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 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 1-12, 15, 16 and 19-25 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 1 recites the limitation “the ultrasonic transducer” in line 6. There is insufficient antecedent basis for this limitation in the claim. Additionally, claim is unclear if “the ultrasonic transducer” refers to “a transducer” recited in claim 1, line 5 or additional. For examination purposes, examiner construes “the ultrasonic transducer” being referring to “the transducer”.
Claims 2-12, 15, 16 and 19-25 being dependent on claim 1 are also rejected.
Regarding claim 2, the recitation “wherein the therapy is delivered to the target while the ultrasound waves are delivered to the target” renders the claim indefinite because the claim is unclear if the claim is positively reciting the action of delivering ultrasound to the target or is configured to deliver the ultrasound to the target. For examination purposes, examiner construes that the catheter is capable to deliver the ultrasound waves to the target when delivering the therapy to the target.
Regarding claim 15, the recitation “acoustic pressure (peak negative) applied to the target within a range of 5 MPa to greater than 50 MPa” renders the claim indefinite because the claim fails to set the upper limit thereby rendering the claim indefinite. Therefore, the claim fails to meet the metes and bounds of the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 5 and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2, 5 and 19-20 recite the limitations that fails to further limit the structural details of the claimed invention “a catheter”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baltes (US 2020/0061211 A1).
Regarding claim 1, Baltes teaches a catheter (paragraph 0098, “catheter assembly”, exemplary shown as element 15 in figure 18) comprising:
an elongated hollow tube (paragraph 0098, lines 13-14, “one or more channels” indicate presence of an elongated hollow tube);
a first lumen (paragraph 0098, lines 16-17, one of channels in “dual-channel”, triple channel or quadruple channel”) in the elongated hollow tube;
a second lumen (paragraph 0098, lines 16-17, second of channels in “dual-channel”, triple channel or quadruple channel”) in the elongated hollow tube;
a transducer 42 (figure 1, paragraph 0098, lines 1-4, “sonicator or electrode”) positioned within the elongated hollow tube and adjacent to the first lumen or the second lumen, the ultrasonic transducer (paragraphs 0097, 0098) configured to emit ultrasound waves through the lumen to a target; and
a needle (paragraph 0098, lines 19-23, “a needle”) positioned within the elongated hollow tube and configured to extend from the first lumen or the second lumen to enter the target to deliver a therapy to the target (paragraph 0087, lines 13-15).
Regarding claim 2, Baltes teaches wherein the therapy is delivered to the target while the ultrasound waves are delivered to the target (paragraphs 0097, 0098).
Regarding claim 3, Baltes teaches wherein the transducer is configured to deliver intracorporeal sonoporation to the target (paragraph 0097, lines 4-8).
Regarding claim 4, Baltes teaches wherein the intracorporeal sonoporation generates acoustic cavitation at the target to induce formation of pores in a cell membrane of the target to increase permeability of the target (paragraph 0097, lines 2-8).
Regarding claim 5, Baltes teaches wherein the target is malignant tissue, tumor tissue (paragraph 0114), peritumoral tissue, non-malignant tissue, hematologic cells, or immune cells.
Regarding claim 6, Baltes teaches wherein the needle is configured to deliver immunotherapy directly within the target (paragraph 0087, lines 13-15, needle is capable to perform the claimed function).
Regarding claim 7, Baltes teaches wherein the needle is configured to deliver gene therapy directly within the target (paragraph 0097, lines 13-15, needle is capable to perform the claimed function).
Regarding claim 8, Baltes teaches wherein the needle is configured to deliver one or more therapeutics directly within the target (paragraph 0087, lines 13-15, needle is capable to perform the claimed function).
Regarding claim 9, Baltes teaches wherein the transducer (paragraph 0097, lines 2-8) is configured to deliver high-pressure acoustic bursts of focused ultrasound waves toward the target to generate acoustic cavitation at the target.
Regarding claim 10, Baltes teaches wherein the acoustic cavitation (paragraph 0097, lines 2-8, fragmentation of the bubble will cause expansion and collapse of microbubble to induce poration) at the target provides expansion and collapse of microbubbles to release high-pressure cavitation energy to disrupt extra- cellular matrix of the target.
Regarding claim 11, Baltes teaches wherein the target is malignant tissue, tumor tissue (paragraph 0114), peritumoral tissue, non-malignant tissue, hematologic cells, or immune cells.
Regarding claim 12, Baltes teaches wherein the needle is configured (paragraph 0087, lines 13-15, needle is capable to perform the claimed function) to
deliver immunotherapy directly within the target, or
deliver gene therapy within the target, or
deliver one or more therapeutics directly within the target.
Regarding claims 19 and 20, Baltes teaches wherein the target is adjacent to or within a gas-filled anatomical organ wherein the gas-filled anatomical organ is a lung, a bowel, an airway or a bladder (Baltes device is capable to be used with the target that is adjacent to or within a gas-filled anatomical organ which can include any of the claimed organs).
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 16 are rejected under 35 U.S.C. 103 as being unpatentable over Baltes (US 2020/0061211 A1) in view of Greenleaf et al. (US 2003/0078227 A1).
Regarding claim 15, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes is silent regarding wherein the transducer is configured to deliver energy to the target that results in acoustic pressure (peak negative) applied to the target within a range of 5 MPa to greater than 50 MPa.
However, Greenleaf teaches a method for delivery of the substances to the cell wherein the transducer is configured to deliver energy to the target that results in acoustic pressure (peak negative) applied to the target within a range of 5 MPa to greater than 50 MPa (paragraph 0115, lines 14-17) for the purpose of performing sonoporation to enhance the delivery of the substance (paragraph 0145, lines 1-2).
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 transducer of Baltes to incorporate wherein the transducer is configured to deliver energy to the target that results in acoustic pressure (peak negative) applied to the target within a range of 5 MPa to greater than 50 MPa as taught by Greenleaf for the purpose of performing sonoporation to enhance the delivery of the substance (paragraph 0145, lines 1-2).
Regarding claim 16, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes is silent regarding wherein the acoustic pressure applied to the target is within a range of 15 MPa to 30 MPa or within a range of 20 MPa to 45 MPa.
However, Greenleaf teaches a method for delivery of the substances to the cell wherein the acoustic pressure applied to the target is within a range of 15 MPa to 30 MPa or within a range of 20 MPa to 45 MPa (paragraph 0115, lines 14-17) for the purpose of performing sonoporation to enhance the delivery of the substance (paragraph 0145, lines 1-2).
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 transducer of Baltes to incorporate wherein the acoustic pressure applied to the target is within a range of 15 MPa to 30 MPa or within a range of 20 MPa to 45 MPa as taught by Greenleaf for the purpose of performing sonoporation to enhance the delivery of the substance (paragraph 0145, lines 1-2).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Baltes (US 2020/0061211 A1) in view of Deem et al. (US 2007/0055181 A1).
Regarding claim 18, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes is silent regarding wherein the transducer is configured to ablate the target.
However, Deem teaches a design of an apparatus (figure 12) for treating subcutaneous tissue wherein the transducer 204 is configured to ablate the target (paragraph 0104, lines 1-12) for the purpose of treating the tissue as medically necessary and to deliver the fluids (paragraph 0104, lines 1-12, paragraph 0106, lines 9-17).
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 transducer of Baltes to incorporate wherein the transducer is configured to ablate the target as taught by Deem for the purpose of treating the tissue as medically necessary and to deliver the fluids (paragraph 0104, lines 1-12, paragraph 0106, lines 9-17).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Baltes (US 2020/0061211 A1) in view of Sverdlik et al. (US 2012/0095335 A1).
Regarding claim 21, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes is silent regarding wherein the transducer includes a plurality of electrodes positioned adjacent to one another in a non-linear orientation.
However, Sverdlik teaches a design of an ultrasound transducer (figure 8A0 includes a plurality of electrodes 170 positioned adjacent to one another in a non-linear orientation (figure 8A) for the purpose of designing the transducer that serves the purpose of performing the intended medical procedure (abstract).
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 transducer of Baltes to incorporate wherein the transducer includes a plurality of electrodes positioned adjacent to one another in a non-linear orientation as taught by Sverdlik for the purpose of designing the transducer that serves the purpose of performing the intended medical procedure (abstract).
Regarding claim 22, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes in view of Sverdlik discloses wherein the plurality of electrodes is positioned to form a radius of curvature but is silent regarding the specifics of a range of 5mm to 10mm.
There is no evidence of record that establishes that changing the radius of curvature would result in a difference in function of Baltes/Sverdlik device. Further, a person having ordinary skill in the art, being faced with modifying the radius of curvature would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed range. Lastly, applicant has not disclosed that the claimed range solves any stated problem. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of curvature of Baltes/Sverdlik to have the range of 5mm to 1mm as an obvious matter of design choice within the skill of the art.
Regarding claim 23, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes in view of Sverdlik is silent regarding the specifics of each of the plurality of electrodes having an aperture size of about 1.4mm x 1.8 mm.
There is no evidence of record that establishes that changing the aperture size would result in a difference in function of Baltes/Sverdlik device. Further, a person having ordinary skill in the art, being faced with modifying the aperture size would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed range. Lastly, applicant has not disclosed that the claimed range solves any stated problem. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the aperture size of Baltes/Sverdlik to have the aperture size of about 1.4mm x 1.8 mm as an obvious matter of design choice within the skill of the art.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Baltes (US 2020/0061211 A1) in view of Sverdlik et al. (US 2012/0095335 A1) and further in view of Hed (US 5,139,496).
Regarding claim 24, Baltes/Sverdlik (hereinafter referred as “modified Baltes”) discloses the claimed invention substantially as claimed, as set forth above in claim 21. Modified Baltes is silent regarding wherein at least one of the plurality of electrodes comprising a piezoelectric plate with a thickness of less than about 50 µm to about 500 µm.
However, Hed teaches ultrasonic freeze ablation catheter (figure 2A) wherein at least one of the plurality of electrodes 31 comprising a piezoelectric plate (column 7, lines 32-38) with a thickness of less than about 50 µm to about 500 µm for the purpose of setting desired center frequency of the ultrasound (column 7, lines 32-38).
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 size of a piezoelectric plate of modified Baltes to incorporate a thickness of less than about 50 µm to about 500 µm as taught by Hed for the purpose of setting desired center frequency of the ultrasound (column 7, lines 32-38).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Baltes (US 2020/0061211 A1) in view of Imran (US 5,342,295).
Regarding claim 25, Baltes discloses the claimed invention substantially as claimed, as set forth above in claim 1. Baltes is silent regarding wherein the catheter is a 6 - 7 Fr catheter or the catheter is an 8 - 10 Fr catheter.
However, Imran teaches a design of a catheter (figure 2) wherein the catheter is a 6 - 7 Fr catheter (column 5, lines 46-49) or the catheter is an 8 - 10 Fr catheter for the purpose of having a suitable size of the catheter to reach the desired target size (column 5, lines 35-49).
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 catheter size of Baltes to incorporate wherein the catheter is a 6 - 7 Fr catheter or the catheter is an 8 - 10 Fr catheter as taught by Imran for the purpose of having a suitable size of the catheter to reach the desired target size (column 5, lines 35-49).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tachibana (US 5,197,946) discloses a design of a catheter including ultrasound to inject the fluid into the injection site.
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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