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 .
Detailed Action
This is in response to the preliminary amendment filed 05/14/2025.
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.
Claim(s) 1, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.)
Regarding claims 1, 3 Schulthesis et al. discloses as shown in Figure 1, a catheter for intravascular lithotripsy procedures comprising: an elongated body (catheter shaft 110, see paragraph [0036]) sized to fit within a blood vessel, a guide wire lumen (guidewire lumen 118, see paragraph [0036]) extending through the catheter, a thin-walled balloon (balloon 104, see paragraph [0039]) located near a distal end of the elongated body with a distal and proximal end of the balloon being sealed to afford inflation and deflation thereof by a fluid; at least two electrode pairs (light guides 122a, each light guide including an electrode pair, see paragraph [0040]) within the balloon capable of receiving high voltage pulses and generating arcs within the fluid when the fluid inflates the thin-walled balloon, the catheter providing energy within the balloon that is sufficient to create a plasma arc within the fluid resulting in a shock wave within the balloon; see paragraph [0040].
Schulthesis fails to disclose wherein the balloon material is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon.
Mantell et al., from the same field of endevaor teaches a similar balloon as shown in Figure 2, used for the same purpose of encasing electrodes in liquid, wherein the balloon material (mylar) is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon, wherein the balloon material has a dielectric strength that is higher than nylon. See paragraph [0029].
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 disclosed by Schulthesis by substituting the material of the ballon disclosed by Schulthesis for the mylar taught by Mantell et al. because it would only require a simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Note, applicant discloses in paragraph [0054] of the specification that a balloon material that is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon is mylar.
Claim(s) 2, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2015/0039002 (Hawkins)
Regarding claims 2, 4 Schulthesis in view of Mantell et al. fail to disclose wherein the balloon material also has a dielectric constant that is lower than that of nylon, wherein the balloon material also has a loss factor that is lower than that of nylon.
Hawkins, from the same field of endeavor teaches a similar balloon as shown in Figure 2 where the balloon material (polyethylene) also has a dielectric constant that is lower than that of nylon, wherein the balloon material also has a loss factor that is lower than that of nylon. See paragraph [0037].
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 disclosed by Schulthesis by substituting some of the material of the ballon disclosed by Schulthesis for the polyethylene taught by Hawkins et al. because it would only require a simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Note, the applicant discloses in paragraph [0055] of their specification that Nylon’s dielectric constant is 2.4 and a loss factor of .0083. Polyethylene’s dielectric constant is known to be less than 2.4 and has a loss factor of .002. see paragraph [0020] of U.S. Patent Publication Number 2018/0337743 (Jou et al.) and U.S. Patent Number 2,339,958 (Sparks) page 3, lines 16-29.
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2014/0243845 (Aggerhholm et al.)
Regarding claims 5, 7 Schulthesis in view of Mantell et al. fail to disclose wherein the balloon material is 0.0009 inches in thickness or less, wherein the thin-walled balloon comprises material that is less than 0.0009 inches thick prior to inflation.
Aggerhholm et al., from the same field of endeavor teaches a similar balloon and shown in Figure 2, where the balloon material is 0.0009 inches in thickness or less, wherein the thin-walled balloon comprises material that is less than 0.0009 inches thick prior to inflation. See paragraph [0031].
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 disclosed by Schulthesis in view of Mantell et al. by substituting the thickness of the balloon disclosed by Schulthesis in view of Mantell et al. for the thickness of the balloon taught by Aggerhholm et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predicable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2008/0097301 (Alpini et al.)
Regarding claim 6, Schulthesis in view of Mantell et al. fail to disclose wherein the balloon material has a burst strength of between about 4 and 20 atmospheres.
Alpini et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, wherein the balloon material has a burst strength of between about 4 and 20 atmospheres. See paragraph [0061].
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 disclosed by Schulthesis in view of Mantell such that the balloon material has a burst strength of between about 4 and 20 atmospheres in order to configure the balloon to have a burst strength of between about 4 and 20 atmospheres, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2014/0243845 (Aggerhholm et al.)
Regarding claim 8, Schulthesis et al. discloses as shown in Figure 1, a catheter for intravascular lithotripsy procedures comprising: an elongated body (catheter shaft 110, see paragraph [0036]) sized to fit within a blood vessel, a guide wire lumen (guidewire lumen 118, see paragraph [0036]) extending through the catheter, a thin-walled balloon (balloon 104, see paragraph [0039]) located near a distal end of the elongated body with a distal and proximal end of the balloon being sealed to afford inflation and deflation thereof by a fluid; at least two electrode pairs (light guides 122a, each light guide including an electrode pair, see paragraph [0040]) within the balloon capable of receiving high voltage pulses and generating arcs within the fluid when the fluid inflates the thin-walled balloon, the catheter providing energy within the balloon that is sufficient to create a plasma arc within the fluid resulting in a shock wave within the balloon; see paragraph [0040].
Schulthesis fail to disclose wherein the balloon material is 0.0009 inches in thickness or less, wherein the thin-walled balloon comprises material that is less than 0.0009 inches thick prior to inflation.
Aggerhholm et al., from the same field of endeavor teaches a similar balloon and shown in Figure 2, where the balloon material is 0.0009 inches in thickness or less, wherein the thin-walled balloon comprises material that is less than 0.0009 inches thick prior to inflation. See paragraph [0031].
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 disclosed by Schulthesis in view of Mantell et al. by substituting the thickness of the balloon disclosed by Schulthesis in view of Mantell et al. for the thickness of the balloon taught by Aggerhholm et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predicable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claims 9-12, Schulthesis discloses wherein the thin-walled balloon has a relative permittivity that is at least the same as nylon of the Grilamid or Pebax families or less, wherein the thin-walled balloon has a dielectric constant that is the same or lower than nylon of the Grilamid or Pebax families, wherein the balloon material has a dielectric strength that is equal to or higher than nylon of the Grilamid or Pebax families, wherein the balloon material also has a loss factor that is equal to or lower than that of nylon. See paragraph [0041].
Claim(s) 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.), U.S. Patent Publication Number 2014/0243845 (Aggerhholm et al.)
Regarding claims 13, 15 Schulthesis et al. discloses as shown in Figure 1, a catheter for intravascular lithotripsy procedures comprising: an elongated body (catheter shaft 110, see paragraph [0036]) sized to fit within a blood vessel, a guide wire lumen (guidewire lumen 118, see paragraph [0036]) extending through the catheter, a thin-walled balloon (balloon 104, see paragraph [0039]) located near a distal end of the elongated body with a distal and proximal end of the balloon being sealed to afford inflation and deflation thereof by a fluid; at least two electrode pairs (light guides 122a, each light guide including an electrode pair, see paragraph [0040]) within the balloon capable of receiving high voltage pulses and generating arcs within the fluid when the fluid inflates the thin-walled balloon, the catheter providing energy within the balloon that is sufficient to create a plasma arc within the fluid resulting in a shock wave within the balloon; see paragraph [0040].
Schulthesis fails to disclose wherein the balloon material is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon.
Mantell et al., from the same field of endevaor teaches a similar balloon as shown in Figure 2, used for the same purpose of encasing electrodes in liquid, wherein the balloon material (mylar) is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon, wherein the balloon material has a dielectric strength that is higher than nylon. See paragraph [0029].
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 disclosed by Schulthesis by substituting the material of the ballon disclosed by Schulthesis for the mylar taught by Mantell et al. because it would only require a simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Note, applicant discloses in paragraph [0054] of the specification that a balloon material that is more dielectric than nylon based upon having a relative permittivity that is less than that for nylon is mylar.
Aggerhholm et al., from the same field of endeavor teaches a similar balloon and shown in Figure 2, where the balloon material is 0.0009 inches in thickness or less, wherein the thin-walled balloon comprises material that is less than 0.0009 inches thick prior to inflation. See paragraph [0031].
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 disclosed by Schulthesis in view of Mantell et al. by substituting the thickness of the balloon disclosed by Schulthesis in view of Mantell et al. for the thickness of the balloon taught by Aggerhholm et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predicable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.), U.S. Patent Publication Number 2014/0243845 (Aggerhholm et al.) as applied to claim 13 above, and further in view of U.S. Patent Publication Number 2015/0039002 (Hawkins)
Regarding claims 14, 16 Schulthesis in view of Mantell et al. fail to disclose wherein the balloon material also has a dielectric constant that is lower than that of nylon, wherein the balloon material also has a loss factor that is lower than that of nylon.
Hawkins, from the same field of endeavor teaches a similar balloon as shown in Figure 2 where the balloon material (polyethylene) also has a dielectric constant that is lower than that of nylon, wherein the balloon material also has a loss factor that is lower than that of nylon. See paragraph [0037].
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 disclosed by Schulthesis by substituting some of the material of the ballon disclosed by Schulthesis for the polyethylene taught by Hawkins et al. because it would only require a simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Note, the applicant discloses in paragraph [0055] of their specification that Nylon’s dielectric constant is 2.4 and a loss factor of .0083. Polyethylene’s dielectric constant is known to be less than 2.4 and has a loss factor of .002. see paragraph [0020] of U.S. Patent Publication
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267685 (Schulthesis et al.) in view of U.S. Patent Publication Number 2010/0036294 (Mantell et al.), U.S. Patent Publication Number 2014/0243845 (Aggerhholm et al.) as applied to claim 13 above, and further in view of U.S. Patent Publication Number 2008/0097301 (Alpini et al.)
Regarding claim 17, Schulthesis in view of Mantell et al. fail to disclose wherein the balloon material has a burst strength of between about 4 and 20 atmospheres.
Alpini et al., from the same field of endeavor teaches a similar catheter as shown in Figure 1, wherein the balloon material has a burst strength of between about 4 and 20 atmospheres. See paragraph [0061].
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 disclosed by Schulthesis in view of Mantell such that the balloon material has a burst strength of between about 4 and 20 atmospheres in order to configure the balloon to have a burst strength of between about 4 and 20 atmospheres, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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