as set forth above in claims 12-15. Chomas is silent regarding wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof.
However, Reb teaches wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof (paragraph 0345) for the purpose of using a therapeutic form that demonstrates better embolic property (paragraph 0005).
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 therapeutic agent of Chomas to incorporate wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof as taught by Reb for the purpose of using a therapeutic form that demonstrates better embolic property (paragraph 0005).
Regarding claim 19, Chomas discloses the claimed invention substantially as claimed, as set forth above in claim 18. Chomas is silent regarding wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof.
However, Reb teaches wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof (paragraph 0345) for the purpose of treating the blood vessels affected by tumors (paragraph 045).
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 therapeutic agent of Chomas to incorporate wherein the therapeutic agent comprises radiotherapeutic agent, chemotherapeutic agent, or combinations thereof as taught by Reb for the purpose of treating the blood vessels affected by tumors (paragraph 045).
Regarding claim 20, Chomas discloses the claimed invention substantially as claimed, as set forth above in claim 18. Chomas is silent regarding wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof.
However, Reb teaches wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof (paragraph 0345) for the purpose of using a therapeutic form that demonstrates better embolic property (paragraph 0005).
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 therapeutic agent of Chomas to incorporate wherein the therapeutic agent comprises radiotherapeutic microspheres, chemotherapeutic microspheres or combinations thereof as taught by Reb for the purpose of using a therapeutic form that demonstrates better embolic property (paragraph 0005).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mickley et al. (US 2010/0145306 A1): discloses a catheter comprising a core shaft and core lumen with flared distal tip.
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
