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 30 and 33 are objected to because of the following informalities:
In claim 30, line 2, the phrase “into the body lumen have the calcified lesion” should read “into the body lumen having the calcified lesion”.
In claim 33, lines 9-10, the phrase “the second treatment inflation balloon” should read “the second treatment balloon”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-18, 20-21, 28 and 30-35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tabiliran (US 2022/0280765 A1).
Regarding claim 16, Tabiliran discloses (see abstract; paras. [0126]-[0138]; figs. 1-11) a multi-modality catheter (figs. 5a-b) for treating a lesion of a body lumen (para. [0001]) comprising:
a catheter body (504, para. [0130]) configured to be received in the body lumen (para. [0132]), the catheter body having opposite proximal and distal end portions and a longitudinal axis extending between the proximal and distal end portions (longitudinal axis of 504, figs. 5a-b);
an intravascular lithotripsy balloon (second balloon 501, para. [0130]; fig. 5a) coupled to the distal end portion of the catheter body (fig. 5a), wherein the intravascular lithotripsy balloon includes i) a balloon body (body of 501) configured to receive fluid to expand the balloon body (second balloon chamber 507 is inflatable), and ii) a shock wave emitter (includes electrode pairs 104 and 105, para. [0126]; figs. 1 and 5a) received in the balloon (fig. 5a) and configured to produce a shock wave within the balloon (paras. [0126] and [0130]); and
a second treatment balloon (502) coupled to the distal end portion of the catheter body (fig. 5a) and being spaced apart longitudinally from the intravascular lithotripsy balloon (considered to have end portions spaced longitudinally from end portions of 501, figs. 5a-b), wherein the second treatment balloon includes a balloon body (body of 502) configured to receive fluid to expand the balloon body (inflatable, para. [0130]),
wherein the intravascular lithotripsy balloon and the second treatment balloon are independently expandable (separately inflatable, para. [0130]).
Regarding claim 17, Tabiliran discloses the multi-modality catheter set forth in claim 16. Tabiliran further discloses wherein the balloon body of the intravascular lithotripsy balloon has a maximum cross-sectional dimension that is less than a maximum cross-sectional dimension of the balloon body of the second treatment balloon (depicted in figs. 5a-b).
Regarding claim 18, Tabiliran discloses the multi-modality catheter set forth in claim 17. Tabiliran further discloses wherein the balloon body of the intravascular lithotripsy balloon has a length that is less than a length of the balloon body of the second treatment balloon (depicted in figs. 5a-b).
Regarding claim 20, Tabiliran discloses the multi-modality catheter set forth in claim 16. Tabiliran further discloses wherein the catheter body defines a lithotripsy inflation lumen (lumen of 505, para. [0130]) extending along the longitudinal axis in fluid communication with the intravascular lithotripsy balloon (fig. 5b), and a separate treatment inflation lumen (lumen of 504) extending along the longitudinal axis in fluid communication with the second treatment balloon (para. [0130]; fig. 5b).
Regarding claim 21, Tabiliran discloses the multi-modality catheter set forth in claim 20. Tabiliran further discloses further comprising at least one electrical conductor (conductive wires, para. [0070]) coupled to the shock wave emitter (para. [0070]), wherein the at least one electrical conductor is received in an electrical conductor lumen (considered to be formed by insulating jacket) extending along the longitudinal axis of the catheter body (extends along first elongate member, such that wires are considered to extend along the longitudinal axis of the first elongate member).
Regarding claim 28, Tabiliran discloses the multi-modality catheter set forth in claim 16. Tabiliran further discloses wherein the second treatment balloon is a drug-injectable balloon (drug forced out of micropores, para. [0130]).
Regarding claim 30, Tabiliran discloses (see abstract; paras. [0126]-[0138]; figs. 1-11) a method of treating a calcified lesion in a body lumen (abstract, paras. [0001] and [0130]) comprising:
inserting a multi-modality catheter (figs. 5a-b) into the body lumen have the calcified lesion (paras. [0072]-[0073]);
advancing the multi-modality catheter so that an intravascular lithotripsy balloon (second balloon 501, para. [0130]; fig. 5a) of the multi-modality catheter is received in the calcified lesion (received within vessel, para. [0072]) and at least a portion of a second treatment balloon (502) is disposed outside the calcified lesion (considered to include a portion disposed proximal or distal of lesion and therefore outside of lesion), wherein each of the intravascular lithotripsy balloon and the second treatment balloon is unexpanded (considered to be unexpanded during positioning, paras. [0072] and [0135]);
delivering fluid into the intravascular lithotripsy balloon to expand the intravascular lithotripsy balloon after said advancing the multi-modality catheter (initially filled, para. [0130]); and
generating a shock wave within the intravascular lithotripsy balloon (shockwaves propagated, para. [0126]) using a shock wave emitter (includes electrode pairs 104 and 105, para. [0126]) disposed within the intravascular lithotripsy balloon (figs. 1 and 5a) after said delivering fluid into the intravascular lithotripsy balloon to modify the calcified lesion (para. [0126]).
Regarding claim 31, Tabiliran discloses the method of treating the calcified lesion in the body lumen set forth in claim 30. Tabiliran further discloses wherein the second treatment balloon remains uninflated during said generating a shock wave within the intravascular lithotripsy balloon (balloon 501 initially inflated prior to balloon 502, and para. [0073] describes two-staged shockwave application in which an initial shockwave fracturing step occurs prior to the step of releasing the drug, such that balloon 502 is considered to be inflated during the drug releasing step, and therefore be inflated at least after one shockwave application, paras. [0073] and [0130]).
Regarding claim 32, Tabiliran discloses the method of treating the calcified lesion in the body lumen set forth in claim 30. Tabiliran discloses further comprising: further advancing, after said generating a shock wave, the multi-modality catheter so that the uninflated second treatment balloon of the multi-modality catheter is received in the lesion that needs treatment (considered to be further advanced after initial inflation of balloon 501 when balloon 502 is received in the lesion upon contact with the plaque, para. [0130]); and delivering fluid into the second treatment balloon to expand the second treatment balloon after said further advancing the multi-modality catheter (balloon 502 inflated after inflation of balloon 501).
Regarding claim 33, Tabiliran discloses the method of treating the calcified lesion in the body lumen set forth in claim 32. Tabiliran further discloses wherein said delivering fluid into the intravascular lithotripsy balloon comprises delivering fluid into a lithotripsy inflation lumen (lumen of 505, para. [0130]) defined by a catheter body of the multi-modality catheter (figs. 5a-b), the lithotripsy inflation lumen being in fluid communication with the intravascular lithotripsy balloon (fig. 5b), wherein said delivering fluid into the second treatment balloon comprises delivering fluid into a separate treatment inflation lumen (lumen of 504) defined by the catheter body of the multi-modality catheter (fig. 5b), the treatment inflation lumen being in fluid communication with the second treatment inflation balloon (fig. 5b).
Regarding claim 34, Tabiliran discloses the method of treating the calcified lesion in the body lumen set forth in claim 30. Tabiliran further discloses wherein a balloon body of the intravascular lithotripsy balloon has a maximum cross-sectional dimension that is less than a maximum cross-sectional dimension of a balloon body of the second treatment balloon (depicted in figs. 5a-b).
Regarding claim 35, Tabiliran discloses the method of treating the calcified lesion in the body lumen set forth in claim 34. Tabiliran further discloses wherein the balloon body of the intravascular lithotripsy balloon has a length that is less than a length of the balloon body of the second treatment balloon (depicted in figs. 5a-b).
Claim(s) 16, 22-24 and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (US 2012/0116289 A1).
Regarding claim 16, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7) a multi-modality catheter (fig. 3) for treating a lesion of a body lumen (abstract) comprising:
a catheter body (32, para. [0031]) configured to be received in the body lumen (figs. 1-3), the catheter body having opposite proximal and distal end portions and a longitudinal axis extending between the proximal and distal end portions (longitudinal axis of 32, fig. 3);
an intravascular lithotripsy balloon (26, para. [0030]) coupled to the distal end portion of the catheter body (fig. 3), wherein the intravascular lithotripsy balloon includes i) a balloon body (body of 26) configured to receive fluid to expand the balloon body (inflatable, para. [0030]), and ii) a shock wave emitter (includes electrode pair 36, para. [0031]) received in the balloon (fig. 3) and configured to produce a shock wave within the balloon (para. [0031]); and
a second treatment balloon (24) coupled to the distal end portion of the catheter body (fig. 3) and being spaced apart longitudinally from the intravascular lithotripsy balloon (para. [0030]; fig. 3), wherein the second treatment balloon includes a balloon body (body of 24) configured to receive fluid to expand the balloon body (para. [0030]),
wherein the intravascular lithotripsy balloon and the second treatment balloon are independently expandable (may not share same inflation fluid path, considered to be independently expandable via separate inflation fluid paths, para. [0030]).
Regarding claim 23, Hawkins discloses the multi-modality catheter set forth in claim 16. Hawkins further discloses wherein the shock wave emitter includes at least one electrode (includes 36) configured to produce an electrical arc when electrical energy is applied to the at least one electrode thereby creating a shock wave within the balloon (para. [0031]).
Regarding claim 24, Hawkins discloses the multi-modality catheter set forth in claim 23. Hawkins further discloses the catheter in combination with a source of electrical energy (30, para. [0031]) electrically coupled to the at least one electrode (para. [0031]).
Regarding claim 29, Hawkins discloses the multi-modality catheter set forth in claim 16. Hawkins further discloses wherein the intravascular lithotripsy balloon is distal of the second treatment balloon on the catheter body (depicted in fig. 3).
Regarding claim 16, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7), under an alternative interpretation with respect to the catheter, a multi-modality catheter (fig. 5) for treating a lesion of a body lumen (abstract) comprising:
a catheter body (53, para. [0033]) configured to be received in the body lumen (fig. 5), the catheter body having opposite proximal and distal end portions and a longitudinal axis extending between the proximal and distal end portions (longitudinal axis of 53, fig. 5);
an intravascular lithotripsy balloon (56, para. [0033]) coupled to the distal end portion of the catheter body (fig. 5), wherein the intravascular lithotripsy balloon includes i) a balloon body (body of 56) configured to receive fluid to expand the balloon body (inflatable, para. [0033]), and ii) a shock wave emitter (includes electrode pair 66, para. [0035]) received in the balloon (fig. 5) and configured to produce a shock wave within the balloon (paras. [0036]-[0037]); and
a second treatment balloon (54) coupled to the distal end portion of the catheter body (fig. 5) and being spaced apart longitudinally from the intravascular lithotripsy balloon (para. [0033]; fig. 5), wherein the second treatment balloon includes a balloon body (body of 54) configured to receive fluid to expand the balloon body (para. [0033]),
wherein the intravascular lithotripsy balloon and the second treatment balloon are independently expandable (may not share same inflation fluid path, considered to be independently expandable via separate inflation fluid paths, para. [0033]).
Regarding claim 22, Hawkins discloses the multi-modality catheter set forth in claim 16. Hawkins further discloses wherein the catheter body defines a guidewire lumen (70) extending along the longitudinal axis configured to receive a guidewire (72) therein (para. [0035]).
Regarding claim 30, Hawkins discloses (see abstract; paras. [0029]-[0044]; figs. 1-7) a method of treating a calcified lesion in a body lumen (abstract, paras. [0030]-[0031]) comprising:
inserting a multi-modality catheter (32, para. [0031]) into the body lumen have the calcified lesion (figs. 1-3);
advancing the multi-modality catheter so that an intravascular lithotripsy balloon (26, para. [0030]) of the multi-modality catheter is received in the calcified lesion (considered to be received within ventricle and on one side of valve leaflets, figs. 2-3) and at least a portion of a second treatment balloon (24) is disposed outside the calcified lesion (considered to be disposed outside at least a portion of valve leaflets 18 by being located within atrium, figs. 2-3), wherein each of the intravascular lithotripsy balloon and the second treatment balloon is unexpanded (considered to be unexpanded during positioning, para. [0030]);
delivering fluid into the intravascular lithotripsy balloon to expand the intravascular lithotripsy balloon after said advancing the multi-modality catheter (inflated, para. [0030]); and
generating a shock wave within the intravascular lithotripsy balloon (para. [0030]) using a shock wave emitter (includes electrode pair 36, para. [0031]) disposed within the intravascular lithotripsy balloon (fig. 3) after said delivering fluid into the intravascular lithotripsy balloon to modify the calcified lesion (para. [0030]).
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.
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.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Hawkins (US 2014/0163592 A1, hereinafter ‘Hawkins2’).
Regarding claim 19, Hawkins discloses the multi-modality catheter set forth in claim 16.
However, Hawkins fails to disclose wherein the catheter body includes a flexible joint coupling the second treatment balloon to the intravascular lithotripsy balloon.
Hawkins2 teaches (paras. [0028]-[0030]; figs. 1-2), in the same field of endeavor a multi-modality catheter comprising a catheter body (body of 22) including a flexible joint (bends 34 and 35) coupling chambers of a balloon (first and second chambers/lobes of balloon depicted in fig. 1), for the purpose of biasing the electrode pair towards the inner surface of the balloon (para. [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter body of Hawkins to include a flexible joint coupling chambers 24 and 26, in order to bias the electrode pairs of the catheter body towards the inner surface of the balloon, providing more localized application of energy, based on the teachings of Hawkins2 (para. [0028]).
Claim(s) 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Flores (US 2022/0183738 A1).
Regarding claim 25, Hawkins discloses the multi-modality catheter set forth in claim 16.
However, Hawkins fails to disclose wherein the second treatment balloon is a drug-coated balloon.
Flores teaches (para. [0056]; fig. 1), in the same field of endeavor, a multi-modality catheter (fig. 1) comprising a drug-coated balloon (104A including drug eluting coating), for the purpose of providing a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents (para. [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon chamber 24 of Hawkins with a drug coating, in order to provide a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents, based on the teachings of Flores (para. [0056]).
Regarding claim 26, Hawkins discloses the multi-modality catheter set forth in claim 16.
However, Hawkins fails to disclose wherein the second treatment balloon is a drug-eluting stent balloon.
Flores teaches (para. [0056]; fig. 1), in the same field of endeavor, a multi-modality catheter (fig. 1) comprising a drug-eluting stent balloon (104A includes drug eluting stent structure), for the purpose of providing a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents (para. [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon chamber 24 of Hawkins with a drug-eluting stent structure, in order to provide a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents, based on the teachings of Flores (para. [0056]).
Regarding claim 27, Hawkins discloses the multi-modality catheter set forth in claim 16.
However, Hawkins fails to disclose wherein the second treatment balloon is a caged balloon.
Flores teaches (para. [0056]; fig. 1), in the same field of endeavor, a multi-modality catheter (fig. 1) comprising a caged balloon (104A includes drug eluting stent structure, considered to cage the balloon such that balloon 104A is considered to be a caged balloon), for the purpose of providing a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents (para. [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon chamber 24 of Hawkins with a drug-eluting stent structure such that the balloon is caged, in order to provide a therapeutic agent for aiding the procedure, such as anti-inflammatory agents, anti-neoplastic agents, and anti-angiogenic agents, based on the teachings of Flores (para. [0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2022/0287731 A1 to Tan, disclosing a shockwave device.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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